Earlier this month, the Food and Drug Administration (FDA) approved lecanemab, a drug for treating Alzheimer’s disease, through its accelerated approval program. The decision comes at a unique time, both for the Alzheimer’s community seeking to benefit from monoclonal antibodies (mAbs) and the life sciences industry, as the FDA is facing increased scrutiny over its accelerated, conditional approval program.
Lecanemab seems poised to make a real difference for those coping with Alzheimer’s disease. A study in the New England Journal of Medicine found that the drug moderately slowed the progression of Alzheimer’s among 1,795 patients who participated in a phase III clinical trial over 18 months. In recent years, the approval of other pharmaceuticals designed to treat Alzheimer’s disease has resulted in a national debate over the approval process for these treatments, as well as their price and efficacy.
As a result of this, the approval of lecanemab received increased scrutiny from policymakers, industry experts and advocates. Fortunately, support from advocacy groups, such as the Alzheimer’s Association, remained strong throughout the process due to its performance throughout the approval process. Patrick Rigby, Senior Vice President, Reputation and Risk Management (RRM) at Syneos Health, examined the approval process for lecanemab and noted several important takeaways:
Clinical trial diversity improved the efficacy and accuracy of clinical trials by working with the communities actually affected by diseases. The lecanemab study took a step in including a broader and more diverse population than previous anti-amyloid studies, with 4.5% Black and 22.5% Hispanic participants. It also allowed a range of comorbidities including hypertension, diabetes, heart disease, obesity and renal disease.
Stakeholder sentiment can quickly change following approval. The focus on efficacy and unmet need among the Alzheimer’s community can shift towards price (disclosed at $26,500 per year), access and reimbursement. There are already signals toward heated debate, with discussions on safety and appropriate patient populations mounting.
The Centers for Medicare & Medicaid Services (CMS) coverage restriction for monoclonal antibodies (mAbs) directed against amyloid remains. With the approval of lecanemab, access and coverage will likely become the next prominent discussion. Will this approval force a change in CMS policy and open the door to similar treatments in the pipeline or continue to require coverage with evidence development (CED)?
The life sciences industry should pay close attention to post-approval events as the focus turns to price, access and reimbursement.
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Senior Vice President, Reputation and Risk Management | Syneos Health