Innovatix | Issue 2 | 2017
Two Minds Are Better Than One: The Benefits of Using an Advisor for Specialty Pharmacy Accreditation
PLUS
Pharmacists + Nurses: Earn CE credits by completing the program in this issue.
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Table of Contents Issue 2 | 2017
An Innovatix Publication Series
EDITORIAL STAFF EDITOR IN CHIEF
Gary Feit, MS Vice President, Corporate Communications
CLINICAL EDITOR
Sylvia Thomas, PharmD, MS, BCPS Vice President, Clinical Pharmacy Services
MANAGING EDITOR
Eric Rodriguez Director, Corporate Communications
DESIGNER
Jaclyn Alvarado Creative Director, J2 Design NYC, Inc.
DESIGN ASSISTANT Riki Mistry
COPY EDITOR Tina Harlan
LAYOUT EDITOR Laura F. Yandell
CONTRIBUTORS
1 2 5 7 11 13 16 19 26 29
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Welcome Letter Two Minds Are Better Than One: The Benefits of Using an Advisor for Speciality Pharmacy Accreditation The Innovatix Accreditation Advisory Services Program: Q&A with Cynthia Radford Building for Success: Trends in Non-Acute Healthcare Facility Design and Construction Payment Security for Healthcare Providers: Protecting Your Business and Your Patients Knowledge is Power: The Importance of Ongoing Pharmacy Education Congress Considers Policy Options to Lower Medication Costs Continuing Education: Update on Biosimilars— Current status in the United States Clinical Corner: Syndros™ Contract Updates
Insight
Ericka Ciancarelli Liya Davydov, PharmD, BCPS, BCGP Shawn Ecksel Gary Feit, MS Brad Kile, PhD Eric Rodriguez Shara Siegel, MS Sylvia Thomas, PharmD, MS, BCPS
555 West 57th St., 12th Floor New York, NY 10019 phone 888.258.3273 fax 646.638.2641 innovatix.com Insight magazine is published biannually by Innovatix and is complimentary for Innovatix members. For membership information, please call 888.258.3273. To submit ideas for editorial consideration, please contact Eric Rodriguez at 212.901.1242 or eric_rodriguez@innovatix.com. This publication is intended to provide general information on issues of interest to the members of Innovatix, LLC (“Innovatix”) and the general public. It does not constitute nor should it be used as a substitute for any business, legal, or regulatory advice. Innovatix hereby disclaims all warranties, express or implied, as to the accuracy of any of the information contained herein, whether such information is up-to-date, or its fitness for any particular use or purpose. Nothing contained in it is intended as a treatment recommendation for any particular patient or group of patients. Treating institutions and/ or physicians must make all clinical decisions regarding the use of pharmaceuticals and other products on a case-by-case basis. You should always refer to federal, state, and local laws, rules, and regulations governing the operation of your organization and should consult your own legal counsel. The opinions expressed by the authors of articles included in this issue do not necessarily reflect those of Innovatix, its affiliates, or its representatives. Furthermore, some of the content contained herein may have been originally prepared by or funded by organizations with financial interests in products or services related to the topics discussed in such article. While every effort was made to ensure the accuracy of information conveyed in this magazine, Innovatix, its affiliates, and its representatives do not accept responsibility and cannot be held liable for any errors that may exist within the publication. Innovatix is not responsible for the contents of any Web pages that are referenced by this communication. Links from this communication to other sites do not constitute an endorsement by Innovatix. These links are for convenience only. It is the responsibility of the user to evaluate the content and usefulness of information obtained from other sites. Innovatix has no control over and is not responsible for the information, practices, or content of these or any other sites. The contents of this publication are protected by copyright and are the property of Innovatix. They may not be reproduced or transmitted in any form without the express written permission of Innovatix.
Dear Valued Members, Since its inception, Innovatix has taken great pride in listening closely to our members’ needs, and finding or building practical solutions to make running your business more effective and efficient. True to our name, innovating and staying ahead of the curve is at the core of what we do. This issue of Insight highlights several emerging trends that are transforming the non-acute healthcare industry and explores successful strategies— including our own recently introduced or enhanced offerings—for navigating the current environment. Some of the most impactful trends for non-acute care providers involve facility planning, design, and construction. It’s critical that your facility serve as more than just a backdrop to the care you provide—it can, and should, be an integral part of that care. In addition to fostering an aesthetically pleasing environment that places patients and families at ease, facilities need to be sustainable, high-performing, and safe environments. To learn more about trends in non-acute healthcare facility design and construction and the ways in which we can help, turn to page 7. And if your facility is planning a construction or capital project, please contact us immediately for hands-on guidance to help you complete your project in the most cost-effective manner possible. As competition grows among specialty pharmacies, accreditation has moved from an option to an obligation. Pharmacies that do not pursue accreditation may not only lose out on a competitive edge, but also lose the ability to work with payers that now require accreditation as a term of doing business. With so much on the line, pharmacies are increasingly turning to accreditation advisors for help. If you’re contemplating using an accreditation advisor, but are unsure of the value they provide or how to proceed, please review this issue’s cover story for practical, easy-to-follow guidance on how to approach the process. This issue of Insight also features an in-depth Q&A with Cynthia Radford, senior vice president, Innovatix, regarding the Innovatix Accreditation Advisory Services program that launched last year. In the piece, Radford answers some of the more frequently asked questions about specialty pharmacy accreditation and her group’s specific services. As always, Insight offers complimentary continuing education. This issue’s CE provides an overview of specialty drugs, oral/parenteral oncology drugs, and biosimilars that are either in the late stages of development or have been submitted to the FDA for review. We have also included an article that discusses the importance of ongoing pharmacy education. On page 13 you can learn about how innovations in drug discovery, delivery, monitoring, and informatics have significantly increased the need for advanced pharmacy education and training. Finally, as patients absorb more out-of-pocket healthcare costs, they increasingly expect a secure and convenient way to pay for these services. Please see page 11 for an article that provides tips on payment security for healthcare providers. At the same time, numerous legislative efforts are taking place to try and lower the rising cost of medication. See page 16 for an overview of these proposals and how they may affect you and your patients. I hope this issue of Insight helps you and your business stay a step ahead of industry trends. Your success is our success, and we remain committed to working for you. Sincerely,
John P. Sganga Senior vice president, Alternate site programs Premier Innovatix | innovatix.com 1
Two Minds Are Better Than One: The Benefits of Using an Advisor for Specialty Pharmacy Accreditation Eric Rodriguez, director, corporate communications, Innovatix
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ocus on accreditation has become ubiquitous across the healthcare landscape. This is especially true in specialty pharmacy, where accreditation is now a minimum requirement for pharmacies wishing to participate in networks associated with managed care organizations, pharmacy benefit managers, and manufacturers. The accreditation process itself helps specialty pharmacies improve operations and meet the demands of today’s value-based reimbursement model. But accreditation is not an easy undertaking and is getting more difficult as competition grows and standards evolve. As a result, pharmacies are increasingly turning to accreditation advisors for help. 2 |
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The Accreditation Landscape According to this year’s Accreditation Commission for Healthcare (ACHC) data, more than 2,000 retail pharmacies within the supermarket chains Albertsons, Meijer, and Price Chopper have received specialty pharmacy accreditation.1 Excluding these supermarket locations, 499 unique facilities currently maintain active specialty pharmacy accreditation — a 32 percent increase since March 2016.2 With so many entities entering the market, payers are starting to require two accreditations to access their networks, thus making the accreditation process more daunting than it was just a year ago.
In addition to more competition, specialty pharmacies are also challenged to keep pace with evolving accreditation standards. URAC’s updated specialty pharmacy accreditation standards, released in 2015,3 incorporate multiple changes. This is particularly true in the patient management category, where standards were edited, added, and removed, in addition to undergoing name, number, and weighting changes. The ACHC updated its accreditation standards with new care plan enhancements and disease state-specific requirements.4 Staying aligned with accreditation standards has proved difficult for some, as URAC and the ACHC have experienced compliance issues for specialty pharmacies in such key areas as maintaining proper documentation.5 For URAC, requirements include coordination of care documentation, cold chain validation documentation, and patient management data (e.g., initial and follow-up assessments). The ACHC also reports a lack of documentation specific to training records, meeting minutes, and annual evaluations of the performance improvement program.
Benefits of Using an Accreditation Advisor Although URAC, the ACHC, and other specialty pharmacy accrediting bodies offer resources to prepare pharmacies for the process, the demand for advice from accreditation advisors is growing. Nevertheless, questions remain, including: • How and when to hire an accreditation advisor; and • Whether such advisors truly add value and ROI. Accreditation advisors can help on multiple levels. First, they often bring expertise to the project that internal pharmacy teams may lack. Accreditation advisors commonly come from specialized healthcare organizations that compete to hire talented individuals with training in the latest accreditation standards. These professional advisors can ensure that a pharmacy’s accreditation requirements are fully accounted for and that nothing has been omitted.
The advisors also know how to select an accrediting body that: • Is aligned with a pharmacy’s needs; • Will deliver the best return on financial investment; and • Is a good fit with existing contracts — a consideration that pharmacy decision makers may overlook in their haste to achieve accreditation. In addition, accreditation advisors have typically handled the process for pharmacies representing a variety of sizes and geographic locations, each with unique challenges and opportunities. The advisors understand pharmacy challenges as well as what meets standards and what falls short. This valuable insight can help pharmacies more accurately assess deficiencies so there are no surprises at review time. Accreditation is a serious undertaking with many moving parts. Accreditation advisors can take pressure off of internal staff by reviewing criteria, collecting documentation, and uploading data. The advisors can also save time when preparing for a review by finding quick, efficient solutions to problems that arise. Additionally, it can be cost effective to hire an accreditation advisor. The advisors know what it takes to achieve successful accreditation and will immediately lower a pharmacy’s chances of failing a review and forfeiting the fees already paid to the accrediting body. Further, many advisors create their own tools and templates, which enable pharmacies to streamline their accreditation efforts without the cost of creating materials from scratch. Lastly, an accreditation advisor can conduct a critically important mock review. Most pharmacies that don’t hire an advisor don’t invest sufficient time preparing for their scheduled interview. Practice does indeed make perfect, and accreditation reviews are no exception. From providing standard questions that reviewers ask to ensuring employees know what is expected of them during the interview, holding a mock review Innovatix | innovatix.com 3
Choosing the Right Advisor
Selecting the right specialty pharmacy accreditation advisor is an important decision. It can also be a frustrating experience for many pharmacy managers. These five questions can help you make a thoughtful and methodical decision.
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How well does the accreditation advisor understand your pharmacy’s challenges? The specialty marketplace is rapidly changing. Your pharmacy must keep pace if it is to succeed. Accreditation is one piece of the puzzle, but your advisor needs to understand how it fits with the big picture.
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Has the accreditation advisor been through the process before? With accreditation, first-hand experience is a good indicator of future success. The process is demanding, rigorous, and time-consuming. An advisor who has been through it can more fully understand the myriad challenges it entails.
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Does the advisor offer different levels of support to meet your pharmacy’s needs? One size does not fit all when it comes to accreditation. Pharmacies have differing support needs. Some have resources in place and only need an advisor to review standards and processes and polish the application. Other pharmacies need more hands-on help, up to and including a full-time advisor who can prepare the accreditation submission from start to finish.
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What is the fee structure? With changes to reimbursement, many pharmacies operate on very tight margins. Accreditation is an investment in the future of your business and requires a substantial commitment of resources. Your advisor should respect the financial impact of your decision and offer a fair fee structure that’s fully disclosed up front, with no hidden costs.
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Is the advisory service invested in your success? Your pharmacy’s success with an accreditation advisor largely depends on the relationship. Will you be just another client who gets a paint-by-numbers service and is then left to sink or swim? Or will there be hands-on support, customized service, and a long-term relationship that extends beyond the accreditation process?
is crucial for accreditation success. It can identify problems ahead of time and improve staff confidence during the onsite portion of the review.
Plan For the Future Accreditation advisors add expertise, quality, and value so that your pharmacy is more likely to realize success at the conclu-
sion of its accreditation review. However, it’s important to remember your pharmacy controls and owns its plans, processes, and outcomes. An effective accreditation plan should show clear evidence of employee involvement. Use the advice of an advisor, if you choose to hire one, but know that your pharmacy is ultimately responsible for its accreditation success.
Successful pharmacy accreditation represents more than a symbol of excellence and a commitment to patient safety. Accreditation is now essential to effectively serve specialty patients, participate in payer networks, and receive referrals in an era of accountable care. In this environment, a comprehensive and thorough accreditation plan is a must.
REFERENCES
1. “Exclusive Update: The State of Specialty Pharmacy Accreditation in 2017,” Drug Channels, April 13, 2017, http://www.drugchannels.net/2017/04/exclusiveupdate-state-of-specialty.html (accessed August 21). 2. Ibid. 3. “Standards & Measures at a Glance.” URAC, https://www.urac.org/resource-center/research-publications/standards-and-measures-at-a-glance/ (accessed August 21). 4. “Changes Coming in Specialty Pharmacy Accreditation,” Specialty Pharmacy Times, March 15, 2017, https://www.specialtypharmacytimes.com/publications/ specialty-pharmacy-times/2017/march-2017/changes-coming-in-specialty-pharmacy-accreditation/P-2 (accessed August 21). 5. Ibid.
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The Innovatix Accreditation Advisory Services Program: Q&A with Cynthia Radford
Cynthia Radford, senior vice president, Innovatix, has more than 21 years of experience in the specialty distribution and pharmaceutical industry. In her current role, Radford leads the Customer Care division and manages all specialty pharmacy- and oncology-focused initiatives. Radford was a member of the business development team at US Oncology, a physician management company, where she was responsible for engaging physicians and hospital outpatient centers in a joint effort to build free-standing cancer clinics. She also managed payer arrangements with each cancer center, as well as all practice management programs. In addition, Radford directed the launch of the first generic equivalent to Taxol for Ivax Pharmaceuticals, overseeing product marketing and forecasting for its release in Europe, South America, Canada, and the United States.
