Dennis Bourdette, M.D., FAAN, FANA Chair and Roy and Eulalia Swank Family Research Professor, Department of Neurology, Oregon Health & Science University
Yousaf Ali, M.D., FACR Chief, Division of Rheumatology, Mount Sinai St. Luke's and Mount Sinai West; Professor of Medicine, Icahn School of Medicine at Mount Sinai
Steven L. D’Amato, B.S.Pharm. Founding Partner, Scientia Pharmacy Advisors
Joseph Mikhael, M.D., M.Ed., FRCPC, FACP Chief Medical Officer, International Myeloma Foundation
Steve Marciniak, RPh President, ClarityRX
Saira A. Jan, M.S., PharmD VP and Chief Pharmacy Officer, Horizon Blue Cross Blue Shield of New Jersey
Contents
CHALLENGES
A note from our SVP
Dear managed care colleagues,
Welcome to the spring 2025 issue of the Prime Therapeutics Report! 2025 promises to be an exciting year. The FDA is expected to approve as many as 74 novel drugs — the highest number in a decade. Prime is dedicated to bringing our readership the most timely, up-to-date information to keep you informed and help with management planning.
Our cover story (Page 18) highlights the autoimmune category. As different formulations with different administration routes emerge, it’s increasingly important to manage across the medical and pharmacy benefits. We also discuss updates around biosimilars in the space, including a pipeline.
Another article focuses on advances in gene therapies, including recent approvals and the expansive pipeline (Page 4). We also outline the new CMS Cell and Gene Therapy Access Model for sickle cell disease gene therapies and how it may impact payers.
This issue also includes a highlight of Prime’s IntegratedRx® solution (Page 12), an update on GLP-1 treatments (Page 30) and results from a Prime precision oncology clinical program that evaluated real-world operational processes in biomarker testing (Page 25). As always, we’ve rounded out the issues with our pipeline (Page 35) and managed care newsstand (Page 2).
To learn more about how we’re supporting transformative payer initiatives, feel free to contact us at PTReport@PrimeTherapeutics.com. As always, we value any feedback you may have. Enjoy the report!
Sincerely,
Steve Cutts, PharmD
Senior Vice President, Specialty and Clinical Solutions Prime Therapeutics
Federal regulations
Medicare
Contract Year 2026 MA and Part D
Proposed Rule (CMS-4208-P): On Nov. 26, CMS released the contract year 2026 proposed rule for the Medicare Advantage program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program and Programs of All-Inclusive Care for the Elderly (the “Proposed Rule”). Among the changes impacting Part D, CMS proposed a “reinterpretation” of the Part D coverage exclusion for weight loss drugs to cover anti-obesity medications (AOMs) for treating obesity under Medicare Part D and Medicaid.
CMS also clarifies that plan formularies must ensure beneficiaries have broad access to generics, biosimilars and other lower-cost drugs to comply with the statutory requirement. Moreover, CMS intends to enhance its formulary review process by evaluating whether the Part D plan’s formulary and utilization management (UM) practices concerning generics and biosimilars constitute a drug UM program that is “cost effective,” “reasonable and appropriate,” and inclusive of “incentives to reduce costs.”
CMS proposes two changes to how PBMs contract with pharmacies to improve PBM transparency. First, CMS proposes requiring PBMs to notify pharmacies of their in-network plans for the upcoming year (by Oct. 1). Second, CMS proposes that Part D plans or its PBMs allow pharmacies the right to terminate their network contracts without cause after providing the same notice that Part D plans or PBMs have for terminating contracts without cause.
According to the proposed rule, CMS will codify existing subregulatory
guidance in the Part D program under the Inflation Reduction Act (IRA) related to the Medicare Prescription Payment Plan, vaccine cost-sharing and insulin cost-sharing requirements. Of particular interest is CMS’ proposed changes to the IRA Medicare Drug Price Negotiation Program. CMS proposes reducing the time frame for Part D plans to submit prescription drug event records for selected drugs from 30 to seven days. Also, CMS proposes to mandate Part D plans to include in their network contracts with pharmacies a requirement for the pharmacy to enroll with the Medicare Transaction Facilitator (MTF).
With a new administration, the proposed rule is likely to face challenges.
Health insurance market
Coverage of Certain Preventive Services Under the ACA (CMS9903-P): On Dec. 23, the Department of Health and Human Services, Department of Labor, and Department of Treasury (together, “Departments”) announced they were withdrawing proposed regulations that would have prohibited employers from claiming an exemption based on “nonreligious moral objections” to the Affordable Care Act’s contraception mandate. The Departments proposed creating a new pathway independent from the employer, group health plan, plan sponsor or issuer that objects to contraception access based on sincerely held religious beliefs so individuals could obtain contraceptive services from a willing provider at no cost. The rule was proposed in January 2023.
In a notice in the Federal Register, the Departments said they decided to withdraw the proposed rule partly
While there may be legislative action to regulate PBMs in 2025, a closely divided 119th Congress could make passing legislation particularly challenging.
because they wanted to “focus their time and resources on matters other than finalizing these rules.” Officials said the Departments also want more time to consider the draft regulations in light of the comments received.
HIPPA Security Rule to Strengthen the Cybersecurity of Electronic Protected Health NPRM: On Dec. 27, the Office for Civil Rights (OCR) announced a notice of proposed rulemaking (NPRM) meant to strengthen cybersecurity provisions of sensitive health information from cyberattacks. The proposal comes at a crucial time for the healthcare sector after major breaches to UnitedHealthcare and Ascension. The NPRM would require new cybersecurity mandates and update existing HIPAA security regulations.
