All Alzheimer’s Eyes On Medicare: CMS Will Take The Lead On Tailoring Access To Aduhelm
Executive Summary
Biogen/Eisai’s newly-approved Alzheimer’s drug could be headed to CMS’ Medicare advisory committee, which is chaired by vocal drug pricing reform advocate Peter Bach.
The Centers for Medicare and Medicaid Services faces the challenge of managing access to the new Alzheimer’s drug developed by Biogen, Inc. and Eisai Co., Ltd. for the majority of patients seeking treatment now that the US Food and Drug Administration has approved Aduhelm (aducanumab) for all stages of the disease without requiring pre-screening of patients.
Aducanumab was cleared under the agency’s accelerated approval pathway on 7 June with a broad label that came as a big surprise to many, given the conflicting nature of clinical evidence supporting the application. (Also see "Biogen Gets ‘Almost Shockingly Broad’ Label For Alzheimer’s Drug Aducanumab" - Pink Sheet, 7 Jun, 2021.)
As a result, many decisions on patient eligibility criteria will be left primarily to prescribers and payers. At a wholesale acquisition cost of $56,000 per year for an average weight patient, and a potential patient population of up to 1 to 2 million, the drug will no doubt be tightly managed by payers until there is stronger evidence of its efficacy.
Medicare Part B is expected to cover treatment for approximately 80% of all patients, according to Biogen. Most of those are enrolled in traditional fee-for-service Medicare. But a growing number, about 40% in 2020, are covered by Medicare Advantage plans operated by private insurers, according to recent data from the Kaiser Family Foundation.
For those enrollees, coverage policy can be developed by Medicare Advantage plan sponsors, but CMS and its local contractors can also determine overriding national or regional coverage parameters when needed.
Because Aduhelm could have a major impact on Medicare financing, CMS is already facing pressure to open a national coverage determination for the drug. (Also see "Is Aducanumab In Alzheimer’s A Candidate For Medicare ‘Coverage With Evidence Development’?" - Pink Sheet, 6 May, 2021.) A national policy could be viewed as more desirable to payers and patients because it would ensure consistency.
In a statement on Aduhelm, a CMS spokesperson said “yesterday’s milestone provides hope to families, caregivers and the older Americans living with Alzheimer’s who rely on Medicare for health coverage. CMS is reviewing the FDA’s decision regarding aducanumab and will have more information soon.”
“As we develop our coverage policy at Humana, we will look to [CMS] for guidance to ensure that there is consistent access to this therapy in the Medicare program.”
Humana, which is a leading sponsor of Medicare Advantage plans, said it is “committed to ensuring that our members living with the devastating effects of Alzheimer’s disease have access to high-quality, effective treatment. As we develop our coverage policy at Humana, we will look to [CMS] for guidance to ensure that there is consistent access to this therapy in the Medicare program.”
The process of developing an NCD takes about six to nine months, depending on the need for external technology assessments or coverage advisory committee reviews. The process is rarely undertaken for drugs, but the situation involving Aduhelm seems tailored made for it.
The last time CMS opened an NCD for drugs, it focused on CAR-T treatments. (Also see "Medicare Final CAR-T Policy Eases Coverage Requirements" - Pink Sheet, 8 Aug, 2019.) As part of that process, CMS convened a meeting of its Medicare Evidence Development and Coverage Advisory Committee. (Also see "Medicare Advisers Endorse Patient Reported Outcomes For CAR-T With Caveats " - Pink Sheet, 3 Sep, 2018.)
Medicare Advisory Panel Chair Is Peter Bach
The agency could decide to do so again for Aduhelm, and interestingly the committee is currently chaired by a vocal advocate for drug pricing reform, Memorial Sloan Kettering Center for Health Policy and Outcomes director Peter Bach. (Also see "Drug Pricing Critic Peter Bach Named Chair Of Medicare Advisory Panel" - Pink Sheet, 5 Sep, 2018.)
Bach’s work on MedCAC is not likely to overlap with his interest in drug pricing policy because Medicare coverage decisions are supposed to be based on a determination of “medical necessity” and not on cost. But he could give CMS a sounding board if it wanted the panel to dive into the issue. Some industry commentators have already pointed out that Aduhelm’s list price puts on a spotlight on the need for reforming Medicare Part B drug pricing and payment policy.
Medicare Coverage For Amyloid PET Scans
Aduhelm has another challenge related to Medicare coverage. The program does not cover positron emission tomography (PET) amyloid beta imaging outside of clinical trials, except in very narrow circumstances, under an NCD released by CMS in 2013.
Biogen executives acknowledged the issue during a 8 June call with analysts, noting it used amyloid PET to screen subjects for its clinical trials on aducanumab. “The desire to confirm amyloid beta pathology by physicians could be a major bottleneck,” CEO Michel Vountasos said.
The drug’s label does not require screening, but prescribers are expected to want to do so. Another diagnostic that could be used to determine patient eligibility for treatment is cerebral spinal fluid (CSF) testing, the company noted.
Biogen US President Alisha Alaimo said the company believes both PET scans and CSF testing are needed and added the company has been working with “a coalition of healthcare and advocacy organizations to support a pathway to PET reimbursement from CMS.”
Alaimo explained the PET scan is more desirable for some patients than the more invasive CSF procedure. “We need PET because the lumbar puncture will not be for everyone. About 30% to 40% of the patients might have contraindication with taking blood thinners or anticoagulants.” A stakeholder petition asking CMS to reconsider the amyloid PET NCD was submitted to the agency in September 2020.