By Dhirendra Tripathi
Investing.com – Biogen stock (NASDAQ:BIIB) slumped 9% in Wednesday’s premarket trading after a decision to restrict Medicare coverage of certain alzheimer’s drugs, limiting the scope to generate revenue from its aduhelm drug.
U.S. Centers for Medicare and Medicaid Services, the health agency that runs Medicare, has decided that it will only cover the costs of such drugs for patients enrolled in clinical trials. The decision is preliminary and the public has a 30-day window to give its comments. A final decision will be taken in April.
The decision to require the trial "denies nearly all Medicare beneficiaries," Biogen said in a statement. The company warned that if the proposed provision comes to stay, “it would likely take in excess of a year to begin enrolling patients, further delaying reimbursement for Medicare beneficiaries”.
Medicare currently pays for the treatment on a case-to-case basis.
The move to require continued clinical trials for a drug that has already been approved is unusual and reflects the controversy over the Food and Drug Administration's decision to authorize its use in June, which overrode strong objections from some experts on its own advisory panel. They argued that the company needed to place more evidence of the drug’s benefits.
The final CMS coverage terms are expected to apply to all drugs in the class, including experimental medications in development by Eli Lilly (NYSE:LLY), Roche (OTC:RHHBY) and Eisai (OTC:ESALY), Reuters said.
The drug's high price - $56,000 annually - was another sore point and hospitals and doctors backed away from endorsing the treatment because of this. The company has since cut the price to $28,200.