There was more good news this week for Alzheimer’s patients and their families. Eli Lilly’s drug slowed the disease by 35%, and nearly half the patients had no decline in cognition after a year. The results are the best ever recorded for an Alzheimer’s treatment, signifying momentous progress for the field.
All eyes now turn to FDA, which will review the drug for approval, and to the Centers for Medicare and Medicaid Services (CMS), which has so far refused to grant broad coverage for FDA-approved treatments. Writing in The Wall Street Journal, Joe Grogan explains how CMS is stifling innovation and calls on the agency to reverse course.
If the FDA deems a treatment safe and effective, historically CMS has almost always determined it to be worthy of reimbursement under the “reasonable and necessary” standard—a nebulous term that gives the agency maximum leeway. The FDA and CMS have followed this path in granting broad access to innovative treatments for cancer, heart disease and HIV/AIDS.
But CMS has inexplicably bucked precedent with Alzheimer’s, questioning the FDA’s judgment on safety and efficacy and restricting coverage of any new medicines to CMS-approved clinical trials. Guess how many such trials are currently enrolling Alzheimer’s patients? None.
The policy CMS is wielding, known as the “Coverage with Evidence Development,” is an innovation killer. It was created during President George W. Bush’s administration to speed access to medical devices. The idea was to have CMS cover medical technologies on which research data was still being collected. In practice CED has become an interminable slog for companies, which often have to follow more than 30 complex steps to establish an evidence development program. This entails identifying study sponsors and investigators, establishing protocols, securing CMS approvals and funding, establishing databases, enrolling patients, and running clinical trials.
Since 2005, 27 medical devices or procedures have been subjected to CED and only four have had their evidence development programs retired. One took 12 years to do so. Others are still required to generate clinical data today.
By subjecting Alzheimer’s treatments to CED, CMS has expanded the policy beyond devices and procedures. This move calls into question the FDA’s scientific judgment and will restrict, rather than expand, patients’ access to these treatments. There is no indication CMS will reverse course but bipartisan pressure on the agency is growing.
Democratic and Republican lawmakers hammered CMS Administrator Chiquita Brooks-LaSure on the policy before the House Energy and Commerce Committee’s Subcommittee on Health last week. The same day, 26 attorneys general from red and blue states sent Ms. Brooks-LaSure and Health and Human Services Secretary Xavier Becerra a letter urging them to expand access. Both groups highlighted the administration’s conflicting policy on the matter, noting that the Department of Veterans’ Affairs granted coverage for Eisai and Biogen’s treatment in February.
Alzheimer’s is a very risky bet for innovators. In the past quarter-century, more than 150 clinical trials have ended in failure. Despite billions of dollars of private investment, only six treatments have achieved FDA approval. The recent momentous advances are milestones toward treatments that can slow the disease and perhaps one day reverse it. Innovation must be rewarded—not suppressed
In many ways, we are today with Alzheimer’s where we were with cancer 40 years ago. When President Richard Nixon signed the National Cancer Act of 1971, the five-year survival rate was below 50%. After decades of investment, supported by policies rewarding incremental innovation, the rate is approaching 70%. It is nearly 100% for breast, prostate, and other cancers caught in the early stages. Similar progress is possible for Alzheimer’s—and the first step is getting FDA-approved treatments out of CED.
You can read the full piece here.