With a new administration, a final rule could be postponed or never promulgated.
Patrick Gleason, PharmD
FCCP, FAMCP, BCPS
AVP, Health Outcomes
Prime Therapeutics
Cell and gene therapy
Advances and management challenges
More than 1,000 cell and gene therapy candidates are in clinical trials worldwide, and the U.S. Food and Drug Administration (FDA) expects to approve potentially dozens yearly over the next few years.1 The 2024 edition of the Gene, Cell, & RNA Therapy Landscape Report from the American Society of Gene and Cell Therapy identified 4,099 therapies in development across the pipeline; gene therapies accounted for 49% of all cell, gene and RNA therapeutics in development.2 The current cell and gene therapy pipeline seems to be shifting toward non-oncology indications, with 51% of newly initiated gene therapy trials targeting conditions other than cancer.2
Recent approvals
Eladocagene exuparvovec-tneq (Kebilidi)
In November 2024, the FDA granted accelerated approval to eladocagene exuparvovec-tneq (Kebilidi, PTC Therapeutics) for the treatment of pediatric and adult patients with aromatic L-amino acid decarboxylase (AADC) deficiency, including the full spectrum of disease severity.3 The efficacy and safety of eladocagene exuparvovec has been demonstrated through clinical trials and compassionate use programs; however, traditional approval is contingent upon verification and description of clinical benefit in a confirmatory trial.3
A 2021 analysis of three major clinical trials that included 26 children with AADC deficiency treated at total doses of either 1.8 x 1011 vg (n=21) or 2.4 x 1011 vg (n=7), found a significantly higher number of patients who were treated with the gene therapy achieved full head control and sat unassisted than those in the Natural History Database (NHDB).4 Of those who received the drug, 44% of patients achieved head control and 20% could sit unassisted as early as 12 months after receiving the drug.5 Then, 24 months after receiving
The 2024 edition of the Gene,
Cell, and RNA Therapy Landscape
Report ... identified 4,099 therapies in development across the pipeline.
treatment, 64% achieved head control, 50% could sit unassisted and 18% could stand without support.5 Further, at 60 months of treatment, 75% achieved head control, 67% could sit unassisted, 25% could stand without support and 8% could walk without support. Only 4% of those from the NHDB achieved key milestones.5
A May 2022 post hoc analysis of the three trials showed eladocagene exuparvovec improved body weight and
reduced respiratory infections in patients with AADC deficiency.6 While 83.3% of patients at baseline had body weight in the bottom third percentile, 95.9% maintained or gained weight relative to age- and gender-matched children without AADC deficiency after 12 months of treatment.6 Additionally, 42% shifted to a higher percentile and 54% maintained the same percentile as they did at baseline.6 The annual rate of upper respiratory tract infections and pneumonia decreased from 2.41 at one year after treatment to 0.31 at five years after treatment.6
Remestemcel-L-rknd (Ryoncil)
In December 2024, the FDA approved remestemcel-L-rknd (Ryoncil) for the treatment of steroid-refractory acute graft-versus-host disease (SR-aGVHD) in pediatric patients 2 months of age and older.7 Remestemcel is an allogeneic bone marrow-derived mesenchymal stromal cell (MSC) therapy, which marks the first approval of an MSC therapy by the FDA.7 MSCs are a type of cell that can have various roles in the body and can differentiate into multiple other types of cells.7
Approval was based on results from the multicenter, single-arm study in 54 pediatric patients with SR-aGVHD undergoing allogeneic hematopoietic stem
• Providing people their cancer meds through in-house pharmacies
With new recent approvals and more in the pipeline, there are competitor gene therapy products in the rare blood disorder space.
CMS initiative: Sickle cell disease
In December 2024, the Biden-Harris administration announced Bluebird Bio and Vertex Pharmaceuticals, manufacturers of lovo-cel and exa-cel, respectively, entered agreements with the Centers for Medicare & Medicaid Services (CMS) to participate in the Cell and Gene Therapy Access Model.16 The agreements are structured to tie payments to improved health outcomes for people with Medicaid who receive these drugs.16
The objectives of this model are to lower the cost of cell and gene therapies, increase the access to potentially transformative therapies for all individuals with SCD, and offer states funding for activities that reduce barriers to access for people with Medicaid.17 The model also requires manufacturers to cover certain fertility preservation services, as the care journey for SCD with cell and gene therapies typically results in infertility.17 Ultimately, the goal is increasing beneficiary access, reducing SCD burden, improving quality of life and streamlining authorization processes for easier care navigation.17
The model was developed in response to an executive order issued by President Biden in October 2022 that directed the U.S. Department of Health and Human Services to consider developing models that address access to novel therapies and lower drug costs.16,17 It launched in January 2025, and states may begin participating between January of 2025 and January 2026.16,17 After launch, the model may expand to include cell and gene therapies for other indications.16,17 It is important to note that, under the new administration, the CMS Cell and Gene Therapy Access Model, as well as initiatives to expand access to sickle cell treatments, may change or no longer move forward.
