Alzheimer's volunteer urges Medicare, Medicaid to approve new drug

Mar. 23--MOULTRIE, Ga. -- Alzheimer's disease and other dementias are devastating. On Jan. 6, the U.S. Food and Drug Administration approved a medication that offers hope to those with Alzheimer's.

It's great news if you can afford it -- but a simultaneous decision by the Centers for Medicare and Medicaid Services means very few people actually can.

A South Georgia volunteer with the Alzheimer's Association returned Tuesday from meeting with staff of Rep. Austin Scott and Sens. Jon Ossoff and Raphael Warnock in Washington, where she encouraged the congressmen to pressure the CMS to change its mind.

Kim Blackstock, a Tifton woman who works for Southern Care Hospice in Moultrie, said the staffers told her they would research the issue, and she's to meet with Scott's South Georgia representative in a couple of weeks for an update.

Blackstock has worked in the geriatric field for 25 years and has volunteered with the Alzheimer's Association since 2009. She's lost relatives to dementia and through her job she's seen the effect of Alzheimer's disease on victims, on their caregivers and on their other loved ones.

"They're grieving their loved one before they've even left this earth," she said.

Like others in the field, Blackstock was heartened by positive results of Leqembi (generic name lecanemab) during tests. She said she first heard of the drug in 2018 as it was moving from Phase 2 to Phase 3 trials. The FDA approved it through an accelerated procedure on Jan. 6.

The medical website PrivateHealth.com describes Leqembi this way:

Leqembi is a monoclonal antibody approved for the treatment of Alzheimer's disease in patients with mild cognitive impairment or mild dementia. It is administered intravenously every two weeks and takes about one hour to receive each dose.

Leqembi works by targeting a peptide called amyloid-beta (Ab), which is known to build up and form plaques in the brains of patients with Alzheimer's disease. Leqembi binds to and eliminates the Ab fibers that aggregate to form those plaques. Researchers believe that medications that reduce the formation of Ab plaques may mitigate the symptoms of Alzheimer's and slow the progression of the disease.

The medicine is not a cure for Alzheimer's -- it will not restore lost function or lost memories -- but by slowing the disease's progress it can add months or years of productive time for a patient.

"They might be able to see their kids get married, to see their grandchildren," Blackstock said. "It's more quality time to see their loved ones."

Blackstock said 150,000 Georgians age 65 or older have Alzheimer's disease (as of 2020). An Alzheimer's Association estimate predicts an increase of 26.7% by 2025.

"We're also getting a lot of early onset Alzheimer's diagnoses," she said. "These people are in their 40s and 50s. They're still in the workforce."

Blackstock said Leqembi has been shown to help Alzheimer's patients with mild symptoms to not get worse, at least for a while. It has not been tested on those with more serious impairment. She said more than 2,000 Alzheimer's patients each day progress to a more serious phase of the disease, making them ineligible for Leqembi. That lends an urgency to her argument.

But just because the FDA has declared the drug safe and effective, that doesn't mean it's available to everyone. A year's supply of Leqembi costs more than $26,000, and until the CMS approves the drug, that money is completely from the patient's pocket.

Unless the patient is a veteran, that is. The Veterans Health Administration approved Leqembi March 13, according to a press release from the drug's maker, Eisai. That means patients with veterans benefits can receive the drug with a copay comparable to those of other medicines.

Back on Jan. 6, the same day the FDA approved use of Leqembi, the CMS refused to put it on the list of drugs that Medicare and Medicaid pay for. The Alzheimer's Association appealed, and the appeal was denied Feb. 22.

The CMS issued statements at each of those denials that seem to point a finger at the accelerated approval process the FDA used.

The Jan. 6 statement reads, in part:

In the April 2022 National Coverage Determination (NCD), CMS stated it was interested in data that could answer the following questions:

--Does the antiamyloid mAb meaningfully improve health outcomes (i.e., slow the decline of cognition and function) for patients in broad community practice?

--Do benefits, and harms such as brain hemorrhage and edema, associated with use of the antiamyloid mAb, depend on characteristics of patients, treating clinicians, and settings?

--How do the benefits and harms change over time?

CMS continues to actively engage with all interested stakeholders and is reviewing data that may answer these Coverage with Evidence Development (CED) questions that were listed in the April 2022 NCD. CMS encourages any stakeholder to send relevant data to assist in a reconsideration of the current coverage.

The Feb. 22 statement reiterated those questions and added:

As defined in statute, to provide coverage nationally, CMS is required to examine whether a medication is reasonable and necessary. This standard differs from the criteria used by the FDA to assess whether medications are safe and effective. We are aware that additional publications may be forthcoming that include information relevant to the questions included in the current NCD. CMS will expeditiously review any new evidence that becomes available that could lead to a reconsideration and change in the NCD, such as evidence that answers the Coverage with Evidence Development (CED) questions or approval by the FDA based upon evidence of clinical benefit.

"Approval by the FDA ..." in the last sentence is a reference to the FDA's traditional approval process, not the accelerated one used in this case.

Blackstock said the CMS told the Alzheimer's Association that it would revisit the question over the summer.

The CMS is key to so much about the drug, she said, not only because so many Alzheimer's patients are on Medicare or Medicaid, but private insurers generally follow the CMS's lead in approving medicines. If Medicare or Medicaid won't pay for Leqembi, private insurance companies usually won't either.

She urged area residents to contact the offices of Rep. Austin Scott, Sen. Jon Ossoff and Sen. Raphael Warnock, as well as CMS Administrator Chiquita Brooks-LaSure to encourage them to support the drug's approval by the CMS.

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