Medi-Cal Coverage of Aduhelm: Frequently Asked Questions

Summary of Aduhelm Coverage for Medicare, Medi-Cal, and Dually Eligible Beneficiaries

On April 7, 2022, the Centers for Medicare & Medicaid Services (CMS) released a National Coverage Determination (NCD) limiting the Medicare coverage of Aduhelm and other monoclonal antibodies that target amyloid (or plaque) for the treatment of Alzheimer’s disease, to Medicare enrollees who are enrolled in a controlled clinical trial. Additional information can be found on the Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease web page of the CMS website.

Under the terms of the NCD, since Aduhelm is not covered by Medicare Part B, CMS considers it a Medicare Part D drug. Since Medicaid does not pay for Part D drugs for full-benefit dually eligible enrollees, regardless of Medicare Part D enrollment status, Medi-Cal will not cover Aduhelm for patients with Medicare-Medicaid coverage (dually eligible enrollees). Medicare-Medi-Cal dual-eligible enrollees are required to obtain the medication via their Medicare benefit by enrolling in clinical trials.

State Medicaid programs are required to cover Aduhelm if the manufacturer has signed a National Drug Rebate Agreement with the U.S. Department of Health and Human Services (HHS) when the drug is used for a medically accepted indication, subject to utilization management. CMS further clarified that since the manufacturer of Aduhelm has signed a Medicaid drug rebate agreement with HHS, and satisfied the definition of a covered outpatient drug pursuant to section 1927(k)(2) of the Social Security Act (Act), it is a Medicaid covered benefit if medically necessary but States have the authority to apply appropriate utilization management controls. Given that, Aduhelm is a covered benefit for Medi-Cal beneficiaries (who are not dually enrolled in Medicare) who meet the coverage requirements as specified in the policy published in Medi-Cal Provider Manual.

Frequently Asked Questions

  1. What is Aduhelm?

  2. Aduhelm (Aducanumab-avwa) is an amyloid beta-directed antibody indicated for the treatment of Alzheimer’s disease. Aduhelm is for patients with mild cognitive impairment (MCI) or mild dementia stage of disease, with a confirmed presence of plaque on the brain, the population studied in clinical trials.

  1. Who is eligible for Aduhelm coverage under Medi-Cal?

    Coverage is limited to Medi-Cal beneficiaries who are not dually-eligible (do not have Medicare coverage) and meet the medical eligibility criteria as published in the Medi-Cal provider manual.

  1. I am a provider, where can I find the coverage policy for a Medi-Cal patient?

  2. The current coverage policy and requirements are found in the Injections: Drugs A-D Policy section of the Medi-Cal provider manual.

  1. Does Medicare cover Aduhelm?

  2. Under the terms of the NCD, Medicare limits Aduhelm coverage to Medicare Part B enrollees who are participating in a clinical trial for the drug. Aduhelm and other monoclonal antibodies that target amyloid (or plaque) for the treatment of Alzheimer’s disease that receive traditional approval from the Food and Drug Administration (FDA) will be covered under coverage with evidence development (CED) and must be participating in a clinical trial.

  1. Why is Medi-Cal not covering Aduhelm for full-benefit dually eligible enrollees when it is not covered under the NCD (that is, when a full-benefit dually eligible enrollee is not part of a clinical trial)?

  2. For purposes of this NCD, when Aduhelm or other drugs included in the NCD are non-covered by Medicare Part B under the terms of the NCD, CMS considers them Part D drugs. Medicaid (Medi-Cal) does not pay for Part D drugs for full-benefit dually eligible individuals, regardless of whether they are enrolled in a Part D plan. This means that when the drugs included in the NCD are non-covered by Part B under the terms of the NCD, regardless of whether a full-benefit dually eligible individual’s Part D plan actually covers the drug, Medicaid (Medi-Cal) will not cover them.

  1. Are Medicare Part D plans covering this drug?

  2. As stated in Question 5 above, when an FDA-approved drug is not eligible for coverage under Parts A or B, the drug would be covered under Part D based on statutory definition of a Part D drug and be covered by a Part D sponsor. By this definition, CMS considers Aduhelm a Part D drug. However, since a Part D sponsor may exclude from Part D coverage any drug for which payment under Part A and Part B would not be made because the drug is not reasonable and necessary, they are not required to cover Aduhelm.

  1. Is Medi-Cal required to cover this drug for Medicaid-only beneficiaries?

  2. Yes. As previously stated in Question 2 above, Medi-Cal covers Aduhelm for eligible beneficiaries. Since the manufacturer of Aduhelm has signed a Medicaid drug rebate agreement with HHS and Aduhelm also satisfies the definition of a covered outpatient drug, as set forth in section 1927(k)(2) of the Social Security Act (Act), State Medicaid programs are required to cover it when used for a medically accepted indication. However, utilization management techniques, such as prior authorizations, may be applied. Given this, Medi-Cal covers Aduhelm for Medi-Cal-only beneficiaries who meet the eligibility criteria as specified in the Treatment Authorization Request (TAR) criteria published in the Medi-Cal Provider Manual.

  1. How do I enroll in a clinical trial?

  2. Patients/caregivers may go to clinicaltrials.gov to search for a particular study of interest. A search using the terms "Alzheimer's disease", "Biogen", and "recruiting" may help yield results. If study locations and contacts are listed on clinicaltrials.gov, please contact the site directly for more information on how to enroll.

    If study locations and contacts are NOT listed please contact Biogen (the manufacturer of Aduhelm) directly for further information, using the information on their Contact Us page. 

    Below are Enrolling/Upcoming Studies in the United States (US):

  1. Phase 4 ENVISION Confirmatory Study
  2. As part of the post-marketing requirement, in June 2021, the US Food and Drug Administration (FDA) announced that a confirmatory trial of Aduhelm was required as part of the accelerated approval. The initiation of patient screening for ENVISION is planned for May 2022. The ENVISION study will be a global, placebo-controlled trial, aiming to enroll 1,500 patients with early Alzheimer’s disease. Once the study begins recruiting, information will be posted on: clinicaltrials.gov. Please check that website for the most up-to-date information.

  1. ICARE AD Trial in the US
  2. Biogen is conducting an ongoing Observational Study of Aducanumab-avwa in participants with Alzheimer’s Disease in the US, also known as an International Collaboration for Real-World Evidence in Alzheimer’s Disease (ICARE AD) trial (NCT05097131) in the US. The ICARE AD trial is only enrolling patients who will be prescribed aducanumab-avwa by their treating physician, independently of their participation in the study. The study is taking place at sites in the US and patients can participate at an approved site if they meet study criteria. Further information about the study, such as eligibility criteria and Contacts and Locations, can be found on the web page for the Observational Study of Aducanumab-avwa in participants with Alzheimer’s Disease in the US study on the clinicaltrials.gov website.

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