REFERENCES
1 Gottlieb, S. (2019, January 15). Statement from FDA Commissioner Scott Gottlieb, M.D. and Peter Marks, M.D., Ph.D., Director of the Centers of Biologics Evaluation and Research on new policies to advance development of safe and effective cell and gene therapies. U.S. Food and Drug Administration fda.gov/news-events/press-announcements/ statement-fda-commissioner-scott-gottlieb-md-andpeter-marks-md-phd-director-center-biologics
2 Buntz, B. (2024, December 20). 100 cell and gene therapy leaders to watch in 2025. Drug Discovery & Development https://www.drugdiscoverytrends.com/100-cell-andgene-therapy-leaders-to-watch-in-2025/
3 PTC Therapeutics announces FDA approval of AADC deficiency gene therapy. News release. (2024, November 13). PTC Therapeutics. https://ir.ptcbio.com/ news-releases/news-release-details/ptc-therapeuticsannounces-fda-approval-aadc-deficiency-gene
4 Upstaza granted marketing authorization by European Commission as first disease-modifying treatment for AADC deficiency. News release. (2022, July 20). PTC Therapeutics. https://www.prnewswire.com/news-releases/ upstaza-granted-marketing-authorization-by-europeancommission-as-first-disease-modifying-treatment-foraadc-deficiency-301589884.html
5 Hwu P.W.L., et al. (2021). 390 Efficacy of gene therapy with eladocagene exuparvovec in patients with AADC deficiency compared with natural history controls. Archives of Disease in Childhood, 106(Supplement 2), A163-A164. https://adc.bmj.com/content/106/Suppl_2/ A163.2
6 Hwu P.W.L., et al. (2022). Eladocagene exuparvovec improves body weight and reduces respiratory infections in patients with aromatic L-amino acid decarboxylase deficiency. Neurology, 98(Supplement 18). https://doi. org/10.1212/WNL.98.18_supplement.2014
7 FDA approves first mesenchymal stromal cell therapy to treat steroid-refractory acute graftversus-host disease. (2024, December 18). U.S. Food and Drug Administration. https://www. fda.gov/news-events/press-announcements/ fda-approves-first-mesenchymal-stromal-cell-therapytreat-steroid-refractory-acute-graft-versus-host
8 Kurtzberg, J., et al. (2021). A phase 3, single-arm, prospective study of remestemcel-L, ex vivo cultureexpanded adult human mesenchymal stromal cells for the treatment of pediatric patients who failed to respond to steroid treatment for acute graft-versus-host disease. Biology of Blood and Marrow Transplantation: Journal of the American Society for Blood and Marrow Transplantation, 26(5), 845–854. https://doi.org/10.1016/j. bbmt.2020.01.018
9 Abeona Therapeutics announces FDA accepts and grants priority review for pz-cel biologics license application (BLA). (2023, November 27). Abeona Therapeutics. https:// investors.abeonatherapeutics.com/press-releases/ detail/268/abeona-therapeutics-announces-fdaaccepts-and-grants
10 Abeona Therapeutics announces additional phase 3 VIITAL™ study results for EB-101 presented at the International Societies for Investigative Dermatology 2023 Meeting. (2023, May 11). Abeona Therapeutics. https:// investors.abeonatherapeutics.com/press-releases/ detail/251/abeona-therapeutics-announces-additionalphase-3-viital
REFERENCES (CONT.)
11 Maragkou, I. (2024, August 29). The most expensive drugs in the US. Pharmaceutical Technology. https:// www.pharmaceutical-technology.com/features/ the-most-expensive-drugs-in-the-us
12 Blum, K. (2024, December 13). $1 million health plan savings for hemophilia gene therapy projected. Specialty Pharmacy Continuum. https://www. specialtypharmacycontinuum.com/Clinical/Article/12-24/ Gene-Therapy-Cost-Savings/75552
13 Joszt, L. (2024, December 24). Trends and transformation: Gene therapies in rare blood disorders. Managed Healthcare Executive. https://www. managedhealthcareexecutive.com/view/trends-andtransformation-gene-therapies-in-rare-blood-disorders
14 Nimura, C., et al. (2024, December 9). Exploring the patient perspectives of gene therapy for sickle cell disease. American Society of Hematology. https://ash.confex.com/ ash/2024/webprogram/Paper198475.html
15 ICER publishes final evidence report on gene therapies for sickle cell disease. (2023, August 21). Institute for Clinical and Economic Review. https://icer.org/news-insights/ press-releases/icer-publishes-final-evidence-report-ongene-therapies-for-sickle-cell-disease/
16 Biden-Harris administration takes next steps to increase access to sickle cell disease treatments. (2024, December 4). Centers for Medicare and Medicaid Services Newsroom. https://www.cms.gov/newsroom/ press-releases/biden-harris-administration-takes-nextsteps-increase-access-sickle-cell-disease-treatments
17 Cell and gene therapy (CGT) access model overview factsheet. Centers for Medicare and Medicaid Services. https://www.cms.gov/files/document/cgt-model-ovwfact-sheet.pdf
Jason Graveline, M.B.A. Senior Director, Specialty Innovation & Strategy Prime Therapeutics
Prime Therapeutics IntegratedRx®
Oncology and cystic fibrosis solutions
Prime Therapeutics (Prime) offers our IntegratedRx solution, which delivers enhanced value on medications with a breakthrough integrated experience for members. Through both IntegratedRx Oncology® and IntegratedRx Cystic Fibrosis®, the solution offers access to a national network of clinically integrated, provider-based specialty pharmacies. IntegratedRx offers several strategic benefits, including channel independence to avoid conflicts and to comply with regulations, cost-saving opportunities through market competitive rates, more coordinated care and a highly rated member experience.
Integrated pharmacies
Provider-based pharmacies have unique drug purchasing power, enabling market-leading rates. Prescriber and pharmacist are both part of the member’s care team to further enhance coordination of care. Members can receive prescriptions directly from their provider’s integrated pharmacy, leading to higher satisfaction. The pharmacy has access to an electronic medical records (EMR) system that enables interventions for which other pharmacies lack the capability and capacity.
