Adaptive Biotechnologies Gains Broader Medicare Coverage for clonoSEQ® in Mantle Cell Lymphoma

Adaptive Biotechnologies Corporation recently announced that Palmetto GBA, a Medicare Administrative Contractor, has expanded the coverage of clonoSEQ to include the detection and monitoring of measurable residual disease (MRD) in Medicare patients with mantle cell lymphoma (MCL). This coverage decision leverages new Medicare episode pricing established based on the updated clonoSEQ gapfill rate.

MCL, a subtype of non-Hodgkin lymphoma (NHL), affects approximately 4,000 individuals annually in the United States. It is a particularly aggressive form of cancer, with many patients experiencing multiple relapses, some occurring shortly after initial treatment while others may relapse as late as 15 years after remission. Due to these challenges, it is crucial to accurately assess the depth of response during treatment and monitor for recurrence or disease progression following remission.

MRD refers to the cancer cells that persist in a patient's body during and after treatment, typically assessed through a series of tests. In the context of MCL, clonoSEQ offers a minimally invasive, blood-based MRD testing option. This test helps in evaluating responses to treatment, understanding prognoses, and monitoring for molecular recurrences prior to clinical or radiographic relapse.

Dr. Anita Kumar, an associate attending physician at Memorial Sloan Kettering Cancer Center, emphasized the value of MRD in MCL, highlighting that new treatment strategies are enhancing patient outcomes. She noted that blood-based MRD testing like clonoSEQ complements traditional monitoring tools such as imaging and empowers clinicians to more precisely monitor response and remission, as well as predict clinical relapse.

The updated coverage policy notably expands access to clonoSEQ MRD testing for MCL patients, most of whom are Medicare beneficiaries. This policy applies to all patients with MCL, irrespective of their treatment regimen or line of therapy. The MolDX coverage aligns with the existing Medicare episode payment structure used for other clonoSEQ indications and follows the recent update to clonoSEQ episode pricing across all covered indications, set at $8,029, in accordance with the gapfill rate recommended by Medicare Administrative Contractors.

This expansion adds to the existing Medicare coverage for clonoSEQ, which includes MRD testing in multiple myeloma, chronic lymphocytic leukemia (CLL), B-cell acute lymphoblastic leukemia (ALL), and circulating tumor DNA-based MRD testing in diffuse large B-cell lymphoma (DLBCL).

Ben Eckert, senior vice president of Market Access at Adaptive Biotechnologies, stated that clonoSEQ MRD assessment is vital in MCL, an incurable disease, to identify patients at high risk of relapse and to support patient-centric treatment and monitoring strategies. He expressed satisfaction with the decision by MolDX to provide access to clonoSEQ for the Medicare MCL population, as this will facilitate the integration of this crucial tool into lymphoma care pathways, ultimately improving patient outcomes.

clonoSEQ testing for MCL patients is currently available for clinical use as a laboratory-developed test performed at Adaptive’s CLIA-certified lab in Seattle. The test has also been previously approved by New York State’s Clinical Laboratory Evaluation Program (CLEP).

clonoSEQ is the first and only FDA-cleared in vitro diagnostic test service for detecting minimal residual disease in bone marrow from patients with multiple myeloma (MM) or B-cell acute lymphoblastic leukemia (B-ALL) and in blood or bone marrow from patients with chronic lymphocytic leukemia (CLL). The test is also available for clinical use in diffuse large B-cell lymphoma (DLBCL) as a laboratory-developed test at Adaptive’s CLIA-certified lab. clonoSEQ is CE-marked under the In Vitro Diagnostic Regulation in the European Union.

Leveraging Adaptive Biotechnologies’ proprietary immune medicine platform, clonoSEQ identifies and quantifies specific DNA sequences in malignant cells, allowing clinicians to monitor MRD during and after treatment. The assay provides standardized, accurate, and sensitive MRD measurement, helping physicians predict outcomes, assess treatment responses, inform therapy adjustments, monitor disease burden over time, and detect potential relapses early. Clinical practice guidelines in hematologic malignancies recognize MRD status as a reliable indicator of outcomes and treatment response, with outcomes strongly associated with MRD levels measured by clonoSEQ in patients diagnosed with CLL, MM, B-ALL, and DLBCL.