The insurance lobbying group AHIP lauding the Biden administration’s decision to have Medicare only cover Alzheimer’s disease drug Aduhelm for beneficiaries in clinical trials, but wants more guidance on how it will affect Medicare Advantage plans.
AHIP and other groups commented on the proposed national coverage determination for drugs that treat amyloid plaques in the brain in the hopes of combating mild cognitive decline caused by Alzheimer’s. The comments come as insurers have been reluctant to cover the first of this class of drugs—Biogen’s Aduhelm—due to questions over its efficacy and the high price tag.
AHIP commented that the Centers for Medicare & Medicaid Services (CMS) was right to call for more evidence on Aduhelm and the class of drugs.
“We commend CMS for its comprehensive, thoughtful and objective analysis of the clinical evidence, benefits and potential side effects of this class of therapies,” AHIP said in comments.
The Food and Drug Administration approved Aduhelm last year despite objections from agency advisors questioning the benefits of the disease.
CMS proposed last month for Medicare to cover the drug but only if a beneficiary is in a qualifying clinical trial in a hospital outpatient setting.
The clinical trials will help “ensure that clinicians with experience in caring for patients with [Alzheimer’s disease] will be involved in the administration of this class of medication and allow for closer monitoring and management of adverse events,” AHIP said.
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The insurance lobbying group said that it supported the agency’s coverage determination be extended to the entire class of drugs that treat amyloid products and not just Aduhelm. While Biogen’s drug is the only one approved to treat amyloid plaques in the brain, there are three other treatments approaching late-stage clinical trials.
“CMS has the flexibility to revisit this [national coverage determination] and reassess coverage policies for the Medicare program as the evidence evolves,” the group added.
But AHIP also asked for more information from CMS on key parts of the coverage proposal, chief among them guidance on the coverage obligations for Medicare Advantage plans.
“Key issues that should be addressed include CMS maintaining an updated list of all clinical trials that meet the proposed requirements under the [coverage determination] pathway and making it publicly available to all MA plans and other stakeholders,” AHIP said.
CMS also needs to clarify coverage for people on Medicare who already are getting Aduhelm by participation in phase 3 and 4 clinical trials.
Other groups supported CMS’ coverage decision. The Academy of Managed Care Pharmacy commented though that it has concerns about the impact of the drug on state Medicaid programs.
“Under current rules, for the dual-eligible population, Medicare is typically the primary payer and Medicaid assists by covering an individual’s cost-sharing (in the case of Part B, 20%),” the group said. “As a consequence of the … policy, Medicaid will now become the primary payer for this significant population.”
The group asked CMS to use “available and appropriate” resources to reduce the burden.
On the other hand, Biogen and several patient advocacy groups slammed the decision as directly contradicting the FDA’s finding that the drug is safe and effective.
The advocacy group Us Against Alzheimer’s wrote in a letter to Department of Health and Human Services Secretary Xavier Becerra that the decision would “set up CMS as the final arbiters of whether Americans can access an Alzheimer’s therapeutic drug, a role they have no history of playing.”
Biogen commented that initiating studies to meet CMS’ requirement “could take years.”
Such delays could cause “serious and irreparable harm,” the company added.
The comments are the latest blowback CMS has faced on the proposal. More than 70 House Republicans wrote to Becerra earlier this week calling for the coverage determination to be withdrawn.
CMS is expected to issue a final decision on coverage by April 11.