Radford answers some of the more frequently asked questions about accreditation and her group’s specific services.
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Innovatix has been the leading solution for supply chain optimization and strategic purchasing in the non-acute care marketplace for years. Why did you decide to launch pharmacy accreditation services?
For 25 years, we’ve provided pharmacies with strategic supply chain solutions that improve business operations. We have a longstanding commitment to helping pharmacies offer the best service at the lowest cost while maximizing reimbursements. Third-party accreditation has become increasingly important, particularly with respect to reimbursement rates. Pharmacy benefit managers (PBMs) and other payers rely on accrediting bodies to verify quality and patient safety. We decided to launch Innovatix Accreditation Advisory Services to support those pharmacies that want to achieve accreditation.
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What is accreditation?
Pharmacy accreditation is a process in which an impartial, third-party organization thoroughly reviews a pharmacy to certify that its operations are consistent with national standards, primarily with a focus on patient safety and continuous quality improvement. Accreditation can take many months, because it requires significant work to document policies and procedures in order to meet the standards.
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What are the benefits?
Accreditation is not only vital to the success of any healthcare organization, but in some cases, essential to licensure and compliance. Accreditation is a symbol of excellence and represents a commitment to quality and patient safety. Approval by an accrediting body demonstrates that a pharmacy has the staff, resources, and expertise that payers and manufacturers require for an expanded relationship.
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Why is accreditation important for pharmacies interested in entering the specialty market?
Most drug manufacturers limit the number of pharmacies authorized to dispense specialty products to ensure high-quality care and patient compliance. Manufacturer networks typically consist of between five and 20 specialty pharmacies, out of the hundreds that want to play in the specialty arena. On top of that, third-party payers may further restrict the number of specialty pharmacies authorized to serve their beneficiaries. One of the main criteria for being in the payer network is whether a pharmacy is accredited. With more pharmacies entering the specialty market, and manufacturers and payers limiting their networks, competition is increasing. The result will be compressed margins for undifferentiated pharmacies. Therefore, accreditation is more important than ever for pharmacies looking to compete.
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Which accreditation should I pursue?
There are many healthcare accrediting bodies. The decision to select one accreditation over another depends on your speciďŹ c Innovatix | innovatix.com 5
organizational needs, contracting requirements, budget, and other factors. The Innovatix Accreditation Advisory Services team can help guide you to the accreditation that best meets your needs from both a quality and cost perspective.
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Is Innovatix accredited? Yes, we’re a URAC-accredited pharmacy education and training organization.
How can Innovatix help pharmacies with accreditation? We offer pharmacies three levels of support to streamline initial accreditation submissions and renewals.
• In a L E VE L 1 engagement, Innovatix reviews your pharmacy’s standards and processes against accreditation measures. Then we help polish your application prior to submission to the accrediting body. • A LEVE L 2 engagement is more hands-on, with Innovatix experts helping your staff create the required standards and processes through a series of weekly calls and monthly on-site meetings. • LE VE L 3 offers the most comprehensive support through a full-time consultant who prepares your pharmacy’s accreditation submission from start to finish. While engagements vary, the accreditation process for an initial submission typically takes from six to nine months to complete. Our services are priced according to an hourly fee model, based on the level of support selected.
Meet the Team
Radford is joined by a strong team that includes April Mohr, operations trainer, and Jennifer Valentine, program specialist. Mohr provides direction to member pharmacies during critical transition phases, with guidance that includes specialty pharmacy operations training and education; process development and implementation; compliance monitoring; and client satisfaction. With more than 15 years of experience in the pharmacy industry (nine in oncology specialty services), Mohr has participated in the development, growth, and Joint Commission accreditation of one of the largest oncology pharmacies in the nation. She also led the successful URAC accreditation of the Innovatix pharmacy education programs. Mohr, who is nationally certified by the Pharmacy Technician Certification Board (PTCB), prefers a direct approach to training. “Initially I learn the intended goals and needs of the organization to determine what materials, skills, and knowledge are required to reach those goals,” she explains. “I then get to know the trainees to determine their experience and any additional education, training, or implementation required to achieve success. We develop a customized training plan, including manuals, materials, worksheets, assignments, and live training sessions conducted via webinars. Throughout the entire training process, I encourage questions and feedback to ensure program improvement and satisfaction.” Jennifer Valentine’s background encompasses specialty pharmacy, compounding, and dietetics. She has helped facilitate numerous healthcare projects, including the startup of two specialty pharmacies and the planning of a multi-specialty medical center and home health nursing agency. She also led her facility through the accreditation process, which gave her insights into the program requirements that promote optimal outcomes for those with chronic, complex conditions. Her focus includes specialty pharmacy management, compounding laboratory operations, quality assurance and improvement, regulatory compliance, and program development. Valentine is a nationally certified pharmaceutical technician with the PTCB and a certified professional compliance officer with the AAPC. Valentine believes specialty pharmacies have a unique role within what is sometimes a fragmented health system. “These facilities provide essential services like patient management, education, advocacy, and coordination of care,” she notes. “Expertise in specialty operations and services is so important, because it translates to improved patient outcomes. Accreditation reinforces the programs offered and demonstrates a commitment to quality care. Since each pharmacy is different, I like to take a collaborative approach to training, tailoring our process to the specific needs of an individual pharmacy while helping it provide quality services and achieve accreditation.”
TO LEARN MORE 6 |
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about what the Innovatix Accreditation Advisory Services program has to offer, call us at 888.258.3273 or visit www.innovatix.com/accreditation. Our team will be happy to provide more details about how we can help your pharmacy thrive.
Building for Success: Trends in Non-Acute Healthcare Facility Design and Construction Gary Feit, MS, vice president, corporate communications, Innovatix
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oday’s healthcare providers operate within the framework of an evolving medical system impacted by volatile external forces. Economic and regulatory factors continually influence changes in: • How, where, and from whom patients receive healthcare services; • Who pays for these services; and • The manner in which providers and payers evaluate service outcomes.
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Changes are particularly profound in non-acute healthcare settings, such as senior living facilities, pharmacies, and physician offices. Senior living providers are focusing on value-based care, which means only those that deliver the best patient outcomes will receive future health system referrals. Increased emphasis on hospital avoidance forces providers to offer additional health services on-site. Pharmacies that provide diagnosis and treatment are becoming commonplace. And physician practices, especially those associated with large oncology groups, may conduct in-house tests previously performed in a hospital setting. All of these changes have a less-apparent but no-less-important impact on healthcare delivery. They demand a new way of imagining, designing, and constructing a non-acute healthcare facility’s physical space. For example: • Senior living facilities require enhanced safety features, room for new diagnostic and rehabilitation equipment, and a home-like environment. • Pharmacies need new layouts that accommodate private examination areas. • All healthcare facilities must be in compliance with new processes for safe handling of hazardous substances.
In general, designs and layouts that worked in the past no longer satisfy the needs of today’s non-acute healthcare facilities. This reality is driving multiple trends in design and construction.
Senior Living: Designed for Better Outcomes Though seemingly counterintuitive, senior living facilities are incorporating construction and design elements that make them both more and less like hospitals. One noticeable trend is the incorporation of new safety features. According to Alex Fairley, director of facilities, construction, and environmental services at Premier, “Acoustics, fall avoidance measures, and better patient monitoring are all important aspects in maintaining wellness in the senior population. These design concepts from the acute care world are now an important part of the continuum of care.” Adding flooring and ceilings with better acoustics to senior living facilities is a design trend that creates a space more conducive to wellness. “A quiet environment is a healing environment,” explains Mark Huxta, director of healthcare sales at Ecore, a company that transforms reclaimed waste into unique surfacing.
“Floors that effectively reduce the noise generated within the space yet still meet the rigorous senior living facility demands represent value-based solutions.” Noise-reducing ceiling panels achieve a similar outcome. Anita Snader, environmental sustainability manager at Armstrong World Industries, a company that designs and manufactures innovative ceiling, wall, and suspension system solutions, says that “noise levels in patient rooms often exceed the World Health Organization guidelines of 35 decibels during the day and 30 decibels at night, creating more stressful environments for patients and disrupting sleep.” Ceiling systems with a combination of sound absorption and sound blocking help reduce this unwanted noise and create a more restful environment for residents. Senior living facilities are also using flooring that reduces the risk of falls, in yet another effort to improve patient safety and promote better outcomes. Injuries from falls can often lead to re-hospitalization, which has negative financial implications for providers in addition to the pain and suffering it causes patients. A flooring product made with materials that provide force reduction and cushioning “may
Considering a Construction Project? Don’t DIY - Talk to Us
If your facility is planning a construction project, don’t go it alone. Take advantage of the combined resources of Innovatix and Premier. These include supplier selection, contract bidding, and help with project management. The services — and their associated savings — are available at no cost to Innovatix members. To get started, register your construction project with us. You’ll fill out a form that provides some basic details about your project, including budget, anticipated start and completion dates, and the architect and general contractor you plan to use. Then Premier’s capital and construction services team will work with you throughout the project to ensure you unlock the full value of our expertise and supplier relationships. Don’t wait until your project is underway to start working with us. Contact your Innovatix representative and get your project registered today!
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reduce the risk of a serious injury from a fall,” says Ecore’s Huxta, while offering “tremendous financial value to providers and a quality of life enhancement to residents.” While ceilings and flooring that promote better outcomes are design trends that mirror acute care facilities, senior living providers are taking their
cues from the hospitality industry when it comes to other elements of design. The goal is to create a home-like environment that’s more comfortable for residents. “Designing spaces with warmer wood finishes delivers a more natural, residential feel versus a cold, sterile, clinical environment,” says Armstrong’s Snader. She notes that trends among senior living facilities include “adding warm colors, finishes, interesting textures, shapes, and fun designs.”
Pharmacy: Space for New Patient Services
Investing in Capital Equipment? Unlock the Power of MEMdata. Many healthcare construction projects are accompanied by an investment in capital equipment. Now Innovatix members have a new resource to help. Through its subsidiary, Capital and Construction Services powered by MEMdata, Premier offers equipment planning and procurement support for projects of any size. It also provides procurement support for routine capital expenses. To learn more, visit: www.memdata.com.
As senior living facilities redesign layouts to promote better outcomes, pharmacies are adapting to a different trend: offering patient services that go beyond filling prescriptions. “Both open-door and closed-door pharmacies are seeing a shift towards patient-centric services,” says Chris Jones, director of pharmacy automation and technology at Premier. “Pharmacists now serve as physician extenders in many states, offering disease management clinics, therapeutic drug monitoring, and other services historically provided in the physician office space.” A recent Accenture report projects a 47 percent rise in retail health clinics (primarily in pharmacies but also in other retail locations), increasing from 1,900 to more than 2,800 nationwide from 2014 to 2017.1 With pharmacies offering more primary healthcare services, Jones notes that “facilities will need to be renovated to allow for more non-dispensing, private areas for patient assessment and consultation.” As pharmacies build or renovate facilities to accommodate these services, a primary consideration is adhering to HIPAA requirements and ensuring patient privacy. As with senior facilities, noise-reducing building materials can help. Armstrong’s Snader explains that “the ceiling can reduce sound intrusion levels between patient spaces and create spaces with confidential speech privacy levels where medical information can be discussed.”
In addition to adding health clinics, pharmacies are increasingly adopting other roles as healthcare providers, including mixing, dispensing, and in some cases, delivering on-site, complex specialty and infusion drugs. As they offer more of these services, flexible and adaptable building designs are critically important. To facilitate space planning, many pharmacies are using building information modeling (BIM) and similar tools that integrate construction documents and provide a visual simulation of building design. These can help pharmacies and other providers identify opportunities to use pre-engineered solutions and systems (lighting, heating, cooling, air diffusers, and sprinklers) to create a flexible, cost-effective interior.
Safety First: USP<800> A final factor affecting non-acute facility design and construction is a focus on safely handling hazardous drugs. The United States Pharmacopeia (USP) published new guidelines, known as USP<800>, in February 2016, with an implementation date of July 1, 2018. They apply in any healthcare setting and to any individual handling hazardous drugs, including pharmacists, technicians, nurses, physicians, physician assistants, and home healthcare workers.2 USP<800> also requires external venting for all C-PECs (special drug compounding ventilated equipment) used in manipulation of sterile hazardous drugs. To comply with these policies and processes, facilities such as compounding pharmacies must add negative pressure airflow systems. Other USP<800> building changes could affect sink placement, designated spaces for spill kit storage, and the location where hazardous drug handling takes place. Safety concerns, shifting healthcare delivery roles, and an emphasis on outcomes are all primary factors influencing the design and construction of non-acute healthcare facilities today. Whether building from scratch or adapting an existing site, providers must be aware that their physical space is a vital component of the care they provide. Innovatix | innovatix.com 9
The Innovatix Construction Services Portfolio Construction and renovation are among the most complex and costly projects a facility undertakes. An enormous investment is required to plan the space, purchase the materials, and coordinate the work of architects and contractors. Innovatix has a full array of suppliers and contracts to help you complete your construction project in the most cost-effective manner possible. Our construction portfolio consists of more than 30 product and service categories representing over 115 nationally recognized manufacturers, distributors, and service providers. The contracts cover virtually every conceivable category, from mechanical, electrical, and plumbing to furniture and fixtures. Specific contract categories include:
Mechanical, Electrical, and Plumbing • HVAC equipment, controls, and service • Fire, security systems, and service • Total building control systems and services • Switchgear, panels, and electrical components • Lighting fixtures, lamps, and ballasts • Elevator and escalator equipment and service • Plumbing fixtures and supplies • Medical gas systems • Air filtration products • Roofing products, systems, and service • Water treatment products, systems, and service
Furniture, Fixtures, and Equipment • Carpet and resilient flooring • Paint and related sundries • Clinical casework
• Clinical headwalls • Carts (stainless steel, caster, IV Poles, etc.) • Television systems and service • Ice machines and dispensers • High-density mobile storage solutions • Kitchen equipment
Other Services • Facilities management assistance • Capital equipment procurement • Engineering, application and design assistance • Risk assessments and construction planning • Environmental monitoring, air quality • Capital asset inventories
Contact Speak with your Innovatix representative today for a full listing of construction suppliers and contracts.
