On January 30, AMCP joined 24 patient and provider organizations in filing an amicus brief which urges the Supreme Court to reverse the Fifth Circuit's decision in "Alliance for Hippocratic Medicine et al. v FDA et al". The filing organizations believe that the ruling threatens the FDA's role in ensuring Americans' access to safe, effective drugs and treatments.
On December 5, Senate Health, Education, Labor, & Pensions (HELP) Committee Ranking Member Bill Cassidy (R-LA) released a Request for Information (RFI) titled "Improving Access to Americans' Gene Therapies." On January 22, AMCP submitted a letter in response, which positions the Medicaid VBPs for Patients (MVP) Act of 2023 (H.R. 2666) as a useful tool for improving access to and the affordability of emerging cell and gene therapies. The MVP Act of 2023 codifies the existing “multiple best price” rule that allows manufacturers to report multiple best prices, the lowest drug price paid by any health payer, for drugs that are subject to value-based purchasing arrangements when certain other criteria are met.
The Academy of Managed Care Pharmacy (AMCP) reflects on a year marked by triumphs, innovation and notable acheivements and looks forward toward the potential opportunities and challenges awaiting managed care professionals in 2024.
January 2024 Legislative & Regulatory Briefing: AMCP Unveils New Pharmacy Advocacy Leaders (PAL) Program; AMCP Comments on Regulatory Considerations for Prescription Drug Use-Related Software; AMCP Comments on Medicare Program; Contract Year 2025 Policy and Technical Changes to the Medicare Advantage Program; AMCP Comments on HHS Notice of Benefit and Payment Parameters for 2025; AMCP Report Illustrates Benefits of Managed Care Pharmacy.
In a historic decision in December, the FDA approved the first gene therapy utilizing CRISPR, an innovative type of genome editing technology. This significant moment means that the novel therapy Casgevy is approved for the treatment of sickle cell disease—which affects 100,000 Americans—in patients 12 years of age and older.
On January 17, AMCP joined dozens of other pharmacy organizations in a joint letter which expresses concerns about the FDA's recent authorization of Florida's state drug importation program. The undersigning organizations believe this importation program may lead to the importation of harmful and counterfeit drugs into the United States, with little evidence of cost savings. The organizations remain committed to alleviating the high cost of medicines in the United States, but oppose state drug importation programs that may compromise patient safety.
On Jan. 11, AMCP joined with 65 other healthcare organizations in a sign-on letter urging the Biden Administration to implement policies that would stabilize and support a strong, sustainable Medicare Advantage program for its beneficiaries. The letter comes as the Administration and CMS continue to enact significant policy changes to the Medicare Advantage program, which serves 51 percent of the Medicare population.