Insight_2017_Issue 1_Innovatix

Innovatix | Issue 1 | 2017

Analyze This:

Realizing the Potential for Savings Through Purchasing Analytics Profit Expenses

PLUS

Pharmacists + Nurses: Earn CE credits by completing the program in this issue.

Innovatix | innovatix.com 1

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 Assistant Director, Corporate Communications

DESIGNER

Jaclyn Alvarado Creative Director J2 Design NYC, Inc.

COPY EDITOR Tina Harlan

LAYOUT EDITOR Laura F. Yandell

CONTRIBUTORS

Table of Contents Issue 1 | 2017

1

Welcome Letter

2

Analyze This: Realizing the Potential for Savings Through Purchasing Analytics

6

Old Friends, New Trends: Emerging PBM Strategies for Specialty Pharmacies

10

Six Factors Influencing Food and Supply Costs

12

Remain a Medicare Provider in Good Standing: Initiate Regular Self-Audits

14

Continuing Education: Rethinking Warfarin: Time To Change the Dose or Change the Drug?

21 24

Clinical Corner: Inflectra®

2 |

Contract Updates

Insight

Paul Childers Leigh Davitian, JD Gary Feit, MS Robert G. Richardt, MS, RPh Eric Rodriguez Sylvia Thomas, PharmD, MS, BCPS Innovatix 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 erodriguez@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, Over my 30 years in the healthcare sector, I’ve observed that the most successful organizations and leaders are those most willing to change and adapt. But change is hard. It’s uncomfortable and inconvenient. Often our first inclination is to resist. Ironically, change is also the one constant we should come to expect. The healthcare industry evolves rapidly, which is why our future success depends on our ability to effectively navigate change.

At Innovatix, our goal is to enable our members to stay ahead of the never-ending changes taking place in our industry. We have transitioned from a price-based focus to one that encompasses an intelligent purchasing strategy accompanied by demonstrated operational expertise.

One of the keys to our evolution has been our unique ability to analyze member purchasing, compare it to industry standards, and deliver tangible recommendations for cost savings. I encourage you to review this issue’s cover story, “Analyze This: Realizing the Potential for Savings through Purchasing Analytics,” to learn how your organization can begin harnessing the power of its purchasing data to achieve greater savings and more effective spend management.

Our suite of pharmacy operations improvement programs also continues to evolve with the launch of Innovatix Credentialing Counsel, our new solution for specialty pharmacies facing increasingly stringent requirements from payers. If your pharmacy has been challenged by narrowing payer networks or changes to your third-party payer contracts, please see page six for an in-depth review of emerging specialty pharmacy PBM strategies.

In addition, our members are dealing with a regulatory environment that includes both new policies and new technologies. In response, this issue features an article from our Government Affairs team on the government’s enhanced scrutiny of Medicare providers and the importance of conducting self-audits to avoid fraud, abuse, waste, and errors.

Finally, I want to take this opportunity to discuss another very exciting change at Innovatix—our recent acquisition by Premier. Over the past few months, many of you have expressed your support for this union between two entities that were already so closely intertwined. I appreciate your support and share your confidence. Moving forward, Innovatix will be leading Premier’s continuum of care strategy and business. With our combined strengths and resources, we will be even more effective and competitive in the marketplace. Together, we will take our contract portfolios, solutions, and services to the next level to help you evolve and grow with the times.

As always, I hope you find this issue of Insight informative and enjoyable.

Sincerely,

John P. Sganga, FACHE President & CEO, Innovatix P.S. Please don’t forget to visit www.innovatix.com and register for the 2017 Innovatix + Essensa National Meeting & Expo. This year’s meeting will be held October 9 –11 at the Hilton Austin Hotel in Austin, TX. You’ll not only find the outstanding networking opportunities and educational programming you’ve come to expect, but also some exciting new features and engaging speakers, including our guest keynote speaker, Jay Leno. I look forward to seeing you there!

Innovatix | innovatix.com 1

Analyze This: Realizing the Potential for Savings Through Purchasing Analytics

By Gary Feit, MS, vice president, corporate communications

B

usinesses today face ever-increasing pressures that force them to operate with tight margins and an eye on the bottom line. This is especially true in healthcare, where an evolving regulatory landscape, changing reimbursement models, and an uncertain future result in scrutiny of every dollar.

Under such precarious financial conditions, new cost-reduction options become critically important.

Purchasing is one area that’s often rife with savings potential—yet healthcare has lagged in using purchasing analytics in the same fashion as it has leveraged clinical data to optimize decision making.

Without the 360-degree view that purchasing analytics provides, managers risk making uninformed spending decisions that can leave thousands of dollars on the table. Fortunately, solutions are available to help collect, evaluate, and monetize purchasing data.

2 |

Insight

Surveying the field Last fall, Innovatix commissioned a survey of more than 80 high-level procurement executives at organizations throughout the U.S. Participants represented a cross section of industries, including healthcare, consumer products, and manufacturing, among others.

The goal of the study was to better understand purchasing trends, challenges, and best practices from the perspective of leading professionals.

One clear take-away from the survey is the need for better purchasing analytics and benchmarking. While respondents largely indicated that purchasing and procurement are becoming more strategic functions within their organizations, the value is limited without improved analytics. Incorporating analytics can improve the bottom line while helping those responsible for purchasing demonstrate superior results.

“We’re always trying to aim for a more calibrated and strategic approach to our purchasing spend,” says Tim Dougherty, director of procurement—Americas at DP DHL. “We want to leverage as much as we can back to the market, so that we can drive the best price based on volumes and establish a strategic level of partnership with our selected vendors. The fact of the matter is that a lot of purchasing is done ad hoc.”

Some of the survey questions and responses shed light on the challenges and opportunities for businesses to incorporate purchasing analytics.

Notably, 80 percent of survey respondents indicate that they understand the importance of purchasing analytics but are not yet incorporating them as effectively as they need to. (See Figure 1.) And for those who are using analytics to guide their purchasing decisions to some extent, 74 percent indicate they have significant room for improvement. By contrast, only one in 10 respondents strongly agrees that they excel at analytics, and another 31 percent agree that their analytics are where they should be.

Only 15 percent of respondents use third-party data from suppliers to benchmark their purchasing, while an additional 11 percent incorporate published pricing information to some extent.

Figure 1: Incorporation of purchasing analytics To what extent do you agree or disagree with the following statements Disagree We are not interested in procurement analytics Procurement analytics is a distant goal

Somewhat disagree

Agree

Strongly agree

56% 22%

13%

9%

28% 27%

35%

10%

58%

22%

47%

27%

31%

10%

We understand the importance of analytics, but are not executing to 4% 16% our full potential Our procurement analytics have significant 4% 22% room for improvement We excel at procurement analytics 19% 40%

Purchasing professionals desire stronger analytics, and most feel they have vast room to improve in this area.

Figure 2: Benchmarking purchasing spend How does your company benchmark its spending in indirect categories?

49% Review year-over-year company spending data within categories 16% We do not benchmark spending in indirect categories 15% Use data supplied by vendor or outside sources to determine category spending

11% Spot check spending in some or all categories vs. published pricing information 9% Other

Most businesses rely on internal data only to benchmark their purchasing spend.

(See Figure 2.) By far the most common strategy for benchmarking spending is reviewing year-over-year internal data, on which 49 percent of respondents rely. By failing to incorporate external data, these businesses limit their ability to accurately assess their purchasing programs in the context of the broader marketplace and are effectively blindly negotiating pricing with suppliers.

According to DP DHL’s Dougherty, “Most people in the industry are still looking for that magic bullet that provides a full solution for their benchmarking.” He believes that organizations need to look beyond internal data to make progress

toward this goal, since “stakeholders are becoming less concerned with historical volumes and more concerned with forecasting and what they can expect in regards to their bottom line.”

To validate savings achieved through supplier contracts, a business must ensure that it’s receiving products and services at the contracted rates. Only 40 percent of survey respondents indicate that their business has such a system in place. (See Figure 3.) And a quarter of respondents have no formal savings methodology at all, making it challenging for them to have any perspective into the success of their purchasing program.

Figure 3: Calculating savings What methodology does your organization have in place to calculate savings related to your procurement: 44%

Standard company-wide guidelines

40%

Audit, analyze, and validate savings

25% No formal savings methodology used

20% Key finance ratios

3%

3%

Not Applicable.

We don’t calculate savings.

Others

A minority of businesses rely on auditing procedures to validate savings achieved through purchasing.

Innovatix | innovatix.com 3

SHOW US YOUR

SPENDING . . . . . . AND WE’LL SHOW

YOU THE SAVINGS! Innovatix has launched a new campaign to make it easier than ever for members to share the purchasing information necessary for a spending analysis. Further, we’ve identified a combined $50 million in member savings through analyses performed last year.

Savings average more than 6 percent of total purchasing spend and can be as high as 40 percent in some categories.

The simple, four-step process works like this:

1. Contact an Innovatix representative or visit Innovatix.com/ showyourspending to get started.

2. Receive instruction for working with purchasing and accounting staff to gather purchasing records (AP files).

3. Review the customized analysis from Innovatix showing current, category-specific spending and potential savings available by using Innovatix suppliers and contracts.

GPOs to the rescue Based on the survey results, many organizations clearly have much room to improve their use of analytics to achieve better purchasing value. One of the first hurdles to clear is collecting and organizing internal spending data in a way that allows for analysis against external pricing and spending benchmarks. This is where a group purchasing organization (GPO)—such as Innovatix—can be an invaluable ally.

While GPOs have historically provided their members with access to better pricing through supplier contracts based on aggregated purchasing volume, their abilities have expanded significantly over the years. Innovatix, for example, has evolved to take a consultative approach, offering in-depth analytics to guide members’ purchasing decisions.

The key is data. As a GPO serving thousands of members, Innovatix has access to purchasing data across industries and spend categories. Innovatix also has access to supplier pricing through contracts that encompass tens of thousands of products and services. Together, this information gives Innovatix the ability to analyze members’ purchasing in a way that they likely would not be able to do on their own.

Shrewd purchasing professionals are learning how GPOs can help them find better value through analytics. “Any savvy company using a GPO has to be asking the question, ‘What’s the value add that I’m getting?’ It’s up to the GPOs to communicate that,” says Joanna Martinez, former executive managing director and chief procurement officer at Cushman & Wakefield. “The good thing about GPOs is that they often have data that companies don’t because they don’t take the time to gather it, or they don’t ask participating suppliers to provide it.”

A full set of tools 4. Begin to use Innovatix contracts for your purchasing in the categories with maximum savings potential.

This is a free, no-obligation analysis. All information provided to Innovatix is strictly confidential. innovatix.com/showyourspending 4 |

Insight

Once a business has determined that it can benefit from better purchasing analysis and benchmarking, it must determine what a particular GPO can offer. In the case of Innovatix, the answer is detailed, customized reporting, delivered by a representative who can help interpret the numbers and turn them into a purchasing strategy designed to hit a defined savings target.

An Innovatix spend analysis is a prime example. First, Innovatix works with a member to gather purchasing records across various categories. Then Innovatix provides a detailed analysis that breaks down spend by category—while identifying savings available by using different suppliers and contracts. (See Figure 4.)

Innovatix can conduct this analysis across a member’s entire purchasing function or within a specific category.

The benefit of this analysis lies in its ability to show where an organization is receiving good value for its purchasing dollars and where there is room for improvement. “It lets our members know where they stand,” says Cynthia Radford, senior vice president, customer care at Innovatix. “Once we present the data, we can then help our members achieve their specific budgetary goals.”

