Eli Lilly and Co on Monday said the federal government has unfairly blocked patient access to its Amyvid diagnostic test for Alzheimer's disease by denying reimbursement for such products, and said a requested new study of the test could create additional delay.
"We are committed to this space and aren't letting this product go by the wayside," Eric Dozier, senior director of Lilly's Alzheimer's business division, said in an interview.
The U.S. Centers for Medicare & Medicaid Services (CMS), the agency that runs Medicare, on Friday determined that there was insufficient evidence that the type of radioactive imaging test "is reasonable and necessary" for diagnosing and helping treat dementia.
CMS said it would consider coverage for the test only in limited circumstances: for clinical trials that must be approved in advance by the agency.
Lilly said the decision denies appropriate patient access to the test, and conflicts with the National Alzheimer's Plan, a sweeping effort to find an effective way to prevent or treat Alzheimer's by 2025 and improve care of those already inflicted.
The radioactive drug is used with positron emission tomography, or PET, imaging to detect levels in the brain of beta amyloid, a protein that creates brain plaques believed to be a leading cause of the progressive memory-robbing disease.
It is meant to help indicate whether patients have Alzheimer's or some other disease that causes symptoms of dementia.
Amyvid was approved in the United States in April 2012, and is the only such diagnostic test currently available to doctors and patients. But it cannot hope to have appreciable sales unless CMS agrees to reimburse the $3,000 test. Many people begin showing signs of dementia at around 65, the age when Medicare coverage begins.
Dozier said CMS will reconsider its decision only if a new clinical study is conducted and better demonstrates that use of the product can meaningfully improve patient outcomes.
Lilly's eventual decision whether to conduct such a trial, and how it will be designed, will be determined after the company consults with doctors, researchers, the medical community and CMS, Dozier said.
"We need to really understand what a study would look like, how we could demonstrate outcomes CMS would like," Dozier said.
Amyvid had second-quarter sales of $1.2 million, mainly from individuals with means to pay for the scans themselves and from coverage by private insurance companies on a case by case basis. It is available at 450 imaging centers across the country.
The Alzheimer's Association on Monday cited disappointment with the CMS restrictions on coverage, saying Amyvid has the potential to "resolve distressing medical uncertainty" about whether patients have Alzheimer's disease.
The association said more than 5 million Americans have Alzheimer's disease, a number that could jump to as many as 16 million by 2050, as the population ages.
(Reporting by Ransdell Pierson; Editing by L Gevirtz)