CMS opens national coverage determination analysis on Alzheimer's treatment
The analysis will target aducanumab, recently approved by the FDA, as well as any future monoclonal antibodies that treat Alzheimer's.
Photo: Jasmin Merdan/Getty Images
The Centers for Medicare and Medicaid Services said this week it's opening a National Coverage Determination analysis, a process that will allow the agency to review and determine whether Medicare will establish a national coverage policy for monoclonal antibodies targeting amyloid for the treatment of Alzheimer's disease.
NCDs are program instructions developed by CMS to describe the nationwide conditions for Medicare coverage for a specific item or service. The NCD analysis will be applicable to national coverage considerations for aducanumab, which was recently approved by the Food and Drug Administration, as well as any future monoclonal antibodies that target amyloid for the treatment of Alzheimer's disease.
As part of the NCD process, a 30-day public comment period began on Monday. CMS will also host two public listening sessions in July to provide an opportunity for public input.
WHAT'S THE IMPACT?
Currently, coverage determinations for aducanumab are being made at the local level by Medicare Administrative Contractors who represent 12 jurisdictions across the country. CMS said its coverage decisions are based on analysis of the evidence and benefits a given therapy provides to Medicare beneficiaries.
To determine whether a national policy is appropriate, CMS intends to follow a standard process that includes opportunities for public participation and commentary through both listening sessions and the CMS coverage website. The analysis will determine whether the evidence meets the Medicare law's requirements that items or services be "reasonable and necessary for the diagnosis or treatment of illness or injury …".
To make that determination, CMS uses a formal process established by statute. The process includes an assessment of the clinical evidence, such as published clinical studies, professional society guidelines and public comments, to determine coverage.
Following this analysis, CMS will post a proposed national coverage determination, which will be open to a second 30-day public comment period. After reviewing all comments received on a proposed determination, CMS will announce its final decision for a national policy, which could range from Medicare coverage of the product type, coverage with evidence development, non-coverage, or deference to the Medicare Administrative Contractors.
A proposed decision is expected to be posted within six months, and a final one within nine months.
NCDs are posted on the CMS Medicare Coverage Center website, and provide stakeholders with the Medicare coverage criteria, a summary of the evidence considered, and CMS's rationale for the decision.
THE LARGER TREND
When the FDA approved aducanumab, manufactured by drugmaker Biogen, there was controversy as to whether the drug was actually effective. But that hasn't stopped Biogen from teaming up with major payers, including Cigna and CVS Health, to increase patient access to the drug.
Partnering with Japanese pharmaceutical and research company Eisai, Biogen said last month that it intends to enter into a value-based contract with Cigna to streamline access to the Alzheimer's drug, marketed as Aduhelm, and will be tracking performance based on certain outcome metrics.
According to NPR, aducanumab has been controversial in that it's unclear whether it truly slows the progression of Alzheimer's disease. It has shown effectiveness at reducing plaques that build up in the brains of people afflicted with the disease, but separate studies have disagreed on whether it slows the decline in memory and thinking typically associated with Alzheimer's.
Among the FDA's conditions of approval is that Biogen will be required to conduct another clinical trial to confirm that the reduction of plaques translates into true clinical improvement. If that study fails to demonstrate the drug's efficacy, the FDA could withdraw the approval, effectively pulling the product from shelves.
With an aging baby boomer population and ever larger numbers of people being diagnosed with Alzheimer's, the cost of treating the disease has reached significant levels. According to a 2018 report from the Alzheimer's Association, the cost will only grow. It's projected to reach as high as $1.1 trillion by 2050.
By that time, the number of Americans officially diagnosed with Alzheimer's could reach nearly 14 million, at least if current rates hold.
Yet despite the sobering projections, there's a silver lining from a cost perspective. Early detection is the key. Diagnosis during the mild cognitive impairment, or MCI, stage of the disease could save up to $7.9 trillion and also make the condition's effects more manageable as the person ages.
Medicare and Medicaid feel the cost impact as well. While Medicare typically pays about $7,000 per year for an Alzheimer's-free individual, a person with the disease costs about $23,000. Those figures become compounded when factoring in Alzheimer's rising prevalence, with one in 10 people age 65 and older showing symptoms of the disease, and Alzheimer's deaths rising 123% between 2000 and 2015.
ON THE RECORD
"Alzheimer's is a devastating illness that has touched the lives of millions of American families and as CMS opens our National Coverage Determination analysis, we invite interested stakeholders to participate," said CMS Administrator Chiquita Brooks-LaSure. "We want to consider Medicare coverage of new treatments very carefully in light of the evidence available. That's why our process will include opportunities to hear from many stakeholders, including patient advocacy groups, medical experts, states, issuers, industry professionals, and family members and caregivers of those living with this disease."
Twitter: @JELagasse
Email the writer: jeff.lagasse@himssmedia.com