While serving a range of members, Innovatix can also zero in on information that is pertinent to a specific industry. For pharmacies and other healthcare organizations that purchase drugs, Innovatix produces Contract Advantage Tools, which: • Compare two or more drugs used to treat a medical condition; and • Look at clinical (FDA indications, dosing, and similar data) and financial information across numerous data points (reimbursement estimates, pricing with and without contracted rates, projected profit and savings, and more).

Members can then use the comparison to make smarter purchasing decisions, and at the same time, gain insight into reimbursement that can be useful in payer negotiations. (See Figure 5.)

At your fingertips With the support of a GPO such as Innovatix, purchasing analytics need not be a distant goal for businesses that want to rely on data to increase savings and add value. With advances in technology come new opportunities for smarter purchasing. For example, Innovatix 24/7 is a new web-based application that allows GPO members to access customized lists of suggested contracts based on a facility’s specific purchasing history. It also provides purchasing data from industry peers. With greater pressure to produce savings across all operational areas, those responsible for purchasing are increasingly turning to analytics for strategic guidance.

Figure 4: Sample spend analysis Demo HS Purchased Services Number of Rows

Number of Vendors

INITIAL FILE (excludes vendors with total spend below $5,000)

57,930

1,351

$3,585,369,041

CATEGORIZED SPEND

55,906

1,249

$3,119,271,065

87%

UNCATEGORIZED SPEND

2,024

102

$466,097,976

13%

Savings Summary

Potential Savings (for Top Level 2 categories)

Total Spend

% of Total

Report key: indicates these categories are the easiest projects, quick data collection indicates these categories are moderately complex and may require writing service line agreements prior to a RFP event

$7,132,200 $19,933,145

indicates these categories are very complex and result in contracts that could be difficult to manage, require service line agreements and involve multiple stakeholders

$10,000,014

Demo HS Purchased Services Summary - Facilities Level 2 category

Spend

Vendor Count

Savings Range Low

Savings Range High

Savings Average

Potential Savings

Difficulty Level

Premier Contract

$36,435,552

141

CONSTRUCTION SERVICES

$18,795,579

21

5.0%

15.0%

10.0%

$1,879,558

YES

POWER AND ELECTRIC SERVICES

$4,609,435

15

8.0%

16.0%

12.0%

$553,132

NO

INTERIOR DESIGN AND SERVICES

$2,918,406

9

5.0%

18.0%

11.5%

$335,617

NO

GENERAL FACILITIES SERVICES

$2,507,225

13

8.0%

16.0%

12.0%

$300,867

NO

ENERGY EFFICIENCY SERVICES

$2,202,634

3

5.0%

10.0%

7.5%

$165,198

YES

HVAC EQUIPMENT CONTROL AND SERVICES

$1,031,483

12

3.0%

10.0%

6.5%

$67,046

YES

MAINTENANCE REPAIR AND OPERATIONS

$724,679

14

3.0%

10.0%

6.5%

$47,104

NO

HOUSEKEEPING AND JANITORIAL SERVICES

$705,892

4

8.0%

16.0%

12.0%

$84,707

YES

LAUNDRY PRODUCTS AND SERVICES

$477,475

2

3.0%

10.0%

6.5%

$31,036

YES

FIRE, LIFE SAFETY, SECURITY SYSTEMS

$431,595

5

8.0%

16.0%

12.0%

$51,791

YES

OTHERS

$2,031,149

43

Facilities Category Breakdown

$3,694,386

$178,330

51.6% Construction Services 12.7% Power and Electric Services 8.0% Interior Design and Services 6.9% General Facilities Services 6.0% Energy Efficiency Services HVAC Equipment Controls and Services 2.8% 2.0% Maintenance Repair and Operations Housekeeping and Janitorial Services 1.9% 1.3% Laundry Products and Services Fire, Life Safety, Security Systems and Services 1.2% Others 5.6%

Figure 5: Sample Contract Advantage Tool

Innovatix | innovatix.com 5

Old Friends, New Trends:

Emerging PBM Strategies for Specialty Pharmacies

By Eric Rodriguez, assistant director, corporate communications

C

omplex, novel, and costly specialty drugs continue to enter the U.S. healthcare market at a rapid rate. In many cases, these drugs offer meaningful therapeutic advances over existing treatments and give hope to patients with rare and chronic illnesses who’ve historically had few treatment options.

As the cost of these medications consume an increasing proportion of healthcare expenditures, payers and pharmacy benefit managers (PBMs) have adopted a diverse range of tactics for contracting with specialty pharmacies. From “closed” networks to heightened credentialing requirements, today’s specialty pharmacies face an intricate web of contracting choices and challenges.

6 |

Insight

The specialty pipeline and the financial impact of specialty drugs Specialty drugs are one of the fastest-growing areas of healthcare spending.

Although there are a range of possible trajectories for specialty spending growth, estimates suggest it could reach nearly $400 billion, or 9.1 percent of national healthcare spending, by 2020.1 The pharmaceutical pipeline reflects this projection, as 40 percent of the products currently under development are considered specialty drugs.2 The spending implications are substantial. According to one of the nation’s largest PBMs, specialty drugs currently account for less than 1 percent of U.S. prescriptions but approximately one-third of prescription drug spending.3 Some healthcare industry analysts predict that specialty drugs could be responsible for 50 percent of all annual prescription drug costs by 2018.4 To date, the rapid increases in specialty spending have been driven largely by price inflation. However, utilization is starting to play a greater role as manufacturers develop specialty drugs for more common conditions such as high cholesterol. (See Figure 1.)

Specialty pharmacies see these trends as growth opportunities, while payers perceive them as a challenge. Many chain pharmacies are already in the specialty space, and a growing number of other pharmacies are also hoping to secure a share of the market. As more providers enter the specialty sector, payers, and the PBMs with which they contract, are demanding more evidence that their patients are receiving a high quality of care that will ultimately lead to cost-savings.

The role of PBMs Based on the growth in the specialty market, payers are eager to determine the total cost of care for conditions that require specialty drugs and establish guidelines to ensure their proper use.

To accomplish this, payers rely on thirdparty administrators, known as PBMs, to manage prescription drug programs on

Figure 1: Target conditions for specialty drug treatment5 Condition HEPATITIS C ALZHEIMER’S DISEASE ONCOLOGY INFLAMMATORY DISORDERS HIGH CHOLESTEROL

U.S. patient population 3.2 million 5.4 million 14 million 24–50 million 71 million

behalf of their beneficiaries.6 According to the Pharmaceutical Care Management Association (PCMA), PBMs currently administer drug plans for more than 266 million Americans.7

Trends in PBM contracting strategies for specialty pharmacies To tame specialty drug spending, PBMs have begun using more intense and restrictive utilization techniques. Some PBMs now identify pharmacies as primarily specialty pharmacies and indicate that they are no longer eligible for standard retail pharmacy network reimbursement rates.

According to James Vasquenza, Jr., vice president, Innovatix Preferred Provider Network, “Some pharmacies have even been presented with network amendments or reimbursement addendums with rates that are 3-5 percent lower than retail rates, with little to no dispensing fees.”

How do PBMs define a specialty pharmacy?

How PBMs define a specialty pharmacy continues to change as the specialty drug pipeline evolves.8 The PCMA says a specialty drug possesses any of these common attributes.9 • Prescribed for a person with a complex or chronic medical condition, defined as a physical, behavioral, or developmental condition that may have no known cure, is progressive, and/or is debilitating or fatal if left untreated or under-treated; • Treats rare or orphan disease indications; • Requires additional patient education, adherence, and support beyond traditional dispensing activities; • Is an oral, injectable, inhalable, or infusible drug product; • Has a high monthly cost (over $600 a month);

Estimated treatment costs (per patient) $100,000 per course of therapy $35,000 annually >$100,000 annually >$50,000 annually $10,000 annually

• Has unique storage or shipment requirements, such as refrigeration; and • Is not stocked at a majority of retail pharmacies.

“While some PBMs have very broad definitions, others have none and instead rely on constantly updated drug lists,” explains Vasquenza. “The way specialty pharmacy is defined is particularly important as it dictates not only the type of contractual arrangement that exists between a pharmacy and PBM, but also the type of credentialing requirements a pharmacy must meet.”

Growth of narrow specialty pharmacy networks Specialty pharmacies are also impacted by the narrowing of PBM-managed specialty pharmacy networks.10 A PBMmanaged specialty pharmacy network consists of pharmacies that have entered into an agreement with a PBM to dispense specialty drugs to payer enrollees. By contracting with select pharmacies, PBMs are able to deliver consistency and quality care management across their networks while also controlling costs in the specialty channel.11

The trend toward heightened credentialing requirements Historically, PBMs employed “closed” specialty networks that would route as many specialty drugs as possible to their wholly owned mail order specialty pharmacies. As time went on, PBMs began letting specialty pharmacies into Medicare Part D networks but not necessarily into commercial networks. “After a series of rebukes by the CMS, PBMs began to recognize the applicability of the Part D Any Willing Provider Law,” explains Vasquenza. More recently, some PBMs have begun to identify specialty Innovatix | innovatix.com 7

Introducing

Innovatix Credentialing Counsel Innovatix Credentialing Counsel is our new solution for specialty pharmacies facing PBM credentialing challenges. As part of our suite of pharmacy operations improvement programs, this service provides guidance for each task required to achieve specialty credentialing and helps users navigate the evolving PBM specialty landscape.

Innovatix offers specialty pharmacies two levels of support to meet specific needs and available time.

pharmacies based on the volume of claims submissions for specialty drugs and have used this as an opportunity to apply newer, lower reimbursement rates for commercial plans. Other PBMs have begun creating “open” specialty networks, with heightened credentialing requirements.

While these new credentialing requirements provide the means for PBMs to validate that a pharmacy is compliant with applicable laws, they can be taxing for smaller or independent pharmacies. “Many seek high application or processing fees, as much as $3,000, and contain an onsite inspection requirement,” says Vasquenza.

In a LEVEL ONE engagement, Innovatix provides the following services:

requirements involves an investment of

- Pharmacy assessment;

fees. Recently introduced requirements

- Credentialing education; - Application guidance; - Document collection; - Weekly or monthly touchpoints; - Application submission; and

Meeting

specialty

credentialing

time and money beyond any such direct include: • Proof of accreditation from at least one of three specifically named organizations (ACHC, URAC, TJC); • Higher insurance coverage; • Detailed reporting of all specialty

medications dispensed within 12 months (by therapy class and AWP volume); • A business continuity and/or disaster recovery plan; and • Policies and procedures confirming access and communication.

Specialty pharmacies adding value As specialty pharmacy continues to grow, and new drugs enter the market, payers will continue to change strategies surrounding specialty pharmacy utilization and cost. Specialty pharmacies must improve service offerings, particularly medication therapy management and patient adherence programs, to demonstrate to payers that their patients are receiving quality care. Vasquenza sums it up: “Now, more than ever, it’s important that specialty pharmacies know the type of contract they have, want to have, and could have with their PBMs. More importantly, they need to proactively take steps to ensure their organization can meet these new credentialing requirements in the event they are presented with them.”

- Simulated onsite review.

A LEVEL TWO engagement is more comprehensive, with Innovatix experts providing two additional services: - Policy creation; and - Full access to the Innovatix Accreditation Advisory Services (IAAS) program, which supports pharmacies seeking recognition from various accrediting bodies.

Innovatix is a URACaccredited pharmacy education and training organization.

Want to learn more?

Please contact April Mohr at amohr@innovatix.com or visit innovatix.com/credentialing.

