Senators urge Medicare to broaden Alzheimer treatment coverage

Senators urge Medicare to broaden Alzheimer treatment coverage, a group of 20 Senators led by Republicans Susan Collins and Shelly Moore Capito of Maine and West Virginia respectively, wrote a letter to Health and Human Services Secretary Xavier Becerra and Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure calling on them to ease restrictions on the access of Alzheimer’s drugs such as Eisai and Biogen’s Leqembi.

In the letter, they urged the organizations to offer broad coverage of Alzheimer’s treatments approved by the Food and Drug Administration (FDA) given the fact that any delay can cause disease progression to a point of no return. 

“Given the progressive nature of this terminal disease, we encourage you to take steps now to ensure patients have immediate access to FDA-approved treatments if the patient and clinician decide it is right for the patient,” the senators said. 

The senators further explained the need for decisive action by sharing how by 2050 the disease would have caused the nation around $1 trillion in healthcare costs. Not only this but according to the Census Bureau over the next 3 decades, the number of senior population affected by the disease is expected to go up by 50% to 86 million.

The Alzheimer’s Association and the American Academy of Neurology (AAN) have also spoken in favor of expanding coverage. Experts at ANN have also stated that data from Eisai’s late-stage trial was clinically and statistically significant and trials well-designed. 

Medicare is still reluctant however to expand coverage due to past experiences with Aduhelm. Aduhelm was the first monoclonal antibody that scored a controversial accelerated approval by the FDA even after advisors raised concerns regarding its efficacy. Independent advisors claimed that data did not prove that the drug had any visible advantages for patients and when the drug was approved, 3 advisors resigned in protest. The drug was also co-developed by Eisai and Biogen.

Regulatory approval and clinical trials:

• Public pressure has also increased since the FDA granted accelerated approval to Eisai and Biogen’s Leqembi. Leqembi is an antibody that target’s the brain’s area responsible for the disease and has been observed to slow cognitive decline by 27% in late-stage clinical trials. Presently, access to the drug is limited to people enrolled in clinical trials for the drug approved by the FDA and NIH.
• Since Eisai has already completed its trial and is no longer enrolling participants this means that access to this drug is almost non-existent, coupled with the fact that the drug is priced at $26,500 per year, price is, therefore, another factor to consider when assessing barriers to accessing the drug.
• 70 House lawmakers issued a similar statement where they particularly discussed the implications of the current restrictions on seniors suffering from the disease that belong to rural communities. Since medical trials are often conducted in big cities chances are that people from rural areas will not have the same opportunity for access to care. Especially taking into account the physical and financial toll of traveling to institutes where these trials are held.

Ivan Cheung, the U.S. CEO of Eisai is still hopeful and feels that since there is a high level of evidence supporting the treatment’s benefits restrictions should be very limited in the future or none at all.