GUIDELINE NOTE 173, INTERVENTIONS THAT ARE …



CPT 81320 PLCG2 (phospholipase C gamma 2) (eg, chronic lymphocytic leukemia) gene analysis, common variants (eg, R665W, S707F, L845F)Last reviewed at VbBS in November 2018. Minutes indicate that the staff recommendation was accepted without significant discussion. HERC approved the recommendations without change. Genetic testing in chronic lymphocytic leukemiaCPT 81233 (BTK (Bruton's tyrosine kinase) (eg, chronic lymphocytic leukemia) gene analysis, common variants (eg, C481S, C481R, C481F))CPT 81320 PLCG2 (phospholipase C gamma 2) (eg, chronic lymphocytic leukemia) gene analysis, common variants (eg, R665W, S707F, L845F)Definition: BTK is an enzyme that in humans is encoded by the BTK gene. BTK is a kinase that plays a crucial role in B-cell development. Oncology drugs that target BTK are ibrutinib and acalabrutinib (only FDA approved for mantel cell lymphoma). This gene test is for mutations that confer resistance to ibrutinib.PLCG2 is another gene involved in CLL. Mutations may confer ibrutinib resistance.Expert input: Dr. John Godwin, Providence oncologyBTK:Not routinely done prior to therapy and rare. CLINICAL utility smallWhile BTK/PLCG2 mutations have characteristics suggesting that they can drive ibrutinib resistance, this conclusion remains formally unproven until specific inhibition of such mutations is shown to cause regression of ibrutinib-resistant CLL. Data suggest that alternative mechanisms of resistance do exist in some patients.PLCG2: UNCLEAR if useful. Simply change therapy if ibrutinib is failing. While BTK/PLCG2 mutations have characteristics suggesting that they can drive ibrutinib resistance, this conclusion remains formally unproven until specific inhibition of such mutations is shown to cause regression of ibrutinib-resistant CLL. Data suggest that alternative mechanisms of resistance do exist in some patients.NCCN 2018, lymphocytic leukemia: CGP-stimulated karyotype is useful to identify high-risk patients, particularly for…BTK inhibitor therapyAcalabrutinib has no activity against CLL cells with BTK C481S mutations and should not be administered to patients with ibrutinib-refractory disease who have this mutation present in their tumor cells.Testing for BTK and PLCG2 mutations may be useful in patients receiving ibrutinib and suspected of having progression. BTK and PLCG2 mutation status alone is not an indication to change treatment.…testing for [BTK and PLCG2 mutations] may be helpful to confirm ibrutinib resistance. Testing for mutations as screening for resistance is not currently recommended. HERC staff summary: BTK and PLCG2 gene tests do not appear to have wide clinical use. BTK gene testing is recommended by NCCN prior to acalabrutinib therapy, and may be useful to confirm ibrutinib resistance. Expert input is that this test has limited clinical utility. PLCG2 gene testing appears to have less utility than BTK, and expert input is that therapy can simply be changed based on clinical indications.HERC staff recommendations:Add CPT 81233 (BTK (Bruton's tyrosine kinase) (eg, chronic lymphocytic leukemia) gene analysis, common variants (eg, C481S, C481R, C481F)) to line 418 CHRONIC LEUKEMIAS WITH POOR PROGNOSISAdd CPT 81320 PLCG2 (phospholipase C gamma 2) (eg, chronic lymphocytic leukemia) gene analysis, common variants (eg, R665W, S707F, L845F) to line 660 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS ARE UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS Add the following entry to GN173GUIDELINE NOTE 173, INTERVENTIONS THAT ARE UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS FOR CERTAIN CONDITIONSLine 660The following Interventions are prioritized on Line 660 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS ARE UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS:Procedure CodeIntervention DescriptionRationaleLast Review81320PLCG2 (phospholipase C gamma 2) (eg, chronic lymphocytic leukemia) gene analysis, common variants (eg, R665W, S707F, L845F)Insufficient evidence of effectivenessNovember 2018 ................
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