8 |

Insight

REFERENCES 1. G. Bennett, “PBM Tools Play Key Role in Managing Specialty Drug Costs,” The American Journal of Pharmacy Benefits, February 15, 2016, http://www.ajpb.com/articles/pharmacy-benefit-managertools-play-key-role-in-managing-specialty-drug-costs?p=1 (accessed March 25, 2017).

2. J. Kerr, “Employers becoming more savvy about specialty pharmacy, but need more cost controls,” Health Leaders InterStudy, February 6, 2013, http://hl-isy.com/Healthcare-Reform-Blog/ February-2013/Employers-specialty-drugs-pharmacy-benefits-020613 (accessed March 25, 2017).

3. 2016 Drug Trend Report, “U.S. Rx Spending Increased 13.1% in 2014,” Express Scripts Holding Company, February 24, 2017, http://lab.express-scripts.com/lab/insights/industry-updates/us-rxspending-increased-13-percent-in-2014 (accessed March 25, 2017).

4. G. Bennett, “PBM Tools Play Key Role in Managing Specialty Drug Costs,” The American Journal of Pharmacy Benefits, February 15, 2016, http://www.ajpb.com/articles/pharmacy-benefit-managertools-play-key-role-in-managing-specialty-drug-costs?p=1 (accessed March 25, 2017).

5. Ibid.

6. What is a PBM?, National Community Pharmacists Association, http://www.ncpanet.org/ advocacy/pbm-resources/what-is-a-pbm- (accessed March 25, 2017).

7. “About PCMA,” Pharmaceutical Care Management Association, https://www.pcmanet.org/about/ (accessed March 25, 2017).

8. J. Sederstrom, “Pathways to specialty: How to gain a foothold in a field dominated by ESRX, CVS, WAG,” Drug Topics, July 10, 2014, http://drugtopics.modernmedicine.com/drug-topics/content/ tags/hospital-pharmacy/pathways-specialty-pharmacy?page=full (accessed March 27, 2017).

9. “What is a specialty drug?,” Pharmaceutical Care Management Association, https://www.pcmanet. org/pcma-cardstack/what-is-a-specialty-drug/ (accessed March 27, 2017).

10. A. Garcia, “Growing a Specialty Pharmacy Business Represents Opportunity for Today’s Pharmacy Operation,” Specialty Pharmacy Times, August 20, 2012, https://www. specialtypharmacytimes.com/publications/specialty-pharmacy-times/2012/august-2012/ growing-a-specialty-pharmacy-business-represents-opportunity-for-todays-pharmacy-operation (accessed March 27, 2017).

11. “What is a specialty pharmacy network?,” Pharmaceutical Care Management Association, https://www.pcmanet.org/pcma-cardstack/what-is-a-specialty-pharmacy-network/ (accessed March 27, 2017).

Expect More from your GPO

Innovatix member benefits extend beyond the significant savings we provide. While group purchasing is at the core of what we do, Innovatix is committed to developing programs that help our members grow and excel.

Our suite of pharmacy operations improvement programs are designed to address your operations needs without distracting from your main mission— providing high-quality patient care.

Innovatix Suite of Pharmacy Operations Improvement Programs

CREDENTIALING COUNSEL

Get hands-on support to help achieve recognition from accrediting bodies.

Obtain guidance and clarity on specialty pharmacy credentialing and the evolving payer landscape.

Remove the barriers to serving your patients’ specialty needs.

Navigate the Medicare Part D arena effectively and save on claims.

Use the industry’s most complete tool for accurate and reliable reimbursement services.

To learn more about our suite of pharmacy operations improvement programs, visit us at Innovatix.com, email info@innovatix.com, or call 888.258.3273.

Innovatix | innovatix.com 9

Six Factors Influencing Food and Supply Costs

By Paul Childers, director, national sales, business solutions, US Foods

I

ncreasingly, savvy senior living providers are managing expenses—while maintaining quality—by focusing on the high-cost areas of food and supplies.

Six factors, in particular, can leverage spending and increase margins, both within foodservice and throughout the facility as a whole.

10 |

Insight

1

The menu is the central component of a senior living facility’s foodservice program and is the foundation for purchasing, staffing, and operating requirements. Continual evaluation of a community’s menu and the nutritional needs of its residents is vitally important.

One approach is creating an in-house focus group that meets regularly, assesses operations, and makes recommendations. At the same time, it’s necessary to develop and manage a food and supply budget that aligns with the community’s financial objectives. US Foods has worked to reconcile these two areas by developing popular menus that meet the budget requirements of skilled nursing, assisted living, and other senior living communities, based on the needs of their clients.

Recipes are the cornerstone of a well-designed menu. Properly developed recipes allow providers to meet cost objectives and nutritional requirements of a specific resident population.

When possible, senior living facilities should develop recipes with the help of a registered dietitian who can ensure compliance with all applicable nutritional regulations.

Keeping an eye on the cost of ingredients in each recipe, while time consuming, will pay dividends in the long run. Facilities should consider their available production labor and level of expertise when deciding on the right mix of convenience items and in-house preparation. The availability of equipment and storage space also influences recipe development.

Once a provider has created daily menus and recipes, foodservice managers must hold their teams accountable for following the guidelines set forth.

Production and portion control are other critical components of a well-run food service operation focused on balancing costs and resident satisfaction. Production sheets should accompany the daily recipes and clearly detail the amount of product to be produced and the correct portion sizes.

Consistently using production sheets and recording the information will help the operator understand the popularity of food items and how frequently overproduction occurs.

Waste, whether from overproduction or poor production skills, can lead to high food costs. Rates for unnecessary foodservice waste typically range from 3-6 percent, and it can account for as

2

3

4

much as 3 percent of food cost.

Managers can begin to make adjustments to production and menu items by working with staff to evaluate leftovers and waste on a meal-by-meal basis. Waste is measured based on the recipe and ingredient cost. Routine waste measurement increases awareness of issues such as overproduction, poor production technique, and recipe compliance. Reducing waste is often a matter of changing kitchen behaviors.

Purchasing and buying habits have a definitive impact on food and supply expense. It’s important to understand both a product’s application and how it works within a menu.

Senior living providers that use a group purchasing organization (GPO), such as Innovatix, should take advantage of available nationally negotiated contracts and participate fully to optimize benefits. The program, coupled with US Foods’ scale, ensures providers receive the best value at the best price.

These programs often return double-digit savings, and some suppliers offer additional rebates, including one-time, product-specific, and volume promotions.

Operators can work with distributors to take advantage of all the incentives available while learning about new contracts, products, and concepts.

Services can also contribute to high costs, so it’s important that administrators make informed buying decisions.

Foodservice directors and facility leadership should have ongoing conversations to evaluate (and change, if necessary) services based on costs and outcomes.

Services that can contribute to higher costs include:

5

6

• Snack and hydration carts; • Floor stock; • Catering; • Free meals and beverages; • Birthdays and other special events; • Holiday meals; and • Employee recognition ceremonies.

For example, a free coffee program in a senior living community that serves 200 cups a day can cost up to $18,000 over the course of a year.

As this scenario illustrates, even the smallest decision may have a major impact on total operating expenses.

Understanding the factors that drive costs will enable providers to make sound financial decisions, control expenses, and maintain (or improve) resident satisfaction.

US Foods Inc., a national food distributor (Rosemont, IL), with more than 20 years of experience in delivering cost-management solutions, offers tips to help senior living providers keep costs down.

Tools At Your Service Menu management to meet your needs

Understanding residents’ preferences is a key factor in managing inventory, production, and waste. Well-crafted menus ensure a facility meets residents’ needs while controlling costs.

To help senior living facilities meet these goals, registered dietitians have developed the US Foods Blue Print Menu Management System®. The system is a comprehensive, web-based solution for providers such as: • Retirement communities; • Assisted living centers; • Adult day cares; and • Nursing homes/long-term care facilities.

The BluePrint Menu Management System is fully integrated, with product-specific information. Capabilities include cost reporting, online recipe creation and modification, linking therapeutic diets and nutritionals, and multi-facility menu planning.

Using technology to measure waste

US Foods has entered into a partnership with LeanPath® to help senior living providers track waste and its associated costs. LeanPath uses scales and fully integrated software to more accurately measure and correct for post-meal food waste.

Improve efficiency, increase revenue

The US Foods Legacy® portfolio of tools and processes is a value-added service to help senior living providers reduce foodservice operating expenses and improve efficiency, ultimately leading to increased revenue.

Knowledgeable healthcare experts help implement the portfolio, which was designed by other senior living providers based on their collective challenges.

For a free operational assessment or to learn more, please email Legacy@usfoods.com.

Innovatix | innovatix.com 11

Remain a Medicare Provider in Good Standing: Initiate Regular Self-Audits

By Leigh Davitian, JD, founder & CEO, Dumbarton Group & Associates

A

ny Medicare provider must face a tedious vetting process to formally take part in the government’s largest healthcare programs, Medicare and Medicaid. No matter the type of provider —physician, nurse practitioner, pharmacy, nursing home, or durable equipment supply company—each must undergo a lengthy process before gaining approval to provide services to beneficiaries and receive payment.

With the passage of the Patient Protection and Affordable Care Act of 2010, the government instituted many aggressive regulations to ensure Medicare providers remain compliant and avoid all forms of fraud, abuse, waste, and errors.

Given these changes, providers that expect to remain a part of Medicare must be proactive and vigilant.

The process steps include:

Over the past 15 years, the fraudulent and abusive practices of some providers have cost the Medicare Trust Fund billions of dollars. Examples of abusive practices include billing for services that were not performed, ordering excessive or inappropriate tests, falsifying a diagnosis, and prescribing medicines that are not medically necessary.

• Obtaining a unique national provider identifier; • Undergoing eligibility tests to meet conditions of participation; • Completing an extensive enrollment application; and • Enrolling in elaborate electronic data submission protocols.

For decades, providers that met enrollment requirements could remain in the program assuming they complied with state and federal requirements (that were rarely enforced). Today, that is no longer the case.

12 |

Insight

Enhanced scrutiny of Medicare providers

The dishonest actions of a few providers have heightened government scrutiny of the entire Medicare provider community. In response, the government has increased aggressive investigations, enhanced screening and enrollment requirements (including database mining

and unscheduled site visits), and has even imposed a temporary moratorium on new providers in some states.

Providers are understandably asking how they can avoid government enforcement efforts and inspections—and how to determine if they are fully compliant with ever-changing regulatory requirements.

One option that has proven to be a lifeline to many honest Medicare providers is proactive monitoring, including an internal self-audit.

What is a self-audit and why is it important?

A self-audit is an examination, review, or other inspection performed by and within a healthcare professional’s business.

Self-audits generally focus on assessing, correcting, and maintaining controls to promote compliance with all applicable laws, rules, and regulations. Self-auditing is important to ensure processes are compliant and to identify any areas of concern (e.g., documentation, billing practices). In short, a self-audit can highlight a potential problem that could put the provider at risk for an unannounced government audit.

While self-audits are not mandatory for Medicare providers, the Health and Human Services’ Office of Inspector General (HHS-OIG) recommends that healthcare providers use self-audits and other evaluation techniques to identify potential risk areas and avoid improper conduct. Selfaudits can: • Minimize billing mistakes and errors; • Ensure submitted claims are true and accurate; • Reduce or prevent improper payments; • Avoid violations of strict anti-kickback statute requirements; • Ensure compliance with important HIPAA and HITECH requirements; • Show good faith and a commitment to robust compliance efforts; and • Reduce chances of external audits.

