Following CMS's preliminary decision to limit the coverage of Biogen's Alzehimer's disease treatment Aduhelm, advocates are calling on the agency to broaden its coverage or risk the future of similar drugs, according to a Jan. 17 Politico report.
While the decision currently only impacts Aduhelm, due to its drug classification, drugs that are still in development could also be impacted by the ruling.
"If drugs go through the FDA, get approved and then have to go through another clinical trial process to get coverage, then no one's going to invest in this space," George Vradenburg, chair and co-founder of patient group UsAgainstAlzheimer’s, told Politico. "This is just not a tolerable situation. FDA was charged with this decision, they made the decision, CMS should honor it."
Opponents of CMS's ruling are staking their claim by making over 80 public comments on the decision just days after it was unveiled. There are also efforts to pressure lawmakers to act on the decision, according to Politico.
In addition to increasing much-needed access to Alzheimer's disease treatment, advocates say that without a change, key pharmaceutical players may back out of the Alzheimer's landscape.
"Alzheimer's is an area that has just been littered with the carcasses of failed efforts," an anonymous pharmaceutical lobbyist told Politico. "Back in 2018, Pfizer just abandoned the field entirely. [Eli] Lilly has sunk hundreds of millions of dollars here. So I would definitely never underestimate that your adding these obstacles has real impact."