The Centers for Medicare and Medicaid Services (CMS) have announced a proposal for Medicare to cover a controversial Alzheimer's disease drug from Biogen. The drug, called Aduhelm, would be made available in clinical trials for patients who have early-stage symptoms of the disease.
- Medicare officials have announced a proposal to cover the cost of Biogen's Alzheimer's disease drug, Aduhelm, to help assess its effectiveness and safety.
- The proposal is subject to a 30-day comment period for public opinions, after which a final decision will be made in April.
- The controversial drug has the potential to help Alzheimer's patients but also comes with potentially severe side effects and a large price tag.
- Biogen has criticized the proposed policy, arguing that the eligibility criteria are too narrow.
How the New Policy Would Work
The new policy proposed by CMS officials would cover the cost of Aduhelm for certain patients in clinical trials. Those patients must exhibit symptoms of early-stage Alzheimer's disease, which involves a lab test—the cost of which Medicare would also cover—to confirm that the brain has accumulated amyloid, a protein linked to the disease. According to Biogen, the drug is designed to clear the protein.
Two studies have been performed by the pharmaceutical company, only one of which showed that patients who took the drug exhibited a slowing in cognitive decline compared with patients who took a placebo.
The decision for Medicare to possibly cover the cost of the drug has been a controversial one, not only due to the uncertainty of its effectiveness but also its cost.
When Biogen initially launched the drug, the price tag was a staggering $56,000 annually per patient. More recently, that price has been cut by nearly half, to $28,200 annually. Even at that price, critics fear that covering it would cause costs to the Medicare program to balloon out of control.
Medicare officials are expected to make a final decision in April, following a 30-day period in which members of the public can provide comments.
Biogen Complains About Narrow Criteria of the Policy
Without Medicare coverage, Aduhelm's future is uncertain. As such, Biogen has criticized the proposed policy, arguing that making coverage available only to clinical trial patients with early-stage symptoms leaves out the vast majority of people who suffer from the disease.
The company has argued that the policy would delay treatment for many patients who are Medicare beneficiaries, potentially to the point where treatment may no longer be an option for them.
But since the pharmaceutical firm halted its studies in 2019, the policy proposal appears to be a conservative step forward in light of uncertain results.
Biogen's complaints may be largely driven by the fact that Aduhelm hasn't received much traction since it was approved by the Food and Drug Administration in June 2021. Many physicians and hospitals have held off because the drug, which is administered via monthly intravenous infusions, must be paid for upfront.
With no support from the Medicare program up until now, healthcare providers have balked at the idea of purchasing a product where there's no guarantee of getting reimbursement from insurance companies. Others have cited concerns about the drug's safety and effectiveness.
The FDA has required Biogen to complete one more study to confirm its effectiveness. If that fails, the pharmaceutical company may choose to pull the drug from the market entirely.