A number of self-audit options are available, but in general, it’s best to develop a program that aligns with the specific nature, size, and resources of the provider. Performing a self-audit is relatively simple and affordable, especially compared to the costs associated with noncompliance and an unannounced government audit.

standards are current and complete or need to be updated to reflect any regulatory changes. By doing such a review, a business can monitor internal controls and compliance and create boundaries that limit at-risk behavior.

This type of audit should ask: • Is the Medicare compliance manual updated?

• Are all written policies and procedures current?

• Is timely fraud, waste, and abuse training offered?

• Are internal systems for tracking and resolving allegations and noncompliance functional?

• Is there a clearly communicated process for reporting fraud?

• Have there been criminal, exclusion, suspension, and debarment checks on all staff?

• Are contracts reviewed and updated to meet all new regulatory requirements?

• Is staff reviewing all updates to applicable regulatory and statutory requirements?

The self-audit process Select a team Forming a comprehensive audit team is a critical first step, and the makeup of the team will depend on the size of a provider’s practice. It is essential that the audit staff have a full understanding of the provider’s financial infrastructure, relevant coding and billing procedures, and federal and state laws and regulations that govern the business. Typically, the audit team includes representatives from operations, finance, human resources, clinical, and information technology departments who focus on specific areas of the business. An audit team might also include a point person from the executive or senior management team.

Determine what to audit The OIG recommends two types of self-audits: operational standards and procedures audits and claims submission audits.

In an operational standards and procedures review, the audit team periodically determines if business operations and

Various government agencies recommend a claims audit that extends over a minimum of three months and includes a random sample selection ranging from 10 to 20 submitted claims. Suggestions for selecting a valid random sample are available from the OIG website, https://oig.hhs.gov/compliance/ alerts/index.asp.

The second type of self-auditing is the claims submission audit. Claims audits involve reviewing bills and medical records for compliance with relevant coding, billing, and documentation requirements on state and federal levels. Audits can determine if bills were accurately coded and reflect services rendered, if documentation was complete and correct, and if services or items provided were reasonable and necessary.

If the self-audit identifies a problem in claims submission, the sample should

be expanded to determine if a pattern or trend exists. The provider should take immediate action to eliminate any problems that are discovered. Individuals involved in these self-audits would ideally include those in charge of billing and coding, as well as a medically or clinically trained person.

Self-reporting findings After the initial self-audit is completed, the audit team should thoroughly review all documentation and prioritize audit results.

If the audit uncovers areas with possible risks or vulnerabilities, the provider should immediately create and implement a corrective action plan that includes detailed processes and controls and minimizes vulnerabilities.

At this stage it’s important to: • Educate staff about the corrective actions; • Track progress toward controlling identified risks; and • Evaluate how well the new policies are working.

In the case of possible fraud, abuse, and consistent errors, a provider should make every effort to self-disclose the findings to a germane government entity as quickly as possible. Providers that voluntarily disclose self-discovered potential fraud may do so using the Self-Disclosure Protocols (SDPs) under the Office of Inspector General. Self-disclosure gives the healthcare industry the opportunity to avoid the costs and disruptions associated with a government-directed investigation and civil or administrative litigation.

The OIG self-disclosure process can be found at https://oig.hhs.gov/compliance/ self-disclosure-info.

Proactive efforts save money and time While self-audits may seem daunting, conducting them is often easier than expected. By creating a clear plan and goals up front, these internal examinations help healthcare providers assess, correct, and maintain compliance with applicable state and federal laws, rules, and regulations. The self-auditing process will help reduce improper payments, lessen the chances of an external government audit, and create a robust business culture of ethical compliance.

Innovatix | innovatix.com 13

CONTINUING EDUCATION

Continuing Education

Rethinking Warfarin: Time To Change the Dose or Change the Drug?

By Robert G. Richardt, MS, RPh senior director, clinical pharmacy services

14 |

Insight

CONTINUING EDUCATION

Rethinking Warfarin: Time To Change the Dose or Change the Drug?

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 both warfarin and the newer anticoagulants and to enable participants to select 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. Summarize the pathology and human costs associated with venous thromboembolism and atrial fibrillation.

2. Identify points of drug action in the coagulation cascade.

3. Describe the management challenges associated with patients who take warfarin.

4. Compare and contrast warfarin and the newer oral anticoagulants.

Disclosures

This continuing education activity is managed and accredited by Innovatix in cooperation with Professional Education Services Group (PESG). Mr. Richardt, 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 two common conditions treated with anticoagulants.

2. Describe the management challenges associated with patients who take warfarin.

3. List three newer oral anticoagulants.

Innovatix, LLC is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This activity has been approved for one contact hour for pharmacists and pharmacy technicians. Universal activity number: 0409-0000-17-004-H01-P (pharmacists) and 0409-0000-17-004-H01-T (technicians).

Nursing Accreditation

Type of activity Knowledge-based

Cost

This activity is free of charge.

This activity for 1 contact hour is co-provided by Innovatix and the Professional Educational Services Group (PESG), 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 must go to innovatix.com/evaluations.

To receive CE credit Nurses must go to innovatix.cds.pesgce.com/index.php.

Click on Insight Magazine and scroll to find the title of this CE article.

Scroll to find the title of this CE article and click "Take Exam."

Complete the evaluation form. A score of 70 percent 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 April 1, 2020.

A score of 70 percent 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 April 1, 2020.

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.

Innovatix | innovatix.com 15

CONTINUING EDUCATION

W

arfarin has been used for decades as an anticoagulant for the prophylaxis and treatment of venous thrombosis and thromboembolic complications associated with atrial fibrillation or cardiac valve replacement. It is also used to reduce the risk of death, recurrent myocardial infarction, and thromboembolic events after myocardial infarction.1 It is still in wide use today, even though it presents challenges in patient management.

Venous thromboembolism (VTE) encompasses deep vein thrombosis (DVT), pulmonary embolism (PE), or both. DVT mainly affects the large veins in the lower leg or thigh. In DVT, a clot forms in the vein. This causes pain, swelling, and other changes. PE occurs when a DVT clot breaks free from a vein wall, travels to the lung, and blocks its blood supply. PE can cause shortness of breath, chest pain, tachycardia, or even sudden death, which is often the first symptom. One-third of people with VTE will have a recurrence within 10 years, and about half of patients with DVT have long-term complications in the affected limb. Risk factors for VTE include surgery, trauma, prolonged periods of immobilization, hormone therapy, and cancer. In the United States, VTE could affect as many as 900,000 people each year. Estimates suggest that 60,000 to 100,000 people die annually from VTE, and 10-30 percent will die within one month of diagnosis.2,3,4,5 In addition, as many as six million people in the United States may suffer from atrial fibrillation (AF). When a person has AF, beating in the atria is irregular. The irregular beating may cause blood to pool in the atria and form blood clots. If a clot forms, it could dislodge and travel to the brain, where it might block blood flow and cause a stroke. AF increases a person’s risk for stroke by at least four fold as compared to people without AF, and strokes caused by complications from AF tend to be more severe than strokes from other causes.

Risk factors for AF include age, hypertension, and obesity. AF causes more than 750,000 hospitalizations and contributes to an estimated 130,000 deaths each year.6,7 The formation of a blood clot is a multistep process involving a number of clotting factors that lead to the generation of fibrin.5 Warfarin acts by inhibiting the synthesis of vitamin K-dependent clotting factors. (See Figure 1.)1 By suppressing the production of clotting factors, warfarin prevents the formation and propagation of clots. Warfarin has no direct effect on previously circulating clotting factors or previously formed clots.8 Large quantities of dietary or supplemental vitamin K can overcome the anticoagulant effect of warfarin, thus patients taking warfarin are cautioned against consuming very large or highly variable quantities of the vitamin.9 Warfarin is inexpensive, and prescribers are experienced in its use. Warfarin is advantageous in that it can be monitored

16 |

Insight

using prothrombin time (PT) and international normalized ratio (INR). For most indications, prescribers target an INR of 2.5, with an acceptable range of 2 to 3. For patients with prosthetic heart valves, they target an INR of 3, with an acceptable range of 2.5 to 3.5.8 These ranges should provide adequate anticoagulation while minimizing the bleeding risk.

However, keeping patients in these ranges is often difficult.

Drug interactions, drug-food interactions, genetic variation, smoking, alcohol use, patient adherence, and comorbidities all affect the level of anticoagulation, which is reflected in the INR. Therefore, frequent INR testing and dose adjustments are typically required. 8,10,11

“Warfarin is associated with five of the 10 most dangerous drug interactions in post-acute, long-term care.”

AMDA14 The percentage of time within these target ranges is another important consideration in using warfarin. In one nursing home study, residents were out of range more than half of the time, which could have put them at risk for complications.12 Dosing algorithms, anticoagulation clinics, and point-of-care testing are all used to improve anticoagulation management with warfarin.

Bleeding from warfarin can occur even when the INR is within an acceptable range.10 The gastrointestinal tract and the nose are the most frequent sites of bleeding. However, intracranial hemorrhage, which is the most serious and feared complication of warfarin therapy, can occur and lead to permanent disability or death.8 In a study of medications commonly implicated in emergency hospitalizations for adverse drug events in older adults, warfarin was implicated in 33 percent of hospitalizations, mostly for warfarin-related hemorrhages.13

T E S T YO U R K N O W L E D G E Q U E ST I O N # 1:

Can you name some of the risk factors for VTE? Anyone who watches television or follows the news has undoubtedly heard about the benefits of alternatives to warfarin for patients with atrial fibrillation not caused by a heart valve problem. These newer drugs include a direct

CONTINUING EDUCATION

Figure 1: Drug action in the coagulation cascade5

Warfarin

Factor XIIa

Factor XIa Tissue factor Factor VIIa

Factor IXa Factor Xa apixaban, edoxaban, and rivaroxaban Thrombin

Fibrinogen

thrombin inhibitor and three factor Xa inhibitors. They are indicated for AF, VTE, and other conditions. Acronyms used for these agents include DOACs (direct oral anticoagulants), NOACs (novel oral anticoagulants or non-Vitamin K oral anticoagulants), and TSOACs (target-specific oral anticoagulants). DOAC is used in this article to collectively describe them. The table on page 18 provides key information on the DOACs. As seen in Figure 1, thrombin is the final enzyme in the clotting cascade that produces fibrin. Thrombin cleaves fibrinogen to fibrin, activates other procoagulant factors, and activates platelets. The DOAC dabigatran etexilate is an oral prodrug. It is rapidly converted by a serum esterase to dabigatran, which is a direct thrombin inhibitor. It binds to

Dabigatran

Fibrin

• Taken with a full glass of water; • Discarded four months after opening the bottle; and • Stored in its tightly-closed original bottle and not placed in pill boxes or pill organizers. (A manufacturer-supplied blister pack is available.)15 The DOACs apixaban, edoxaban, and rivaroxaban are oral Factor Xa inhibitors that act further up in the clotting cascade.

(See Figure 1.)

Factor Xa inhibitors bind to the active site of Factor Xa and inhibit its activity. Factor Xa is active in both circulating and clot-bound forms, and Factor Xa inhibitors are able to block the action of both forms. Factor Xa inhibitors

the active site of the thrombin enzyme and blocks the action of thrombin in both circulating and clot-bound forms.19,20 Dabigatran is metabolized in the kidney, and its half-life is prolonged in patients with renal insufficiency. It does not require routine blood-coagulation testing nor does it have any dietary restrictions, and its absorption is not affected by food. The capsules must be swallowed whole. Breaking, 19

chewing, or emptying the contents of the capsule can result

T E S T YO U R K N O W L E D G E Q U E ST I O N # 2:

What enzyme is key to the formation of fibrin?

in increased drug exposure. Dabigatran should also be:

Innovatix | innovatix.com 17

CONTINUING EDUCATION

DIRECT ORAL ANTICOAGULANTS: PRODUCT SUMMARY15-18 Generic name BRAND NAME DOSAGE FORMS/ STRENGTHS INDICATION/ DOSAGE

DOSING ADJUSTMENTS FOR RENAL FUNCTION

Dabigatran etexilate mesylate

Apixaban

Pradaxa®

Eliquis®

Capsules: 75 mg, 110 mg, and 150 mg

Tablets: 2.5 mg and 5 mg

DVT/PE treatment 150 mg twice daily after 5-10 days of parenteral anticoagulation.

