According to Medicare officials, The Federal Health Insurance Program will restrict the coverage of Aduhelm, the new Alzheimer’s drug, to only patients who are participating in the randomized controlled clinical trials. The final decision is set to take place by April 11.
The drug, Aduhelm, is the first treatment to be approved for the treatment of Alzheimer’s disease at the early stage. The new limit, if implemented, will result in the drug being available for only Medicare recipients participating in the approved clinical trials, or studies by the National Institutes of Health.
Alzheimer’s disease is a neurodegenerative disorder. It is characterized by impairment in cognition and behaviour. It is progressive from mild to moderate-to-severe stages of Alzheimer’s disease. Furthermore, it has no treatment.
In June 2021, Aduhelm, manufactured by Biogen, was approved by the FDA amid strong objections by senior figures in FDA and clinical experts. The clinical trial shows safety concerns, lack of benefits and potential risks to patients.
It was approved under the accelerated approval pathway. This is an exceptional approval for drugs used in serious diseases when there is hope for the benefit to patients, even if there are concerns about the level of benefit. However, if the drugmaker cannot prove the clinical benefit of the drug in the post-approval trial, the FDA can choose to withdraw the drug.
Initially, the drugmaker, Biogen, pegged the price at $56,000 per year before slashing it to $28,200 in December due to weak sales. In the first three months, the company only made $300,000 in sales.
Aduhelm, a monoclonal antibody, is administered monthly as an infusion. The drug scientifically called aducanumab works by reducing a protein called amyloid. Amyloid clumps into plaque in Alzheimer’s patient’s brain. But health experts are questioning the role of amyloid in cognitive decline, and if the drug is of benefit to patients.
The medication is approved for use in mild Alzheimer’s-related cognitive decline, which affects about 1.5 million Americans. But the new measure by the agency will limit the reach of the drug since only those who have enrolled for the clinical trials will have access to it. Other races such as Latinos and Blacks who are at more risk for Alzheimer’s disease will be much impacted.
The European Medicines Agency (EMA), through the Committee for Medicinal Products for Human Use (CHMP) also made recommendations to stop the Alzheimer’s disease drug because there is no proof of its effectiveness and safety.