There is a biological product.
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The US Centers for Medicare and Medicaid Services set a limit on the company's coverage of Aduhelm, the drug it uses to treat Alzheimer's disease.
If patients enroll in a clinical trial, Medicare will cover Aduhelm and other drugs in the same class.
The agency said it was committed to providing the American public with a clear, trusted, evidence-based decision that is made only after a thorough analysis of public feedback on the benefits and risks of coverage for Medicare patients.
The final decision on Medicare coverage will be made on April 11. The agency will take public comments for 30 days.
In premarket trade, shares dropped as much as 10.5%. After regular trading began, Biogen stock was down 9%.
The Alzheimer's therapy was approved by the FDA in June. The FDA's backing of Aduhelm went against the advice of its outside advisers. The FDA said it can slow dementia by reducing plaque in the brain, but it hasn't shown it can reverse or slow Alzheimer's significantly.
Biogen slashed the price of Aduhelm by 50% to $28,000 to expand patient access. About 50,000 patients could potentially start treatment this year if they had insurance and access to specialized centers.
The company said in a statement Tuesday that it believes the coverage with evidence development decision for anti-amyloid therapies denies nearly all Medicare beneficiaries access to Aduhelm.
It is important to change the draft decision to align it with reimbursement for other therapies for progressive diseases, where patients have immediate and equal access to medicines approved by the FDA. Clinical data showed that Aduhelm impacted the underlying pathology of Alzheimer's disease.
Business Insider has an original article.