The Food and Drug Administration (FDA) approved Alzheimer’s disease (AD) drug lecanemab 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 FDA as scrutiny over its accelerated, conditional approval program intensifies. While the environmental conditions and parallels that led to the perfect storm of Biogen’s Aduhelm experience in 2021 are stark, the implications of the lecanemab approval should be carefully considered.
The life science industry should pay close attention to post-approval events as the focus turns to price, access and reimbursement.
Environmental conditions are critical for pricing decisions:
- Top of mind: The approval of Biogen’s Aduhelm in 2021 sparked numerous controversies around the accelerated approval program, the drug’s price and efficacy.
- This resulted in a restrictive national coverage decision for FDA-approved monoclonal antibodies (mAbs), subsequent reduction in list price, and negative reputational impact for the manufacturer.
- The weeks leading up to the approval of lecanemab were marked by scrutiny from policymakers and drug pricing hawks:
- A Congressional report determined the “FDA’s interactions with Biogen were atypical” and the “FDA and Biogen inappropriately collaborated” on the approval of Aduhelm.
- The Institute for Clinical and Economic Review (ICER) published its draft evidence report recommending that lecanemab should be priced between $8,500 and $20,600 to meet traditional cost-effectiveness thresholds.
- Yet, advocacy support for lecanemab has been steady leading up to approval.
- The Alzheimer’s Association was encouraged by lecanemab’s Phase 3 results and has focused its attention on the existing Centers for Medicare and Medicaid Services (CMS) policy that may block treatment.
Why this matters:
- Progress: A study in NEJM found that lecanemab moderately slowed the progression of Alzheimer’s among 1,795 patients who participated in a Phase 3 clinical trial over 18 months.
- While there may still be concerns about accelerated approval and shadows of Aduhelm lurking, this could be an important step for a community with high unmet need.
- Clinical trial diversity: The 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 are mounting.
- This was evident with Aduhelm (Biogen) and Relyvrio (Amylyx) in 2021.
- CMS coverage restriction for monoclonal antibodies (mAbs) directed against amyloid remain:
- 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 other treatments of a similar nature in the pipeline or continue to require coverage with evidence development (CED)?
The Syneos Health ® Reputation & Risk Management team will continue to monitor the policy landscape, provide insights and recommendations for clients with stakeholder engagement and value communications strategies. If you have questions, please reach out to [email protected].