Who should get a stem cell transplant for multiple myeloma?
That’s the question Medicare agency is weighing in a new coverage proposal
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There are many treatments now available for multiple myeloma.
Quadruplet therapy, bispecific therapy, CAR T-cell therapy, and cereblon E3 ligase modulators (CELMoDs) are now all part of the myeloma toolkit. All have been approved in the seven years since my diagnosis. The U.S. Food and Drug Administration approved the CELMoD Zenbexus (iberdomide) earlier this month.
I missed out on the new stuff. I received triplet therapy followed by an autologous stem cell transplant (ASCT), the longtime standard of care for myeloma. But will it be the standard much longer?
Whether or not to transplant was a topic at this month’s International Myeloma Foundation (IMF) Patient and Family Seminar in Los Angeles during a panel titled “Controversies in Myeloma.” But that’s not the only transplant controversy brewing. The U.S. Centers for Medicare & Medicaid Services (CMS) is “reconsidering one aspect of the Stem Cell Transplantation national coverage determination (NCD).”
An NCD is a policy about what Medicare covers.
The proposal
Right now, Medicare covers ASCT for patients classified as Stage 2 or 3 under the Durie Salmon Staging System. Developed in 1975, it stages patients based on their amount of myeloma cells and the damage they’ve suffered. But the IMF says Durie Salmon overlooks some essential factors that could help predict outcomes. These days, many doctors instead use the blood work-based International Staging System (ISS).
CMS says it wants to expand coverage for patients at ISS Stage 2 or 3. It reviewed 31 studies, finding ISS staging is better than Durie Salmon at predicting progression-free and overall survival for ASCT patients.
Several organizations asked for the review, including the American Society of Hematology, the Association of Cancer Care Centers, and the IMF, in a request letter.
The reaction
You can also read dozens of comments submitted to CMS since the memo went online last month. There is support for the ISS. The Association for Molecular Pathology and the College of American Pathologists said “the proposed update would modernize the disease-staging criteria used to determine eligibility for [ASCT].”
But Stage 1 patients are not included in the NCD. That “is not supported by contemporary evidence or clinical practice,” wrote Francesca Cottini, MD, of Ohio State University.
The proposed change “would create a serious new problem while fixing an old one,” warn Murali Janakiram, MD, of City of Hope in Los Angeles and Jennifer Kanakry, MD, of MedStar Georgetown University Hospital in Washington, D.C. They submitted the same comment separately, saying they support moving beyond Durie-Salmon but want staging removed as a coverage criterion, or coverage for all stages.
Samuel Rubinstein, MD, of the University of North Carolina at Chapel Hill, noted he manages many high-risk patients “who technically would be classified under the ISS as having stage 1 disease.”
And Jeffrey Zonder, MD, of the Karmanos Cancer Center in Detroit, wrote: “The largest randomized study of transplant conducted in the United States, the DETERMINATION trial, confirmed that patients with ISS stage 1 myeloma benefitted the most from ASCT relative to those with other stages. The proposal to deny access to ASCT for R-ISS stage 1 myeloma patients appears to be based on the extremely flawed assumption that ‘R-ISS stage 1’ is equivalent to ‘Durie-Salmon Stage 1,’ which is INCORRECT.”
The patient perspective
Only a few of the nonmedical commenters revealed their connections to myeloma, but they were all focused on concerns about excluding Stage 1 patients.
”No treatment option should be taken away from a person with an incurable disease. Whether or not they choose the SCT route is their decision,” wrote patient Renee Conner, while care partner Diane Kennedy commented, “TRUST ME when I say — no one signs up for an ASCT for fun!!”
Indeed, we don’t.
Public comment for this proposal closed on Saturday, Aug. 29. CMS’ decision is expected by Oct. 28.
Note: Rare Cancer News is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of Rare Cancer News or its parent company, Bionews, and are intended to spark discussion about issues pertaining to rare cancer.
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