title: The Medical Imaging & Technology Alliance conference on research endpoints appropriate for Medicare coverage of new PET radiopharmaceuticals.
abstract: The outcomes of a 2011 Medical Imaging & Technology Alliance (MITA) conference helped shape considerations about what might be the most appropriate pathways for the regulatory and payment considerations of new PET radiopharmaceuticals. As follow-up to that conference, MITA convened a second conference of stakeholders to advise payers on what might be acceptable endpoints for clinical trials to support the coverage of novel PET agents. The conference involved experts on imaging and clinical research, providers of PET services, as well as representatives of interested medical societies, the PET industry, and the regulatory and payer communities. The principal outcome of their deliberations was that it was unrealistic to expect trials of new PET radiopharmaceuticals to directly demonstrate a health benefit. Rather, intermediate outcomes, such as a positive change in patient management, would be more efficient and appropriate.
authors.affiliation: Department of Radiology and Medical Imaging, University of Virginia, Charlottesville, Virginia, USA. BJH8A@virginia.edu
authors.forename: Bruce J
authors.initials: BJ
authors.lastname: Hillman
authors.forename: Richard A
authors.initials: RA
authors.lastname: Frank
authors.forename: Brian C
authors.initials: BC
authors.lastname: Abraham
mesh_terms: D023381:Endpoint Determination / Q000191:economics* / Q000592:standards; D006801:Humans; D007349:Insurance, Health, Reimbursement / Q000191:economics* / Q000331:legislation & jurisprudence*; D006278:Medicare / Q000191:economics* / Q000331:legislation & jurisprudence*; D049268:Positron-Emission Tomography / Q000191:economics* / Q000592:standards; D019275:Radiopharmaceuticals / Q000191:economics*; D014481:United States
chemical_list: D019275:Radiopharmaceuticals
keywords: National Oncologic PET Registry; PET; clinical trial endpoints; diagnostic endpoints; payment; regulation