Earlier this year, the Institute for Clinical and Economic Review (ICER) released a draft report on treatment options for MM, focusing on adults with relapsed or refractory disease, who are not currently on maintenance therapy, and who are not considered eligible for hematopoietic cell transplantation (HCT). Industry and pharmaceutical representatives, including the American Society of Hematology (ASH), submitted comments to ICER expressing concern with the group’s comparative-effectiveness analyses, citing a need for more transparency on review methods.
Since then, ICER has released more than 300 pages of comments on its drug review process from more than 50 pharmaceutical companies and patient organizations and has announced that it is meeting with several representatives to discuss potential changes to the process.
“We want to make sure that the rules of the road are clear [and] that they appear valid,” said Steven D. Pearson, MD, MSc, president of ICER. “For that to work, we want people to feel like their voices are being heard.”
In its letter to ICER requesting more openness in its review methods, ASH expressed concern with the group’s comparative-effectiveness analysis, focusing on the difference between clinical trial data and clinical experience that is gained following approval.
“Unfortunately, the scope of ICER’s analysis is far too narrow because it does not represent the realities of clinical practice,” ASH President Charles S. Abrams, MD, and President-Elect Kenneth Anderson, MD, wrote. “As such, ASH believes that the type of analysis has only limited value in determining the just price and utility of novel drugs and drug combinations in this rapidly advancing field.”
Despite these concerns, “ASH strongly encourages other efforts to measure the comparative effectiveness of new myeloma drugs, such as comparative-effectiveness trials, or the development of clinical data registries,” they continued.
ICER plans to revise and publish new draft policies in December for another round of public comment.
Sources: Fierce Pharma, October 5, 2016; ASH correspondence, April 20, 2016.