• Furniture: Office, lobby, patient, exam, etc.
REFERENCES
1. Retail Health Clinics Expected to Surge by 2017, (Accenture, 2017), https://www.accenture.com/t20151218T022015__w__/us-en/_acnmedia/PDF-2/Accenture-Retail-Health-Clinics-POV.pdf. 2. USP Compounding Expert Committee, “FAQs: <800> Hazardous Drugs—Handling in Healthcare Settings,”
United States Pharmacopeia, 2017, http://www.usp.org/frequently-asked-questions/hazardous-drugs-handling-healthcare-settings.
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Payment Security for Healthcare Providers: Protecting Your Business and Your Patients Shawn Ecksel, vice president, sales & business development, USPAY
O
ver a five-month period in 2014, malware, installed on 7,500
cessors that offer security features not possible with magnetic
Home Depot cash registers, collected personal and finan-
stripes. When a cardholder uses EMV to pay at an EMV terminal,
cial data from nearly 56 million cardholders. The breach should
the card is identified as an authentic payment instrument. At
have sounded an alarm and prompted the credit card industry to
present, more than 80 countries support EMV payments. The
complete its transition to chip-enabled cards. Yet today, studies
United States is the last of the top 20 global economies to convert
show only 52 percent of merchants have the ability to accept
from magnetic stripe cards to EMV.
chip card payments, and only 63 percent of all cards have chip capability.
On October 1, 2015, fraud liability for credit card transactions
The New Global Standard
the card-issuing bank or the merchant). Before then, card
Europay, MasterCard, and Visa (EMV) is now the international standard for credit and debit card payments and the U.S. standard for in-person payments. EMV uses embedded microchips to
officially shifted to the party that does not support EMV (either issuers were responsible for fraud. The liability shift is not law, however, and there are no legal consequences for businesses (other than assuming unnecessary fraud liability).
authenticate card transactions. Its chip cards contain microproInnovatix | innovatix.com 11
Benefits of Accepting EMV Payments EMV technology secures payments, reduces the likelihood of stolen credit card data, and improves customer confidence. Consumers have begun to expect banks and merchants to offer EMV. They may perceive those that have yet to adopt its use as lagging behind the industry — and should be uncomfortable making purchases or payments using “less secure” technology.
Financial data security is critical for
industry. Healthcare providers can
everyone today, and this is especially
work with credit card processors
true in healthcare. Providers and facili-
to adopt appropriate strategies and
ties are desirable targets for criminals.
determine which types of payments to
Experts recommend that healthcare
accept (mobile, contactless, and online
organizations provide additional secu-
bill pay, for instance). While paying
rity for financial transactions beyond
with EMV requires changed behavior
that required by law. With the rapid
by the cardholder (dipping instead of
growth of consumer card payments,
swiping), consumers quickly adapt to
financial data security is a serious
new processes. Educating employees that
concern, as is the continuing protection
accept payments at each checkout point
of patient health information.
is another key component to a successful EMV strategy.
The switch from the magnetic stripe to EMV also adds another layer of protection against a specific form of “friendly fraud.” This occurs when a cardholder falsely claims not to have made a card purchase to avoid paying for it. The “I didn’t buy it” strategy now selectively targets merchants that have not upgraded to EMV. Those merchants often lose the dispute even when they have physical evidence of the cardholder’s purchase (signed receipt or photo/video). While friendly fraud is not a new practice, the recent shift in liability leaves non-EMV merchants at risk.
Did You Know? Innovatix offers credit card services from: American Express Paymentus SOLUPAY Sun Communications USPAY For more information, contact your Innovatix representative at 888.258.3273.
a dramatic increase in the number of patients paying with credit or debit cards and in the dollar amount of those transactions. A primary cause of these increases is the rise in high-deductible insurance plans, a trend that is expected to continue for the foreseeable future. As a result, providers are expanding their consumer focus; superior patient care now includes safe and convenient payment options and protection of patient financial data (in addition to medical information). Providers increasingly must be prepared to accept all forms of consumer payments, including EMV, mobile, online, and contactless (Apple Pay, Samsung Pay, Android Pay, and others). Given the speed at which issuing banks
cation and incorporation of best practices. One of the more important lessons is minimizing the number left behind, whether credit/debit cards without chip capability or merchants with outdated terminals that cannot accept the chip. EMV is here to stay. Card-issuing banks and merchants are migrating to EMV to enhance the security of
follow. Software updates will eventually
Ensuring Patient Payment Security Three components can help ensure card data security — EMV chip technology, encryption, and tokenization. Encryption protects cardholder data from the entry point to the payment processor and provides a shield against data-capturing malware. Tokenization replaces cardholder data with tokens, allowing healthcare providers to limit the storage of personal information. This technology helps mitigate the risk of financial data breaches and reduces compliance efforts required to meet the Payment Card Industry Data Security Standard (PCI DSS). A layered approach to security,
will expect to use this technology when
incorporating all three technologies,
paying for healthcare services.
has become common in the payments
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EMV technology in the U.S. is the identifi-
providers of all sizes are being urged to
are adding EMV to their cards, patients
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One benefit of the slow adoption of
payment information, and healthcare
EMV’s Impact on Healthcare Most healthcare providers have seen
Lessons Learned
be required for providers that have payments integrated with EMR/EHR or point-of-sale systems. Change has become the norm in the payments industry, as it has in healthcare. In addition to EMV, mobile payments made with watches, phones, and rings are becoming widespread. To ensure their payment technology doesn’t lag behind their medical care, healthcare providers should consult with card processors to adopt payment-acceptance methods that include EMV. USPAY is a leader in the electronic transaction processing industry, providing credit card processing services to merchants of all types and offering a wide array of the most advanced POS credit card terminals.
Knowledge Is Power: The Importance of Ongoing Pharmacy Education Ericka Ciancarelli, operations manager, Specialty Pharma Education Center (SPEC)
I
nnovations in drug discovery, delivery, monitoring, and informatics have significantly increased the need for advanced pharmacy education and training. Pharmacists are an integral part of the healthcare team charged with delivering high-quality, low-cost solutions that diagnose, treat, and manage medical conditions. These pharmacy professionals must be knowledgeable, informed, and equipped with the right tools if they are to apply evidenced-based strategies and therapies that address patient needs and improve outcomes.
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Pharmacy education can contribute to the healthcare industry as a whole by optimizing patient health and decreasing costs. According to Kevin Sneed, PharmD, senior associate vice president and dean of the University of South Florida College of Pharmacy, Tampa, FL: “The numerous health educational platforms must become transformational change agents in addition to the traditional knowledge transfer entities they have been for decades. With medical knowledge increasing exponentially, we must use education to teach future clinicians how to manage data, while assessing and implementing evidence-based approaches to healthcare. This must be accomplished while maintaining the interpersonal touch with the patient. Further, education must model the team-based care that will lead to optimized patient outcomes, which we expect to improve patient safety and reduce overall healthcare costs.” Dr. Sneed’s assertions are particularly true in specialty pharmacy.
Specialty Pharmacy Requires Special Knowledge Over the past decade, specialty pharmacy has been the fastest growing segment of the pharmaceutical industry and has dominated new drug development.1,2,3 Specialty drugs currently comprise approximately one-third of the pharmacy industry’s revenue, and that share is expected to rise as new treatment advances become available.1,4 Healthcare delivery methods are constantly evolving to keep up in this rapidly changing sector. When dealing with complex conditions, a coordinated care model is imperative. All members of the healthcare team must assume specific roles to ensure appropriate care. In recent years, the pharmacist’s focus has expanded, particularly with regard to specialty drugs. Once considered exclusively “medication experts,” pharmacists have evolved to meet the demands of modern healthcare systems. This new role involves participating in patient treatment as a caregiver, communicator, decision maker, teacher, life-long learner, 14 |
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leader, manager, and researcher. Today’s pharmacist is responsible for identifying, resolving, and preventing such medication-related problems as untreated indications, improper drug selection, inadequate or toxic dosing, adverse drug reactions and interactions, and medication use without indication. Pharmacists are accountable, influential, and indispensable team members especially those who dispense specialty drugs.
Educated Pharmacists Reduce Healthcare Costs Established, trusting patient-pharmacist relationships have tremendous potential to improve patient health and contribute to the overall quality and affordability of healthcare. Studies have shown that patients are more likely to adhere to medication regimens when they have a positive, communicative relationship with their pharmacists.5 In the U.S., annual healthcare costs resulting from medication nonadherence exceed $100 billion.6 Improving medication adherence is a vital component in reducing otherwise avoidable hospital admissions and readmissions, which account for much of that annual expense. As Michael Crocco, a pharmacy manager at Publix Pharmacy, Fort Myers, FL, and a Certified Specialty Pharmacist notes, “Improving patient adherence is a key focal point at Publix pharmacies. We currently have a program called ‘Time My Meds,’ which helps patients remember when to pick up their medications. The program also allows us to work with patients more closely to synchronize their medications, so they can pick them up on the same day. However, the system is only as good as the pharmacist and pharmacy team running it. It is imperative to continuously learn new ways to communicate and motivate patients to stay adherent to their medications.” At least one-third of all medication-related hospitalizations in the U.S. happen because of nonadherence.7 Continually educating pharmacists on the best methods of patient communication and monitoring has the potential to reduce
The Impact of Rapid Clinical Progress Several novel therapies that revolutionize the treatment of various disease states have emerged in recent years. The breakthroughs in treating Hepatitis C exemplify this trend. In the past, only two drugs were approved for treatment of the disease. Today, more than 10 different medications can be tailored to individual patients, based on specific genotypes and disease severity. These specialized treatment regimens allow for shorter duration, greater tolerability, and for some patients, a curative potential. Additionally, the U.S. Food and Drug Administration (FDA) has approved several drugs as the “first” to treat certain rare conditions with unmet medical needs, including Duchenne muscular dystrophy, tardive dyskinesia, and giant cell arteritis. Advances in precision medicine have resulted in new technologies and devices, as well as targeted therapies for patients with specific genetic mutations. This has been particularly beneficial in treating certain cancers. Pharmacists need ongoing education to keep pace with these changes if they are to provide the best possible care for their patients. these costs while improving patient longevity and quality of life. One of the most common barriers to medication adherence is lack of access, which generally refers to patients who are unable to afford their medication. Patients are often unaware of the various
Meeting Geriatric Patient Needs Pharmacists who continually educate themselves regarding advances in drug and disease management will be better able to advise patients about new drugs, potential adverse events, and the importance of adherence. Staying up-to-date professionally is particularly important with the elderly. Patients are living longer as more drugs are developed to combat previously fatal conditions. The pharmacist plays an essential role with geriatric patients, because they often experience drug-related problems that require discussion and possible intervention. Education that enhances pharmacists’ knowledge and skills will optimize patient outcomes. assistance programs and financial aid opportunities available, and a well-educated, proactive pharmacist can serve as a lifeline in these situations. By staying up-to-date about available assistance programs, pharmacists can lessen the financial burden of health complications.
Putting Patient Safety First It is vitally important for pharmacists to be informed about drug interactions and potential drug-related adverse events. Estimates show that more than 40 percent of individuals 65 or older use five or more medications, and 12 percent use 10 or more.8 Studies have also found that nonadherence rates with prescribed therapies range from 20 to 80 percent.6,9,10 Due to potential complications, patients must be educated about drug interactions, drug-related adverse events, and the importance of medication adherence. Communicating this information to patients may reduce the risk of unnecessary hospital and emergency room admissions. Proper medication handling is another important component of pharmacy education, especially for specialty pharmaceuticals. Due to the high cost and precise handling requirements of these drugs, pharmacists should be fully equipped and educated regarding correct storage methods. If the drugs are mishandled or stored improperly, the error could cost the pharmacy thousands of dollars. Education is critical for pharmacists who want to stay abreast of the rapid and constant evolution in healthcare. By continually educating themselves about emerging trends and best practices for treating complex conditions, pharmacists can make a major contribution toward improving the health of our communities.
The mission of the Specialty Pharma Education Center (SPEC) is to provide continuing education/continuing medical education (CE/CME) programs, patient education, certification curriculum, and educational forums designed to address the needs of patients requiring specialty pharmaceuticals and emerging novel therapies requiring additional skillsets, including use of healthcare informatics, registries, and clinical markers to improve patient care. Learn more at www.specialtycme.org.
Did You Know? Innovatix members receive discounted rates and complimentary access to all of SPEC’s continuing education courses. To take advantage of this offer: 1. Sign in to your SPEC account or sign up at www.spec.learnercommunity.com/account/login/secure. 2. Once you are logged in, visit www.spec.learnercommunity.com. 3. Enter enrollment code SPECINVX. 4. Click redeem. For more information, please contact April Mohr, operations trainer, Innovatix Specialty Pharmacy Management, at AMohr@innovatix.com or at 212.901.1318.
