The Center for Medicare and Medicaid Services' final national coverage determination for amyloid-clearing monoclonal antibodies does not open the door further for Biogen, Inc.’s Aduhelm (aducanumab), but it will provide a boost for other Alzheimer's disease candidates.
Biogen’s Aduhelm Competitors Boosted By Final CMS Coverage Decision
Eisai, Roche, Lilly Will Have Efficacy Data Much Sooner
The Center for Medicare and Medicaid Services’ final decision on Medicare coverage favors anti-amyloid antibodies approved for Alzheimer’s disease based on efficacy rather than biomarker data.

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Lilly’s Mounjaro arrives in India, with the 2.5mg vial priced at under $41 in a market that has over 100 million diabetics and increasing obesity rates. Will the product see sharp demand like in China, carving out a chunk of the pie ahead of the potential arrival of semaglutide generics and could there be concerns of ‘suitcase' exports?
The development could highlight the power of competitive market forces over government price controls or suggest Medicare price negotiation is enhancing competitive market forces.
Amvuttra will target a substantially larger patient population with a new indication, but it is third to market behind Pfizer’s Vyndaqel and Bridge Bio’s Attruby and will cost more.
Policy advances, measures to back local production and crowdfunding action for gene therapies like Zolgensma bring hope for rare disease patients in India. Gaps in financing, high prices and an ongoing court case, however, stunt efforts to ensure timely access.
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By allowing it to enter the brain more easily, trontinemab’s brain shuttle brings more patients to ‘amyloid zero’ levels faster, and with fewer brain swelling side effects.
Compass' bispecific antibody tovecimig hits primary efficacy endpoint in Phase II/III top-line data in advanced biliary tract cancer, and may have class side-effect advantages. But additional survival data may be needed to support US approval.
AstraZeneca remains committed to investing in R&D and alliances in China, where Susan Galbraith, the UK major’s head of oncology R&D, sees innovation eventually reaching parity with the US and Europe.