Director, Govt Strategy, Fed Accts and Quality
Re: National Coverage Analysis (NCA) Tracking Sheet for Positron Emission Tomography (CAG-00065R2)
Dear Dr. Roche and Mr. Caplan:
On behalf of Lilly USA, LLC, we appreciate the opportunity to submit public comments to the Centers for Medicare & Medicaid (CMS) requesting reconsideration of the non-coverage language in Section 220.6 of the Medicare National Coverage Determinations Manual for PET scans. With this letter we reiterate our support for removing legacy language that blocks coverage of novel FDA approved PET imaging agents.
We support the joint society stakeholder request submitted by the Medical Imaging Technology Alliance (MITA) jointly with the American College of Radiology (ACR), the Society of Nuclear Medicine (SNM), the Council on Radionuclides and Radiopharmaceuticals (CORAR) and the World Molecular Imaging Society (WMIS), which proposes a revision of the Medicare NCD Manual maintaining the status of the NCD for tracers reviewed to date, but does not preemptively limit coverage of new FDA-approved tracers. The proposed MITA revision to the existing NCD would make the treatment of newly FDA-approved PET radiopharmaceuticals consistent with the treatment of other new technologies, approved by the FDA under a New Drug Application (NDA) or Biologic License Agreement (BLA.)
While we support the MITA request, we respectfully request the agency to move forward in parallel with opening Lilly’s reconsideration request specific to the beta-amyloid imaging class. Given the recent FDA approval of Amyvid™ and the importance of Alzheimer’s disease to the Medicare population, Lilly firmly believes that beta-amyloid imaging should be addressed directly by CMS to establish appropriate coverage criteria for the Medicare population that reflects the best available scientific evidence and broad stakeholder input.
Current Policy Limits Beneficiary Access to New Agents and Stifles Innovation
The existing Manual policy entirely blocks Medicare beneficiary access in medical need of PET scans with new FDA-approved tracers regardless of the medical necessity of the tracer in the management of the patient’s clinical situation. This bar to coverage occurs without any review of the indication or clinical data regarding that application of PET scanning, and is inconsistent with typical coverage policy. There are no other examples of Medicare coverage policies that explicitly non-cover any and all new FDA approved technologies across such a broad area of new technologies, indications, and FDA approvals. Under the current policy, a beneficiary has no option to appeal coverage, regardless of the urgency or medical necessity of clinical imaging for the management of his or her illness.
Existing NCD policy stifles the very innovation which could directly benefit Medicare beneficiaries. The non-coverage language applies to any new FDA approved radiopharmaceutical. This blocks efforts of innovators, hospital and other imaging providers, physicians, and medical associations to work collaboratively to provide improved and more precise management pathways for patients. Indeed, because Medicare’s coverage framework is predicated on existing CMS coverage decisions, even Medicare contractors that believe that a new imaging agent will efficiently improve patient management and outcomes in their clinics are unable to use the radiopharmaceutical.
There is an international effort to move toward highly targeted radiopharmaceuticals. The barriers to successful innovation, including the long duration of clinical trials, scientific risk and finding clinical use in an increasingly efficiency-directed framework, are already very high and encourage only work to develop tracers that are likely to be impactful on the clinical care of patients. The automatic ban to coverage, before any evidence review, lengthens the timeline of development even farther than that required by rigorous clinical trials and FDA review, and is thus a major negative consideration on decisions to create the innovation that precision medicine requires. Because of the limited bandwidth of the CMS NCD process, innovators have no certainty at all of when a coverage decision could even be opened on a particular new tracer they are creating, or how long it would take to calendar and revise an NCD that has proven incorrect based on additional clinical evidence.
Focus on Alzheimer’s Disease
In parallel to the MITA request, opening a PET reconsideration request focused on the beta-amyloid imaging class as requested by Lilly is particularly important now. Earlier in the year Secretary Sebelius announced a commitment to transform the approach to diagnosis and treatment of Alzheimer’s disease. Pursuant to the National Alzheimer’s Project Act (NAPA) the Department of Health and Human Services released the nation’s first ever strategic plan for Alzheimer’s disease. Lilly shares in this national goal and has a robust pre-clinical and clinical development program focused on Alzheimer’s disease. We believe the increased national attention NAPA has brought forth relative to this terrible disease will open new and much needed possibilities for patients.
Shortly thereafter on April 6, 2012, the Food and Drug Administration (FDA) announced approval of florbetapir F 18 injection (Amyvid™) for Positron Emission Tomography (PET) imaging of the brain to estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive decline. Amyvid™ is an adjunct to other diagnostic evaluations.
Lilly refers the reader to Amyvid’s FDA approved label for full prescribing information.
There is a high level of public and professional interest in beta-amyloid imaging. Amyloid deposition in the brain is one of the most important pathological hallmarks of Alzheimer’s disease, and it would be inconsistent to have a neuropatholigical diagnosis of Alzeheimers Disease for those patients who are found to have sparse to no neuritic beta-amyloid plaque. Accordingly, appropriate use recommendations for the use of beta amyloid imaging agents are being developed by the Alzheimer’s Association in partnership with the Society of Nuclear Medicine, and similar efforts are underway by the International Working Group for New Research Criteria for Alzheimer’s Disease.
Amyvid has been commercially available since June 1st, 2012 but Medicare beneficiaries do not have access to it due to the non-coverage policies. Lilly submitted a formal coverage request for beta amyloid imaging to CMS in June. As CMS has acknowledged, it will consider a reconsideration at any time "if the requestor presents ... material medical and/or scientific information that was not considered during the initial review, that is, results from new clinical trials, new scientific or medical publications, or studies supporting the request." (Medicare Program; Revised Process for Making Medicare National Coverage Determinations. 68 Fed. Reg.55638 (Sep 26, 2003). The Amyvid clinical trials and its FDA approval clearly meet this standard.
Request for National Coverage Analysis for Beta Amyloid Imaging
While we support the MITA request, we strongly urge the agency to move forward in parallel with opening Lilly’s reconsideration request specific to the beta-amyloid imaging class. Given the recent FDA approval of Amyvid™ and the importance of Alzheimer’s disease to the Medicare population, Lilly firmly believes that beta-amyloid imaging should be addressed directly by CMS in a process that collects broad stakeholder input. Lilly is committed to working with CMS to ensure that Medicare beneficiaries have access to this important new technology and other technologies like it. Please contact Derek Asay at 908-268-8720 or email@example.com with any questions regarding our comments.
Derek L. Asay
Director, Government Strategy, Federal Accounts and Quality
Lilly USA LLC