REFERENCES
1. sPCMA, The Management of Specialty Drugs, (Washington, DC: Pharmaceutical Care Management Association, 2016), https://www.spcma.org/wp-content/ uploads/2016/06/sPCMA_The_Management_of_Specialty_Drugs.pdf. 2. Independent Health, Specialty Pharmaceuticals: Ensuring Access And Affordability Through Coordinated Approaches, (Independent Health Association, Inc., 2016), https://www.independenthealth.com/Portals/0/PDFs/Employer/IHSpecialtyRxReport.pdf. 3. Dan Steiber and Dean Erhardt, Specialty Pharmacy in Community Pharmacy: The Time Is Now-And How! (Alexandria, VA: National Association of Chain Drug Stores, 2006), http://www.nacds.org/pdfs/membership/white_paper_speciality_pharmacy.pdf. 4. Express Scripts, Express Scripts 2016 Drug Trend Report, (Express Scripts Holding Company, 2017), http://lab.express-scripts.com/lab/drug-trend-report. 5. National Community Pharmacists Association, Medication Adherence in America: A National Report Card, (Langer Research Associates, 2013), http://www. ncpa.co/adherence/AdherenceReportCard_Full.pdf. 6. PhRMA, Improving Prescription Medicine Adherence Is Key To Better Health Care, (Washington, DC, 2011), http://phrma-docs.phrma.org/sites/default/files/ pdf/PhRMA_Improving%20Medication%20Adherence_Issue%20Brief.pdf. 7. Hayden B. Bosworth, Bradi B. Granger, Phil Mendys, Ralph Brindis, Rebecca Burkholder, Susan M. Czajkowski, and Jodi G. Daniel et al., “Medication Adherence: A Call for Action.” American Heart Journal 162 (3): 412-424, 2011, doi:10.1016/j.ahj.2011.06.007. 8. Maria Cristina Soares Rodrigues and Cesar de Oliveira, “Drug-Drug Interactions and Adverse Drug Reactions In Polypharmacy Among Older Adults: An Integrative Review,” Revista Latino-Americana De Enfermagem 24 (0), 2016, doi:10.1590/1518-8345.1316.2800. 9. Jimmy, Bena, and Jimmy Jose, “Patient Medication Adherence: Measures In Daily Practice,” Oman Medical Journal 26 (3): 155-159, 2011, doi:10.5001/ omg.2011.38. 10. Zohra Zaidi, “Importance of Adherence to Medical Treatment,” Journal of Pakistan Medical Association 60 (5), 2010.
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Congress Considers Policy Options to Lower Medication Costs Brad Kile, PhD, president, Dumbarton Group & Associates Shara Siegel, MS, director, government affairs, Innovatix
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he egregious behavior of certain drug manufacturers and the burgeoning price spikes for older generic drugs have prompted Washington lawmakers to place lowering the cost of medications at the top of their policy agendas. In recent years, drug pricing increases have risen sharply and are a key driver in U.S. healthcare spending growth, outpacing other healthcare sectors.1 Steep price increases have caused problems for healthcare providers that operate on set Medicare reimbursements. They have also placed significant burdens on patients, who often are left to pay for the high costs of drugs in the retail marketplace because lesscostly alternatives do not exist.
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Research has repeatedly shown that pharmaceutical competition brings down prices — the market forces work best when multiple manufacturers compete for business. Based on this proven economic theory, Congress has introduced several pieces of legislation designed to increase competition in the pharmaceutical market and lower the costs of medications. Competition from generic drugs has saved the U.S. healthcare system $1.46 trillion from 2005 to 2015.2 According to the U.S. Food and Drug Administration (FDA), drug prices drop to roughly 52 percent of a brand-name drug with two manufacturers producing a generic product, 44 percent with three manufacturers, and 13 percent with 15 manufacturers.3 Congress is also focused on the need for greater pricing transparency across the supply chain. Toward that end, several bills have been introduced that would require the disclosure of any financial arrangements among prescription benefit managers (PBMs), health plans, and other relevant parties. Consumer groups believe uncovering the financial relationships of PBMs is a necessary step in lowering drug prices. Such action would separate a manufacturer’s cost for a medication from any PBM administrative fees.
Legislation Addressing Competition Several legislative initiatives have focused on increasing competition by reducing the FDA’s large backlog of generic drug approvals. These would expand the agency’s authority to expedite review and approval for new generic options. The FDA continues to face a significant backlog in this area, with more than 4,000 applications pending and average approval times of three or more years.4 This long waiting period stifles manufacturers’ ability to bring drugs to market and improve generic competition. Lack of competition also arises from current policies that allow some pharmaceutical manufacturers to prevent or slow the introduction of more affordable alternatives or to boost prices for drugs that have been in the market for decades.
On August 18, President Trump signed the FDA Reauthorization Act (PL 115-52) into law. The legislation reauthorizes the FDA’s user fee programs, which would have expired on September 30, for five additional years, allowing the agency to continue collecting fees from the industry that comprise roughly half of its yearly budget. The fees will generate billions of dollars over the next five years to support regulatory oversight of prescription drugs and biologics, generic drugs, medical devices, and biosimilars. Importantly, the bill includes a provision that requires that the FDA give priority review of generic drug applications when three or fewer manufacturers of a particular drug exist. With competitor drugs being approved more quickly by the FDA, downward pressure is exerted on drug prices through enhanced competition in the market. The Enacting the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act (H.R. 2212/S .974) and the Fair Access for Safe and Timely (FAST) Generics Act (H.R. 2051), would prevent drug companies from restricting generic manufacturers’ access to product samples used for the bioequivalence testing required for FDA generic drug approval. The Preserve Access to Affordable Generics Act (S. 124) was introduced to end pay-for-delay deals that extend brand-name drugs marketing exclusivity. In these instances, brandname drug manufacturers offer payments to generic companies, so they do not bring lower-cost alternatives to market, effectively sidestepping competition.
Pending Legislation Addressing Transparency Congress has also introduced legislation to improve pricing transparency. The Prescription Drug Price Transparency Act (H.R. 1316) would require PBMs to: • Update their maximum allowable cost (MAC) standard at least once every seven days to accurately reflect the market price of a drug; • Disclose to pharmacies the sources used for making any updates;
• Make advance disclosures to pharmacies regarding all individual drug prices to be updated, if the source is not publicly available; and • Establish a process to appeal, investigate, and resolve disputes regarding individual drug prices that are lower than the pharmacy acquisition price. The legislation also includes provisions that prohibit PBMs from: • Transmitting personally identifiable utilization or claims data to a PBM-owned pharmacy, unless the patient voluntarily elects to fill the prescription at such pharmacy; and • Requiring any enrolled individual to use a retail, mail order, specialty, or other pharmacy entity in which the PBM has an ownership interest. The Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act (S.637) would require PBMs to publicly disclose data regarding rebates, discounts, and other accrued payments, as well as their impact on Medicare Part D beneficiaries and the Part D program overall. The bill would bring greater transparency to rebates and discounts negotiated by PBMs and their impact on health plans — in effect, establishing a minimum percentage of rebates and discounts that must be passed on from a PBM to a health plan. Additionally, the legislation would provide for public disclosure of PBM-aggregated pricing information via the Centers for Medicare & Medicaid Services (CMS) public website. Finally, the Improving Transparency and Accuracy in Medicare Part D Spending Act (H.R. 1038/S. 413) would provide greater transparency by addressing the enormous growth of direct and indirect remuneration (DIR) fees. DIR fees often reflect rebates and concessions among pharmaceutical manufacturers, prescription drug plan (PDP) sponsors, PBMs, and pharmacies. A January 2017 CMS analysis5 found significant growth in DIR fees collected and reported by Part D sponsors, noting DIR could have serious financial implications for beneficiaries, the government, Innovatix | innovatix.com 17
Legislation Aimed at Lowering Prescription Drug Costs The FDA Reauthorization Act (PL 115-52) • President Trump signed the bill into law after it passed the Senate on August 3 and the House on July 12. • Amends the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs and biosimilar biological products, and for other purposes. • Also requires that the FDA give priority review, within eight months of submission, to abbreviated new drug applications for drugs with three or fewer approved alternatives, which will help streamline the process for additional manufacturers to enter the generic drug market. This competitive pressure will aid in lowering drug prices. The Enacting the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act (H.R. 2212/S .974): • Was introduced in the House by Representatives Tom Marino (R-PA-10) and David Cicilline (D-RI-1) and in the Senate by Senators Patrick Leahy (D-VT), Chuck Grassley (R-IA), and 10 other cosponsors. • Promotes competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products. The Fair Access for Safe and Timely (FAST) Generics Act (H.R. 2051): • Was introduced by Representatives David McKinley (R-WV-1) and Peter Welch (D-VT-At Large). • Amends the Federal Food, Drug, and Cosmetic Act to ensure that eligible product developers have competitive access to approved drugs and licensed biological products, thus enabling the development and testing of new products. 18 |
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The Preserve Access to Affordable Generics Act (S. 124): • Was introduced by Senators Amy Klobuchar (D-MN) and Chuck Grassley (R-IA). • Prohibits brand-name drug companies from compensating generic drug companies for delaying the entry of a generic drug into the market. The Prescription Drug Price Transparency Act (H.R. 1316): • Was introduced by Representatives Doug Collins (R-GA-9) and David Loebsack (D-IA-2). • Provides for pharmacy benefit manager standards under the Medicare prescription drug program and Medicare Advantage program, thus improving transparency of payment methodologies to pharmacies. The Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act (S.637): • Was introduced by Senator Ron Wyden (D-OR). • Requires pharmacy benefit managers in Medicare to disclose the aggregate rebates provided by drug manufacturers as well as the amount of those rebates that are passed on to health plans, thus lowering prices for people who need prescription drugs. The Improving Transparency and Accuracy in Medicare Part D Spending Act (H.R. 1038/S. 413): • Was introduced in the House by Representatives Morgan Griffith (R-VA-9) and Peter Welch (D-VT-At Large) and in the Senate by Senators Shelley Moore Capito (R-WV) and Jon Tester (D-MT). • Prohibits prescription drug plan sponsors and Medicare Advantage Prescription Drug Plan organizations under the Medicare program from retroactively reducing payment on clean claims submitted by pharmacies.
and pharmacies. In recent years, the analysis showed DIR fees growing at a blistering pace, averaging 22 percent per year, compared to an average increase in drug costs of 12 percent per year during the same period. The analysis attributed the rise in DIR fees to network participation, payment rate reconciliation, and performance on quality measures. H.R.1038/S.413 would prohibit Medicare PDP sponsors and Medicare Advantage Plans (MA-PD) from retroactively reducing payment on clean claims submitted by pharmacies. The sharp increase in prices has limited the drug availability for many individuals who require specific medications. Skyrocketing prices create negative consequences for many in the healthcare system, including, patients, payers, providers, hospitals, and the government. While attempts to “repeal and replace” the Affordable Care Act have dominated the 2017 health policy agenda, addressing the cost of drugs is also a priority for members of Congress on both sides of the aisle, as well as the Trump administration. Expect to see action in the coming months. REFERENCES
1. Sean P. Keehan, Devin A. Stone, John A. Poisal, Gigi A. Cuckler, Andrea M. Sisko, Sheila D. Smith, Andrew J. Madison, Christian J. Wolfe and Joseph M. Lizonitz, “National Health Expenditure Projections, 2016–25: Price Increases, Aging Push Sector To 20 Percent Of Economy,” Health Affairs (February 15, 2017), doi: 10.1377/hlthaff.2016.1627, http://content. healthaffairs.org/content/early/2017/02/14/ hlthaff.2016.1627. 2. Janet Woodcock, M.D., testifying as Director, Center for Drug Evaluation and Research, to the Committee on Energy and Commerce Subcommittee, United States House of Representatives, HealthQuintilesIMS Institute. 3. Center for Drug Evaluation and Research, “Generic Competition and Drug Prices,” U.S. Food and Drug Administration, Office of Medical Products and Tobacco, https:// www.fda.gov/aboutfda/centersoffices/ officeofmedicalproductsandtobacco/cder/ ucm129385.html. 4. Office of Generic Drugs, The Generic Drug Review Dashboard, U.S. Food and Drug Administration, https://www.fda.gov/drugs/ developmentapprovalprocess. 5. Centers for Medicare and Medicaid Services, “Medicare Part D – Direct and Indirect Remuneration (DIR),” news release fact sheet, January 19, 2017, https://www.cms.gov/ Newsroom/MediaReleaseDatabase/Factsheets/2017-Fact-Sheet-items/2017-01-19-2.html.
Continuing Education
Update on Biosimilars — Current Status in the United States Liya Davydov, PharmD, BCPS, BCGP, senior director, clinical pharmacy services, Innovatix
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CONTINUING EDUCATION
Update on Biosimilars – Current status in the U.S. This CE activity has been produced by Innovatix Institute, an educational program offered by Innovatix, LLC (“Innovatix”). This activity is accredited for pharmacists, pharmacy technicians, and nurses.
Goal Statement
The purpose of this activity is to provide the participant with the knowledge needed to understand the place in therapy for biosimilars, and to be able to select and dispense the best agent for a particular patient.
Learning Objectives – Pharmacists and Nurses
At the completion of this activity, the participant will be able to: 1. Differentiate between concepts of Biosimilarity and Interchangeability with respect to the biosimilars. 2. Summarize the guidance documents released by the FDA in 2016 and 2017 with respect to the biosimilars. 3. List the biosimilars that have been approved and rejected by the FDA through June 2017. 4. List the biosimilars currently under review by the FDA with decisions pending. 5. Identify barriers to widespread use of biosimilars in the USA.
Type of activity Knowledge-based
Cost Free
Disclosures
This continuing education activity is managed and accredited by Innovatix in cooperation with Professional Education Services Group (PESG). Dr. Davydov, Innovatix and PESG have no relevant or apparent financial interests or relationships to disclose. The material presented for this article has been reviewed by the Innovatix Institute CE Committee and PESG, and has been found to be free of any content influenced or supported by industry. Commercial support was not received for this activity.
Pharmacy Accreditation
Learning Objectives – Pharmacy technicians
At the completion of this activity, the participant will be able to: 1. Identify 2 biosimilars currently on the market, and their brand equivalents. 2. Describe the reimbursement challenges when patients are prescribed a biosimilar agent. 3. Identify barriers to widespread use of biosimilars in the USA.
Target Audience
Innovatix, LLC is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This activity has been approved for 1 contact hour for pharmacists and pharmacy technicians. Universal Activity Number: 0409-0000-17-010-H04-P (Pharmacists) and 0409-0000-17-010-H04-T (Technicians).
Nursing Accreditation
Pharmacy staff and nursing staff involved in the formulary management, dispensing, administration or medical management of patients treated with biosimilar agents.
This activity for 1 contact hour is co-provided by Innovatix and the Professional Educational Services Group, which is accredited as a provider of continuing education in nursing by the American Nurses Credentialing Center’s Commission on Accreditation (ANCC-COA).
To receive CE credit, Pharmacists and Technicians must go to www.innovatix.com/evaluations.
To receive CE credit, Nurses must go to www.innovatix.cds.pesgce.com.
Click on Insight Magazine and scroll to find the title of this CE article. Complete the evaluation form.
