Medicare will limit coverage of the controversial Alzheimer’s drug, aducanumab (Aduhelm, Biogen) via a special program intended to help assess how well this exorbitantly expensive medication works, federal officials announced Tuesday.
On December 20, Biogen announced a plan to reduce the annual US cost of the drug by 50% — from $56,000 to $28,200 — as Centers for Medicare & Medicaid Services (CMS) officials were deciding on Medicare’s coverage policy for the medication.
In making its proposed coverage decision, CMS announced it will pay for aducanumab under its coverage with evidence development (CED) mechanism.
US Food and Drug Administration (FDA)-approved drugs in this class would be covered for those with Medicare only if they are enrolled in qualifying clinical trials, CMS said. The agency will accept public comments on this decision for 30 days.
In a statement, CMS Administrator Chiquita Brooks-LaSure said the agency is “committed to providing the American public with a clear, trusted, evidence-based decision that is made only after a thorough analysis of public feedback on the benefits and risks of coverage for Medicare patients.”
In making its decision, CMS approached aducanumab as the first of a potential new class of monoclonal antibodies drugs for the treatment of Alzheimer’s disease
As reported by Medscape Medical News, the FDA approved aducanumab on June 7 via an accelerated approval process. The approval, which set off a firestorm of controversy that included resignations of three FDA Peripheral and Central Nervous System Drugs Advisory Committee panel members, was granted based on the medication’s ability to reduce beta-amyloid plaque.
Under the accelerated approval mechanism, Biogen still must deliver solid scientific proof that aducanumab has clinically significant disease-modifying effects. However, the final evidence won’t be in any time soon. In its approval letter, the FDA set a 2030 deadline for a final report on this research.
Insurers such as Medicare and drug makers often are at odds about drug prices for agents whose clinical benefit has yet to be proven. BIO, the trade group for biotechnology companies, urged CMS to provide access to aducanumab without excess restrictions.
There already are concerns among drug makers about CMS efforts “to impose new coverage barriers — and, in particular, coverage with evidence development (CED),” Crystal Kuntz, vice president of policy and research at BIO, and Andy Cosgrove, the organization’s senior director for policy and research, noted in a July 2021 comment about the aducanumab review.
Medicare should instead continue to provide access to medicines for indications that the FDA has approved, with additional flexibility for off-label indications of cancer drugs, they noted.
“We believe this should continue to be the case, to ensure that vulnerable Medicare beneficiaries have necessary access to life altering and lifesaving medications,” the BIO officials wrote.
However, CMS also received many pleas from physicians asking the agency to limit use of aducanumab at least until there is evidence that it produces a significant clinical benefit.