Guest Column | January 25, 2023

Pricing Strategy For New Anti-Alzheimer's Drug Puts Access Community On The Defensive

By Nikolina Janakievski and Cheryl Nagowski

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Nikolina Janakievski and Cheryl Middleton

On the heels of the failed launch of Biogen and Eisai’s Aduhelm (aducanumab), an intravenous amyloid beta-directed antibody indicated for patients in the early stages of Alzheimer’s disease, comes the approval of the duo’s Leqembi (lecanemab) for the same indication. The approval of Aduhelm solicited a slew of criticism, chiefly for FDA approval despite poor clinical impact. The criticism culminated in the ultimate, unprecedented CMS policy to restrict coverage of amyloid directed antibodies indicated for Alzheimer’s, which received accelerated approval, to those enrolled in clinical trials.  CMS also stated that for all amyloid therapies approved in the future, access would be covered under Coverage with Evidence Development, resulting in slightly expanded access from those approved via accelerated pathways. This includes coverage for patients participating in a variety of methods of data collection, including clinical trials, routine clinical practice notes or registries.

Equipped with the knowledge that the payer community has heavily restricted access to amyloid directed antibodies, Biogen and Eisai have elected to employ a very different strategy for Leqembi. With the announcement of its accelerated approval, came the news that Biogen and Eisai had filed for traditional approval with the FDA and proactively published detail into their pricing strategy.

It’s not often that manufacturers elect a proactive disclosure strategy thus creating the narrative and effectively making payers refute the Eisai data or provide their own calculations as a reason to not cover the product. Whether their data is biased or not, being first means the burden of change falls to the payers. The access community is now on the defensive, forced to publish data challenging the model.

Leqembi is priced at $26,500 a year, which is less than both Aduhelm’s initial WAC of approximately $56,000 and its subsequent reduced WAC of approximately $28,000. While Eisai and Biogen assert the per patient societal value of the drug is higher than their listed price at $37,600, the Institute for Clinical and Economic Review (ICER), calculated the more moderate price range of $8,500 to $20,600. While the discrepancy between sticker price and third-party cost analysis is not uncommon, the reaction to this decision in such a controversial drug class is much anticipated.

Leqembi’s manufacturers believe their pricing strategy “would also help improve health system sustainability”; however, in seeking early, directional feedback from a variety of past and present formulary decision makers, there was substantial pushback. Decision-makers consulted at two large IDNs expressed concern over the additional, unaccounted costs of identifying appropriate patients based off clinical trial inclusion criteria, especially given the heavy administrative burden that both preforming diagnostic imaging and providing infusions and supportive care to the high volume of patients exhibiting symptoms would present to health systems. The trepidation around whether this drug class can create a clinically meaningful impact with an enduring effect has not dissipated from the Aduhelm launch.

A director of pharmacy at a regional Medicare Advantage plan, echoed these concerns, indicating they did not foresee Medicare ever allowing the coverage of these therapies, which are covered under Part B and managed under Part C, if approved under the accelerated FDA process. He speculated that even if the amyloid beta-directed antibodies achieved traditional approvals, their utilization would be heavily managed under local coverage determinations.

The tremendous excitement around Leqembi’s trial results adds pressure to an access community already struggling to effectively implement new and innovative payment models. The bold public release of Legebi’s pricing strategy and value proposition seems to be perceived by some in the access community as performative, leaving more questions than answers. It remains to be seen if Easai’s novel launch approach will accelerate smooth access but it has certainly prompted the access community to start preparing its defense. 

About the authors:

Nikolina Janakievski is a Key Account Manager at Amplity Health where she works to equip pharmaceutical manufacturers with the data and strategy required to successfully engage federal and commercial markets.

As Head of Market Access at Amplity Health, Cheryl Nagowski develops and enhances managed care strategies for biopharmaceutical and medical device clients.