* Centers for Medicare & Medicaid wants further study
* Diagnostic test costs $3,000
By Ransdell Pierson
Sept 30 (Reuters) - Eli Lilly and Co on Monday saidthe federal government has unfairly blocked patient access toits Amyvid diagnostic test for Alzheimer's disease by denyingreimbursement for such products, and said a requested new studyof the test could create additional delay.
"We are committed to this space and aren't letting thisproduct go by the wayside," Eric Dozier, senior director ofLilly's Alzheimer's business division, said in an interview. The U.S. Centers for Medicare & Medicaid Services (CMS), theagency that runs Medicare, on Friday determined that there wasinsufficient evidence that the type of radioactive imaging test"is reasonable and necessary" for diagnosing and helping treatdementia.
CMS said it would consider coverage for the test only inlimited circumstances: for clinical trials that must be approvedin advance by the agency.
Lilly said the decision denies appropriate patient access tothe test, and conflicts with the National Alzheimer's Plan, asweeping effort to find an effective way to prevent or treatAlzheimer's by 2025 and improve care of those already inflicted.
The radioactive drug is used with positron emissiontomography, or PET, imaging to detect levels in the brain ofbeta amyloid, a protein that creates brain plaques believed tobe a leading cause of the progressive memory-robbing disease.
It is meant to help indicate whether patients haveAlzheimer's or some other disease that causes symptoms ofdementia.
Amyvid was approved in the United States in April 2012, andis the only such diagnostic test currently available to doctorsand patients. But it cannot hope to have appreciable salesunless CMS agrees to reimburse the $3,000 test. Many peoplebegin showing signs of dementia at around 65, the age whenMedicare coverage begins.
Dozier said CMS will reconsider its decision only if a newclinical study is conducted and better demonstates that use ofthe 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 thecompany consults with doctors, researchers, the medicalcommunity and CMS, Dozier said.
"We need to really understand what a study would look like,how we could demonstate outcomes CMS would like," Dozier said.
Amyvid had second-quarter sales of $1.2 million, mainly fromindividuals with means to pay for the scans themselves and fromcoverage 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 disappointmentwith the CMS restrictions on coverage, saying Amyvid has thepotential to "resolve distressing medical uncertainty" aboutwhether patients have Alzheimer's disease.
The association said more than 5 million Americans haveAlzheimer's disease, a number that could jump to as many as 16million by 2050, as the population ages.
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