Over the summer, when the U.S. Food and Drug Administration (FDA) approved the drug Aduhelm to treat Alzheimer’s Disease, I said that the news was met with both hope and skepticism, specifically in terms of safety, efficacy, and cost. Six months later, after careful analysis of the clinical trial and other data on the drug, it seems evident that skepticism is more warranted than hope. We presume that the Centers for Medicare & Medicaid Services (CMS), in looking at the same data, will reach the same conclusion in its open National Coverage Determination, expected in January. Likewise, pharmacy benefit managers (PBMs) have considered the balance of evidence for this drug in making recommendations to their clients on whether Aduhelm should receive insurance coverage.
As they do when any drug comes onto the market, America’s PBMs turned to their pharmacy and therapeutics (P&T) committees to review the clinical data and evidence on Aduhelm. Each PBM has a P&T committee composed of independent clinical experts, which include practicing physicians and pharmacist specialists in the range of human diseases and conditions. P&T committees perform an important role for PBMs in evaluating the safety and efficacy evidence for prescription drugs.
PCMA surveyed our PBM members to learn more about the P&T committees’ findings on Aduhelm and whether they recommended its insurance coverage. All of the companies participating in our survey indicated that their P&T committees have completed evaluations of Aduhelm, and the PBMs have made coverage recommendations to clients.
Ultimately, most P&T committees recommended against coverage, while just one in five recommended in favor of coverage. The most common reasons cited for the committees’ decisions were a lack of evidence of clinical benefit, risk of side effects or adverse events, and concerns about the safety of the drug or drug administration. Cost was considered by only one in five companies as an element of their decision-making process.
For a drug like Aduhelm, P&T committee evaluations complement the FDA’s accelerated approval parameters to help physicians navigate a decision-making process. That process may be further complicated by the additional evidence the drug manufacturer must generate in the coming years as the FDA balances early access to this treatment against the fundamental considerations of safety and efficacy.
Our companies’ top mission is to help patients get safe, effective, appropriate, and affordable access to the treatments they need. The process PBMs have used to evaluate Aduhelm and make coverage recommendations to plan sponsors is a key element in fulfilling that mission. We expect CMS will reach a similar conclusion for the Part B program based on the evidence.