Radar on Specialty Pharmacy

As fiduciaries, employers must act in the best interests of their employees and plan, but when it comes to biosimilars, some are not fully promoting them over higher-cost, rebatable reference drugs. During a recent webinar hosted by Midwest Business Group on Health (MBGH), employers including United Airlines and Caterpillar Inc. shared details of their successful efforts to move employees onto the cost-saving drugs.

MBGH also unveiled an Employer Action Brief on biosimilars with the same title as the webinar: Improved Adoption of Biosimilars by Employers Matters.

Even though uptake of the agents could be much better, they produced more than $12.4 billion in savings in 2024, according to the Association for Accessible Medicines. Overall, since the first biosimilar launched in the U.S. in 2015, they have produced more than $36 billion in savings and have had more than 344 million patient days of therapy.

With a new executive order on prescription drug prices, President Donald Trump directed HHS to extend the period in which new-to-market small molecule drugs are exempt from Medicare price negotiation, a policy change that pharmaceutical companies have long supported.

The Medicare Drug Price Negotiation Program, which is part of the Inflation Reduction Act, allows the federal government to negotiate the prices of select drugs if they are brand-name medications or biological products without generic or biosimilar equivalents. Drugs subject to negotiation also must have been on the market seven years (for small molecule drugs) or 11 years (for biologics) after FDA approval.

But under the new executive order, HHS is directed to work with Congress to modify the program to “align the treatment of small molecule prescription drugs with that of biological products,” giving small molecule drugs an extra four years before they’re eligible to be selected for the negotiation program.

April 7: The FDA granted interchangeable status to Celltrion, Inc.’s Yuflyma (adalimumab-aaty) for its 20 mg/0.2 mL prefilled syringe and 80 mg/0.8 mL PFS and PFS with safety guard for its nine indications: the treatment of (1) adults with moderately to severely active rheumatoid arthritis, (2) people at least 2 years old with moderately to severely active juvenile idiopathic arthritis, (3) adults with active psoriatic arthritis, (4) adults with active ankylosing spondylitis, (5) people at least 6 years old with moderately to severely active Crohn’s disease, (6) adults with moderately to severely active ulcerative colitis, (7) adults with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy and when other systemic therapies are medically less appropriate, (8) adults with moderate to severe hidradenitis suppurativa and (9) adults with noninfectious intermediate and posterior uveitis and panuveitis. The agency first approved the biosimilar of AbbVie Inc.’s tumor necrosis factor (TNF) blocker Humira (adalimumab) on May 23, 2023. The company tells AIS Health that it “anticipate[s] that the 40 mg dosage will also receive interchangeability approval following the expiration of exclusivity in the coming months.” Dosing via subcutaneous injection varies depending on the indication. The unbranded version of the drug is priced at an 85% discount to Humira’s wholesale acquisition cost, which is around $7,000 for two autoinjectors, and the branded version is priced at a 5% discount to Humira’s WAC.

CMS has dropped certain health equity elements of the Enhancing Oncology Model (EOM) following President Donald Trump’s executive order terminating diversity, equity and inclusion efforts within the federal government, according to an April 22 article in The American Journal of Managed Care (AJMC). The successor of the Oncology Care Model (OCM), the EOM, a voluntary, value-based, patient-centered care model, started on July 1, 2023; a second cohort is scheduled to begin July 1, with both cohorts ending June 30, 2030. Practices initially were tasked with providing reports on cost and utilization patterns for patients to help identify and address any health disparities and to screen for health-related social needs, such as limited transportation access to infusion appointments or lack of proper nutrition during treatment. “HRSN [health-related social needs] screening has not been removed from the program,” Lalan Wilfong, M.D., senior vice president for value-based care at Thyme Care, told AJMC, revealing that the change was communicated via revised agreements sent to participating practices. “However, CMS will not require or accept submissions of health equity plans in EOM for 2025 and beyond, which was a previous requirement for the program.” When AJMC asked CMS about tracking HRSNs in the EOM, it replied, “The CMS Innovation Center will remain transparent regarding changes to advance its mission to lower costs and improve quality of care. The Center looks forward to sharing information about next steps, including its new strategic vision, modifications to models to improve their potential for certification and expansion, and new models that empower Americans to live healthier lives while protecting taxpayers.”

Shortly before Martin Makary, M.D., was sworn in as FDA commissioner on March 28, he was briefed on the plan to push out Center for Biologics Evaluation and Research (CBER) Director Peter Marks, M.D., Ph.D., the agency’s leader of vaccines and cell and gene therapy work, per a former agency official, the Pink Sheet reports.

The news likely will concern industry and other agency stakeholders, including lawmakers, who were banking on Makary trying to keep politics and anti-vaccine sentiment from higher up in the Trump administration out of the agency.