Scroll to find the title of this CE article and click "Take Exam."
A score of 70% or higher is required to receive credit. Statements of Credit will be available from CPE Monitor within eight weeks, upon successful completion and submission of the verification of Continuing Education and Program Evaluation online forms and obtaining a passing score on the test. This lesson will not be valid for CE credit after 10/1/2018.
A score of 70% or higher is required to receive credit. Statements of Credit will be available from PESG upon successful completion and submission of the verification of Continuing Education and Program Evaluation online forms and obtaining a passing score on the test. This lesson will not be valid for CE credit after 10/1/2018.
Legal Disclaimer The materials in this CE activity do not necessarily reflect the views of Innovatix or its affiliates. A qualified healthcare professional should be consulted before using any therapeutic product referenced as part of the program. Readers should verify all information and data before treating patients or employing any therapies described in the activity materials. As a condition to participating in this program, you acknowledge and agree that Innovatix is not providing any medical conclusions or advice, but is rather summarizing publicly available clinical information. The activity and corresponding materials may contain statements that may appear to be recommendations or advisory in nature, however, such statements are merely being recounted by Innovatix from the literature cited and do not constitute the recommendations or advice of Innovatix. Accordingly, Innovatix hereby disclaims all warranties, express or implied, as to the accuracy of any of the materials or information contained in the activity, or their fitness for any particular use or purpose. Clinical information and comments contained in the activity are for general guidance only. Mention of specific products in the activity or corresponding materials do not constitute an endorsement or advertisement. The activity provided is intended to provide you with information and is not intended to be used as a substitute for clinical or medical judgment. You agree that Innovatix shall not be responsible to you or any other third party for any clinical advice rendered by you, including advice related in any way to the activity. You agree to indemnify, defend, and hold Innovatix and its officers, directors, affiliates, employees, and agents (the “Innovatix Indemnitees”), harmless from and against any liability, costs, expenses, or damages, including attorneys’ fees and other costs of defense, incurred by any Innovatix Indemnitee in any action, proceeding, claim, or demand that is caused by, relates to, or arises out of your acts or omissions, or that in any way relate to your use of the information contained in the program or program materials. You agree that the activity and corresponding materials will be used for educational purposes only, and will not otherwise be copied or distributed without the prior written consent of Innovatix.
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CONTINUING EDUCATION
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o date, the U.S. Food and Drug Administration (FDA) has approved five biosimilars, with two of them yet to enter the market due to different barriers.1-6 While three biosimilar drugs have been introduced in the U.S., and their biosimilarity established, many unanswered questions remain. This article describes: • Differences between biosimilarity and interchangeability; • Recent FDA guidance regulating the biosimilar industry; • Which biosimilars have been approved or rejected to date; • The biosimilar applications that are waiting for an FDA decision and the estimated target dates for those decisions; and
the reference product without the intervention of the prescribing health care provider.”7-9 This means the biosimilar agent must obtain the interchangeability designation for state-governed mandatory generic substitution laws to apply to a particular biosimilar.7-10 It is important to understand the difference between these two concepts. Determining if a biosimilar agent can be substituted at the pharmacy level for the original brand biologic — as part of individual state-governed generic substitution laws — depends on whether the agent was approved only as a biosimilar, or both as a biosimilar and an interchangeable agent.
• Barriers that may hinder widespread use of biosimilars in the United States.
T E S T YO U R K N O W L E D G E Q U E ST I O N # 1:
Differences between Biosimilarity and Interchangeability
When would a biosimilar agent be considered an interchangeable?
DEFINITION OF BIOSIMILARITY According to the Public Health Service Act (PHS Act), section 351(i), in order for a drug to be considered a biosimilar, two criteria must be met:7-9 • “That the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components.”7-9 • “There are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.”7-9
DEFINITION OF INTERCHANGEABILITY Section 351(k)(4) of the PHS Act says that to receive the interchangeability designation, the manufacturer of the biosimilar agent “must provide sufficient information to demonstrate biosimilarity and also to demonstrate that the biological product can be expected to produce the same clinical result as the reference product in any given patient, and if the biological product is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between the use of the biological product and the reference product is not greater than the risk of using the reference product without such alternation or switch.”7-9 Section 351(i)(3) of the PHS Act further stipulates that “interchangeable products may be substituted for
Biosimilar Agents Currently on the Market or Awaiting Launch after FDA Approval September 3, 2015 marked the first time a biosimilar drug was introduced in the U.S.1 Filgrastim-sndz (Zarxio™, manufactured by Sandoz)1 was approved by the FDA on March 6, 2015, for all five indications that its reference branded biologic (Neupogen® [filgrastim, manufactured by Amgen]) had when filgrastim-sndz received FDA approval.1, 11, 12 Since then, a second biosimilar product, infliximab-dyyb (Inflectra™, manufactured by Celltrion/Pfizer and a biosimilar of Janssen’s infliximab [Remicade®]), was granted FDA approval on April 5, 2016 for all indications of the original branded biologic agent, with the exception of pediatric ulcerative colitis.13-15 Inflectra was launched in the U.S. market on November 28, 2016.2 A second biosimilar of Remicade, infliximab-abda (Renflexis™, manufactured by Samsung Bioepis [and to be distributed by Merck in the U.S.]), was approved on April 21, 2017.5 Due to the recent decision by the U.S. Supreme Court which now allows biosimilars to be launched as soon as they are granted FDA approval (provided no other barriers
Table 1. FDA-Approved Biosimilars and Their Respective Launch Status1-6, 11, 13 Biosimilar Name Filgrastim-sndz (Zarxio™) Infliximab-dyyb (Inflectra™) Etanercept-szzs (Erelzi®) Adalimumab-atto (Amjevita™) Infliximab-abda (Renflexis™)
Biosimilar Manufacturer Sandoz Celltrion/Pfizer
Pharmacologic Category Hematopoietic agent TNF inhibitor
Sandoz
TNF inhibitor
Amgen
TNF inhibitor
Samsung Bioepis/ TNF inhibitor Merck
Reference Biologic Filgrastim (Neupogen) Infliximab (Remicade) Etanercept (Enbrel) Adalimumab (Humira) Infliximab (Remicade)
Reference Biologic FDA Approval Date Current Launch Manufacturer for the Biosimilar Status in the U.S. Amgen March 6, 2015 Launched September 3, 2015 Janssen April 5, 2016 Launched November 28, 2016 Amgen August 30, 2016 Not yet launched Abbvie
September 23, 2016 Not yet launched
Janssen
April 21, 2017
Launched July 24, 2017
Note: FDA is U.S. Food & Drug Administration. TNF is tumor necrosis factor.
Innovatix | innovatix.com 21
CONTINUING EDUCATION prevent the launch, such as ongoing litigation), Merck was able to launch Renflexis in the U.S. on July 24, 2017.6, 16 Like Zarxio and Inflectra, Renflexis does not have interchangeability status.17 Two additional biosimilars of tumor necrosis factor (TNF) blockers were approved in 2016, but neither is expected to launch for some time yet, due to various barriers.18, 19 The first was etanercept-szzs (Erelzi, manufactured by Sandoz, and a biosimilar of Amgen’s etanercept [Enbrel®]).3 Etanercept-szzs was approved as a biosimilar agent on August 30, 2016 for all of indications of Enbrel, but did not receive a designation of interchangeability.3 The second biosimilar was adalimumab-atto (Amjevita™, manufactured by Amgen, and a biosimilar of Abbvie’s adalimumab [Humira®]).4 Adalimumab-atto was approved as a biosimilar agent on September 23, 2016 for seven of 10 indications of Humira, and like Erelzi, it did not receive a designation of interchangeability.4 Table 1 provides a summary of approved biosimilars to date with their respective launch status.
Biosimilar Applications Awaiting FDA Decision or Previously Rejected The pipeline of biosimilar agents is robust.20 As of August 16, 2017, multiple applications for various biosimilars have been either submitted to or already accepted by the FDA for review and are currently awaiting a decision (See Table 2.)21-30 Before making a final decision to approve or deny a biosimilar application, the FDA will likely conduct an advisory committee meeting to discuss the merits of the application, given the novelty of the approval process and the biosimilars themselves.31-32 As of June 22, 2017, three biosimilar applications have been rejected, with one rejected twice.33-37 The first was Retacrit (manufactured by Pfizer, and a biosimilar
T E S T YO U R K N O W L E D G E Q U E ST I O N # 2:
How many biosimilars are currently approved by the FDA? of Epogen®/Procrit®).34, 35 The manufacturer received a complete response letter (CRL) from the FDA in October 2015. 34, 35 Pfizer subsequently resubmitted Retacrit to the FDA in December 2016,36 and the FDA Advisory Committee reviewed it on May 25, 2017 with a recommendation for approval.37 However, Pfizer received a CRL from the FDA on June 22, 2017, once again rejecting Retacrit, due primarily to manufacturing issues (the FDA did not require additional clinical data in the CRL).38 Two other rejected products were biosimilars of Neulasta — one by Sandoz (LA-EP2006; CRL was received in the second quarter 2016),39 and one by Coherus (CHS-1701; CRL received on June 12, 2017).33 Table 3 provides a summary of rejected biosimilars to date.
Ongoing Issues and Litigation Affecting the U.S. Biosimilar Market Originators of reference biologics rely on various strategies to delay or prevent the launch of biosimilars—not only while the FDA reviews them but even after they receive approval.40, 41 These strategies include but are not limited to: • Lawsuits pertaining to perceived patent infringements; and • Re-examination of the original biologic’s patents for confirmation of validity by the U.S. Patent and Trademark Office (USPTO).
Table 2. Biosimilar Agents Awaiting FDA Decision21-30, 59, 60 Biosimilar Name
Biosimilar Manufacturer
Pharmacologic Category
Reference Biologic Pegfilgrastim (Neulasta) Filgrastim (Neupogen) Trastuzumab (Herceptin)
Pegfilgrastim
Apotex
Hematopoietic agent
Grastofil
Apotex
Hematopoietic agent
HERMyl 1401O
Mylan/Biocon
ABP 215
Amgen/Allergan
BI 695501
Boehringer Ingelheim
MYL-1401H
Mylan/Biocon
CT-P10 (Truxsima)
Celltrion/Teva
CT-P6
Celltrion/Teva
ABP 980
Amgen/Allergan
Monoclonal antibody (anti-HER2 antineoplastic agent) Monoclonal antibody Bevacizumab (VEGF inhibitor; (Avastin) antineoplastic agent) TNF inhibitor Adalimumab (Humira) Hematopoietic agent Pegfilgrastim (Neulasta) Monoclonal Rituximab antibody (anti-CD20; (Rituxan) antineoplastic agent) Anti-HER2 antibody Trastuzumab (Herceptin) Anti-HER2 antibody Trastuzumab (Herceptin)
Reference Biologic Manufacturer Amgen
Projected BsUFA Target or Launch Date Pending
Amgen
Pending
Genentech/Roche Genentech/Roche
Date of Advisory Committee Meeting (If Available)
ODAC of the FDA recommended approval on July 13, 2017. ODAC of the FDA recommended approval on July 13, 2017.
Insight
September 14, 2017
AbbVie
September 2017
Amgen
October 9, 2017
Genentech/Roche
First quarter of 2018
Genentech/Roche
First half of 2018
Genentech/Roche
First half of 2018
Note: FDA is U.S. Food & Drug Administration. ODAC is Oncologic Drugs Advisory Committee. VEGF is vascular endothelial growth factor. TNF is tumor necrosis factor. BsUFA is Biosimilars User Fee Act.
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CONTINUING EDUCATION Table 3. Rejected Biosimilars as of July 5, 2017
33-37
Biosimilar Name Retacrit
Biosimilar Manufacturer Pfizer
Pharmacologic Category Hematopoietic agent
Reference Biologic Epoetin Alfa (Epogen/ Procrit)
LA-EP2006
Sandoz
CHS-1701
Coherus
Hematopoietic agent Hematopoietic agent
Pegfilgrastim (Neulasta) Pegfilgrastim (Neulasta)
Reference Biologic Manufacturer • Amgen (for Epogen) • Janssen (for Procrit) Amgen Amgen
Current U.S. Launch Status • • • • • • •
First CRL received in October 2015. Second CRL received June 22, 2017. Currently not available in U.S. CRL received in second quarter 2016. Currently not available in U.S. CRL received June 12, 2017. Currently not available in U.S.
Note: CRL is complete response letter.
T E S T YO U R K N O W L E D G E QUESTION #3:
How many biosimilars have been rejected by the FDA to date? If decisions from the USPTO or the original lawsuits and subsequent appeals favor the originator biologic, the launch of biosimilars will be further delayed.40, 41 The U.S. Supreme Court issued an important decision on June 12, 2017 that affects how rapidly biosimilar agents can enter the market.42 It overturned a previous ruling that required a 180-day waiting period between a biosimilar’s FDA approval and its launch.42 Therefore, as long as there are no other barriers (e.g., perceived patent infringements, etc), a biosimilar can now launch as soon as the FDA approves it,42 which should speed up biosimilar entry into the U.S. market.