Enabling provider-based pharmacies to dispense specialty medications has led to plan savings across oncology and cystic fibrosis. Annual per utilizing member savings attributable to IntegratedRx pharmacy were
Annual per utilizing member savings attributable to IntegratedRx pharmacy were $8,400 for oncology and $28,200 for cystic fibrosis.
$8,400 for oncology and $28,200 for cystic fibrosis. The solution also has a 94% satisfaction rate for utilizing members and reduced medical total cost of care by 9%.
The IntegratedRx national network provides access from coast to coast via timely and convenient access to cancer and cystic fibrosis medications, with more than 440 provider pharmacies across 47 states. Recent additions to the network include Children's Hospital of Philadelphia, North Memorial Health, Northwestern Medicine, Texas Oncology and the University of Illinois system.
Growth and adoption
IntegratedRx Oncology has been adopted by 13 Blue Plans and five national employers, encompassing 12.5 million eligible commercial lives. Meanwhile, IntegratedRx Cystic Fibrosis has been adopted by nine Blue Plans and three national employers, covering 8.4 million eligible commercial lives. This broad adoption has resulted in realized cumulative drug savings of more than $45 million by 2024.
IntegratedRx Oncology
The IntegratedRx Oncology solution is a strategy for high-cost specialty drug therapies covered under the pharmacy benefit that offers market-leading economics, better coordinated care and a highly rated member experience. The strategy is a gateway to best-in-class
discounts, which generate plan savings, and a differentiated care delivery model through prescriber and pharmacist coordination. Ninety-four percent of utilizing members have reported satisfaction with their experience.
Oral oncology waste reduction
In 2023, Prime enhanced its IntegratedRx Oncology program by adding an Oral Oncology Waste Reduction feature to optimize waste reduction opportunities for oral oncolytics. This feature focuses on coordination and appropriate timing of drug refills and provider appointments, patient education, toxicity monitoring and enhanced communication. Prime also assembled a toolkit to support participating pharmacies in these key areas.
IntegratedRx Cystic Fibrosis
The cystic fibrosis category has seen specialty medication drive cost increases as well as lifetime treatment that results in longer lifespans. Cystic fibrosis impacts a small population whose life expectancy is on the rise with the use of long-term, high-cost medications. There are nearly 40,000 people living with cystic fibrosis, with
approximately 1,000 new cases diagnosed each year and more than 75% diagnosed by age 2.1, 2 The predicted median survival rate is 53 years, and almost 60% of the population is age 18 or older.3
Cystic fibrosis treatment centers are integral to patient outcomes, and there are 130 nationally accredited cystic fibrosis care centers. The IntegratedRx Cystic Fibrosis program has about 80 specialty pharmacies associated with these care centers in network. As part of the cystic fibrosis care center model, a multidisciplinary team is assigned to each cystic fibrosis member, and each member will see the care team at least four times per year, per the clinical care guidelines. Coordination between a cystic fibrosis specialty pharmacy and pharmacist is key to driving better adherence and outcomes and preventing waste. In-person clinic visits to touch base four times a year, in addition to specialty pharmacist calls in between, are key to maintaining patient care and data.
Disconnected patient and provider care impacts overall costs. Requiring a cystic fibrosis patient to receive medications from a pharmacy that is not affiliated with their specialized care team, including a specialty pharmacist, can result in poor outcomes and increased costs, including hospitalizations, lower adherence, polypharmacy, and low- or no-rebate core category drugs.
Traditional specialty pharmacy model (nonintegrated pharmacy)
Provider has no connection to central specialty pharmacy
The cystic fibrosis category is driving trend 4.5%, or $3.01 per member per month (PMPM). Low adherence is common, leading to increased hospitalizations and total cost of care. The use of multiple drugs per patient is a major contributor to low adherence. Patients with cystic fibrosis take an average of eight to 10 medications per day and, on average, are 45% adherent to medications.4
With the IntegratedRx Cystic Fibrosis network, members can receive all their medications through their cystic fibrosis care center’s pharmacy. Prime offers negotiated best-in-class pharmacy discount rates. This end-to-end coordination across the treatment pathway uniquely integrates the specialty pharmacy and provider ecosystem to unlock the best value, create a better member and provider experience and reduce total cost of care. The IntegratedRx Cystic Fibrosis solution offers 12.17% better effective rate brand AWP discounts than central fill and an average plan savings of $28,200 annually per utilizing member.
Impact
In 2024, IntegratedRx produced total client savings of $45 million. The program delivered year-over-year incremental savings growth of about $21.5 million combined across
Prime's IntegratedRx model (integrated pharmacy)
The provider, pharmacist and member are connected
all implemented clients, accounting for more than 90% growth year over year.
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Cystic fibrosis care center with integrated specialty pharmacy — 4 visits/year Prescription
with care team
Cystic fibrosis care center with integrated specialty pharmacy — 4 visits/year
1 CF Foundation estimates increase in CF population. (2022, July 28). Cystic Fibrosis Foundation. https://www.cff.org/news/2022-07/ cf-foundation-estimates-increase-cf-population
REFERENCES
2 What is cystic fibrosis? Cystic Fibrosis Foundation. https:// www.cff.org/intro-cf/about-cystic-fibrosis
3 Sullivan, B. (2022, Aug. 11). People with CF are living longer. What does that mean for our care? Cystic Fibrosis Foundation. https:// www.cff.org/community-posts/2022-08/ people-cf-are-living-longer-what-does-mean-our-care
4 Tjugum, S.L., Hansen, B.K., & McKinzie, C.J. (2021). Association of medication regimen complexity with clinical endpoints in pediatric patients with cystic fibrosis. The Journal of Pediatric Pharmacology and Therapeutics: JPPT; the official journal of PPAG, 26(3), 248–252. https:// doi.org/10.5863/155106776026.3.248
Solutions that make a real di erence
Prime is transforming the way health care works for pharmacies, providers and the people we serve. And we’re delivering human-centered, intelligently designed solutions with a focus on the three things that matter most to you.