NVAF 150 mg twice daily.

DVT/PE prophylaxis following hip replacement surgery 110 mg for the first day, then 220 mg once daily for 28-35 days.

Reduction in risk of recurrence of DVT/PE 150 mg twice daily after previous treatment.

DVT/PE treatment 10 mg twice daily for 7 days, then 5 mg twice daily.

NVAF 5 mg twice daily. Reduce dose to 2.5 mg twice daily if patient has at least 2 of the following: age ≥80 years, body weight ≤60 kg, or serum creatinine ≥1.5 mg/dL. DVT prophylaxis following hip or knee replacement surgery 2.5 mg twice daily for 35 days (hip) or 12 days (knee).

Reduction in risk of recurrence of DVT/PE 2.5 mg twice daily after at least 6 months of treatment for DVT or PE. DVT/PE treatment DVT/PE treatment CrCl >30 mL/min: 150 mg twice daily after No dosage adjustment is 5-10 days of parenteral anticoagulation. recommended by the manufacturer.

CrCl ≤30 mL/min or on dialysis: not NVAF recommended.

Reduce dose to 2.5 mg twice daily NVAF if patient has at least 2 of the CrCl >30 mL/min: 150 mg twice daily. following: age ≥80 years, body CrCl 15-30 mL/min: 75 mg twice daily. weight ≤60 kg, or serum creatinine CrCl <15 mL/min or on dialysis: not ≥1.5 mg/dL. recommended.

DVT/PE prophylaxis following hip or DVT/PE prophylaxis following hip knee replacement surgery replacement surgery No dosage adjustment is CrCl >30 mL/min: 110 mg for the first day, recommended by the manufacturer. then 220 mg once daily for 28-35 days.

Reduction in the risk of recurrence CrCl ≤30 mL/min or on dialysis: not of DVT/PE recommended.

No dosage adjustment is Reduction in risk of recurrence of DVT/PE recommended by the manufacturer.

CrCl >30 mL/min: 150 mg twice daily after previous treatment.

CrCl ≤30 mL/min or on dialysis: not recommended.

DOSING FOR IMPAIRED HEPATIC FUNCTION

Patients with moderate impairment (Child-Pugh B) showed a large intersubject variability, but no evidence of a consistent change in exposure or pharmacodynamics.

DRUG INTERACTIONS

Reduce the dose or avoid concomitant use of some P-glycoprotein inhibitors (e.g., ketoconazole) in the presence of renal impairment.

Avoid concomitant use with P-glycoprotein inducers (e.g., rifampin).

HALF-LIFE (HOURS)

12 to 17

No dosing recommendations provided by the manufacturer for moderate impairment.

Not recommended in patients with severe impairment (Child-Pugh C).

Reduce the dose or avoid use with drugs that are strong dual P-glycoprotein and CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin).

Avoid concomitant use with strong dual P-glycoprotein and CYP3A4 inducers (e.g. rifampin, phenytoin).

Approximately 12 hours

Edoxaban

Rivaroxaban

Savaysa™

Xarelto®

Tablets: 15 mg, 30 mg, and 60 mg DVT/PE treatment 60 mg once daily following 5-10 days of a parenteral anticoagulation.

Reduce dose to 30 mg once daily for patients with body weight ≤60 kg.

NVAF 60 mg once daily

Tablets: 10 mg, 15 mg, and 20 mg

DVT/PE treatment CrCl 15-50 mL/ min: 30 mg once daily.

CrCl <15 mL/ min: not recommended.

NVAF CrCl 15-50 mL/ min: 30 mg once daily.

CrCl <15 mL/ min: not recommended.

CrCl >95 mL/ min: do not use for NVAF.

DVT/PE treatment 15 mg twice daily for the first 21 days, then 20 mg once daily. Give with food.

NVAF 20 mg once daily with the evening meal.

DVT prophylaxis following hip or knee replacement surgery 10 mg once daily for 35 days (hip) or 12 days (knee).

Reduction in risk of recurrence of DVT/PE 20 mg once daily. Give with food.

DVT/PE treatment CrCl <30 mL/min: avoid use.

NVAF CrCl 15 to 50 mL/min: 15 mg once daily with evening meal.

DVT/PE prophylaxis following hip or knee replacement surgery CrCl <30 mL/min: avoid use.

Reduction in the risk of recurrence of DVT/PE CrCl <30 mL/min: avoid use.

Not recommended in patients with moderate or severe impairment.

Concomitant use with the P-glycoprotein inducer, rifampin, is to be avoided.

Avoid use in moderate or severe impairment or in any hepatic disease associated with coagulopathy.

10 to 14

5 to 9 hours

Avoid use with drugs that are dual P-glycoprotein and strong CYP3A4 inhibitors and inducers.

>, greater than; <, less than; ≥, greater than or equal to; ≤, less than or equal to; CrCl, creatinine clearance; dl, deciliter; DVT, deep vein thrombosis; kg, kilogram; mg, milligram; mL/min, milliliter per minute; NVAF, nonvalvular atrial fibrillation; PE, pulmonary embolism

18 |

Insight

CONTINUING EDUCATION

are metabolized in the kidney and liver, and severe hepatic

(or concomitant use) with unfractionated heparin, low-mo-

impairment could result in drug accumulation. Factor Xa

lecular-weight heparin, or fondaparinux for at least five

inhibitors do not require routine blood-coagulation testing.

days is required for certain indications (e.g., VTE). Also, the

Factor Xa inhibitors do not have any dietary restrictions, and apixaban and edoxaban can be taken with or without food.16,17,19 The absolute bioavailability of rivaroxaban is dose dependent. The 15 mg and 20 mg tablets of rivaroxaban should be taken with food, while the 10 mg tablets can be taken with or without food.

18

There are settings where warfarin is preferred over a DOAC. For example, DOACs are not used in patients with prosthetic heart valves due to the greater risk of valve thrombosis. Warfarin is generally preferred over DOACs

TEST YOUR KNOWLEDGE QUESTION #3:

What drug(s) are strong dual P-glycoprotein and CYP3A4 inhibitors?

for patients requiring long-term anticoagulation where the CrCl is <30 mL/min. DOACs are more costly than warfarin, and patients that are successfully using warfarin with good control and no side effects would have little to gain by changing from warfarin to a DOAC. Also, for patients that might forget to take their dose, missing a dose or two of warfarin is unlikely to substantially increase the time out of the therapeutic range. However, missing a dose or two of a DOAC can leave the patient inadequately anticoagulated.19

effect of dose changes may take several days to be reflected in the INR.8 In contrast, DOACs have a rapid onset of action, fixed dosing, and bridging is not required for apixaban and rivaroxaban.21 There are differences among the individual DOACs. For example, rivaroxaban and edoxaban are administered once daily, instead of the twice-daily administration required for dabigatran and apixaban. Once-daily administration

DOACs are preferred for patients with warfarin allergy

may improve adherence. Apixaban uses primarily a biliary

or intolerance or who are inadequately managed on

route for excretion, and this may be preferred for patients

warfarin. For those experiencing problems due to diet or interacting drugs, the DOACs offer predictable pharmacokinetics with no dietary issues and few drug interactions.

A DOAC might also be preferred for patients who are not candidates for point-of-care testing at home or for those who have difficulties in having blood drawn for PT/INR testing.

This may encompass difficulties with both the venipuncture itself or in getting the patient to the testing site. Note that some consider PT/INR testing an advantage that provides a mechanism for assessing patient compliance. That said, the American College of Chest Physicians guideline recommends a DOAC over warfarin for long-term treatment of patients with VTE without cancer.21 Completing the PT/INR testing and adjusting the warfarin dose based on the results (where necessary) requires follow-up and communication involving the laboratory, office staff, prescriber, patient or caregiver, pharmacy, and nurse. Poor coordination, inadequate follow-up, or miscommunication by any of these parties could lead to a life-threatening medication error.

Since warfarinâ&#x20AC;&#x2122;s full antithrombotic effect is not achieved for several days following initiation of therapy, bridging

with renal impairment. Apixaban and rivaroxaban can be crushed to facilitate oral or nasogastric tube administration, whereas dabigatran capsules must be swallowed whole. Dabigatran is the only DOAC that has a reversal agent.19,20,22 DOACs are as or more effective than warfarin in preventing stroke or systemic embolism in patients with NVAF. They also appear to be safer. In the pivotal clinical trials, DOACs had significantly lower rates of intracranial bleeding and hemorrhagic stroke than warfarin.23 In the treatment of acute symptomatic VTE, DOACs were compared to warfarin in an analysis of six phase 3 randomized controlled trials. The authors concluded that DOACs provide similar efficacy and significantly reduced risk for major bleeding, intracranial bleeding, and fatal and clinically relevant nonmajor bleeding.24 The pharmacokinetic profiles of the DOACs generally allow bleeding episodes to be managed with conservative approaches.25 However, for patients experiencing acute major bleeding or for those requiring emergency surgery, the ability to reverse the anticoagulant effect is important.

Innovatix | innovatix.com 19

CONTINUING EDUCATION

The American College of Chest Physicians recommends

is in development, as is a universal reversal agent for

the administration of a four-factor prothrombin complex

many anticoagulants, including the DOACs (ciraparantag).29

concentrate (Kcentra®) and vitamin K (phytonadione)

In the meantime, it may be advisable to avoid Factor Xa

for warfarin-treated patients who experience major

inhibitors in patients with a history of gastrointestinal

bleeding.26 For patients receiving dabigatran who experi-

bleeding due to the lack of a specific antidote.19

ence life-threatening bleeding or who require emergency surgery, idarucizumab (Praxbind®) can rapidly reverse its anticoagulant effects by binding to dabigatran and its metabolites.27

improved safety compared to treatment with warfarin.

Their favorable pharmacokinetic profiles eliminate the need for, inconvenience, and expense associated with routine

For the Factor Xa inhibitors, supportive care and inter-

PT/INR monitoring. Their use also eliminates the need

ventions for local hemostasis are recommended, with

for and risks associated with warfarin dosage adjust-

nonspecific reversal agents (e.g., activated charcoal, antifi-

ments. DOACs have no diet and few drug interactions. For

brinolytic agents) reserved for major bleeding.28,29 An anti-

providers, patients, and caregivers who are struggling in

dote (andexanet alfa), which binds Factor Xa inhibitors,

managing warfarin, the DOACs offer many advantages.

REFERENCES 1. Warfarin prescribing information. Available at: https://dailymed. nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ad881e0-ca41-42ad-9d7deb85b3a30af0. Accessed March 1, 2017 .

2. Centers for Disease Control and Prevention. Venous Thromboembolism (Blood Clots). Available at: https://www.cdc.gov/ ncbddd/dvt/data.html. Accessed March 1, 2017.

3. American Heart Association. What is venous thromboembolism (VTE)? Available at: http://www.heart.org/HEARTORG/Conditions/ More/What-is-Venous-Thromboembolism-VTE_UCM_479052_Article. jsp#.WJ3zHmYzV1N. Accessed March 1, 2017.