Update on FDA Biosimilar Guidance Documents for 2016-2017 On March 29, 2016, the FDA released a draft guidance for the industry (“Labeling for Biosimilar Products”), which explained how to label biosimilars in pertinent documents such as package inserts.7 On January 12, 2017, the FDA released a final guidance (“Nonproprietary Naming of Biological Products”), which provides guidelines for assigning a nonproprietary name for an “originator biological product, related biological product, and biosimilar product.”43 Specifically, the FDA indicated that such nonproprietary names should contain the “core name” hyphenated with a four-letter suffix that should not have any significance and be comprised of lowercase letters (i.e., a meaningless combination of four letters).43 Interestingly, these guidelines regarding the four-letter suffix are applicable to biosimilar products that are not interchangeable.43 The FDA is still considering the suffix format for biosimilar products that have the designation of interchangeability.43 While the approved biosimilar agents have demonstrated biosimilarity to the reference biologic, they have not been labeled interchangeable. This is largely because no guidelines were in place to enable biosimilar manufacturers to demonstrate interchangeability.13, 44 In fact, Zarxio, received a biosimilarity designation but did not apply for (and did not
receive) the interchangeability designation — thus keeping it from mandatory generic substitution at the pharmacy level.45 Currently, no approved biosimilars have been granted interchangeability status.17 The draft guidance on biosimilar interchangeability was originally slated to be released in 2015,46 but the FDA did not release it until January 17, 2017.47 The guidance (“Considerations in Demonstrating Interchangeability with a Reference Product”) provides a number of scientific considerations for manufacturers to incorporate into study designs, data collection, etc., in order for their proposed biosimilar products to be able to demonstrate interchangeability.47 Some of the considerations include (Please note this is not a full list): • How to design a switching study to demonstrate interchangeability; • What kind of data to collect and present for the biosimilar to be considered an interchangeable; and • How to use originator reference biologics in the switching studies.47 The interchangeability guidance is not final, but the public comment period for the draft guidance has ended.48 The FDA is currently reviewing the comments it received and anticipates publishing a revised draft guidance or a finalized interchangeability guidance by 2019, if not before.49
Biosimilar-Created Obstacles for Physicians, Payers, Patients, and Pharmacies Surveys reveal that physicians do not have the same degree of familiarity with biosimilars as they have with traditional generic drugs.50-52 The majority of them feel further education is needed if they are to develop the levels of competency and comfort necessary to prescribe biosimilars rather than reference biologics.51, 52 Adoption by payers — whether they manage commercial, Medicaid, or Medicare patients — has primarily been driven by cost benefits of biosimilars.53, 54 Patients also lag behind in this regard, with a recent survey revealing their lack of knowledge about the subject.55 Patients must be educated if they are to accept biosimilars as safe, clinically effective, and cost-efficient substitutes for original reference biologics.54-56 Additionally, patients must understand that while biosimilars will have similar efficacy to the reference biologic, the delivery device may be different.57 Biosimilar dispensing issues remain, even though specialty Innovatix | innovatix.com 23
CONTINUING EDUCATION pharmacies have been dispensing original reference biologics successfully while gearing up for biosimilars.58 Once interchangeable biosimilars are on the market, another issue to be addressed is substitution for the reference biologic. In anticipation of this, every state has been challenged with establishing guidelines to delineate biosimilar substitution for branded biologic agents at the pharmacy level.10 As of July 1, 2017, at least 37 states have considered biosimilar substitution legislation,10 and 95 percent (35 states) and Puerto Rico
T E S T YO U R K N O W L E D G E QUESTION #4:
What barriers to the widespread use of biosimilars exist at the physician level?
REFERENCES 1. Sandoz, Inc., “Sandoz launches ZarxioTM (filgrastim-sndz), the first biosimilar in the United States,” news release, September 3, 2015, https:// www.novartis.com/news/media-releases/sandoz-launches-zarxiotmfilgrastim-sndz-first-biosimilar-united-states (accessed July 5, 2017). 2. “Celltrion and Hospira Have Launched Inflectra® in U.S.,” Big Molecule Watch, December 8, 2016, http://www.bigmoleculewatch. com/2016/12/08/inflectra-launched-in-us/ (accessed June 22, 2017). 3. U.S. Food and Drug Administration, “FDA approves Erelzi, a biosimilar to Enbrel,” news release, August 30, 2016, https://www.fda.gov/ newsevents/newsroom/pressannouncements/ucm518639.htm (accessed June 27, 2017). 4. U.S. Food and Drug Administration, “FDA approves Amjevita, a biosimilar to Humira,” news release, September 23, 2016, https://www. fda.gov/newsevents/newsroom/pressannouncements/ucm522243. htm (accessed June 27, 2017). 5. Samsung Bioepis Co., Ltd., “Samsung Bioepis Obtains First Drug Approval in the United States, as the U.S. Food and Drug Administration Approves RENFLEXIS™ (Infliximab-abda) Across All Eligible Indications,” news release, April 24, 2017, http://www. samsungbioepis.com/en/newsroom/detail/Samsung-Bioepis-SB2-USFDA-Approval-FINAL.html (accessed July 5, 2017). 6. Merck & Co., Inc., “Merck Announces U.S. Launch of RENFLEXIS™ (infliximab-abda), a Biosimilar of Remicade, for All Eligible Indications,” news release, July 24, 2017, http://investors.merck.com/news/pressrelease-details/2017/Merck-Announces-US-Launch-of-RENFLEXISinfliximab-abda-a-Biosimilar-of-Remicade-for-All-Eligible-Indications/ default.aspx (accessed August 15, 2017). 7. U.S. Food and Drug Administration, Labeling for Biosimilar Products. Guidance for Industry (Draft Guidance) (Silver Spring, MD: FDA CDER and CBER, March 2016), http://www.fda.gov/downloads/ Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ UCM493439.pdf?source=govdelivery&utm_medium=email&utm_ source=govdelivery (accessed July 5, 2017). 8. Cornell Law School, Legal Information Institute, s.v. “42 U.S. Code § 262 – Regulation of biological products,” https://www.law.cornell.edu/ uscode/text/42/262 (accessed July 5, 2017). 9. U.S. Food and Drug Administration, Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009. Guidance for Industry (Silver Spring, MD: FDA, CDER and CBER, April 2015), http://www.fda.gov/downloads/ drugs/guidancecomplianceregulatoryinformation/guidances/ ucm444661.pdf (accessed July 5, 2017). 10. Richard Cauchi, “State laws and legislation related to biologic medications and substitution of biosimilars,” National Conference of State Legislatures, Updated July 1, 2017, http://www.ncsl.org/research/ health/state-laws-and-legislation-related-to-biologic-medications-andsubstitution-of-biosimilars.aspx#Mandatory (accessed July 5, 2017). 11. Sandoz, Inc., “FDA approves first biosimilar Zarxio™ (filgrastim-sndz) from Sandoz,” news release, March 6, 2015, https://www.sandoz. com/news/media-releases/fda-approves-first-biosimilar-zarxiotmfilgrastim-sndz-sandoz (accessed July 5, 2017).
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have already enacted biosimilar substitution-related laws.10 For up-to-date information on state-specific requirements regarding biosimilar substitution, see www.ncsl.org/research/ health/state-laws-and-legislation-related-to-biologic-medications-and-substitution-of-biosimilars.aspx#Mandatory.10
Conclusion Five biosimilars have received approval in the U.S. to date, and three are already on the market. The launch of the other two will be governed by the outcomes of litigation. Resolution of pertinent litigation and a better understanding of issues surrounding the use of biosimilar agents will pave the way for biosimilar acceptance and adoption by applicable stakeholders in the United States. The information in this article was current as of August 16, 2017. To access clinical updates from Innovatix with the latest drug pipeline news, please visit: www.innovatix.com/member-clinical-programs.
12. Libero Marzella (FDA) to Janet Chow (Amgen Inc.), March 30, 2015, sBLA approval letter for Neupogen, https://www.accessdata.fda.gov/drugsatfda_ docs/appletter/2015/103353Orig1s5183ltr.pdf (accessed July 5, 2017). 13. U.S. Food and Drug Administration, “FDA approves Inflectra, a biosimilar to Remicade,” press release, April 5, 2016, https://www.fda. gov/newsevents/newsroom/pressannouncements/ucm494227.htm (accessed July 5, 2017). 14. Remicade Prescribing Information (Horsham, PA: Janssen Biotech, Inc., October 2015), https://www.remicade.com/shared/product/remicade/ prescribing-information.pdf (accessed July 5, 2017). 15. Inflectra Prescribing Information (New York: Pfizer Inc., September 2016), http://labeling.pfizer.com/ShowLabeling.aspx?id=9271 (accessed July 5, 2017). 16. Sohn Ji-young, “US Supreme Court decision speeds up entry of biosimilars to market,” Korea Herald, June 14, 2017, English edition, http://www. koreaherald.com/view.php?ud=20170614000829 (accessed July 5, 2017). 17. Sara W. Koblitz, “FDA Licences Renflexis; Some Firsts for this Remicade Biosimilar,” FDA Law Blog, April 24, 2017, http://www.fdalawblog.net/ fda_law_blog_hyman_phelps/2017/04/fda-licences-renflexis-some-firstsfor-this-remicade-biosimilar.html (accessed July 5, 2017). 18. Stanton Mehr, “Frustration Mounts as Sandoz’s Etanercept Biosimilar Launch Delayed into 2018,” Biosimilars Review and Report, January 27, 2017, https://biosimilarsrr.com/2017/01/27/frustration-mounts-assandozs-etanercept-biosimilar-launch-delayed-into-2018 (accessed July 5, 2017). 19. Ned Pagliarulo, “Coherus wins Humira patent ruling, chipping away at AbbVie’s defenses,” BioPharma Dive, May 17, 2017, http:// www.biopharmadive.com/news/coherus-humira-patent-abbvie-iprbiosimilar/442950 (accessed July 5, 2017). 20. Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research, testimony for the U.S. Food and Drug Administration on Biosimilars Implementation, on February 4, 2016, before Committee on Energy and Commerce, Subcommittee on Health, United States House of Representatives, FDA News and Events, February 4, 2016, https://www.fda.gov/NewsEvents/Testimony/ucm485042.htm (accessed July 5, 2017). 21. Amgen, “Amgen And Allergan Announce FDA Advisory Committee Meeting To Review ABP 215, A Biosimilar Candidate To Bevacizumab,” news release, June 7, 2017, http://www.amgen.com/media/newsreleases/2017/06/amgen-and-allergan-announce-fda-advisorycommittee-meeting-to-review-abp-215-a-biosimilar-candidate-tobevacizumab (accessed June 16, 2017). 22. Apotex Inc., “Apotex announces FDA has accepted for filing its biosimilar application for filgrastim (Grastofil™),” press release, February 17, 2017, http://www.apotex.com/global/about/ press/20150217-2.asp (accessed July 5, 2017). 23. Apotex Inc., “Apotex announces FDA has accepted for filing its biosimilar application for pegfilgrastim,” press release, December 17, 2014, http://www.apotex.com/global/about/press/20141217.asp (accessed July 5, 2017).
