Current Edition

Biogen’s Aduhelm call to action backfires as CMS receives many more comments in favor of restrictive coverage: analyst

During a January Q&A call with investors, Biogen chief Michel Vounatsos pressed Aduhelm supporters to fight the Centers for Medicare & Medicaid Services’ (CMS’) restrictive coverage proposal on the beleaguered Alzheimer’s drug. Turns out, however, most people think CMS made the right call—at least according to one group of analysts.

The public supports CMS’ decision, which would limit Medicare coverage for antibeta-amyloid drugs like Aduhelm to patients enrolled in approved clinical studies, according to a BofA Securities analysis of more than 1,000 comments received by CMS.

There were thrice as many comments in support of CMS’ National Coverage Determination (NCD) and questioning Aduhelm’s efficacy as there were comments asking for a proposal tweak, BofA’s Geoff Meacham wrote in a note to clients Tuesday.

But are all those comments legit? More than 500 letters posted in support of CMS’ restrictive coverage were generated through a campaign run by non-profit media outlet More Perfect Union, a Biogen spokesperson said over email. Biogen forwarded Fierce Pharma a copy of a letter from the publication asking people to copy and paste a statement critical of Aduhelm on the CMS’ comment page.

CMS says similarly worded emails or documents representing a single point of view “are not useful,” adding that multiple iterations of a letter are considered a single comment.

Among commenters analyzed by BofA who were skeptical of Aduhelm (or supportive of CMS’ decision), 93% questioned the drug’s benefit. Many also pushed back on Aduhelm’s price tag, the BofA team said.

Biogen first deployed Aduhelm with a staggering $56,000-per-year list price, shocking many industry watchers, who had expected the drug to land in the $10,000 to $30,000 ballpark. Late last year, the company halved the drug’s price. As of Jan. 1, the annual maintenance cost of Aduhelm is now $28,200 for a patient weighing 74 kg (163 pounds)

The sticker shock also had about 15% of Aduhelm skeptics upset about the effect coverage would have on Medicare premiums, the BofA team said.

Commenters who considered themselves Alzheimer’s experts did not support the drug’s efficacy, either.

In a separate survey by Spherix, U.S. neurologists also tended to agree with CMS’ coverage decision. Half the doctors surveyed said the determination would influence their decision to prescribe potential antibeta-amyloid rivals, too. Those would be Eli Lilly’s donanemab, Roche’s gantenerumab and Biogen’s follow-up monoclonal antibody, lecanemab, which it’s developing with Eisai.

The CMS will take comments on its decision through Feb. 10. A final Aduhelm coverage verdict is expected in April.

Speaking about CMS’ comment period, Biogen CEO Vounatsos said on last month’s investor call, “we encourage others to make their voice heard so that this final decision expected in April will allow for broader and more equitable access.” If the decision goes through in its current form, Biogen thinks Aduhelm may reach just “hundreds” of patients for the foreseeable future, despite the millions affected by Alzheimer’s disease, the CEO said.

Biogen isn’t the only one frustrated by the CMS proposal. Patient advocacy group UsAgainstAlzheimer’s recently penned a letter to Health and Human Services secretary Xavier Becerra asking him to direct Medicare to reassess its proposal, Bloomberg Law reports.

“This is a huge unmet need in our society, causing massive social and economic consequences, both to the government and to American families, and to not have Medicare cover any of the first generation of Alzheimer’s drugs is simply intolerable,” George Vradenburg, chairman and co-founder of UsAgainstAlzheimer’s, told the publication.

There were up to 5.8 million people in the U.S. living with Alzheimer’s disease in 2020. That number is projected to nearly triple to 14 million people by 2060, the Centers for Disease Control and Prevention says.

Biogen, for its part, is working hard to reverse Aduhelm’s fortunes. The company last week said it was revving up its Aduhelm confirmatory trial, Envision, which is meant to shed light on Aduhelm’s clinical benefit and convert its accelerated FDA approval, which was based on biomarker evidence, into a full approval.

The trial could also help Biogen widen Aduhelm’s patient pool under CMS’ current coverage proposal. If CMS were to sign off on Envision, that would give Biogen access to roughly a thousand patients for four years.