Adaptive Biotechnologies Corporation announced that Palmetto GBA, a Medicare Administrative Contractor (MAC), has expanded coverage of clonoSEQ to include the detection and monitoring of measurable residual disease (MRD) in Medicare patients with mantle cell lymphoma (MCL). This decision significantly broadens access to this important diagnostic tool for a patient population where the majority are of Medicare age.
Mantle cell lymphoma, a subtype of non-Hodgkin lymphoma (NHL), affects approximately 4,000 individuals annually in the United States. MCL is an aggressive disease characterized by frequent relapses, sometimes occurring shortly after initial treatment, and other times as late as 15 years post-remission. Effective assessment of treatment response and monitoring for recurrence are therefore critical in managing this disease.
clonoSEQ is a minimally invasive, blood-based MRD test designed to assess response to therapy, provide prognostic information, and monitor patients for molecular recurrence before clinical or radiographic relapse. The test identifies and quantifies specific DNA sequences found in malignant cells, offering a standardized and sensitive measurement of MRD.
According to Anita Kumar, M.D., associate attending physician, Memorial Sloan Kettering Cancer Center, "The value of MRD in MCL has been demonstrated in studies and supported by experiences in our own clinical practice. Access to highly sensitive, blood-based MRD testing will empower clinicians to more precisely monitor the quality and depth of response and remission, and more accurately predict clinical relapse."
The updated coverage policy applies to all patients with MCL, regardless of the line of therapy or treatment regimen they are receiving. The MolDX coverage follows the existing Medicare episode payment structure. The pricing for clonoSEQ across all covered indications was recently updated to $8,029, aligning with the gapfill rate recommended by Medicare Administrative Contractors.
Ben Eckert, senior vice president, Market Access, Adaptive Biotechnologies, stated, "In an incurable disease such as MCL, implementing clonoSEQ MRD assessment is essential not only to identify those patients at high risk of relapse but also for advancing patient-centric treatment interventions and multi-modal monitoring strategies."
clonoSEQ is currently available for clinical use as a laboratory-developed test performed at Adaptive's CLIA-certified lab in Seattle. It has also been approved by New York State's Clinical Laboratory Evaluation Program (CLEP). clonoSEQ is the first and only FDA-cleared in vitro diagnostic (IVD) test service to detect minimal residual disease (MRD) in bone marrow from patients with multiple myeloma (MM) or B-cell acute lymphoblastic leukaemia (B-ALL) and blood or bone marrow from patients with chronic lymphocytic leukaemia (CLL). clonoSEQ testing for patients with diffuse large B-cell lymphoma (DLBCL) is currently available for clinical use as a laboratory-developed test (LDT) performed at Adaptive's CLIA-certified lab in Seattle. clonoSEQ is CE-marked under the In Vitro Diagnostic Regulation (IVDR) in the European Union (EU).
Clinical practice guidelines recognize MRD status as a reliable indicator of clinical outcomes and treatment response. Clinical outcomes have been strongly associated with MRD levels measured by clonoSEQ in patients diagnosed with CLL, MM, B-ALL and DLBCL.
