Lawmakers on Tuesday said too many hurdles remain between Alzheimer’s patients and emerging medications that could slow their deterioration, due to both the high cost of new drugs and the limited response from Congress and regulatory agencies to expand access to them.
Rep. Brad Wenstrup (R-Ohio), co-chair of the GOP Doctors Caucus, said the high price tag of many new medications has been a deterrent for his colleagues in Congress to significantly increase access through federal programs.
“A lot of times in Washington, it all comes down to dollars for too many people, and they’re not thinking of the lives involved,” Wenstrup said at The Hill’s “Accelerated Approvals and The Pathway to Treatments” discussion.
“If you can prevent something like Alzheimer’s, or delay it for years and years, the savings will be tremendous in our total health care system.”
The Food and Drug Administration (FDA) in 2021 approved 14 new drugs through the accelerated approval pathway, which provides patients with certain chronic or life-threatening illnesses early access to innovative treatments.
However, the agency faced criticism last year for swiftly greenlighting a controversial Alzheimer’s treatment, Aduhelm, leading some experts to scrutinize the streamlining process.
Still, Rep. Brian Higgins (D-N.Y.), a member of the House Ways and Means Subcommittee on Health, told The Hill’s Bob Cusack he agreed with his Republican colleague that accelerated approval could open new doors for Alzheimer’s patients and their families.
The New York Democrat, who lost his father to Alzheimer’s disease 15 years ago, introduced the bipartisan Comprehensive Care for Alzheimer’s Act in June.
Co-sponsored by Reps. Darin LaHood (R-Ill.), Paul Tonko (D-N.Y.) and Brett Guthrie (R-Ky.), the bill would create a new payment model for dementia treatment under Medicare to make care more affordable.
“It costs the nation a lot of money,” Higgins said of Alzheimer’s disease. “I think the advocates should be pushing Congress to approve more money for Alzheimer’s. The justification is all around us.”
Tuesday’s event was sponsored by the Alzheimer’s Association.
Maria Carrillo, chief science officer at the association, said the accelerated approval pathway has met a “critical unmet need” of Alzheimer’s patients and is ultimately saving lives.
“When Congress passed the initial law authorizing accelerated approval, and at every reauthorization, they’ve done what’s right: they’ve reaffirmed this pathway, and the FDA has been very encouraged to utilize the pathway on behalf of patients,” Carrillo said. “Lives have been saved, extended and improved because of the pathway.”
The pathway allows the FDA to expedite the approval of medications that fulfill an unmet need, based on data suggesting the drug will be successful. Drugmakers are then required to conduct trials.
Rep. Neal Dunn (R-Fla.), a member of the GOP Doctors Caucus, said fast-tracked FDA approval is sometimes not enough, as the Centers for Medicare and Medicaid Services (CMS) has not always made those drugs readily available to the public.
CMS is less likely to cover a medication under Medicare without substantial data, he said, which can limit patients’ access to some accelerated approval treatments.
“Traditionally, everybody thinks if the FDA approves it, CMS is going to pay for coverage and that’s become the expectation,” Dunn said. “CMS has, in fact, started sort of walking that back with a number of processes that they’ve instituted.”
