When my father was diagnosed with Alzheimer’s disease in 2011, there was little my family could do to prevent the disease from robbing him – and us – of his independence and his memory.
Now, for the first time, there are disease-modifying treatments, which are medicines that address the underlying cause of disease, approved by the U.S. Food and Drug Administration (FDA) for early-stage Alzheimer’s disease. Thirty years of research and frequent failure has finally produced treatment options that have been shown to slow the progression of the disease. Another promising medicine is currently under review by the FDA.
These hard-fought breakthroughs should be cause for celebration. Sadly, they’re not.
Instead, the Centers for Medicare and Medicaid Services (CMS), the agency tasked with making coverage decisions for Medicare patients, recently took the unusual step of requiring physicians who prescribe these medicines to enroll patients in a registry to collect real-world evidence about the performance of these already approved drugs.
CMS’s decision to cover these FDA-approved Alzheimer’s Disease treatments under its “Coverage with Evidence Development” (CED) could make it harder for some historically marginalized patient populations to be prescribed these new drugs, exacerbating existing racial and rural health disparities. For example, rural providers and hospitals with limited staff may have more difficulty meeting the paperwork and participation requirements of the CED registry. And these registries have extremely low minority recruitment rates. Non-hispanic white Americans represented 92 percent of the participants in the original CED registry to scan patients’ brain for amyloid plaque, a prerequisite to be covered for these drugs.
The CED process was originally intended to speed up access to medical devices, but it has instead created a bureaucratic nightmare for companies developing lifesaving drugs. Companies are forced to follow more than 30 complex and impractical steps just to establish an evidence development program. By imposing CED on Alzheimer’s drugs, CMS has applied it outside of its original, intended scope, and at the same time slowed down access to potentially lifesaving medicine.
A recent analysis in Health Affairs demonstrated that previous registries took months to years for design and implementation. This is precious time that many Alzheimer’s patients don’t have before progressing beyond early cognitive impairment and becoming ineligible to benefit from these promising therapies.
Data shared at the Alzheimer’s Association International Conference in Amsterdam earlier this year reinforced a fundamental truth about the disease: The earlier we treat patients, the better their outcomes will be. CMS must lift the CED for these therapeutics. Doing so will not only make a huge difference in the lives of individual patients, but it will address a major global health burden.
Eli Lilly and Company, where I lead global government affairs, has spent 30 years to develop a safe and effective treatment for Alzheimer’s. Along the way, we’ve endured countless failures, but this July we announced Phase 3 results that showed significant slowing of cognitive and functional decline in early-stage patients. We are working with FDA to gain approval for the use of this medicine and hopefully provide patients and their caregivers with another treatment option.
The experience of watching Alzheimer’s affect my father has driven my desire to help others suffering from this debilitating disease. Opportunity is at our fingertips, but time is of the essence. If we’re successful, we will give patients and their loved ones more time to do the things they love. But if we delay access to these treatments, we could miss the window to effectively treat them.
Decades of research and billions of dollars have produced this promising and innovative medicine. This represents a rapid evolution thanks to science, and we now have an opportunity to advance human health. But if we don’t move fast, patient needs will go unmet and too many families will continue to suffer. The science is there, but it can do no good if it’s tied up in bureaucracy. It is time to act.
Shawn O'Neail is senior vice president of global government affairs at Eli Lilly and Company.
