Newsbriefs

Aetna Reverses Cardiac PET/CT Noncoverage Policy

On June 16, SNMMI announced that Aetna, Inc. (Hartford, CT) had reversed a recent noncoverage policy on cardiac PET, in part as a result of responses from SNMMI and the American Society of Nuclear Cardiology (ASNC). SNMMI had received word earlier in the spring that Aetna would refuse coverage for hybrid PET/CT (CPT codes 78429–78431, 78433) on the basis that it was “experimental/investigational” and “not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature.” The policy stated, “The fusion of PET and CT imaging into a single system (PET/CT fusion) is considered experimental and investigational for cardiac indications; a PET scan without CT is adequate to evaluate the myocardium (NIA, 2005).”

SNMMI and ASNC then sent a letter to Aetna requesting that the noncoverage policy be reversed, noting, “this decision is inconsistent with standards and practice for cardiac PET imaging across the United States.” The groups added “not covering hybrid PET/CT denies patient access to standard-of-care testing that is required to make life-saving clinical decisions.” The letter referred to the 2016 joint ASNC imaging guidelines and SNMMI procedure standards and position statement for the role of PET/CT in evaluation of coronary artery disease (J Nucl Cardiol. 2016;23:1227–1231), which have been accepted by the American Medical Association RVS Update Committee and multiple payers, including the Centers for Medicare and Medicaid Services.

Within a few days of receiving the letter, Aetna announced the reversal of the noncoverage policy. SNMMI leadership praised this outcome and Aetna's swift response.

SNMMI

SNMMI Launches Mars Shot Fund for Nuclear Medicine Research

SNMMI announced on June 13 the creation of the Mars Shot Fund, an initiative to raise $100 million for research in nuclear medicine, molecular imaging, and therapy. At the time of the announcement, the fund had received $600,000 in grants and pledges. The fund’s organizers also hope to work to increase federal spending in the target areas. The SNMMI Mars Shot initiative stemmed from an article published in The Journal of Nuclear Medicine (2021;62[1]:6–14) that focused on the potential of innovations in the field. Richard Wahl, MD, 2021–2022 SNMMI president, and coauthors detailed 5 areas for needed growth, including oncologic imaging, cardiac imaging, neurologic imaging, physics and data science, and radiopharmaceutical therapy. “Research and development are critical to advancing these 5 areas of growth; however, current funding is lacking,” said Wahl. “The National Institutes of Health [NIH] funding line is at about 10% right now. The Mars Shot Fund is a way to help fund highly innovative, high-impact research that might not be funded by NIH or other agencies.”

The Mars Shot Fund is led by a board of scientists and funders, as well as a scientific advisory board. As additional funding is obtained, research support will be available through a grant application process. Applications will be reviewed by SNMMI study sections. Individuals and organizations have already made generous donations to the fund. SNMMI is advising the U.S. Congress to include a line item for the Mars Shot Fund in the Department of Energy or Department of Defense budgets in the coming session. Individuals are also being asked to contribute to the fund.

“We are in a revolutionary period for nuclear medicine, molecular imaging, and therapy,” said Wahl. “It’s essential that we capitalize on the momentum of this unparalleled innovation now so that we can continue to transform the nature of disease prevention, diagnosis, and treatment in the near future.” Contributions to the Mars Shot Fund to support nuclear medicine and molecular imaging research can be made through www.snmmi.org/marsshot.

SNMMI

CDC Awards Funding for Cancer Prevention and Control

The Centers for Disease Control and Prevention (CDC) announced on June 8 first-year funding awards of $215 million in a 5-y, $1.1 billion investment into 3 national programs to prevent and control cancer. Eighty-six unique recipients from state, local, tribal, and territorial public health organizations and academic institutions received funding. Funded programs will demonstrate ways in which proven strategies advance health equity and build capacity in cancer prevention and control. Targeted outcomes include improving provision of clinical preventive services, facilitating planning among partners to promote evidence-based strategies in communities, and improving cancer surveillance.

“Today we know cancer as a disease that we often diagnose too late, but thankfully we have a few ways to prevent it and tackle stark inequities across races, regions, and resources,” said Health and Human Services Secretary Xavier Becerra. “This funding is a critical investment in support of President Biden’s Cancer Moonshot initiative and our efforts to help ensure that everyone in the United States equitably benefits from the tools we have to detect and diagnose cancer.”

This new round of funding supports progress toward the CDC cancer prevention and control goals to reduce preventable cancers, ensure the right screening at the right time for the best outcomes, and improve health and wellness for cancer survivors leading to longer, healthier lives. The awardees will work within the framework of 3 national cancer programs: the National Breast and Cervical Cancer Early Detection program, the National Comprehensive Cancer Control Program, and the National Program of Cancer Registries.

“This funding helps organizations work together to take action, address preventable health disparities, and close gaps in cancer care access, quality, and outcomes,” said Becerra.

U.S. Centers for Disease Control and Prevention

Cancer Grand Challenge Awardees Announced

The National Cancer Institute (NCI) and Cancer Research UK, the world’s leading funders of cancer research, announced on June 16 the awardees of $100 million in the Cancer Grand Challenges Program. The program aims to provide multiple rounds of funding for multidisciplinary research teams from around the world with novel ideas that have the greatest potential to advance cancer research and improve outcomes for people affected by cancer. The awards were announced at the Cancer Grand Challenges Summit in Washington, DC.