Save
Make medication more affordable
Simplif y
Deliver an easy, transparent experience
Suppor t
Help people achieve better health
See how we can partner to reimagine pharmacy solutions
Biosimilars
A wave of biosimilars have been introduced in the autoimmune category in recent years. See Table 1 for a breakdown of currently approved and/or available biosimilars for autoimmune diseases.6
Adalimumab (reference Humira) biosimilars began to launch in January 2023, and several more launched over the course of the following two years.
The next big movement in this space will be ustekinumab (reference Stelara) biosimilars. Seven ustekinumab biosimilars have been approved, and the first, Wezlana (ustekinumab-auub), was launched by Amgen on Jan. 1, 2025.7 Ustekinumab has a main indication for the treatment of inflammatory bowel disease, which requires two formulations: an intravenous infusion loading dose (130 mg/26 mL) and the subcutaneous injection maintenance dose (90 mg/mL) every eight weeks.7 The different administration formulations mean ustekinumab crosses medical and pharmacy benefits, which complicates the emerging biosimilar landscape.7
The expanding number of biosimilars and growing competition may contribute to additional payer savings.8 Ensuring proper provider and patient knowledge,
familiarity, and comfort level with biosimilars is critical to improving biosimilar uptake and managing costs.8 A 2022 biosimilar survey of patients and providers showed that although provider understanding of biosimilars has improved in the previous five years, physicians and pharmacists still approach biosimilars with caution.8 They cited concerns with nonmedical switching, interchangeability, pharmacist-led substitution and the extent of cost savings.8
The survey also showed that while patients understand biosimilars’ potential cost benefits, they largely shared many of the providers’ concerns.8 Additionally, patients were concerned that biosimilars would not treat their disease as well as the reference product and that switching would lead to adverse effects.8 These overlapping areas of concern for both patients and providers can be useful in developing education and interventions and lead to improved biosimilar uptake.8
Category spend
Autoimmune treatments tend to be the largest spend driver for payers.9 These conditions account for 1% of commercially insured members, yet the category accounted for 42% of specialty spend in 2022.9
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According to the 2024 Prime Therapeutics Medical Pharmacy Trend Report, there was a continued increase in biologic drugs for autoimmune disorders (BDAIDs) spend in the commercial and Medicaid lines of business (6.1% and 3.3%, respectively).10 This can be attributed mostly to higher vedolizumab (Entyvio) utilization.10
The subcutaneous formulation of vedolizumab was approved in September 2023, and the drug may see spend move to the pharmacy benefit in coming years.10 Infliximab (Remicade) is still among the top 10 drugs for the commercial line of business.10 However, its usage is decreasing across all lines of business, which is likely due to a shift to biosimilar products coupled with the approval of Skyrizi and Rinvoq for additional indications in the space.10 Of the infliximab biosimilars, Inflectra gained the most commercial market share, with an annual cost per utilizer of $19,440 compared to Remicade’s $23,109.10
Management strategies
Cross-benefit management
While many high-cost autoimmune drugs are covered under the medical benefit, different formulations and regimens that require switching administration from intravenous to subcutaneous require management across both benefits.2 For example, the different administration
formulations for ustekinumab require the drug to be covered on both benefits.2 Cross-benefit management is a key factor to understanding the total cost of care and uncovering additional savings opportunities.2 Value-based contracts provide discounts, cost caps and clinical management to flexibly support better health outcomes.2 Also, the HighTouchRx® Prime solution utilizes advanced clinical rules and machine learning to identify non-optimized drug use and present high-cost savings opportunities.2 Since April 2022, this solution has achieved $15 million in savings in the autoimmune category.2
Prime offers holistic support across the medical and pharmacy benefit. Prime’s expert clinical network of key opinion leaders helps ensure members receive appropriate high-quality care.2 Also, the Care Specialists program provides members personalized care from pharmacists and nurses specially trained in their condition to work with them one-on-one to assist with side effects, check dosage schedules and help answer questions they may have about their condition.2
In the autoimmune category, which offers a range of available treatments (many with high price tags), utilization management may be key to managing costs while ensuring treatment access.11 Some payers have managed for dosage and indication to ensure members receive the appropriate dose based on FDA recommendations.11 Other digital tools and targeted interventions can further enhance safety while reducing waste and promoting better outcomes.11
1 Autoimmune diseases. (2024, December 17). National Institute of Environmental Health Sciences. https://www. niehs.nih.gov/health/topics/conditions/autoimmune
2 Support members with autoimmune diseases. Prime Therapeutics. https://www.primetherapeutics.com/ autoimmune
3 Autoimmune diseases. (2022, October 6). National Institute of Allergy and Infectious Diseases. https://www.niaid.nih. gov/diseases-conditions/autoimmune-diseases
4 Ipsen’s Iqirvo® receives U.S. FDA accelerated approval as a first-in-class PPAR treatment for primary biliary cholangitis. (2024, June 10). Ipsen. https://www.ipsen. com/press-releases/ipsens-iqirvo-receives-u-sfda-accelerated-approval-as-a-first-in-class-ppartreatment-for-primary-biliary-cholangitis
