CMS rolls out plan to cover new Alzheimer's drugs
Medicare will cover drugs with traditional FDA approval when a physician and clinical team participates in a registry.
Photo: Jeff Lagasse/Healthcare Finance News
The Centers for Medicare and Medicaid Services is releasing new details about how people can get drugs that may slow the progression of Alzheimer's disease covered by Medicare.
If the Food and Drug Administration grants traditional approval, then Medicare will cover the drug in what CMS deems "appropriate" settings – that also support the collection of real-world information to study the usefulness of these drugs for people with Medicare.
Specifically, Medicare will cover drugs with traditional FDA approval when a physician and clinical team participates in the collection of evidence about how these drugs work in the real world, also known as a registry.
Clinicians will be able to submit this information through a nationwide, CMS-facilitated portal. The portal will be available when any product gains traditional approval, and will collect information in what the agency said is a user-friendly format.
CMS said this method, and any others that may follow, will adhere to privacy protections in accordance with applicable federal laws and regulations, including HIPAA. CMS and researchers will have access to the information to conduct further studies.
The approach adheres to CMS' National Coverage Determination issued on April 7, 2022. To get Medicare coverage people will need to be enrolled in Medicare, be diagnosed with mild cognitive impairment or mild Alzheimer's disease dementia, and have a physician participating in a registry with an appropriate clinical team and follow-up care.
CMS said it's working with multiple organizations preparing to open their own registries. Once more registries are available, they will also be listed online, and clinicians will be able to choose which registry in which to participate.
WHAT'S THE IMPACT?
Consistent with the NCD, Medicare will cover and pay for drugs in the class of monoclonal antibodies directed against amyloid for the treatment of Alzheimer's disease with traditional FDA approval. To obtain coverage, the provider participates in a data submission effort, commonly referred to as a registry, to further evaluate whether the drug is reasonable and necessary in the Medicare population.
CMS said it's collecting information for the registry that will help to evaluate the appropriateness of the treatment for the Medicare population. The data collected will also help CMS to answer the questions outlined in the NCD, such as: Does the drug meaningfully improve health outcomes for patients in broad community practice? Do benefits and harms, such as brain hemorrhage and edema, associated with the use of the drug, depend on the characteristics of patients, treating clinicians, and setting? And how do the benefits and harms change over time?
The registry, the agency said, will be easy to use. Clinicians furnishing this drug will have already gathered the necessary information as part of routine clinical assessment and follow-up care for patients with mild cognitive impairment or mild Alzheimer's disease dementia who are being evaluated for or treated with these medications, CMS said.
The required elements may already be available to the clinician from the patient's medical record. More details are forthcoming about the estimated length of time to enter data into the portal.
The registry will capture information relevant to the questions in the NCD, such as the clinician's National Provider Identifier, the address of the submitter and the Medicare beneficiary ID.
THE LARGER TREND
CMS said earlier this month it would cover the high cost of Alzheimer's drugs if the FDA grants traditional approval, and when a physician and clinical team participates in the collection of evidence about how these drugs work in the real world – i.e., the registry.
That caveat had at least two organizations protesting that CMS' release on Alzheimer drug coverage makes treatment no more accessible than under the agency's current policy of covering the drugs only for those taking part in clinical trials.
PhRMA said, "Today, under the guise of a positive development, CMS released information on the creation of a nation-wide Medicare patient registry for certain new Alzheimer's medicines granted traditional FDA approval. The administration touted this as exciting news, as steps they are taking to ensure seniors can access these medicines. But they buried the lede. In reality, CMS is reaffirming their plan to severely restrict patient access to FDA-approved medicines, leaving in place barriers to potentially life changing treatment options for a devastating illness. Requiring use of a registry to receive these important treatment options significantly constrains access."
Coverage of new Alzheimer's drugs is expensive and CMS has said the benefits of treatment have yet to be shown.
The anti-dementia medication lecanemab, and its ancillary costs, could add $2 billion to $5 billion in annual Medicare spending, according to a research letter in JAMA Internal Medicine.
Currently, the medication is covered only for patients who are enrolled in clinical trials.
Medicare annual spending on lecanemab's medication costs alone would place it among the most expensive Part B medications delivered in outpatient facilities, the letter in JAMA said.
Twitter: @JELagasse Email the writer: Jeff.Lagasse@himssmedia.com
Twitter: @JELagasse
Email the writer: Jeff.Lagasse@himssmedia.com