CONTINUING EDUCATION 24. Boehringer Ingelheim, “Boehringer Ingelheim biosimilar candidate to Humira® accepted for EMA and FDA regulatory review,” press release, January 27, 2017, https://www.boehringer-ingelheim.com/pressrelease/boehringer-ingelheim-biosimilar-candidate-humira-acceptedema-and-fda-regulatory (accessed July 5, 2017). 25. TEVA Pharmaceutical Industries Ltd., “Celltrion and Teva Announce U.S. FDA Acceptance of Biologics License Application for Proposed Biosimilar to Rituxan® (rituximab),” press release, June 29, 2017, http:// www.tevapharm.com/news/celltrion_and_teva_announce_u_s_fda_ acceptance_of_biologics_license_application_for_proposed_biosimilar_to_ rituxan_rituximab_06_17.aspx (accessed July 5, 2017). 26. IPD Analytics,”Clinical Pipeline,” http://www.ipdanalytics.com (accessed July 5, 2017). 27. Mylan, “U.S. FDA Accepts Biologics License Application (BLA) for Mylan and Biocon’s Proposed Biosimilar Trastuzumab,” news release, January 11, 2017, http://newsroom.mylan.com/2017-01-11-U-S-FDAAccepts-Biologics-License-Application-BLA-for-Mylan-and-BioconsProposed-Biosimilar-Trastuzumab (accessed July 5, 2017). 28. Mylan, “U.S. FDA Accepts Biologics License Application (BLA) for Mylan and Biocon’s Proposed Biosimilar Pegfilgrastim for Review,” news release, February 16, 2017, http://newsroom.mylan.com/2017-02-16-U-S-FDAAccepts-Biologics-License-Application-BLA-for-Mylan-and-BioconsProposed-Biosimilar-Pegfilgrastim-for-Review (accessed July 5, 2017). 29. Teva Pharmaceuticals Ltd., “Celltrion and Teva Announce U.S. FDA Acceptance of Biologics License Application for Proposed Biosimilar to Herceptin® (trastuzumab), ” news release, July 31, 2017, http:// www.tevapharm.com/news/celltrion_and_teva_announce_u_s_fda_ acceptance_of_biologics_license_application_for_proposed_biosimilar_ to_herceptin_trastuzumab_07_17.aspx (accessed August 16, 2017). 30. Amgen, Inc., “Amgen And Allergan Submit Biosimilar Biologics License Application For ABP 980 To US Food And Drug Administration,” news release, July 31, 2017, http://www.amgen.com/ media/news-releases/2017/07/amgen-and-allergan-submit-biosimilarbiologics-license-application-for-abp-980-to-us-food-and-drugadministration (accessed August 16, 2017). 31. U.S. Food and Drug Administration, Biosimilar biological product authorization performance goals and procedures fiscal years 2018 through 2022 (Silver Spring, MD: FDA), https://www.fda.gov/ downloads/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/ UCM521121.pdf (accessed July 5, 2017). 32. U.S. Food and Drug Administration, “First biosimilar approval in the United States,” media briefing, March 6, 2015, https://www.fda.gov/ downloads/NewsEvents/Newsroom/MediaTranscripts/UCM437548. pdf (accessed July 5, 2017). 33. Alex Keown, “Bay Area’s Coherus Craters After the FDA Spurns Its Biosimilar for Amgen (AMGN)’s Neulasta,” Biospace, June 12, 2017, http://www.biospace.com/News/bay-areas-coherus-craters-after-thefda-spurns-its/459584 (accessed June 16, 2017). 34. Pfizer Inc., “Q3 2015 Pfizer Inc Earnings Call,” http://www.pfizer. com/system/files/presentation/PFE-Transcript-2015-10-27T14_00.pdf (accessed July 5, 2017). 35. John T. Aquino, “FDA response delays Pfizer’s release of Epogen biosimilar,” Bloomberg BNA, October 28, 2015, https://www.bna.com/ fda-response-delays-n57982062818 (accessed July 5, 2017). 36. Pfizer Inc., “Pfizer reports fourth-quarter and full-year 2016 results,” press release, January 31, 2017, http://press.pfizer.com/press-release/pfizerreports-fourth-quarter-and-full-year-2016-results (accessed July 5, 2017). 37. FDA Advisory Committee Recommends Approval of Pfizer’s Proposed Biosimilar to Epogen®/Procrit® Across All Indications. Available at: http:// www.pfizer.com/news/press-release/press-release-detail/fda_advisory_ committee_recommends_approval_of_pfizer_s_proposed_biosimilar_to_ epogen_procrit_across_all_indications (accessed July 5, 2017). 38. Pfizer Inc., “Pfizer Provides Update on Proposed Epoetin Alfa Biosimilar,” news release, June 22, 2017, http://www.pfizer.com/sites/ default/files/news/Pfizer_Provides_Update_on_Proposed_Epoetin_Alfa_ Biosimilar_6_22_17.pdf (accessed June 26, 2017). 39. Novartis, “Novartis delivered solid Q2 despite full quarter of US Gleevec generic impact; significant positive innovation news strengthens future growth prospects,” news release, July 19, 2016, https://www.novartis. com/news/media-releases/novartis-delivered-solid-q2-despite-fullquarter-us-gleevec-generic-impact (accessed July 5, 2017). 40. Nancy Walsh, “A rocky start for biosimilar Inflectra? Infliximab biosimilar approved, but obstacles remain,” MedPage Today, April 7, 2016, http://www.medpagetoday.com/rheumatology/arthritis/57239 (accessed July 5, 2017). 41. C. Suzuki, D. Yellin, B. Ryland, L. Patterson, J. Fuson, “The long and winding road for biosimilars: charting a pathway through patent, FDA, antitrust, prescription filling, reimbursement and liability law,” Bloomberg BNA, September 18, 2015, https://www.crowell.com/files/ The-Long-and-Winding-Road-for-BIOSIMILARS-Charting-a-Pathway-
through-Patent-FDA-Antitrust-Prescription-Filling-Reimbursementand-Liability-Law.pdf (accessed July 5, 2017). 42. Joanne Hawana, “SCOTUS Ruling Gives a Boost to Biosimilars; FDA Continues to Advance Products Through AdComs,” Health Law and Policy Matters, June 14, 2017, https://www.healthlawpolicymatters. com/2017/06/14/scotus-ruling-gives-boost-biosimilars-fda-continuesadvance-products-adcoms (acessed July 6, 2017). 43. U.S. Federal Drug Administration, Nonproprietary Naming of Biological Products. Guidance for Industry (Silver Spring, MD: FDA), https://www. fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/ document/ucm459987.pdf (accessed June 28, 2017). 44. Gareth MacDonald, “Biosimilar not interchangeable: Sandoz and Pfenex call for US FDA guidelines,” BioPharma-Reporter, September 4, 2015, http://www.biopharma-reporter.com/Markets-Regulations/ Biosimilar-not-interchangeable-Sandoz-and-Pfenex-call-for-US-FDAguidelines (accessed July 5, 2017). 45. Jill Wechsler, “Further guidance on biosimilars needed from FDA,” PharmExec.com, March 9, 2015, http://www.pharmexec.com/furtherguidance-biosimilars-needed-fda (accessed July 5, 2017). 46. Thomas Sullivan, “FDA’s CDER and CDRH release 2015 guidance agenda and comprehensive document search tool,” Policy and Medicine, January 14, 2015, http://www.policymed.com/2015/01/fdascder-releases-2015-guidance-agenda-and-comprehensive-documentsearch-tool-.html (accessed July 5, 2017). 47. Food and Drug Administration, Considerations in Demonstrating Interchangeability With a Reference Product. Guidance for Industry. Draft guidance (Silver Spring, MD: FDA), https://www.fda.gov/ downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/UCM537135.pdf?source=govdelivery&utm_ medium=email&utm_source=govdelivery (accessed June 26, 2017). 48. “Public Comment Period Closes for FDA’s Draft Interchangeability Guidance,” Big Molecule Watch, May 24, 2017, http://www. bigmoleculewatch.com/2017/05/24/public-comment-period-closes-forfdas-draft-interchangeability-guidance (accessed July 6, 2017). 49. Zachary Brennan, “FDA: Interchangeable Biosimilar Approvals Expected Within 2 Years,” Regulatory Affairs Professionals Society, June 26, 2017, http://www.raps.org/Regulatory-Focus/ News/2017/06/26/27969/FDA-Interchangeable-Biosimilar-ApprovalsExpected-Within-2-Years (accessed July 6, 2017). 50. A. D. Zelenetz, I. Ahmed, E. L. Braud, et al., “NCCN Biosimilars White Paper: regulatory, scientific, and patient safety perspectives,” J Natl Compr Canc Netw. 9, Suppl no. 4 (2011): S1-22. 51. Steven Chavez, CME Survey: Biosimilars (Millstone, NJ: NACCME, May 24, 2013), http://www.naccme.com/sites/naccme.com/files/biosimilarsurvey-results.pdf (accessed July 5, 2017). 52. Reading the signs: A roadmap for engaging physicians in the biosimilars discussion (Waltham, MA: Quantia, Inc., 2015), http://cdn2.hubspot. net/hubfs/436920/Whitepaper_-_Quantia_-_Reading_the_Signs_ August_2015.pdf?t=1439483234458 (accessed July 5, 2017). 53. “As patents expire, payers are bullish on price-reducing potential of biosimilars,” Specialty Pharmacy News 13, no.1 (2016): 1-4. 54. Steven D. Lucio, “Adoption of biosimilars: Prescribers, pharmacy, and payer perspectives,” The American Journal of Pharmacy Benefits 8, no.2 (2016): 67-76. 55. I. Jacobs, E. Singh, K.L. Sewell, A. AL-Sabbagh, L. G. Shane, “Patient attitudes and understanding about biosimilars: an international crosssectional survey,” Patient Preference and Adherence 10 (2016): 937—948, https://www.dovepress.com/patient-attitudes-and-understandingabout-biosimilars-an-international-peer-reviewed-article-PPA (accessed July 5, 2017). 56. Dan Stanton, “Patient groups express safety concerns about US FDA’s biosimilar guidance,” BioPharma-Reporter, June 10, 2015, http://www. biopharma-reporter.com/Markets-Regulations/FDA-biosimilar-guidanceleaves-patient-groups-with-safety-concerns (accessed July 5, 2017). 57. U.S. Food and Drug Administration. Guidance for Industry on Biosimilars: Q & As Regarding Implementation of the BPCI Act of 2009: Questions and Answers Part I, (Sliver Spring, MD: FDA), https:// www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/ucm259809.htm#Q4 (accessed July 5, 2017). 58. Dan Steiber, “Biosimilars: The perfect fit for specialty!,” Specialty Pharmacy Times, April 15, 2015, https://www.specialtypharmacytimes. com/publications/specialty-pharmacy-times/2015/april-2015/ biosimilars-the-perfect-fit-for-specialty (accessed July 5, 2017). 59. U.S. Food and Drug Administration, “Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement,” July 13, 2017, https:// www.fda.gov/AdvisoryCommittees/Calendar/ucm562326.htm (accessed July 6, 2017). 60. “FDA’s ODAC Unanimously Recommends Biosimilar Versions of Bevacizumab and Trastuzumab,” The ASCO Post, July 14, 2017, http:// www.ascopost.com/News/57833 (accessed August 16, 2017).
Innovatix | innovatix.com 25
CLINICAL CORNER
CONTINUING EDUCATION
Clinical Corner
Brief Clinical Overview of Syndros™ (dronabinol) Oral Solution, CII Sylvia A. Thomas, PharmD, MS, BCPS, vice president, clinical pharmacy services, Innovatix
DRUG NAME Dronabinol (Syndros, Insys Therapeutics, Inc.) Oral solution, CII 1 FDA-APPROVED INDICATION AND USAGE Dronabinol oral solution is indicated for: ■■ Treatment of anorexia associated with weight loss in adults with Acquired Immune Deficiency Syndrome (AIDS); and
■■ Chemotherapy-induced nausea and vomiting (CINV) in
adults who have not had optimal relief with conventional antiemetic treatments.2, 3
MECHANISM OF ACTION Dronabinol is an orally active synthetic cannabinoid and a naturally occurring component of Cannabis sativa (marijuana). Cannabinoid receptors in neural tissues may be responsible for the effects of dronabinol in the body. The drug, which has a complex impact on the central nervous system (CNS) including sympathomimetic activity, exhibits reversible dose-related effects on appetite, mood, cognition, memory, and perception, with extensive inter-patient variability.4, 5 PHARMACOKINETICS ■■ Absorption: 90-95 percent, with only 10-20 percent reaching the circulation. 26 |
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■■ Volume of distribution: 10 L/kg due to high lipophilicity. ■■ Metabolism: Extensive first-pass hepatic metabolism via microsomal hydroxylation to metabolites (some active).
■■ Onset of action: 30 minutes-1 hour, with peak effect in 2-4 hours.
■■ Duration of action: 4-6 hours for psychoactive effects, and 24 hours for appetite stimulation.
■■ Elimination half-life: Biphasic with alpha, 4-5 hours, and terminal, 25-36 hours.
■■ Excretion: Feces (50 percent with <5 percent as unchanged drug); urine (10-15 percent).
■■ Protein binding: Approximately 97 percent.6,7 DOSAGE The strength of dronabinol oral solution is 5 mg/mL, and it is packaged with a calibrated oral dosing syringe that can contain a maximum of 5 mg. Larger doses need to be divided in two or more portions to equal the prescribed amount. Each dose should be administered with 6-8 ounces of water.8 Anorexia associated with weight loss in patients with AIDS: ■■ Adults: The recommended starting dose is 2.1 mg orally twice daily, one hour before lunch and dinner. The dose may be titrated slowly to 2.1 mg prior to lunch and 4.2 mg
CLINICAL CORNER prior to dinner, and then to 4.2 mg before lunch and 4.2 mg before dinner. If a greater effect is required, the maximum dose is 8.4 mg twice daily.9
■■ Elderly patients or those unable to tolerate 2.1 mg twice
daily: A 2.1 mg dose may be given once daily, one hour before dinner or at bedtime. The lower dose may reduce the risk of CNS symptoms.10
Nausea and vomiting associated with chemotherapy in adult patients: ■■ The recommended starting dose is 4.2 mg/m2 orally 1-3 hours prior to chemotherapy, which may be repeated every 2-4 hours after chemotherapy, for a total of 4-6 doses per day. Round to the nearest 0.1 mL to correspond with the calibrated oral dosing syringe.11
■■ Elderly patients may be started on 2.1 mg/m
once daily, 1-2 hours prior to chemotherapy, to reduce the risk of CNS symptoms. 2
■■ Dose titration: The dose may be increased in increments
of 2.1 mg/m2 during a chemotherapy cycle or subsequent cycles, based on clinical response. The maximum dose is 12.6 mg/m2 per dose for 4-6 doses per day.
■■ Adverse reactions are dose-related, and psychiatric
symptoms increase significantly at the maximum dose.
■■ Administer the first dose on an empty stomach, 30 minutes before eating. Remaining doses may be taken without regard to meals.
■■ After the effective dose has been determined, the timing of
dosing in relation to meal times should be kept consistent for each cycle, as food can substantially change the systemic exposure to dronabinol and its active metabolite.12
DOSING IN SPECIAL POPULATIONS ■■ Pregnancy: Category C.
■■ Lactation: For CINV, do not use dronabinol during
treatment or for 9 days after the last dose of chemotherapy. For nursing mothers with AIDS, do not use dronabinol.
■■ Elderly: Use with caution and reduce initial doses. ■■ Pediatric: Safety and efficacy have not been studied. ■■ Renal and hepatic impairment: No dosage adjustments are recommended.13, 14
CLINICAL STUDIES ■■ Clinical effectiveness of Syndros for the approved indications was established based on studies using dronabinol capsules.15, 16 CONTRAINDICATIONS ■■ A history of hypersensitivity to dronabinol (e.g., lip swelling, hives, rash, oral lesions, skin burning, flushing,
throat tightness).
■■ A history of hypersensitivity to alcohol. Syndros contains 50
percent dehydrated alcohol and 5.5 percent propylene glycol.
■■ Recently received (within 14 days) products containing disulfiram or metronidazole.
WARNINGS, PRECAUTIONS, AND ADVERSE REACTIONS ■■ Avoid use in patients with a history of mania, depression, or schizophrenia, as these conditions may be exacerbated. If used, monitor patients for new or worsening psychiatric symptoms. Avoid concomitant use with drugs associated with similar psychiatric effects.
■■ Cognitive impairment and altered mental state have been
associated with the use of Syndros. If these symptoms appear, either reduce the dose or discontinue use. These symptoms are more likely in elderly and pediatric patients.
■■ Syndros may impair the mental and physical abilities
required for driving a motor vehicle or operating machinery. Concomitant use of other drugs that cause dizziness, confusion, sedation or somnolence may enhance this effect. Advise patients not to operate a motor vehicle or machinery until they are certain that Syndros does not affect them adversely.17
■■ Some patients may experience hemodynamic instability (e.g., hypotension, pretension, syncope or tachycardia). Patients with cardiac disorders may be at higher risk. Avoid concomitant use of drugs associated with similar cardiac effects.
■■ Patients with a history of substance abuse may be more
likely to abuse Syndros as well. Patients should be assessed for risk of abuse or misuse prior to prescribing Syndros.
■■ Patients may develop new or worsening nausea,
vomiting or abdominal pain during dronabinol treatment. Severe cases may require dose reduction or drug discontinuation.18,19
DRUG INTERACTIONS
■■ Disulfiram and metronidazole: Syndros contains 50
percent dehydrated alcohol and 5.5 percent propylene glycol (w/w), so has the potential to cause a disulfiramlike reaction with abdominal cramps, nausea, vomiting, headaches, and flushing when given concurrently with disulfiram or metronidazole. Products containing disulfiram or metronidazole should be discontinued at least 14 days before starting treatment with Syndros, and should not be started within seven days of completing Syndros treatment. 20
■■ Other drugs: Because dronabinol is metabolized by
CYP2C9 and CYP3A4, inhibitors of these enzymes may increase, and inducers may decrease the systemic exposure of dronabinol. Increased adverse reactions Innovatix | innovatix.com 27
CLINICAL CORNER related to dronabinol may occur when co-administered with inhibitors of CYP2C9 (e.g., amiodarone, fluconazole) and inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, erythromycin, grapefruit juice).21 DOSAGE FORMS AND ADMINISTRATION Syndros (dronabinol oral solution) is supplied as a clear, pale yellow-to-brown solution at a strength of 5 mg/mL. It comes in a multi-dose, clear amber-colored 30 mL glass bottle, packaged with an oral syringe and a push-in bottle adapter with NDC 20482-335-30.
