Wednesday, July 27, 2022

Brief Blog: ASCO Publishes Biomarker Guidance for Advanced Breast Cancer Therapies

 Even more than it used to be, Medicare LCDs are appearing which closely tag coverage to guidelines.   The NGS MAC tags BRCA sequencing coverage to "the most recent version of the NCCN guideline" for that.   MolDx recently released an LCD for hereditary cancer risk testing (such as BRCA or Lynch syndromes), which attributes current coverage policy to outside guidelines.   MolDx and Novitas attribute pharmacogenetic testing coverage to external guidelines from FDA or a PGx organization called CPIC.  Finally, Novitas MAC recently released a proposed LCD for oncology that essentially locks coverage to current guidelines from NCCN or two other databases.

So what's in guidelines?  See the most recent ASCO guideline for biomarkers for systemic therapy selection in advanced breast cancer.  It was released June 27, 2022 as Henry et al.  Find it here:

I'll quote the abstract further below.  If you have a NEW test this year (say, a protein or RNA expression test) to select chemotherapy, it won't be in the guideline, which may count against you at coverage time where the LCDs very specifically point to guidelines as the authorities for coverage.

ASCO also updated guidelines in June 2022 for risk biomarkers for adjuvant therapy (here).


Henry et al:

Candidates for a regimen with a phosphatidylinositol 3-kinase inhibitor and hormonal therapy should undergo testing for PIK3CA mutations using next-generation sequencing of tumor tissue or circulating tumor DNA (ctDNA) in plasma to determine eligibility for alpelisib plus fulvestrant. 

     If no mutation is found in ctDNA, testing in tumor tissue, if available, should be used. 

Patients who are candidates for poly (ADP-ribose) polymerase (PARP) inhibitor therapy should undergo testing for germline BRCA1 and BRCA2 pathogenic or likely pathogenic mutations to determine eligibility for a PARP inhibitor. 

There is insufficient evidence for or against testing for a germline PALB2 pathogenic variant to determine eligibility for PARP inhibitor therapy in the metastatic setting. 

Candidates for immune checkpoint inhibitor therapy should undergo testing for expression of programmed cell death ligand-1 in the tumor and immune cells to determine eligibility for treatment with pembrolizumab plus chemotherapy. 

Candidates for an immune checkpoint inhibitor should also undergo testing for deficient mismatch repair/microsatellite instability-high to determine eligibility for dostarlimab-gxly or pembrolizumab, as well as testing for tumor mutational burden. 

Clinicians may test for NTRK fusions to determine eligibility for TRK inhibitors. 

There are insufficient data to recommend routine testing of tumors for ESR1 mutations [estrogen receptor], for homologous recombination deficiency, or for TROP2 expression to guide MBC therapy selection.

 There are insufficient data to recommend routine use of ctDNA or circulating tumor cells to monitor response to therapy among patients with MBC.