This year, reports from the front lines of the battle against Alzheimer’s have been full of superlatives, heralding “a turning point” or “a new era,” and even “the beginning of the end” of this dreadful disease. To be sure, there have been encouraging developments, especially the full approval of Leqembi this month by the FDA. A similar drug is expected to secure comparable approval by the end of the year.
But despite these gains, the reality is that very few patients have access to these treatments and there are still significant roadblocks standing in the way of their use.
This has been a time of conflicting signals and new requirements from government agencies about treatments for the disease. The Centers for Medicare & Medicaid Services (CMS) especially has come under fire for its policies toward the monoclonal antibody treatments approved by the FDA for Alzheimer’s. For instance, after expedited approval in January, Leqembi was covered by Medicare only for patients participating in clinical trials. However, six months later after full FDA approval of the drug, patients who are enrolled in Medicare and diagnosed with mild cognitive impairment or mild Alzheimer’s disease can be treated with Leqembi. But, their doctors must participate in a data-collection system the federal government has established to monitor the treatment’s benefits and risks.
This requirement to fill out additional paperwork has already been cited by physicians as a deterrent to prescribing the drug.
CMS has hardly been without blame for this stop-and-start, mixed signal approach to the introduction of these drugs. But the real concerns here should lie not so much with the month-to-month decision making, but more with the absence of a long-term policy framework for the introduction of these and other drugs that could benefit the health of the elderly.
It has been 20 years since any drug for Alzheimer’s has been approved by the FDA. During that time, there has been intense activity worldwide to develop an effective drug for the condition. Millions of patients, health care professionals, and caregivers have been desperate for any treatments, no matter how incremental, and their number will only grow as the population ages.
To put it simply, the progression of Leqembi through the pharmaceutical pipeline should not have come as a surprise to the decisionmakers at CMS. Nonetheless, they seemed unprepared to make the myriad decisions surrounding the introduction of these drugs.
One example of where longer-term planning might have helped: More than five years ago, I wrote in this space about the need for expanded coverage of PET scans which were then already being used to differentiate between patients who had been misdiagnosed with Alzheimer’s and those who, if fact, had the disease. I wrote: “It’s time for CMS to…reimburse broader use of the PET amyloid scans. From a financial point of view, an investment in the use of these scans could potentially save some of the millions that are currently being spent on treating misdiagnosed Alzheimer patients.”
I am not a physician, but my awareness of the importance of PET scans in helping to diagnose Alzheimer’s and my work with the Alliance lead me to think that expanded coverage of these scans by Medicare might support future Alzheimer’s treatments. In fact, subsequent to the approval of Leqembi, and five years later, CMS has acted to expand coverage of PET scans beyond the one-time-per-patient use. One industry group based in Europe estimates that in the wake of the approval of Leqembi, the need for these tests will increase twenty-fold. And it points out that health systems worldwide are unprepared.
While I admit to being knowledgeable about CMS and its internal processes, I was certainly not clairvoyant or alone in seeing that we needed a plan five years ago to increase the coverage for PET imaging. But instead of acting on this clearly identified need, CMS commissioned a study and allowed for extremely limited coverage. While this is not unique to the way CMS has worked vis-à-vis other diseases, it seems to be uniquely frustrating to the Alzheimer’s community.
While CMS is currently playing catch-up with day-to-day decision making, let’s take a longer look at what the needs of our elderly population could be five years from now. And let’s do it sooner rather than later, CMS, when there could be money to be saved and lives to be improved and extended.