■■ After opening the bottle for the first time, insert the adapter according to the supplied instructions.
■■ Doses greater than 5 mg will need to be withdrawn in two or more portions to equal the prescribed amount.
■■ Each dose should be administered with 6-8 ounces of water.22,23
SPECIAL HANDLING REQUIREMENTS
■■ The carton containing the unopened bottle should be stored in a refrigerator between 2°C and 8°C (36°F and 46°F).
■■ Excursions are permitted between 15°C and 25°C (59°F and 77°F).
■■ The opened bottle may be stored at 25°C (77°F). ■■ The unused portion should be discarded 28 days after opening.24
■■ The oral dosing syringe included with the oral solution
bottle should be used to measure and administer each dose of Syndros.
REFERENCES
1. Syndros prescribing information (Chandler, AZ: Insys Therapeutics, Inc., May 2017), http://syndros.com/assets/pdf/SYNDROS-fullprescribing-information.pdf. 2. Lexicomp Online, https://online.lexi.com/login (accessed July 21, 2017). 3. Syndros prescribing information (Chandler, AZ: Insys Therapeutics, Inc., May 2017), http://syndros.com/assets/pdf/SYNDROS-fullprescribing-information.pdf. 4. Ibid. 5. Lexicomp Online, https://online.lexi.com/login (accessed July 21, 2017). 6. Ibid. 7. Syndros prescribing information (Chandler, AZ: Insys Therapeutics, Inc., May 2017), http://syndros.com/assets/pdf. 8. Ibid. 9. Ibid. 10. Ibid. 11. Ibid. 12. Ibid. 13. Ibid. 14. Lexicomp Online, https://online.lexi.com/login (accessed July 21, 2017). 15. Syndros prescribing information (Chandler, AZ: Insys Therapeutics, Inc., May 2017), http://syndros.com/assets/pdf/SYNDROS-fullprescribing-information.pdf. 16. Marinol prescribing information (North Chicago, IL: AbbVie Inc., May 2017). 17. Syndros prescribing information (Chandler, AZ: Insys Therapeutics, Inc., May 2017), http://syndros.com/assets/pdf/SYNDROS-fullprescribing-information.pdf. 18. Lexicomp Online, https://online.lexi.com/login (accessed July 21, 2017). 19. Syndros prescribing information (Chandler, AZ: Insys Therapeutics, Inc., May 2017), http://syndros.com/assets/pdf/SYNDROS-fullprescribing-information.pdf. 20. Ibid. 21. Ibid. 22. Ibid. 23. Ibid. 24. Ibid.
28 |
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CONTRACT UPDATES
Contract Updates R E BAT E / T I E R E D P R O G R A M S LONG-TERM CARE PHARMACIES
• Par Sterile – The Aplisol (tuberculin PPD injection) tiered rebate program was extended through June 30, 2018. INFUSION PROVIDERS (IP)
• Par Sterile – The Aplisol (tuberculin PPD injection) tiered rebate program was extended through June 30, 2018.
New Brand Items Added To Contract GENERIC NAME
SUPPLIER
EFFECTIVE DATE
ELIGIBLE CLASS OF TRADE
Fluticasone Propionate Armonair
Teva Pharmaceuticals
08/16/17
Home Infusion, Long-Term Care
GlycopyrrolateFormoterol Fumarate
Bevespi Aerosphere
AstraZeneca
08/07/17
Long-Term Care
Glecaprevir and pibrentasvir
Mavyret
Abbvie
08/08/17
Long-Term Care
07/14/17
Home Infusion, Long-Term Care, Mail Order, Oncology, Retail
Dronabinol
TRADE NAME
(alphabetical by trade name)
Syndros
Insys Therapeutics
New Contracted Suppliers
(alphabetical by supplier name)
SUPPLIER
PRODUCTS
DATES
ELIGIBLE CLASS OF TRADE
Amneal Biosciences
Generic injectables
07/15/17 – 06/30/18
Home Infusion, Long-Term Care
Arbor Pharmaceuticals
Branded pharmaceuticals
09/01/17 – 06/30/18
Home Infusion, Long-Term Care, Mail Order, Oncology
Athenex Pharmaceuticals
Generic pharmaceuticals
09/01/17 – 06/30/18
Home Infusion, Long-Term Care, Mail Order, Oncology, Retail
Aurobindo Pharma USA
Generic pharmaceuticals
04/01/17 – 06/30/18
Home Infusion, Long-Term Care, Oncology, Retail
BPI Labs
Epinephrine HCL
05/01/17 – 06/30/18
Home Infusion, Long-Term Care, Mail Order, Oncology, Retail
Cadista Pharmaceuticals
Generic pharmaceuticals
08/01/17 – 06/30/18
Home Infusion, Long-Term Care, Mail Order, Oncology, Retail
Innovatix | innovatix.com 29
CONTRACT UPDATES
Generic Launch Update
(alphabetical by generic name)
GENERIC NAME
SUPPLIER
EFFECTIVE DATE
TRADE NAME
SUPPLIER INNOVATOR
Alosetron HCl
Amneal Pharmaceuticals
06/09/17
Lotronex
Sebela
Atomoxetine
Glenmark Pharmaceuticals
06/29/17
Strattera
Eli Lilly
Atomoxetine
Prasco Laboratories
06/14/17
Strattera
Eli Lilly
Desvenlafaxine ER
Mylan Pharmaceuticals
04/06/17
Pristiq
Pfizer
Doxycycline Hyclate
Mayne Pharma
06/15/17
Acticlate
Aqua
Eletriptan Hydrobromide
Greenstone LLC
07/27/17
Relpax
Pfizer
Eletriptan Hydrobromide
Zydus Pharmaceuticals
08/10/17
Relpax
Pfizer
Fluticasone propionate/ Teva Pharmaceuticals salmeterol
05/04/17
Advair Diskus
GlaxoSmithKline
Moxifloxacin HCl OS
Apotex Corp.
07/07/17
Vigamox
Novartis
Olopatadine HCl Ophth
Teva Pharmaceuticals
06/20/17
Pataday
Alcon
Prasugrel
Mylan Pharmaceuticals
08/28/17
Effient
Eli Lilly
Sevelamer Carbonate
Aurobindo Pharma USA
07/18/17
Renvela
Sanofi Renal
Contract Renewals/Extensions
30 |
(alphabetical by supplier)
SUPPLIER
PRODUCTS
DATES
ELIGIBLE CLASS OF TRADE
Astellas Pharma
Ambisome, Mycamine, Cresemba
01/01/18 – 06/30/18
Long-Term Care, Home Infusion
Astellas Pharma
Myrbetriq
01/01/18 – 06/30/18
Long-Term Care
AstraZeneca
Diabetes products
07/01/17 – 06/30/19
Long-Term Care
Boehringer Ingelheim
Aggrenox, GlucaGen
04/01/17 – 06/30/18
Long-Term Care, Home Infusion
GlaxoSmithKline
Boostrix, Bexsero, Engerix-B, Havrix, Hiberix, Infanrix, Kinrix, Menveo, Menhibrix, Pediarix, Rotarix, Rabvert, Twinrix, Fluarix, Flulaval
07/01/17 – 06/30/18
Retail
Purdue Pharma
Hysingla ER, Butrans
07/01/17 – 06/30/18
Long-Term Care, Home Infusion
Insight
CONTRACT UPDATES
New Innovatix/Premier Contracts
(alphabetical by contract category)
CONTRACT CATEGORY
CONTRACT ID CONTRACT TITLE
SUPPLIER
Administrative, Financial, and Management Services
PP-SV-168
Vehicle Rental Services
Hertz
Facility Management and Maintenance
PP-FA-606
Paper and Janitorial Supply Distribution
Afflink
PP-FA-607
Paper and Janitorial Supply Distribution
Network Services Company
PP-FA-608
Paper and Janitorial Supply Distribution
Office Depot
PP-FA-609
Paper and Janitorial Supply Distribution
Strategic Market Alliance
PP-FA-610
Paper and Janitorial Supply Distribution
SupplyWorks
PP-FA-611
Paper and Janitorial Supply Distribution
Triple S
PP-FA-612
Paper and Janitorial Supply Distribution
Veritiv
PP-IT-163
Hardware and Software Resellers
CDW
PP-IT-166
Hardware and Software Resellers
Insight
PP-IT-164
Hardware and Software Resellers
PC Connection
PP-IT-165
Hardware and Software Resellers
Zones
PP-LA-451
Blood Gas Analyzers, Reagents, Consumables, and Service
Nova Biomedical
PP-LA-452
Blood Gas Analyzers, Reagents, Consumables, and Service
Siemens Healthcare Diagnostics
PP-LA-453
Blood Gas Analyzers, Reagents, Consumables, and Service
Werfen
PP-LA-448
Manual Microbiology
Becton, Dickinson
PP-LA-447
Manual Microbiology
Remel
PP-LA-450
Microbiology Automation
bioMerieux
PP-LA-449
Microbiology Automation
Remel
PP-LA-454
Molecular Analyzers, Reagents, Consumables, and Service
Abbott Laboratories
PP-LA-455
Molecular Analyzers, Reagents, Consumables, and Service
Roche Diagnostics
PP-LA-456
Molecular Rapid Qualitative Screening
Becton, Dickinson
PP-LA-457
Molecular Rapid Qualitative Screening
Luminex
PP-LA-458
Molecular Rapid Qualitative Screening
Meridian Bioscience
PP-LA-459
Near Patient Testing (NPT), Clinical Chemistry/ Immunoassay
bioMerieux
PP-LA-460
Near Patient Testing (NPT), Clinical Chemistry/ Immunoassay
Siemens Healthcare Diagnostics
Information Technology
Laboratory
Innovatix | innovatix.com 31
CONTRACT UPDATES
New Innovatix/Premier Contracts CONTRACT CATEGORY
CONTRACT ID CONTRACT TITLE
SUPPLIER
Materials Management
IE-MM-020
Office Print Services
FedEx
Medical and Surgical Products
IE-MS-029
Incontinence Products
First Quality Enterprises
IE-MS-030
Negative Wound Pressure Therapy (Portable Devices)
Smith & Nephew
IE-MS-031
Occupational, Sensory, Memory Care, Arts and Craft Products
SOAR Life Products
PP-MM-601
Patient Scales
Detecto Scale Company
PP-MM-602
Patient Scales
Health o meter Professional Scales
PP-MM-603
Patient Scales
Seca
PP-NS-1087
Dialysis Products and Accessories
Angiodynamics
PP-NS-1093
Dialysis Products and Accessories
Arrow
PP-NS-1088
Dialysis Products and Accessories
B. Braun
PP-NS-1089
Dialysis Products and Accessories
Bard Access System
PP-NS-1090
Dialysis Products and Accessories
Bard Peripheral Vascular
PP-NS-1092
Dialysis Products and Accessories
Covidien
PP-NS-1091
Dialysis Products and Accessories
Medical Components
PP-NS-1082
ECG Electrodes, Cables, Lead Wires, and Defibrillator Pads
Covidien
PP-NS-1083
ECG Electrodes, Cables, Lead Wires, and Defibrillator Pads
Lifesync
PP-NS-1095
Neonatal Development Products
DandleLION Medical
PP-NS-1098
Neonatal Specialty Products
Covidien
PP-NS-1096
Neonatal Specialty Products
Kentec Medical
PP-NS-1097
Neonatal Specialty Products
Medela
PP-NS-1099
Neonatal Specialty Products
NeoMed
PP-NS-1085
Soaps, Lotions, and Waterless Hand Rinses
DebMed
PP-NS-1084
Soaps, Lotions, and Waterless Hand Rinses
Ecolab
PP-NS-1086
Soaps, Lotions, and Waterless Hand Rinses
GOJO
IN-SS-020
Accreditation Services
Accreditation Commission for Health Care
IE-SS-019
After Hours Answering Service
PATLive
IE-HR-014
Expense Management Software Solutions
Concur Technologies
Nursing
Purchased Services
32 |
(alphabetical by contract category)
Insight
Trade Show Corner UPCOMING EVENTS Visit Innovatix staff at any of these events OCTOBER
14–18
OCTOBER
15–18
OCTOBER
23–26
OCTOBER
24–25
NOVEMBER
2–5
NOVEMBER
6–8
NOVEMBER
12–15
National Community Pharmacists Association (NCPA) Annual Convention | Orlando, FL American Health Care Association (ACHC) & National Center for Assisted Living (NCAL) 68th Annual Convention & Expo | Las Vegas, NV LifeSpan Network (LifeSpan) & Health Facilities Association of Maryland (HFAM) 2017 Annual Conference | Ocean City, MD
Georgia Senior Living Association (GSLA) 2017 Conference & Trade Show | Duluth, GA American Society of Consultant Pharmacy (ASCP) Annual Meeting & Exhibition | Kissimmee, FL California Assisted Living Association (CALA) 2017 Fall Conference & Trade Show | Rancho Mirage, CA
California Association of Health Facilities (CAHF) 67th Annual Convention & Expo | Palm Springs, CA
For more information, contact your Client Service Associate at 888.258.3273.
Innovatix | innovatix.com 33
Save the Date NATIONAL
MEETING
&
EXPO
2018
S H E R AT O N G R A N D C H I C AG O OCTOBER 10–12, 2018
+ P R E M I E R I N C . C O M PA N I E S
Make plans to join us in Chicago, IL, October 10 – 12, for three days of interactive learning, networking, and business development. 34 |
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