4. American Heart Association. Who is at risk for venous thromboembolism? Available at: http://www.heart.org/idc/groups/ heart-public/@wcm/@hcm/documents/downloadable/ucm_480271. pdf. Accessed March 1, 2017.

5. Wolberg A, Rosendaal F, Weitz J, et al. Venous thrombosis. Nat Rev Dis Primers. 2015 May 7;1:15006. doi: 10.1038/nrdp.2015.6.

6. Centers for Disease Control and Prevention. Atrial fibrillation fact sheet. Available at: https://www.cdc.gov/dhdsp/data_statistics/ fact_sheets/fs_atrial_fibrillation.htm. Accessed March 1, 2017.

7. Mayo Foundation for Medical Education and Research. Atrial fibrillation. Available at: http://www.mayoclinic.org/diseasesconditions/atrial-fibrillation/symptoms-causes/dxc-20164936.

Accessed March 1, 2017.

8. Witt D, Nutescu E, Haines S. Venous Thromboembolism. In: Pharmacotherapy: A Pathophysiologic Approach. 8th ed. DiPiro JT, Talbert RL, Yee GC, et al., eds. New York: McGraw-Hill Companies, Inc.: 2011:311-352.

9. Oregon State University. Linus Pauling Institute. Micronutrient Information Center. Vitamin K. Available at: http://lpi.oregonstate. edu/mic/vitamins/vitamin-K#coagulation. Accessed March 1, 2017.

10. UpToDate. Warfarin and other VKAs: dosing and adverse effects.

Available at: http://www.uptodate.com/home. Accessed March 1, 2017.

11. UpToDate. Biology of warfarin and modulators of INR control.

Available at: http://www.uptodate.com/home. Accessed March 1, 2017.

12. Gurwitz JH, Field TS, Radford MJ, et al. The safety of warfarin therapy in the nursing home setting. Am J Med. 2007;120(6):539-544.

13. Budnitz DS, Lovegrove MC, Shehab N, Richards CL. Emergency hospitalizations for adverse drug events in older Americans. N Engl J Med. 2011;365:2002-2012.

14. AMDA. Top 10 particularly dangerous drug interactions in PA/LTC. Available at: http://www.paltc.org/top-10-particularly-dangerousdrug-interactions-paltc. Accessed March 1, 2017.

15. Pradaxa prescribing information. Available at: http://docs. boehringer-ingelheim.com/Prescribing%20Information/PIs/ Pradaxa/Pradaxa.pdf. Accessed March 1, 2017.

20 |

In summary, the DOACs offer comparable efficacy and

Insight

16. Eliquis prescribing information. Available at: http:// packageinserts.bms.com/pi/pi_eliquis.pdf. Accessed March 1, 2017.

17. Savaysa prescribing information. Available at: http://dsi.com/prescribing-information-portlet/ getPIContent?productName=Savaysa&inline=true. Accessed March 1, 2017.

18. Xarelto prescribing information. Available at: https://www. xarelto-us.com/shared/product/xarelto/prescribing-information. pdf. Accessed March 1, 2017.

19. UpToDate. Direct oral anticoagulants: dosing and adverse effects.

Available at: http://www.uptodate.com/home. Accessed March 1, 2017.

20. Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361:1139-1151.

21. Kearon C, Akl E, Ornelas J, et al. Antithrombotic therapy for VTE disease. Chest guideline and expert panel report. Chest. 2016; 149(2):315-352.

22. Shields A, Lip, G. Choosing the right drug to fit the patient when selecting oral anticoagulation for stroke prevention in atrial fibrillation. J Intern Med. 2015 Jul;278(1):1-18.

23. The Medical Letter on Drugs and Therapeutics. Which oral anticoagulant for atrial fibrillation? Available at: http://secure. medicalletter.org/. Accessed March 1, 2017.

24. Van Es N, Coppens M, Schulman S, Middeldorp S, Büller H. Direct oral anticoagulants compared with vitamin K antagonists for acute venous thromboembolism: evidence from phase 3 trials.

Blood. 2014; 124(12):1968-1975.

25. Smythe M, Trujillo T, Fanikos J. Reversal agents for use with direct and indirect anticoagulants. Am J Heath-Syst Pharm. 2016; 73(suppl 2):S27-S48.

26. Holbrook A, Schulman S, Witt D, et al. Evidence-based management of anticoagulant therapy: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest.

2012;141(2)(suppl):e152S-e184S. doi: 10.1378/chest. 11-2295.

27. Praxbind prescribing information. Available at: http://docs. boehringer-ingelheim.com/Prescribing%20Information/PIs/ Praxbind/Praxbind.pdf. Accessed March 1, 2017.

28. Shih A, Crowther M. Reversal of direct oral anticoagulants: a practical approach. Hematology Am Soc Hematol Educ Program.

2016; Dec 2, 2016(1):612-619.

29. UpToDate. Management of bleeding in patients receiving direct oral anticoagulants. Available at: http://www.uptodate.com/home.

Accessed March 1, 2017.

CONTINUING EDUCATION

Clinical Corner

Brief clinical overview of Inflectra® (infliximab-dyyb for injection)

By Sylvia A. Thomas, PharmD, MS, BCPS, vice president, clinical pharmacy services

DRUG NAME Infliximab-dyyb (Inflectra, Hospira, a Pfizer company)

product to the biosimilar product is equally safe and effective to treating them with only the reference product.4

Injection, for intravenous use 1

While Remicade is listed as a reference product for Inflectra injection in the FDA’s Purple Book and infliximab-dyyb has been approved as a biosimilar under a biosimilar-approval pathway, it has NOT been approved as an interchangeable product. As such, it must NOT be automatically substituted for Remicade as part of automatic mandatory generic substitution laws.5, 6

FDA-APPROVED INDICATION AND USAGE Inflectra is biosimilar to infliximab (Remicade®, Janssen Biotech), and is used to treat autoimmune diseases. Infliximabdyyb was approved by the U.S. Food and Drug Administration (FDA) for seven out of eight Remicade indications, excluding pediatric ulcerative colitis.2, 3 Approved indications include: ■■ Crohn’s disease (adult);

■■ Crohn’s disease (pediatric); ■■ Ulcerative colitis (adult); ■■ Rheumatoid arthritis in combination with methotrexate; ■■ Ankylosing spondylitis; ■■ Psoriatic arthritis; and ■■ Plaque psoriasis.

INTERCHANGEABILITY A draft of guidance covering the criteria for biosimilars to meet the standard for interchangeability was recently issued by the FDA. To demonstrate interchangeability, the data submitted to the FDA must show that the proposed interchangeable product is biosimilar to the reference product and that it is expected to produce the same clinical result as the reference product in any given patient. In addition, if the product is administered more than once, the data must show that switching patients from the reference

MECHANISM OF ACTION The chimeric monoclonal antibody, infliximab-dyyb, neutralizes the biological activity of tumor necrosis factor alpha (TNF-a) by binding with high affinity to the soluble (free floating in the blood) and transmembrane (located on the outer membranes of T cells and similar immune cells) forms of TNF-a, inhibiting or preventing the binding of TNF-a with its receptors. 7, 8 PHARMACOKINETICS Following single intravenous infusions of 3 to 20 mg/kg, a linear relationship was shown between the dose and the maximum serum concentration. Repeat infusions at two and six weeks resulted in predictable concentration-time profiles following each treatment, showing no systemic accumulation of infliximab.9 Onset of action: 1-2 weeks in Crohn’s disease, and 3-7 days in rheumatoid arthritis.

Duration of action: 8-48 weeks in Crohn’s disease, and 6-12 weeks in rheumatoid arthritis.

Innovatix | innovatix.com 21

CLINICAL CORNER Volume of distribution: 3-6 L, indicating that distribution was to the vascular compartment.

Elimination half-life: 7-12 days.10 Pharmacokinetic parameters were similar in pediatric patients (6 to 17 years) and adult patients, with no major differences due to age, weight, or gender. Patients with severe impairment of hepatic or renal function have not been studied.11

Indication

Recommended starting doses 12

Crohn’s Disease

5 mg/kg given as an intravenous induction regimen at zero, two, and six weeks followed by a maintenance regimen of 5 mg/kg every eight weeks thereafter.

For adult patients who respond and then lose their response, consideration may be given to treatment with 10 mg/kg.

If no response by week 14 of treatment, patients are unlikely to respond with continued dosing and consideration should be given to stopping Inflectra.

Pediatric Crohn’s Disease

For pediatric patients six years and older with moderately to severely active Crohn’s disease, 5 mg/kg is given as an intravenous induction regimen at zero, two, and six weeks followed by a maintenance regimen of 5 mg/kg every eight weeks thereafter.

Ulcerative Colitis

5 mg/kg given as an intravenous induction regimen at zero, two, and six weeks followed by a maintenance regimen of 5 mg/kg every eight weeks thereafter.

Rheumatoid Arthritis

3 mg/kg given as an intravenous induction regimen at zero, two, and six weeks followed by a maintenance regimen of 3 mg/kg every eight weeks thereafter.

Administer Inflectra in combination with methotrexate.

For patients who have an incomplete response, consideration may be given to adjusting the dose up to 10 mg/kg or treating as often as every four weeks.

(However, risk of serious infections is increased at higher doses.)

Ankylosing Spondylitis

5 mg/kg given as an intravenous induction regimen at zero, two, and six weeks followed by a maintenance regimen of 5 mg/kg every six weeks thereafter.

Psoriatic Arthritis

5 mg/kg given as an intravenous induction regimen at zero, two, and six weeks followed by a maintenance regimen of 5 mg/kg every eight weeks thereafter.

Inflectra can be used with or without methotrexate.

Plaque Psoriasis

5 mg/kg given as an intravenous induction regimen at zero, two, and six weeks followed by a maintenance regimen of 5 mg/kg every eight weeks thereafter.

Insight

■■ Calculate the dose, total volume of reconstituted infliximabdyyb solution needed, and the number of vials required.

■■ Reconstitute each vial with 10 mL Sterile Water for Injection, resulting in a 10 mg/mL solution concentration.

■■ Withdraw a volume equal to the reconstituted dose solution from the 0.9% Sodium Chloride Injection bottle or bag.

DOSAGE

22 |

DOSAGE FORMS AND ADMINISTRATION Inflectra is available as 100 mg of lyophilized infliximabdyyb in a 20 mL vial for intravenous infusion. The procedure is as follows: 13

■■ Slowly inject the total volume of reconstituted infliximab-dyyb

solution into the 250 mL infusion bag or bottle and gently mix.

The resulting concentration should be 0.4—4 mg/mL.

■■ The infliximab-dyyb infusion should begin within three hours of reconstitution and dilution and must be administered over at least two hours with an in-line, sterile, non-pyrogenic, lowprotein-binding filter (pore size 1.2 µm or less).

PRODUCT AVAILABILITY

■■ Each Inflectra 20 mL vial is individually packaged in a carton of 10 vials.

■■ Each single use vial (NDC 32228-001-01) contains 100 mg of infliximab-dyyb for final reconstitution volume of 10 mL.

■■ Store refrigerated at 2ºC to 8ºC (36ºF to 46ºF).

■■ Do not use infliximab-dyyb beyond the expiration

date

located on the carton and the vial.

