This Valentine’s Day we are showing our appreciation for the dedicated managed care professionals —medical directors, pharmacists, nurses, case managers, health care administrators and more — who work every day to optimize and improve patient health.
AMCP convened key stakeholders in managed care to address the balance between patient access and payer requirements in the FDA Accelerated Approval (AA) pathway program. Experts from various fields participated, aiming to identify gaps between FDAAA requirements and payer-valued treatment outcomes, explore evidence ecosystem opportunities, and evaluate policy options. The forum emphasized supporting drug development innovation while recognizing payer needs and promoting stakeholder trust in the AA review process. Notably, incentivizing confirmatory trials emerged as a potential impactful policy solution.
The FDA continues to approve novel therapies, but concerns arise due to the costs of certain treatments. To address this, the AMCP organized a forum to explore solutions. Stakeholders recognize the benefits of high-investment medications, but uptake of payment strategies has been slow. Gradual changes, education, and collaboration are essential to improve predictability, affordability, and accessibility for patients.
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.
Discover how health technology assessment (HTA) and value assessment frameworks play a crucial role in evaluating pharmaceuticals and health interventions. The recent multistakeholder Partnership Forum, hosted by AMCP, delved into recognizing value within resource constraints. Key takeaways include emphasizing innovative pharmaceutical products, comprehensive data, and the need for trusted value assessments in healthcare decision-making. Explore best practices for enhancing value assessment tools and processes across the industry.
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.