Radar on Specialty Pharmacy

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.

Amid unprecedented turmoil and layoffs at HHS, including the forced resignation of Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research (CBER) on March 28, the vast majority of biopharmaceutical industry and Wall Street respondents to a Cantor Fitzgerald, L.P., survey are calling for the removal of HHS Secretary Robert F. Kennedy Jr. 

Of the more than 400 respondents, 44% were from biopharma innovators and 40% worked at investment firms. The responses were revealed in an April 7 research note from Cantor biotechnology analysts Josh Schimmer, M.D., and Eric Schmidt, Ph.D.

Directed by the new head of HHS, Robert F. Kennedy Jr., various federal health care agencies recently began implementing sweeping layoffs with the goal of eliminating about 10,000 positions. It’s difficult to understand exactly what the extent of the ramifications will be, but infectious diseases, including HIV and hepatitis, are among the hardest hit areas.

According to the HIV+Hepatitis Policy Institute, layoffs included the entire staff of the HHS Office of Infectious Diseases & HIV Policy and the HHS Office of Minority Health, the policy and data division supporting the Health Resources & Services Administration’s Ryan White HIV/AIDS Program and hundreds of employees at HRSA’s Bureau of Primary Health Care.