News Alert: CMS Proposes Coverage for Biogen’s Aduhelm for Patients Enrolled in Qualifying Clinical Trials

PRICENTRIC BRIEF:

  • The Centers for Medicare & Medicaid Services (CMS) has released a statement proposing coverage of Biogen’s Aduhelm (aducanumab) but extending the decision only to patients who are enrolled in qualifying clinical trials – the decision means a narrow coverage for the controversial Alzheimer’s therapy, which garnered criticism from the wider industry when it was approved by the Food and Drug Administration (FDA) in June last year.
  • As of yesterday, January 11, CMS has clarified that it will review each submitted clinical trial to determine whether it meets the criteria specified in the proposed National Coverage Determination – CMS clarified that in addition to trials approved under its own name, clinical trials sponsored by the National Institutes of Health (NIH) would be covered under the determination, too.
  • The news comes shortly after the U.S. Secretary of Health and Human Services (HHS), Xavier Becerra, asked Medicare to reassess its 2022 premium hikes based on Biogen’s “compelling” decision to slash Aduhelm’s price in half, noting that the drug had a large part to play in a premium increase for Medicare Part B beneficiaries, as reported last November.

THE DETAILS

WASHINGTON D.C., United States — The Centers for Medicare & Medicaid Services (CMS) has released a statement proposing coverage of Biogen’s Aduhelm (aducanumab),but extending the decision only to patients who are enrolled in qualifying clinical trials.

The decision means a narrow coverage for the controversial Alzheimer’s therapy, which garnered criticism from the wider industry when it was approved by the Food and Drug Administration (FDA) in June last year. The regulatory agency approved the drug under its Accelerated Approval pathway, which allows patients to gain access to the drug even if there remains some uncertainty about its clinical benefit.

Since then, the pharmaceutical industry has been waiting to see how CMS’s decision played out, with some media outlets dubbing it the organization’s “most important coverage decision” ever.

As of yesterday, January 11, CMS has clarified that it will review each submitted clinical trial to determine whether it meets the criteria specified in the proposed National Coverage Determination.

The coverage decision is technically for FDA-approved monoclonal antibodies that target amyloid for the treatment of Alzheimer’s disease through coverage with evidence development (CED), although there is currently only one approved drug that falls under that remit, Aduhelm.

The proposed National Coverage Determination is now open for comments for 30 days for the general public, patient population and industry to have their say on the decision; and after reviewing all comments, CMS will announce its final decision by April 11, 2022.

In the online statement, CMS Administrator Chiquita Brooks-LaSure explained that the organization has proposed an “evidence-based coverage policy,” following expert review of all relevant, publicly available evidence and feedback received from stakeholders.

Brooks-LaSure added, “Before finalizing this proposal, we will have more opportunities to hear from people with Medicare living with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s disease dementia, their family members and caregivers, as well as many other stakeholders, including patient advocacy groups, medical experts, states, payers and industry professionals.”

CMS clarified that in addition to trials approved under its own name, clinical trials sponsored by the National Institutes of Health (NIH) would be covered under the determination, too.

The CMS decision is incredibly important, as it could set a precedent for private insurers’ decisions on coverage in the future.

Medicare Premiums

The news comes shortly after the U.S. Secretary of Health and Human Services (HHS), Xavier Becerra, asked Medicare to reassess its 2022 premium hikes based on Biogen’s “compelling” decision to slash Aduhelm’s price in half, noting that the drug had a large part to play in a premium increase for Medicare Part B beneficiaries, as reported last November.

The 2022 premium Medicare announced represented one of the steepest increases on record. At a minimum, Part B beneficiaries will pay $170.10 per month, 14.5% more than the previous minimum of $148.50.

The projected cost of Aduhelm – before Biogen decided to cut the cost – would have accounted for half of the premium rise, according to Medicare trustees. The rest of the increase was mostly due to “rising prices and utilization across the healthcare system,” according to the CMS.

However, in December Biogen revealed that from January 1, 2022, the wholesale acquisition cost (WAC) of Aduhelm (aducanumab) 100 mg/mL injection for intravenous use was going to drop by approximately 50%. The reduction brings the yearly cost at the maintenance dose (10 mg/kg) to $28,200 for a patient of average weight (74 kg), compared to the previous $56,000.

ICER 

The Institute for Clinical and Economic Review (ICER) has previously criticized Biogen’s pricing of Aduhelm, publishing a Final Evidence Report assessing the comparative clinical effectiveness and value of the therapy in which it declared the drug “insufficient” to show a net health benefit for patients with mild cognitive impairment due to Alzheimer’s disease, as well as for patients with mild Alzheimer’s disease.

Additionally, ICER’s final health-benefit price benchmark (HBPB) range for Aduhelm is $3,000–$8,400 per year for patients with early Alzheimer’s disease — which would have required an 85-95% discount off Biogen’s initial U.S. list price of $56,000. The new price of $28,200 still does not meet ICER’s HBPB range, despite being cut considerably.

 

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