Amyvid makers call for CMS coverage of amyloid imaging

Developers of the first FDA-approved imaging agent for the diagnosis of Alzheimer’s, Eli Lily and Company and Avid Pharmaceuticals, held a conference call May 16 for stakeholders and members of the media to discuss the Center for Medicare & Medicaid Service's (CMS) upcoming draft decision regarding coverage for Amyvid and other beta-amyloid type diagnostic agents.

“Alzheimer’s disease continues to be one of the most significant health challenges facing the United States,” began Wei-Li Shao, senior director of the Alzheimer’s business division at Eli Lilly and Company. “In fact, deaths attributed to Alzheimer’s disease continue to rise. From 2000 to 2010, the rate increased 68 percent. Furthermore, the number of people impacted by Alzheimer’s disease is only expected to rise. One in nine Americans age 65 and older has Alzheimer’s disease and 10,000 Americans are turning 65 each day. It’s estimated that one in five patients clinically diagnosed with Alzheimer’s disease during life do not actually have Alzheimer’s pathology upon autopsy. These numbers present quite a challenge when thinking about the future of America’s health care system.”

Once past opening remarks and statistics, Shao explored some of the concerns Lilly and others have as a result of major developments in amyloid imaging.  After the FDA-approval of Amyvid in April of last year, CMS’s Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) meeting at the beginning of this year disappointed many interested parties with the subsequent non-coverage decision based on low to intermediate confidence that there was adequate evidence to support that PET amyloid imaging would lead to improved health outcomes. A new CMS draft decision regarding coverage is expected within a couple months. Shao stated that having to prove better health outcomes was not the business of diagnostic technologies.

“Treatments exist to improve health outcomes,” he said. “Lilly believes that requiring a diagnostic tool to serve the same role as a treatment in improving health outcomes is inappropriate. We along with the experts in the field believe the true value of these diagnostic imaging agents is that for the very first time in clinical practice, physicians can determine whether patients with signs and symptoms of cognitive impairment have underlying amyloid pathology.”

Both Shao and Daniel Skovronsky, MD, PhD, president and CEO of Avid Radiopharmaceuticals, subsidiary of Eli Lilly and Company, spoke about official statements provided by physician experts and patient advocacy groups as a result of a national coverage analysis and 30-day period of public comment starting in October 2012. Statements in support of CMS coverage were made from key players including the Alzheimer’s Association and the Society of Nuclear Medicine and Molecular Imaging, which culminated in a taskforce to determine appropriate use criteria for diagnostic amyloid imaging that involved an investigation of more that 400 related research studies.

“These groups outlined concerns that we at Lilly fully echo, including that failing to provide coverage for this new technology will suppress innovation and research in the field of dementia in addition to preventing patients with potential Alzheimer’s disease and related dementias from having access to tools that could aid in the early and accurate diagnosis that could lead to appropriate treatment and care management,” said Skovronsky.

Three different coverage possibilities were outlined by Shao regarding CMS’s upcoming decision, including a continued non-coverage decision, a decision to cover amyloid PET imaging in full, or a plan called coverage with evidence development (CED), which would cover certain patient populations but only under special circumstances, such as those who fall within the appropriate use criteria, and he added that it would require extensive and potentially redundant trials to provide evidence deemed necessary for coverage.

“We believe that CED, or coverage with evidence development, should not be applied in cases where the FDA approval process has expressly evaluated and endorsed the use of a drug or biologic in a specific patient population,” said Shao. “We feel this is an unnecessary step that is hindering patients from gaining access to important treatment or scans that could have an impact on their diagnosis or treatment. While we do not believe CED is appropriate, CMS may still choose to issue a CED as its draft decision in July. If the draft decision is CED, CMS could ask Lilly or any other interested stakeholders to conduct a registry trial and/or a randomized controlled trial to collect data the agency has identified as the evidence gap needed to gain coverage of the diagnostic tool. This decision would limit beta amyloid imaging agents only to those within the trials deemed necessary to conduct.”

Skovronsky followed up by asserting that a CED decision by CMS would not only limit access to amyloid imaging to only those included in the trials and delay further access by months and even years, but he insisted that it could also have deleterious effects on future breakthroughs in the industry to combat Alzheimer’s disease.

“In addition to causing a significant delay in patient access to this new technology, such uncertainty in the reimbursement process creates a strong disincentive for future investments in research and development and innovation,” said Skovronsky, who also made a point to remind listeners that physicians should feel confident to prescribe diagnostic imaging with Amyvid, when deemed appropriate, regardless of the CMS decision.

During a question and answer session at the end of the call, an anonymous interviewer asked why it was important to cover diagnostic amyloid PET imaging when still no therapies were available to treat Alzheimer’s disease.

“It’s true that we don’t have yet today anti-amyloid therapies or other therapies that represent a true cure for Alzheimer’s disease,” said Skovronsky, “But we do have a myriad of interventions; we have drugs that are approved; we have management strategies that do offer real benefits for Alzheimer’s patients. In addition, once we have an accurate diagnoses we can manage the comorbidities of Alzheimer’s disease patients better, so it really is quite important even today, even with the therapeutics we have today, to diagnose Alzheimer’s early and accurately.”

Shao expects CMS to have a draft decision for coverage of diagnostic amyloid PET imaging as early as late June, but certainly by end of July.