5 Kowdley, K.V., et al. (2023, November 13). Efficacy and safety of elafibranor in primary biliary cholangitis. New England Journal of Medicine. https://www.nejm.org/doi/ full/10.1056/NEJMoa2306185
6 Biosimilar approvals. (2025, January 7). The Center for Biosimilars. https://centerforbiosimilars.com/ biosimilar-approvals
7 Stelara biosimilars: preparing for the upcoming market shift (2024, December 16), PSG, https://www.psgconsults.com/ blog/stelara-biosimilars-preparing-for-the-upcomingmarket-shift
8 Gibofsky, A., et al. (2022, November 1). Provider and patient knowledge gaps on biosimilars: insights from surveys. American Journal of Managed Care. https://www.ajmc. com/view/biosimilarssuppl-insightssurveys
9 Biosimilars in the autoimmune category. (2023). CVS Health. https://business.caremark.com/content/dam/enterprise/ business-caremark/insights/pdfs/2023/cvshealthbiosimilars-opportunities-and-considerations.pdf
10 Medical pharmacy trend report, 14th edition. (2024, October 14). Prime Therapeutics. https://issuu.com/ primetherapeutics/docs/2024-medical-pharmacy-trendreport?fr=xKAE9_zU1NQ
11 Shah, Prem. (2021, November 2). Industry voices— reimagining cost management for autoimmune diseases. Fierce Healthcare. https://www.fiercehealthcare.com/ payer/industry-voices-reimagining-cost-managementfor-autoimmune-diseases
Keya Shah, PharmD
Clinical Project Manager, Pharmacist
Prime Therapeutics
Simone Ndujiuba, PharmD, BCOP
Director, Clinical Strategy and Innovation, Oncology
Prime Therapeutics
David Eckwright, PharmD
Sr. Director, Clinical Project & Program Management
Prime Therapeutics
Precision oncology
Evaluating real-world operational process of biomarker testing
The enormous growth and complexity of precision oncology has outpaced providers’ ability to keep up without the appropriate decision-support technology. There is a clear unmet need for provider education around testing and targeted treatment options. A poll of oncologists assessing the knowledge gap in molecular profiling for malignancies showed 69% of community oncologists did not know the answer or incorrectly match the molecular alteration to the targeted therapy.1
Evidence suggests many cancer patients do not get full genotyping prior to treatment, which could lead to ineffective treatment regimens. For example, a 2023 study showed only 37% of non-small cell lung cancer (NSCLC) patients are appropriately tested for the nine biomarkers that are proven to inform the latest targeted treatment options and clinical trials.2
Turnaround times are crucial in the diagnosis and treatment timeline for patients with cancer. A study by Ossowski and colleagues showed the median time from biopsy results to next-generation sequencing (NGS) order was seven days, and the median time from diagnosis to NGS results was 24 days. Ultimately, the total time from pathologic diagnosis to appropriate treatment was 33 days with NGS testing.3
Prime sought to assess biomarker order timelines for National Comprehensive Cancer Network (NCCN) concordant biomarker treatment initiation for various tumor types. Prime also aimed to better understand, compile, and share physician perspectives on hurdles and opportunities to improve process-related issues in the prior authorization and approval process of biomarker testing.
Turnaround
times are crucial in the diagnosis and treatment timeline for patients with cancer.
Methodology
A review of medical and pharmacy claims was conducted using eligibility data and prior authorization (PA) data for medical and pharmacy drugs. PA request dates for drugs requiring biomarker testing were queried from April 1, 2021, through March 31, 2023, across all lines of business. Members’ first PA request date for a drug during the identification period was defined as their index date. PAs were included if they were approved and the drug was being used for one of the following cancer types: breast, lung, ovarian, pancreatic or prostate. Cancer type was determined by the diagnosis provided on the PA request. The member’s ICD-10 codes on their medical claims in the last year were used to determine cancer type if a specific cancer type ICD-10 was not provided on the PA.
The patient journey timeline was defined by three main points: the biomarker testing date identified within three months prior to the index date (T1), the drug prior authorization request date (T2) and drug claim date (T3) (Figure 1).
Findings
Out of all in-scope tumor types, breast cancer was the most prevalent, followed by lung cancer. There was a low patient count for ovarian and prostate cancers. The findings indicated that, on average, it takes around 31.3 days from the biomarker testing request to initiate therapy PA. The time from therapy PA processing to final coverage determination for the patient was around 13 days. The entire process of biomarker testing to therapy initiation was around 45 days.
Oncology advisory board insights
Prime convened an advisory board of 10 health care providers and key external physician stakeholders to discuss barriers to operational efficiencies in biomarker testing, review time frames and understand the correlation to time frames seen in practice. Specialties represented in the advisory board included malignant hematologists in the areas of diffuse large B-cell lymphoma, chronic
T2-T3:
Figure 1. Patient journey
lymphocytic leukemia, additional hematologic malignancies, solid tumors such as breast, gynecologic, melanoma, lung, head, neck and gastrointestinal cancers, and pharmacy.
When asked to review the T1-T2 data, or the days between biomarker claims and PA request date, for breast and lung cancer, participants all agreed the timeline seemed too long and is typically within seven days compared to the 33.6 and 27.5 days observed for breast cancer and lung cancer, respectively. They noted there is typically no difference based on cancer stage, and that, in their clinical practice experience, the period between results to therapy initiation is too long.