■■ Note that product contains no preservative.14 ADVERSE REACTIONS During the clinical trials, no significant differences in adverse reactions between Inflectra and Remicade were found. The most frequent severe adverse effects of infliximabdyyb were serious infections (including active tuberculosis, sepsis, etc.), invasive fungal infections, malignancies, hepatitis B virus reactivation, hepatotoxicity, heart failure, cytopenias, serious infusion reactions including anaphylaxis or serum sickness-like reactions, exacerbation of or new onset demyelinating disease, and lupus-like syndrome. 15 The most common adverse reactions were headache, abdominal pain, increased hepatic enzymes, increased ANA titer, infection or abscess, respiratory infections, and infusion reactions.16 DRUG INTERACTIONS Live vaccines or therapeutic infectious agents should not be given with infliximab-dyyb. Pediatric patients should be brought up to date with all vaccinations prior to initiating infliximab-dyyb. At least a six-month waiting period following birth is recommended before the administration of live vaccines to infants exposed in utero to infliximab products.17 There is an increased incidence of serious infection when TNF-a blocking agents are given with anakinra or abatacept, so the combination is not recommended. In addition, the combination of infliximab-dyyb with other biological therapeutics used to treat the some conditions is not recommended.18

CLINICAL CORNER CONTRAINDICATIONS Infliximab-dyyb should not be administered to patients with moderate to severe heart failure (NY Heart Association Functional Class III/IV). The biosimilar should not be re-administered to patients who have experienced a severe hypersensitivity reaction to infliximab products or to patients with a known hypersensitivity to inactive components of the product or any murine proteins.19 RISK MANAGEMENT Inflectra contains a boxed warning to alert healthcare professionals and patients about an increased risk of serious infections leading to hospitalization or death, including tuberculosis, bacterial sepsis, invasive fungal infections (such as histoplasmosis), and others. The boxed warning also notes that lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor blockers, including infliximab products such as Inflectra.20 Infliximab-dyyb must be dispensed with a patient medication guide, covering the most important information that patients should know about Inflectra.21 REIMBURSEMENT CONSIDERATIONS Infliximab-dyyb may be covered under a medical benefit, a pharmacy benefit, or both, depending on the payer.

Under a pharmacy benefit, Inflectra injection should be billed using the applicable above-mentioned NDC codes.

It is classified as a “brand” drug in MediSpan.

While the exact discount off the AWP is not known when reimbursed under the pharmacy benefit (as that information is proprietary and will vary from one plan to another), it is reasonable to anticipate that it will be in the range of 15 to 25 percent.

REFERENCES 1. Inflectra Prescribing Information, (Lake Forest, IL: Hospira, a Pfizer Company, August 2016).

2. Ibid.

3. Lexicomp – Lexi-Drugs (Wolters Kluwer Clinical Drug Information), s.v. “Infliximab” https://online.lexi.com/login (accessed March 15, 2017).

4. “Inflectra – An Infliximab Biosimilar,” Med Lett Drugs Ther. 59, no.

1513 (2017 Jan 30): 23-25.

5. FDA Biosimilars Guidances (Silver Spring, MD: U. S. Food and Drug Administration), www.fda.gov/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/ucm290967. htm (accessed March 17, 2017).

6. FDA Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (Silver Spring, MD: U. S. Food and Drug Administration), http://www.fda.gov/drugs/developmentapprovalprocess/ howdrugsaredevelopedandapproved/approvalapplications/ therapeuticbiologicapplications/biosimilars/ucm411418.htm (accessed March 17, 2017).

7. Inflectra Prescribing Information, (Lake Forest, IL: Hospira, a Pfizer Company, August 2016).

8. Lexicomp – AHFS DI (Adult and Pediatric) (Wolters Kluwer Clinical Drug Information), s.v. “Infliximab” https://online.lexi.com/login (accessed March 15, 2017).

9. Inflectra Prescribing Information, (Lake Forest, IL: Hospira, a Pfizer Company, August 2016).

Under a medical benefit, Inflectra injection should be billed with a new HCPCS code, Q5102 (injection, infliximab, biosimilar, 10 mg), which was added to the quarterly CMS ASP files effective January 1, 2017. The current payment limit under this code represents 106 percent of Inflectra’s WAC. Once ASP for Q5102 becomes available, the reimbursement for Inflectra will be = 100 percent of the biosimilar’s ASP (Q5102 for Inflectra) plus 6 percent of the ASP of the reference product (J1745 for Remicade, which is a reference product for Inflectra) under Medicare Part B.

Estimation of differential based on ASP+6 percent model (based on CURRENT payment limit as of 4/1/2017) for 100 mg vial 22 Drug Name

REMICADE

INFLECTRA

Corresponding HCPCS code

J1745

Q5102

(ASP+6%)-2% sequestration fee per corresponding HCPCS code (per 100 mg vial) for Q2:2017

$838.79

$983.00

Applicable WAC (for Remicade) or contract price (for Inflectra) per 100 mg vial

$1167.82

$927.35

Differential realized per 100 mg vial based on (ASP+6%)-2% sequestration cut

-$329.03

$55.65

For Medicaid or commercial payers under a medical benefit, Q5102 HCPCS code should be billed, and reimbursement will be dependent on the payer.

10. Lexicomp – Lexi-Drugs (Wolters Kluwer Clinical Drug Information), s.v. “Infliximab,” https://online.lexi.com/login (accessed March 15, 2017).

11. Inflectra Prescribing Information, (Lake Forest, IL: Hospira, a Pfizer Company, August 2016).

12. Ibid.

13. Ibid.

14. Ibid.

15. “Inflectra – An Infliximab Biosimilar,” Med Lett Drugs Ther. 59, no.

1513 (2017 Jan 30): 23-25.

16. Inflectra Prescribing Information, (Lake Forest, IL: Hospira, a Pfizer Company, August 2016).

17. Ibid.

18. Lexicomp – Lexi-Drugs (Wolters Kluwer Clinical Drug Information), s.v. “Infliximab” https://online.lexi.com/login (accessed March 15, 2017).

19. Inflectra Prescribing Information, (Lake Forest, IL: Hospira, a Pfizer Company, August 2016).

20. Ibid.

21. Ibid.

22. Centers for Medicare and Medicaid Services, Medicare Part B Drug Average Sales Price: 2017 ASP Drug Pricing Files (Baltimore, MD: CMS.gov, effective April 1 through June 30, 2017), https:// www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/ McrPartBDrugAvgSalesPrice/2017ASPFiles.html (accessed April 17, 2017).

Innovatix | innovatix.com 23

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

• Boehringer Ingelheim: The prescription level rebate program has been extended through June 30, 2018, with changes to the Spiriva® and Tradjenta® rebates.

New Brand Items Added To Contract

24 |

(alphabetical by trade name)

GENERIC NAME

TRADE NAME

SUPPLIER

EFFECTIVE DATE

ELIGIBLE CLASS OF TRADE

Indacaterol

Arcapta Neohaler

Sunovion Pharmaceuticals

04/28/17

Home infusion, long-term care

Insulin Glargine

Basaglar® Kwikpen

Eli Lilly & Company

12/15/16

Long-term care

GlycopyrrolateFormoterol Fumarate

Bevespi Aerosphere®

AstraZeneca

01/01/17

Long-term care

Nebivolol-Valsartan

Byvalson™

Allergan

10/14/16

Long-term care

Certolizumab pegol

Cimzia

UCB Pharma

04/28/17

Home infusion, long-term care

Memantine HCL / Donepezil HCL SR

Namzaric® Pak

Allergan

11/30/16

Long-term care

Memantine HCL ER/ Donepezil HCL

Namzaric 7mg & 21mg

Allergan

10/05/16

Long-term care

Insulin GlargineLixisenatide

Soliqua™ 100/33

Sanofi Aventis

03/10/17

Home infusion, long-term care

Glycopyrrolate

Seebri Neohaler

Sunovion Pharmaceuticals

04/28/17

Home infusion, long-term care

Avanafil

Stendra

Mist Pharmaceuticals

04/15/17

Home infusion, long-term care

Indacaterol/ Glycopyrrolate

Utibron Neohaler

Sunovion Pharmaceuticals

04/28/17

Home infusion, long-term care

Cariprazine

Vraylar

Allergan

04/15/17

Long-term care

Lesinurad

Zurampic®

AstraZeneca

10/01/16

Long-term care

Insight

CONTRACT UPDATES

New Contracted Suppliers SUPPLIER

PRODUCTS

BioDelivery Services International

Belbuca®

Cubex LLC

Hardware and software elements useful in storage, dispensing, and inventory monitoring.

Helsinn Therapeutics

Akynzeo®

Integra LTC Solutions, LLC

(alphabetical by supplier name) DATES

ELIGIBLE CLASS OF TRADE

02/01/17— 6/30/18 04/01/17— 06/30/18 04/01/1706/30/18

Home infusion, long-term care, oncology Home infusion, long-term care, mail order, oncology, retail Home infusion, long-term care, oncology

DocuTrack is a specialized workflow and content management system. DeliveryTrack is a full-featured delivery management solution.

03/01/17— 02/29/20

Home infusion, long-term care, mail order, oncology

Leadiant Biosciences (formerly Sigma-Tau)

Abelcet®, Carnitor®

10/15/16— 06/30/18

Home infusion, long-term care, mail order, oncology, retail

Pari Respiratory Equipment

Hypersal, Complete Formulation Multivitamins, Sodium Chloride, Pari Lc Nebulizer, PARI Baby™ Nebulizer, Pari LC® Mask Set With YP, Vios® Lc Sprint Pari Trek® S Portable Power, Vortex Holding Chamber/Mask.

04/01/17— 06/30/18

Home infusion, long-term care, mail order, oncology, retail

Somerset Therapeutics

Cyanocobalamin injection, Olopatadine HCL, Epinastine HCL

09/01/16— 08/31/19

Home infusion, long-term care, mail order, oncology, retail

Generic Launch Update

(alphabetical by generic name)

GENERIC NAME

SUPPLIER

EFFECTIVE DATE

TRADE NAME

SUPPLIER INNOVATOR

Abacavir/Lamivudine

Teva Pharmaceuticals

09/29/16

Epzicom

GlaxoSmithKline

Aprepitant

Sandoz

12/14/16

Emend

Merck Sharp & Dohme

Bimatoprost Ophthalmic Sandoz

12/19/16

Latisse

Allergan

Mylan Pharmaceuticals

04/06/17

Pristiq

Pfizer

Greenstone, LLC

04/20/17

Pristiq

Pfizer

Doripenum

Apotex

01/19/17

Doribax

Shionogi

Esomprazole Sodium

Accord Healthcare, Inc.

09/29/16

Nexium IV

AstraZeneca

Ezetimibe

Par Pharmaceuticals

01/05/17

Zetia

Merck Sharp & Dohme

Flurandrenolide

Teligent, Inc.

04/10/17

Cordran

Aqua Pharmaceuticals

Levalbuterol Tartrate Inhalation Aerosol

Actavis

12/12/16

Xopenex HFA

Akorn, Inc.

Nitroglycerin

Dr. Reddy’s

09/06/16

Nitrostat

Pfizer

Olmesartan Medoxomil, Amlodipine, HCTZ

Par Pharmaceuticals

11/09/16

Tribenzor

Sankyo Pharma, Inc.

Quetiapine ER

Accord Healthcare, Inc.

11/01/16

Seroquel XR

AstraZeneca

Quetiapine ER

Par Pharmaceuticals

11/17/16

Seroquel XR

AstraZeneca

Tazarotene

Greenstone, LLC

04/11/17

Tazorac

Allergan

Tazarotene

Taro Pharmaceuticals USA, Inc. 04/19/17

Tazorac

Allergan

Zileuton SR

Rising Pharmaceuticals

04/03/17

Zyflo CR

Chiesi USA, Inc.

