Radar on Specialty Pharmacy

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.

A new combination treatment recently gained FDA approval for use in a very small population of cancer patients that has dismal survival rates. Oncologist respondents to a Zitter Insights survey said they believe the treatment will have at least some impact on their prescribing.

On Jan. 16, the FDA gave another approval to Amgen Inc.’s Lumakras (sotorasib), this time in combination with the company’s Vectibix (panitumumab), for the treatment of adults with KRAS G12C-mutated metastatic colorectal cancer (CRC), as determined by an FDA-approved test, who have received fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.