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https://www.discoveriesinhealthpolicy.com/2023/08/busy-day-at-moldx-new-draft-lcd-for.html

Summary of RA LCD L39427:

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Summary:

The document addresses the use of predictive biomarker tests for therapy selection in Rheumatoid Arthritis (RA), discussing the limitations, evidence, and potential utility of such tests. The primary focus is on a specific test known as the molecular signature response classifier (MSRC), developed by Scipher Medicine, which aims to predict non-response (NR) to Tumor Necrosis Factor-alpha inhibitors (TNFis), a common class of biologic therapies for RA.

1. Background and Context: The document highlights the challenges of treating RA, an inflammatory autoimmune disease that can lead to significant morbidity and mortality if inadequately managed. Traditional treatments include conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), but a substantial portion of patients do not respond adequately to these therapies. Hence, biologic and targeted synthetic DMARDs (b/tDMARDs) like TNFis are often employed.

2. Coverage Indications and Limitations: The coverage policy discussed pertains to molecular biomarker tests designed to guide targeted therapy selection in RA. The criteria for coverage include confirmed diagnosis, prior therapy failure, absence of prior biologic therapy, predictive ability of the test for targeted therapy response, and validation according to specific criteria.

3. Discussion of Predictive Biomarker Tests: The document reviews various predictive biomarker tests that have been proposed to aid in predicting response or non-response to specific classes of drugs in RA treatment. One test, the MSRC, developed by Scipher Medicine, is focused on predicting NR to TNFis. This test combines genetic markers, gene transcripts, laboratory tests, and clinical parameters to generate a predictive score. Studies have evaluated the accuracy and efficacy of the test in guiding therapy decisions.

4. Study Findings and Limitations: Several studies have explored the effectiveness of predictive biomarker tests. The MSRC, in particular, demonstrated potential in identifying patients who are likely to be non-responders to TNFis. The studies suggest that the test's predictive accuracy is superior to individual clinical features, providing a valuable tool to guide treatment decisions.

5. Challenges and Considerations: Despite the potential benefits, there are challenges associated with the adoption of predictive biomarker tests. The document discusses the limitations of available evidence, including the heterogeneity of RA and treatment response, the lack of external validation for some tests, and the influence of various clinical and non-clinical factors on treatment decisions.

6. Clinical Application and Future Implications: The document acknowledges the potential utility of predictive biomarker tests in informing targeted therapy decisions for RA. However, it also emphasizes that the current tests, including the MSRC, have limitations in terms of predicting non-response to specific classes of drugs, such as TNFis. The document highlights the need for further research and the development of more accurate tests that can better predict treatment responses in a broader range of RA patients.

7. Coverage Policy and Recommendations: The coverage policy outlined in the document suggests that, despite the limitations of the current predictive biomarker tests, there is a pragmatic value in their limited use for a specific subset of RA patients who are likely to be non-responders to TNFis. The policy also underscores the importance of evidence-based testing and treatment decisions.

8. Monitoring and Future Changes: The document concludes by stating that the contractor will continue to monitor the evidence and may modify coverage policies based on new information and evolving recommendations from the medical community.

In summary, the document extensively explores the use of predictive biomarker tests, primarily focusing on the MSRC, in guiding targeted therapy selection for RA patients. It discusses the challenges, evidence, and implications of such tests, highlighting both their potential benefits and limitations. The document emphasizes the need for continued research to develop more accurate predictive biomarker tests that can enhance treatment outcomes for a broader range of RA patients.