A total of 169 research teams from more than 60 countries submitted preliminary proposals addressing 1 of the 9 challenges posed by the Cancer Grand Challenges program. From those submissions, 11 teams were chosen by an expert group, including patient perspectives, to receive seed funding to develop their ideas into full proposals. Each of the 4 funded teams will receive up to $25 million. The winning multidisciplinary teams will: (1) explore cancer cachexia as a tumor-driven syndrome; (2) elucidate the action and targeting of extrachromosomal DNA in tumor evolution and treatment resistance; (3) develop engineered T-cell therapies for childhood cancer, with a focus on the tumor microenvironment; and (4) investigate the mechanisms that trigger normal cells to become cancerous. The awarded teams represent multidisciplinary international collaborations.

“The partnership with Cancer Research UK to develop the projects funded for the Cancer Grand Challenges program will enable a global collaboration on a disease that has touched everyone around the world,” said Douglas R. Lowy, MD, acting director of NCI. “We’re confident these multidisciplinary teams of scientists—with the flexibility and scale to innovate and carry out cutting-edge research—will be able to address several critical cancer research problems that can advance the understanding of cancer and benefit patients.”

“Through this unique partnership, Cancer Grand Challenges fosters scientific creativity of the highest order, giving priority to innovative ideas that are beyond what can be supported through more traditional mechanisms,” said Dinah S. Singer, PhD, NCI deputy director for scientific strategy and development. The next funding rounds of the NCI–Cancer Research UK partnership are planned for 2023 and 2025. For more information about the Cancer Grand Challenges program, visit https://www.cancer.gov/cancer-grand-challenges.

National Cancer Institute

International Conference on Radioactive Source Safety and Security

The International Conference on the Safety and Security of Radioactive Sources: Accomplishments and Future Endeavors was held by the International Atomic Energy Agency (IAEA) June 20–24 in Vienna, Austria, with more than 600 senior government officials and representatives from interested organizations. “As more people gain access to the huge benefits of radioactive sources, the work you and we are doing becomes even more important,” IAEA Director General Rafael Mariano Grossi said to conference participants. He reported that more than 140 countries had so far expressed political commitment to the IAEA’s Code of Conduct, making it the primary international instrument defining principles for safety and security of radioactive sources.

The conference included presentations in 6 main topic areas: safety and security of radioactive sources throughout their lifecycle, collaboration among national stakeholders, regulatory control of radioactive sources, sustainability and effectiveness of national infrastructures (including lessons learned from the COVID-19 pandemic), international cooperation, and preparation and response to radiologic incidents and emergencies involving radioactive sources.

International Atomic Energy Agency

NorthStar and Curie Announce ²²⁵Ac Supply Agreement

NorthStar Medical Radioisotopes (Beloit, WI) and Curie Therapeutics, Inc. (Cambridge, MA), announced on June 7 the signing of a long-term priority access supply agreement for the therapeutic medical radioisotope ²²⁵Ac. Under the terms of the agreement, NorthStar will provide Curie Therapeutics with priority access to its electron accelerator–produced no-carrier-added (nca) ²²⁵Ac, which is free of long-lived radioactive contaminants and byproducts that pose regulatory and waste management challenges for hospitals and health systems.

“NorthStar is defining the supply chain for commercial-scale, reliable, and environmentally preferred therapeutic radioisotope production. We are very excited to be partnering with Curie Therapeutics, an emerging leader in the development of precision radiopharmaceuticals,” said Stephen Merrick, president and CEO of NorthStar. “Clinical research and commercial use of ²²⁵Ac are severely constrained by chronic short supply due to limitations of current production technologies. Our company is positioned to be the first commercial-scale producer of ²²⁵Ac, utilizing our nca ²²⁵Ac production technology which utilizes state-of-the-art electron-beam accelerator production that provides increased capacity and scheduling flexibility.” Merrick reported that construction of the dedicated NorthStar ²²⁵Ac production facility has begun, with initial production of radiochemical-grade ²²⁵Ac slated for late 2023. The company expects to submit a Drug Master File to the U.S. Food and Drug Administration in 2024, which, on acceptance, will allow NorthStar to provide Current Good Manufacturing Practice–grade ²²⁵Ac.

NorthStar Medical Radioisotopes

Curie Therapeutics, Inc.

Thomas J. Maloney, 1929–2022

Thomas J. Maloney, of Friendswood, TX, whose involvement with nuclear medicine and the radiopharmaceutical industry spanned more than half a century, died on March 29 at the age of 92. He was well known in nuclear medicine as the founder and owner of Iso-Tex Diagnostics, Inc., a radiopharmaceutical manufacturing firm, and Tel-Test, Inc., a provider of molecular reagents. Both companies were in Friendswood.

Maloney’s long career began with completion of a 4-y apprentice program at General Electric (GE) as a tool and die maker, from which he transferred into the GE top-secret atomic submarine and Microgun research programs. He also trained in mechanical engineering at Union College (Schenectady, NY). He enlisted as a Graduate Officer candidate in the U.S. Army, where he served as an Expert Infantry Officer, Paratrooper 101st Airborne Division, Company Commander, Regimental Law Officer, and a commissioned First Lieutenant, Infantry. He later worked at Union Carbide as a mechanical engineer supervisor and a senior licensed atomic energy reactor operator in Tuxedo Park, NY, producing radiochemicals. He went on to become president of Cambridge Nuclear and later of Bio Nuclear (Houston, TX), before founding Iso-Tex and Tel-Test in 1975. His long career in the radiopharmaceutical industry included multiple patents, New Drug Applications, and Investigational New Drug applications.