Finally, after T1-T3 data of 44.7 days was presented to highlight and define the parameters of the date of biomarker lab testing to date of targeted therapy PA, participants discussed that while this may align with real-world practice, it seems too long. They found that the time from diagnosis to therapy initiation is too drawn out and should be quicker, specifically for a newly diagnosed patient. Some participants relayed that chemotherapy would be started in most cases until results are obtained and targeted therapy can be initiated.
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After reviewing the results of T2-T3 data, or days between PA request and drug claim, for breast and lung, participant consensus was that seven to 12 days is more realistic compared to the 14.5 and 11.8 days observed for breast and lung, respectively, and what is typically seen in practice. They responded that the time does not vary depending on specific populations. While the PA process is typically managed by office staff without much visibility for the provider, some providers expressed a desire to be looped in for more difficult cases to expedite time to therapy initiation. Overall, participants agreed the period between results to therapy initiation should be shortened.
Participants noted that tissue and liquid biopsies are completed concurrently, and whole panels are ordered for NGS in case there is not enough tissue to conduct individual panel testing. Some providers shared they conduct testing after progression due to concerns that driver mutations may have changed due to therapy. The overall consensus was that the current average turnaround time for molecular testing takes too long.
In some cases, orders are placed with outside labs based on insurance preference or inability to test internally. This may lead to delays due to the orders placed outside of providers’ electronic health record (EHR) system. When third-party labs are used, there are variabilities in reporting that make results difficult to interpret, and other challenges may arise in the EHR system. Providers noted that determining the plan preferred agent was not a challenge, as they focused on prescribing the therapy they deemed most appropriate and would appeal denials if necessary.
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Our analysis and advisory board findings indicate a need to address the prolonged timelines associated with biomarker testing and initiation of targeted therapy. When physicians conduct molecular testing, the turnaround times often seen do not meet expectations. Understanding these delays can be helpful in addressing the root issue. Some underlying factors may be delays in obtaining samples when a patient transfers care institutions, insufficient tissue samples and a slow testing process. Collaboration between testing labs and providers may minimize incidents of insufficient tissue samples and delays in obtaining samples. Streamlining the testing process to increase ordering efficiency for providers, laboratories and payers may be critical in more effective testing and therapy moving forward.
REFERENCES
1 Singh, B.P., et al. (2019). Molecular profiling (MP) for malignancies: Knowledge gaps and variable practice patterns among United States oncologists (Onc). American Society of Clinical Oncology. https://meetings. asco.org/abstracts-presentations/173392
2 Evangelist, M.C., et al. (2023). Contemporary biomarker testing rates in both early and advanced NSCLC: Results from the MYLUNG pragmatic study. Journal of Clinical Oncology, 41(Supplement 16). https://doi.org/10.1200/ JCO.2023.41.16_suppl.9109
3 Ossowski, S., et al. (2022). Improving time to molecular testing results in patients with newly diagnosed, metastatic non-small cell lung cancer. Journal of Clinical Oncology, 18(11). https://doi.org/10.1200/OP.22.00260
Mona Chitre, PharmD
Chief Pharmacy Officer
Lifetime Healthcare Companies
GLP-1 update
Increased utilization and market impacts
Since the FDA’s approval of glucagon-like peptide-1 receptor agonists (GLP-1s) for chronic weight management in adults with obesity or who are overweight, demand for these drugs has skyrocketed.1 A 2024 study of real-world, nationwide medical records of 45 million individuals with at least one inpatient or outpatient visit from 2011 to 2023 found about 1 million new GLP-1 users.1 These patients were then classified based on diabetes, obesity or other related conditions at the time they were prescribed the treatment.1 In the study period, semaglutide users were disproportionately female, non-Hispanic white and had a body mass index (BMI) of 30 or greater.1 The proportion of new users with type 2 diabetes mellitus (T2DM) also decreased. This represents a significant shift toward users with obesity rather than T2DM.1
Another new study used a U.S. prescription drug database to calculate the use of GLP-1s by adolescents and young adults from 2020 through 2023.2 Wegovy was approved for individuals ages 12 and over in 2023, while Ozempic, Mounjaro and Zepbound are not approved for use in patients under the age of 18. Over the three-year study period, GLP-1 prescriptions jumped nearly 600% in people age 12 to 25.2 The rate of use rose six- and seven-fold among adolescent boys and girls, respectively.2 In young adults, the utilization was close to five-fold among men and almost eight-fold among women.2 The discrepancy in use between sexes illustrates the need for education on sex-specific safety risks.2
survodutide (BI 456906) Boehringer Ingelheim; Zealand Pharma
CT-868 Carmot Therapeutics; Roche
aleniglipron (GSBR-1290) Structure Therapeutics; Gasherbrum Bio
combination GLP-1/basal insulin
insulin icodec; semaglutide (NN1535) Novo Nordisk
