Next week, the Medicare Payment Advisory Commission (MedPAC) will vote on a number of policy proposals for changing Medicare Part B. One of the proposals would recommend that Congress adjust the payment for Part B medicines with accelerated approval, including medicines for serious and life-threatening diseases like cancers, rare diseases and HIV. This could compromise patient access to medicines, which is the opposite of what accelerated approval is designed to do. Here are three reasons why MedPAC should vote no on this proposal.
1. Puts seniors’ access to medicines at risk.
Physicians who administer Part B medicines rely on being reimbursed under Medicare at an adequate rate to cover the cost of the medicines and also the cost of storing them, shipping them to their offices and the ongoing patient monitoring that goes with treating patients with complex conditions.
Part B physicians already faced a payment cut as part of the 2023 Physician Fee Schedule that is threatening their financial stability, and the proposal MedPAC is considering would add to this pressure. The proposal could cut payment for accelerated approval medicines, making it difficult for physicians to afford to administer them.
Policies impacting physician reimbursement, like MedPAC’s proposal, often have a disproportionate impact on smaller and rural communities, where independent practices struggle to keep their doors open as it is, given smaller patient populations. If physicians can’t afford to administer a medicine, then they won’t and that means their patients won’t have access to them either.
Since its inception, over 250 new medicines to treat serious or life-threatening illnesses have been awarded accelerated approval — medicines that patients may no longer have access to through Part B.
2. Based on misconceptions about the successful accelerated approval pathway.
Accelerated approval has helped speed the availability of treatments for patients with serious or life-threatening diseases with significant unmet medical need while adhering to the same safety and effectiveness standards as traditionally approved medicines. The U.S. Food and Drug Administration (FDA) requires manufacturers of accelerated approval products to conduct confirmatory studies to verify the anticipated clinical benefit, and FDA can use expedited procedures to withdraw a product or indication with accelerated approval based on several reasons, including if confirmatory studies fail to verify the predicted clinical benefit. Because a confirmatory trial may take longer than originally planned for various operational reasons including patient enrollment challenges, FDA can and does provide flexibility for manufacturers by revising and extending enrollment milestones for pending confirmatory trials when necessary.
Despite claims to the contrary, the vast majority of the required confirmatory trials are on schedule. Additionally, Congress in 2022 passed the Food and Drug Omnibus Reform Act to give the FDA additional authority regarding initiation and completion of these confirmatory trials and to further refine the expedited procedures for withdrawal of accelerated approval.
3. Potentially delays patients’ access to new medicines.
If manufacturers know in advance that reimbursement for a medicine is going to be artificially cut simply based on the use of accelerated approval, they are less likely to seek it. Instead, manufacturers are more likely to seek traditional approval, which takes on average 3.2 years longer than accelerated approval, taking precious time away from patients who have no other options and otherwise might receive earlier access to a product to address an unmet medical need under accelerated approval. One analysis looked at five medicines with accelerated approval and found their approval resulted in thousands or even millions of patients gaining earlier access with significant clinical benefits. MedPAC’s proposal threatens to undo this progress and delay patients’ access to new medicines.
When you consider that Part B medicines make up less than 5% of total government Medicare spending, prices for Part B medicines have grown more slowly than medical inflation and spending on medicines remains a small, stable share of Part B spending as a whole, this proposal seems to be a solution without a problem that could cause a lot of unintended damage. MedPAC should vote no on this proposal and protect seniors’ access to medicines in Part B.