The first and only test authorized by the FDA to detect and monitor minimal residual disease (MRD) in multiple myeloma (MM) and B-cell acute lymphoblastic leukemia (ALL) has received coverage for Medicare patients.
The first and only test authorized by the FDA to detect and monitor minimal residual disease (MRD) in multiple myeloma (MM) and B-cell acute lymphoblastic leukemia (ALL) has received coverage for Medicare patients. ClonoSEQ, from Adaptive Biotechnologies, received Medicare coverage aligned with the assay’s FDA label and includes assessing MRD at multiple time points throughout therapy.
So far coverage was announced with Palmetto GBA, a Medicare Administrative Contractor that has jurisdiction in Alabama, Georgia, North Carolina, South Carolina, Tennessee, Virginia, and West Virginia.
MRD refers to the number of cancer cells present and can be used to monitor treatment response and help predict patient outcomes. MRD testing can assess disease burden and monitor for remission and detect relapse.
“Availability of sensitive, specific, and standardized MRD testing is increasingly crucial to the delivery of optimal patient care in both multiple myeloma and ALL,” Nikhil Munshi, MD, director of Basic and Correlative Science at the Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute, said in a statement. “Medicare coverage for the clonoSEQ Assay will help ensure that eligible patients across the U.S. have access to a highly advanced option for MRD assessment to support more personalized treatment decisions across their course of care.”
In September 2018, FDA granted De Novo designation for clonoSEQ to detect and monitor MRD in MM and ALL using DNA from the patient’s bone marrow. MRD assessment is becoming standard practice for patient management in blood cancers.
In May 2018, Adaptive had announced it was partnering with Sanofi to use clonoSEQ to assess MRD in response to isatuximab in MM trials. Isatuximab is in development to treat newly diagnosed relapsed/refractory MM.
“This is great news for patients,” said Charles Sang, senior vice president, Adaptive Diagnostics. “The establishment of favorable Medicare coverage for clonoSEQ soon after FDA authorization further demonstrates the clinical relevance of MRD assessment and underscores the benefit that this test delivers in the management of myeloma and ALL patients.”