VA's Aduhelm Restrictions: Big Symbolism But Small Impact?
Executive Summary
Biogen is ‘pleased’ access will be available through exceptions process in formulary restrictions though the US veterans agency does not expect there will be ‘significant’ interest among its clinicians in prescribing through that process. Price was not deciding factor, agency says.
In another blow to the potential uptake of Biogen, Inc.’s and Eisai Co., Ltd.'s controversial new drug for Alzheimer’s disease, the US Department of Veterans Affairs has decided it will not cover Aduhelm on its centralized drug formulary or allow the manufacturers to promote the drug to VA clinicians because it has an unfavorable risk/benefit profile.
“We did not add it to the VA national formulary based on the risk of significant adverse drugs events and the lack of evidence of a positive impact on cognition,” a VA spokesperson said. In addition, she added that “being on the ‘do not promote’ list means that neither the manufacturer nor its proxies may discuss the drug with VA clinicians and may not advocate for its use in the VA health care system.”
Decisions to place drugs on the “non-promotable” list are based on a number of criteria, including that “the drug or supply has significant potential for inappropriate use,” according to the VA.
The VA’s plan to offer very limited access to Aduhelm follows non-coverage decisions by several regional Blue Cross and Blue Shield plans. At least two major medical centers, Mount Sinai and the Cleveland Clinic, have also announced they will not administer the drug.
In the scheme of things, the patient population served by the VA that would be eligible for treatment is small relative to the Medicare beneficiaries that might qualify and the VA decision may have more symbolic significance than actual impact on the market. The Centers for Medicare and Medicaid Services is conducting a national coverage analysis on amyloid-targeted Alzheimer’s drugs, including Aduhelm, and plans to release a draft decision in January. (Also see "Medicare Coverage Analysis Of Alzheimer’s Drugs Begins With Focus On Outcomes, Patient Eligibility" - Pink Sheet, 13 Jul, 2021.)
Exclusion from the VA formulary “happens frequently,” the spokesperson pointed out. “VA does not have a clinical need to offer every drug approved for use in the United States on its formulary. Doing so would defeat the purpose of a drug formulary, which is to list the safest and most cost-effective drugs needed by the population served.”
The spokesperson also said the decision not to cover Aduhelm was not based on the cost of the drug, which is expected to reach an average of $56,000 per year. Cost was “absolutely not” the deciding factor, she maintained. The “VA has a long history of providing access the very expensive pharmaceuticals with good evidence of safety and effectiveness, despite their cost. An example of this is the direct acting antivirals for the treatment of hepatitis C.”
The decision may not have been unexpected to Biogen and Eisai, which have been talking about efforts to forge an “innovative” agreement with the VA in order to support access to Aduhelm since shortly after the drug was approved by the US Food and Drug Administration.
Those efforts don't seem to have produced the desired result, given the VA’s current position on coverage. But Biogen maintains it is heartened by the fact that VA enrollees may still access the drug through an exceptions process that will be available to patients meeting criteria outlined in the clinical monograph on the drug that was developed by the VA’s in-house pharmacy benefit manager. In addition, there is no difference in patient copays between drugs on the formulary and those that are not, the VA spokesperson said.
“We are pleased the Department of Veterans Affairs (VA) recommendation will allow access to Aduhelm for veterans who meet the criteria as published in the “Place in Therapy” section of the clinical monograph,” according to a statement from Biogen. The monograph has not yet been publicly released by the VA PBM but reportedly requires patients to meet extensive criteria before they are allowed access.
“We believe patients, consistent with Aduhelm's label, should have the option to access the first FDA-approved treatment to address a defining pathology of Alzheimer’s disease,” the company maintained, adding: “Biogen remains committed to ensuring veterans have access to the latest therapies for Alzheimer’s and we will continue to engage closely with the VA as they evaluate potential updates to their guidance.”
No ‘Significant’ Demand For Aduhelm Expected By VA
Despite Biogen’s optimism, the VA does not anticipate there will be many requests for exceptions from VA clinicians. “VA generalist and specialist clinicians have not expressed great interest in this drug for … risk/benefit reasons,” the spokesperson said. “Therefore, we do not anticipate significant demand for the drug.” Requests for Aduhelm will be adjudicated on a case-by-case basis, she added.
The VA estimates that about 169,000 patients in its system currently have Alzheimer’s dementia and about 252,000 VA enrollees have dementia from the disease. More broadly, the agency estimates around 457,000 US veterans have Alzheimer’s dementia.
Biogen and Eisai have not provided public estimates of the number of patients who could be treated with Aduhelm. Based on the entry criteria of the clinical trials, they project the overall patient population could be one to two million and Medicare is expected to handle 80% of claims for the drug.
However, the companies have cautioned that they “do not expect all of these patients will be treated with Aduhelm, for a variety of reasons including appropriate patient selection criteria.”