Zileuton SR

Prasco Laboratories

04/25/17

Zyflo CR

Chiesi USA, Inc.

Desvenlafaxine Succinate Desvenlafaxine Succinate

Innovatix | innovatix.com 25

CONTRACT UPDATES

Contract Renewals/Extensions

26 |

(alphabetical by supplier)

SUPPLIER

PRODUCTS

DATES

ELIGIBLE CLASS OF TRADE

AstraZeneca

Seroquel XR®

11/01/16— 12/31/18

Long-term care

Akrimax Pharmaceuticals

Tirosint™, Primlev™, Suprenza™

10/01/16— 09/30/19

Home infusion, long-term care

Amgen, Inc.

Aranesp®

04/01/17— 03/31/18

Long-term care

Berry Plastics

Vials & caps

05/01/14— 06/30/18

Home infusion, long-term care, mail order, oncology, retail

Eli Lilly & Company

Humalog®, Humulin®, Glucagon

01/01/17— 12/31/18

Long-term care

Endo Pharmaceuticals

Cortisporin®

01/01/17— 12/31/19

Retail

Endo Pharmaceuticals

Fortesta®, ColyMycin®S, Opana®, Lidoderm®,Vantas®

01/01/17— 12/31/19

Home infusion, long-term care

Gensco Laboratories

Astero™, ColciGel®, LiDORx®, SpeedGel Rx®, TranzGel®

01/01/14— 06/30/18

Home infusion, long-term care, mail order, oncology, retail

GlaxoSmithKline

Advair Diskus®, Advair® HFA, Amerge®, Anoro® Ellipta®, Arnuity® Ellipta®, Avodart®, Breo® Ellipta®, Ceftin®, Coreg®, Coreg CR®, Dyazide®, Flovent® Diskus, Flovent® HFA, Imitrex®, Imitrex STATdose Refill, Imitrex STATdose System, Incruse Ellipta®, Jalyn®, Rythmol SR®, Serevent® Diskus, Valtrex®, Ventolin® HFA, Wellbutrin SR®, Zantac®, Zyban®, Bexsero®, Boostrix®, Engerix-B®, Havrix®, Infanrix®, Kinrix®, MenHibrix®, Menveo®, PeDIarIx®, RabAvert®, Rotarix®, Twinrix®

07/01/17— 06/30/18

Home infusion, long-term care

Marlex Pharmaceuticals

Acetaminophen, Acetazolamide, Ascorbic Acid, Baclofen, 05/01/2017— Bethanechol Chloride, Chlordiazepoxide Hcl/Clid, Entecavir, 6/30/2018 Felbamate, Folic Acid, Isoniazide, Isopropyl Alcohol, Lamivudine Oral Soln, Loxapine, Niacin Er, Night Time Cold & Flu Relief, Omega-3 Fish Oil, Oxybutynin Chloride Er, Perindopril Erbumine, Phenazopyridine Hcl, Pilocarpine Hcl, Pilocarpine Hydrochloride, Probenecid, Salsalate, Simethicone, Sodium Polystyrene Sulfon, Thiamine Hcl, Triamterene/Hydrochlorothiazide, Ursodiol, Vitamin E

Home infusion, long-term care, mail order, oncology, retail

Merck Sharp & Dohme Corp.

Asmanex® Twisthaler, Avelox®, Cancidas®, Difcid®, Dulera®, Invanz®, Janumet®, Januvia® XR, Nasonex®, Noxafil®, Pneumovax® 23, Primaxin®, Proventil® HFA, Recombivax HB®, Vaqta®, Zostavax®

07/01/14— 06/30/18

Long-term care

Solstice Neurosciences

Myobloc®

03/01/11— 06/30/18

Home infusion, long-term care, mail order

Trigen Laboratories

Avo Cream, Complete Natal DHA, Corvita™, Elite-OB, Ferraplus 90, Folivane-F, Ropinirole ER, Taron Forte, TL Gard Rx, Trinatal Rx, Triveen-Duo DHA, Ultimatecare One, Vemavite-Prx 2, Venlafaxine Hcl ER, Vol-Care Rx, Zatean-CH

09/01/16— 08/31/19

Home infusion, long-term care, mail order, oncology, retail

Tris Pharma

Dextroamphetamine Sulfate, Hydrocodone Polistirex Chlorphen, Hydrocodone/Acetaminophen, Morphine Sulfate, Theophylline

12/01/16— 11/30/19

Home infusion, long-term care, retail

Valeant Pharmaceuticals

Anusol-HC®, Apriso™, Azasan®, Fulyzaq®, Metozolv™ ODT, MoviPrep®, OsmoPrep, Proctocort, Relistor, Xifaxan

09/01/16— 06/30/18

Long-term care, oncology

Valeant Pharmaceuticals

MoviPrep

01/01/09— 06/30/18

Long-term care, oncology

Insight

New Innovatix/Premier Contracts

CONTRACT UPDATES

(alphabetical by contract category)

CONTRACT CATEGORY

CONTRACT ID

CONTRACT TITLE

SUPPLIER

Delivery, shipping, and freight management

IE-MM-011

LTL transportation services

FedEx

Facility management and maintenance

PP-FA-592

Electrical and plumbing building materials

Crescent Electric Supply Company

PP-FA-593

Electrical and plumbing building materials

Graybar Electric Company

PP-FA-595

Electrical and plumbing building materials

Wesco

PP-FA-590

Maintenance, repair, and operations

AirSupply Tools

PP-FA-594

Maintenance, repair, and operations

The Part Works

PP-FA-591

Maintenance, repair, and operations

WW Grainger

PP-IM-361

PET isotopes

Cardinal Health 414

PP-IM-362

PET isotopes

PetNet Solutions

PP-IM-363

PET isotopes

Triad Isotopes

PP-IM-364

PET isotopes

Zevacor Pharma

IE-MS-030

Negative wound pressure therapy: Portable devices

Smith & Nephew

PP-NS-1037

Bladder scanners

Laborie Medical Technologies Corp.

PP-NS-1038

Bladder scanners

Medline Industries

PP-NS-1035

Electronic thermometry

Covidien

PP-NS-1036

Electronic thermometry

Welch Allyn

PP-NS-1034

High-level disinfectants

Crosstex International

PP-NS-1032

High-level disinfectants

Johnson & Johnson

PP-NS-1033

High-level disinfectants

Metrex Research

IE-MS-029

Incontinence products

First Quality Enterprises

PP-NS-1026

Intermediate-level disinfectant wipes

Certol International

PP-NS-1027

Intermediate-level disinfectant wipes

Clorox

PP-NS-1028

Intermediate-level disinfectant wipes

Diversey

PP-NS-1029

Intermediate-level disinfectant wipes

Metrex Research Corporation

PP-NS-1030

Intermediate-level disinfectant wipes

Professional Disposables International (PDI)

PP-NS-1002

Sharps disposal containers

Becton, Dickinson and Company

PP-NS-1001

Sharps disposal containers

Covidien

PP-NS-1020

Skin integrity: Compression wraps

3M Company

PP-NS-1021

Skin Integrity: Compression wraps

BSN Medical

PP-NS-1022

Skin integrity: Compression wraps

Derma Sciences, Inc.

PP-NS-1023

Skin integrity: Compression wraps

Medline Industries

Imaging

Medical Surgical Nursing

Innovatix | innovatix.com 27

CONTRACT UPDATES

New Innovatix/Premier Contracts CONTRACT CATEGORY

CONTRACT ID

CONTRACT TITLE

SUPPLIER

Nursing (cont.)

PP-NS-1024

Skin integrity: Compression wraps

Molnlycke Health Care

PP-NS-1025

Skin integrity: Compression wraps

Smith & Nephew

PP-NS-1004

Skin Integrity: Primary/secondary wound care dressings, and wound debridement

Coloplast Corp.

PP-NS-1005

Skin Integrity: Primary/secondary wound care dressings, and wound debridement

ConvaTec

PP-NS-1006

Skin Integrity: Primary/secondary wound care dressings, and wound debridement

Crawford Healthcare

PP-NS-1007

Skin Integrity: Primary/secondary wound care dressings, and wound debridement

Derma Sciences

PP-NS-1008

Skin Integrity: Primary/secondary wound care dressings, and wound debridement

Hollister

PP-NS-1012

Skin Integrity: Primary/secondary wound care dressings, and wound debridement

KCI

PP-NS-1009

Skin Integrity: Primary/secondary wound care dressings, and wound debridement

Medline Industries

PP-NS-1010

Skin Integrity: Primary/secondary wound care dressings, and wound debridement

Molnlycke Health Care

PP-NS-1011

Skin Integrity: Primary/secondary wound care dressings, and wound debridement

Smith & Nephew

PP-NS-1013

Skin Integrity: Skin cleanser, barrier, and lotion products

3M Company

PP-NS-1014

Skin Integrity: Skin cleanser, barrier, and lotion products

Coloplast Corp.

PP-NS-1015

Skin Integrity: Skin cleanser, barrier, and lotion products

ConvaTec

PP-NS-1016

Skin Integrity: Skin cleanser, barrier, and lotion products

Crawford Healthcare

PP-NS-1017

Skin Integrity: Skin cleanser, barrier, and lotion products

Medline Industries

PP-NS-1018

Skin Integrity: Skin cleanser, barrier, and lotion products

Molnlycke Health Care

PP-NS-1019

Skin Integrity: Skin cleanser, barrier, and lotion products

Smith & Nephew

PP-OR-1398

Lap sponges, OR towels, and specialty sponges

Allcare

PP-OR-1399

Lap sponges, OR towels, and specialty sponges

Amd-Ritmed

PP-OR-1397

Lap sponges, OR towels, and specialty sponges

Cardinal Health 200

PP-OR-1396

Lap sponges, OR towels, and specialty sponges

Medline Industries

PP-OR-1401

Lap sponges, OR towels, and specialty sponges

S2S Global

PP-OR-1388

Orthopedic small joint implants

Integra LifeSciences Sales

PP-OR-1389

Orthopedic small joint implants

Trilliant Surgical

PP-OR-1400

Pain management: Local anesthetic

Ambu

PP-OR-1394

Pain management: Local anesthetic

Halyard

PP-OR-1395

Pain management: Local anesthetic

Teleflex Medical

OR products and supplies

28 |

(alphabetical by contract category)

Insight

Trade Show Corner Upcoming Events Visit Innovatix and Essensa staff at any of these events May 22–25

National Home Infusion Association (NHIA) Annual Conference and Exposition Orlando, FL

June 5–7

California Assisted Living Association (CALA) 2017 Spring Conference and Tradeshow Burlingame, CA

June 27–30

Premier Breakthroughs Conference and Exhibition Washington, D.C.

October 9–11

+

Innovatix + Essensa 2017 National Meeting & Expo Austin, TX

October 14–18

National Community Pharmacists Association (NCPA) Annual Convention Orlando, FL

October 15–18

American Health Care Association and National Center for Assisted Living (AHCA/NCAL) 68th Annual Convention and Expo Las Vegas, NV

For more information, contact your Client Service Associate at 888.258.3273.

Innovatix | innovatix.com 29

Elevate your purchasing strategy and your career at the most respected industry conference dedicated to purchasing and non-acute healthcare professionals.

+

+ A P R E M I E R I N C . C O M PA N Y

30 |

A P R E M I E R I N C . C O M PA N Y

Make plans to join more than 500 of your peers in Austin, TX, October 9 â&#x20AC;&#x201C; 11, for three days of interactive learning, networking, and business development. Visit www.innovatix.com/nationalmeeting for details.

Insight