Abbreviations:
The FDA recently approved Zepbound for the treatment of moderate to severe obstructive sleep apnea (OSA) in adults with obesity.8 It may potentially receive an expanded indication for heart failure with preserved ejection fraction (HFpEF).8 The FDA is expected to decide if Wegovy will receive an expanded indication for HFpEF.8 These expanded indications may contribute to greater GLP-1 utilization. Analysts anticipate these potential launches could add $20 billion to the value of the GLP-1 market in a decade.8
There were recent positive results in the pivotal ESSENCE trial focusing on metabolic dysfunction-associated steatohepatitis (MASH), which may lead to an expanded
control in T2DM Phase 2
control in T2DM Phase 2
2
Phase 2
glycemic control in T2DM Phase 3
indication for Wegovy 2.4-mg dose.9 Preliminary results from the placebo-controlled Phase 3 clinical trial of 1,200 participants with MASH showed that after 72 weeks, 37% of those who received once-weekly injections of Wegovy on top of standard of care showed improvement in liver fibrosis with no worsening of the steatohepatitis, compared to 22.5% for those who received placebo and standard of care.9
In January 2025, Ozempic was approved for use in individuals with type 2 diabetes and kidney disease.10 Label expansions are similarly anticipated for Ozempic for peripheral artery disease and Rybelsus for major adverse cardiovascular events prevention.11-13
REFERENCES
1 Yeo, Y.H., et al. (2024). Shifting trends in the indication of glucagon-like peptide-1 receptor agonist prescriptions: A nationwide analysis. Annals of Internal Medicine, 177(9), 1289–1291. https://doi.org/10.7326/M24-00
2 Mundell, E. (2024, May 22). Use of GLP-1 meds have risen 7-fold among young Americans. HealthDay. https://www. usnews.com/news/health-news/articles/2024-05-22/ use-of-glp-1-meds-have-risen-7-fold-among-youngamericans
3 Gratzl, S., et al. (2024). Monitoring report: GLP-1 RA prescribing trends – March 2024 data. medRxiv. https:// doi.org/10.1101/2024.01.18.24301500
4 Rodriguez, T. (2024, November 15). GLP-1 drug shortages: How do they affect patients with Diabetes? Pulmonology Adviser. https://www.pulmonologyadvisor.com/features/ glp-1-drug-shortages
5 Amneal resubmits DHE autoinjector new drug application and receives U.S. FDA approval of exenatide, its first injectable GLP-1 agonist. (2024, November 21). Amneal. https://investors.amneal.com/ news/press-releases/press-release-details/2024/ Amneal-Resubmits-DHE-Autoinjector-New-DrugApplication-and-Receives-U.S.-FDA-Approval-ofExenatide-its-First-Generic-Injectable-GLP-1-Agonist/ default.aspx
6 Kang, J. (2025, January 10). REDEFINE 1 trial: Superior weight loss seen with CagriSema. Rheumatology Advisor https://www.rheumatologyadvisor.com/news/redefine-1trial-superior-weight-loss-seen-with-cagrisema
7 Sagonowsky, E. (2023, March 27). Novo’s high-dose Rybelsus win tees up regulatory filings- and new rivalries. FiercePharma, https://www.fiercepharma.com/pharma/ novos-high-dose-rybelsus-win-tees-regulatory-filingsand-new-rivalries
8 Taylor, N.P. (2025, January 7). Wegovy and Zepbound tipped to fuel $20B boom in heart failure market. FiercePharma. https://www.fiercepharma.com/marketing/ wegovy-and-zepbound-tipped-fuel-20b-boom-heartfailure-market
9 Vinluan, F. (2024, November 1). Novo Nordisk GLP-1 drug meets goals of MASH trial, setting stage for FDA & EMA filings. MedCityNews. https://medcitynews.com/2024/11/ novo-nordisk-glp-1-wegovy-mash-fatty-liver-disease-nvo
10 Phillips, D. (2025) FDA approves Ozempic to reduce risks from chronic kidney disease in diabetes patients. CNN https://www.cnn.com/2025/01/28/health/ozempickidney-disease-fda-approval/index.html
11 Ozempic by Novo Nordisk for Peripheral Artery Disease (PAD)/Peripheral Vascular Disease (PVD): Likelihood of approval. (2024, December 30). Pharmaceutical Technology. https://www. pharmaceutical-technology.com/data-insights/ ozempic-novo-nordisk-peripheral-arterial-disease-padperipheral-vascular-disease-pvd-likelihood-of-approval
12 Perkovic, V., et al. (2024). Effects of semaglutide on chronic kidney disease in patients with type 2 diabetes. New England Journal of Medicine, 391(2), 109–121. https:// doi.org10.1056/NEJMoa2403347
13 Deswal, P. (2024, October 22). Novo Nordisk plans label expansion for Rybelsus following phase III win. Clinical Trials Arena. https://www.clinicaltrialsarena.com/news/ novo-nordisk-plans-label-expansion-for-rybelsusfollowing-phase-iii-win
14 Ally, A.J., et al. (2023). Payer strategies for GLP-1 medications for weight loss. Milliman. https://www.milliman. com/-/media/milliman/pdfs/2023-articles/8-28-23_glp1s-for-weight-loss_20230824.ashx
15 Weight loss to prevent obesity-related norbidity and mortality in adults: Interventions. (2023, May 18). U.S. Preventive Services Task Force. https://www.uspreventiveservicestaskforce. org/uspstf/document/draft-research-plan/ weight-loss-prevent-obesityrelated-morbidity-mortality
16 Tepper, N. (2023, May 16). Insurers, PBMs restrict access to weight loss drugs as demand soars. Modern Healthcare https://www.modernhealthcare.com/insurance/ pbms-insurers-ozempic-wegovy-weight-loss-drugaccess-cigna-centene (subscription required)
cabozantinib (Cabometyx)
Neuroendocrine tumors (pancreatic and extra-pancreatic tumors, locally advanced/ unresectable or metastatic, well or moderately differentiated, > second-line)
guselkumab (Tremfya)
Pipeline drug list (cont.)
ipilimumab (Yervoy) Bristol Myers Squibb HCC (unresectable, first-line, in combination with nivolumab)
nivolumab (Opdivo) Bristol Myers Squibb HCC (unresectable, first-line, in combination with ipilimumab)
nipocalimab Johnson & Johnson Myasthenia gravis (generalized, anti-AChR, anti-MuSK, anti-LRP4)
