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Centers for Medicare & Medicaid Services

View Public Comments for Positron Emission Tomography (CAG-00065R2)

Dinkelborg, PhD, Ludger
Managing Director
Piramal Imaging GmbH

August 10, 2012

Jeffrey Roche, MD, MPH
Lead Medical Officer
Centers for Medicare and Medicaid Services
Coverage Analysis Group
7500 Security Boulevard
Baltimore, MD 21244

Stuart Caplan, RN, MAS
Lead Analyst
Centers for Medicare and Medicaid Services
Coverage Analysis Group
7500 Security Boulevard
Baltimore, MD 21244

Re: National Coverage Analysis Reconsideration Request for Positron Emission Tomography (CAG-00065R2)

Dear Dr. Roche and Mr. Caplan:

Piramal Imaging SA (a wholly owned subsidiary of Piramal Enterprises) appreciates this opportunity to respond to the Centers for Medicare and Medicaid Services’ (CMS’s) request for comments on the reconsideration request of the National Coverage Determination (NCD) for the use of positron emission tomography (PET) at Section 220.6 of the Medicare Coverage Manual. Piramal Imaging is dedicated to developing innovative imaging technologies and bringing new PET tracers to the market after having acquired Bayer Healthcare’s proprietary molecular imaging PET tracer portfolio in April 2012.

During the past years, preclinical and clinical research in the field of molecular imaging has yielded in a wider range of targeted PET tracers that will provide the Nuclear Medicine community with new options to screen, diagnose and follow-up on patients with disabling and life threatening diseases, and are likely to translate into significant benefits for referring physicians, patients, healthcare providers and payers.

In support of the MITA request, Piramal welcomes the opening of a PET reconsideration request focused on the beta-amyloid imaging class as a highly important initiative. Just a few months ago, 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. Piramal fully supports the goals associated with this plan and currently pursues a large pre-clinical and clinical development program focused on the earlier and more reliable diagnosis of Alzheimer’s disease.

During the past few years, we have acknowledged a growing level of public and professional interest in beta-amyloid imaging. Amyloid deposition in the brain is considered one of the most important pathological hallmarks of Alzheimer’s disease. You may also have noticed that appropriate 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.

Piramal Imaging is pleased to work with CMS to ensure Medicare beneficiaries have proper access to this innovative technology and the new category of PET tracers; we appreciate CMS allowing for our request for re-consideration and are pleased to respond to the areas of interest CMS expressed in its request for comments.

Breadth of the request

Piramal’s reconsideration request addresses new FDA-approved PET radiopharmaceuticals. We stand firm in our belief that approving this request would not reverse the existing National Coverage Determination which encompasses 18F-FDG, 18F-NaF, 13-N ammonia, or 82-Rb rubidium. For PET tracers emerging into this important imaging sector now and in the future, the request enables an updated application of the policy, acknowledging the elevated regulatory approval standards for these new PET tracers. CMS’s approval of the request would allow Medicare beneficiaries to access this innovative technology without delay upon FDA-approval of new, targeted PET tracers, leading to earlier, potentially more reliable diagnosis of their condition, expedient treatment decisions by their physicians and more individualized patient management. We also note that by approving this request, CMS will not discriminate newly-approved PET radiopharmaceuticals from other diagnostic radiopharmaceutical agents that earned approval through the FDA marketing authorization process. In doing so, CMS will apply consistent standards and provide coverage for diagnostic radiopharmaceuticals across imaging modalities and tracer categories.

Assuring success by approving the request

We anticipate that any approval for coverage would involve a thorough consideration of the scientific and pharmaco-economic evidence of the imaging technology and respective agents; we further understand that such evidence (clinical utility, PE benefits) is inherent to the newly approved or to be approved PET tracers developed for the detection of amyloid beta, as opposed to the level of evidence that has been demonstrated for 18F-FDG, 18F-NaF, and 13-N ammonia, which are already covered under Section 220.6 of the CMS National Coverage Determinations Manual.

We acknowledge the concerns expressed by some commenters on the reconsideration request that FDA’s approval alone should not equate to coverage because such regulatory process may not make patient outcomes sufficiently transparent. However, we take this opportunity to reiterate our position that a newly approved diagnostic tracer that successfully passes well-controlled clinical trials and demonstrates clinical efficacy and safety as required for the FDA approval process already provides a significant level of evidence to support coverage. Newly developed PET radiopharmaceuticals certainly should receive the same level of consideration.

We also acknowledge CMS’s and local contractors’ ability to impose boundaries for coverage on any new technology and product entering the marketplace. We appreciate that by approving this reconsideration request, CMS would consent to a process change allowing for coverage of newly approved PET radiopharmaceuticals upon or shortly after FDA approval. It would eliminate the significant delay referring physicians and their patients otherwise incur while awaiting a decision through the current National Coverage Analysis process.

We appreciate the open and cooperative nature that CMS has exhibited throughout this process. If you have additional questions, please feel free to contact me, Dr. Ludger Dinkelborg PhD, at

Ludger Dinkelborg
Managing Director
Piramal Imaging GmbH
Director of the Board
Piramal Imaging S.A.