Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Breast Cancer, Ovarian Cancer.

Treatment: Genetic Testing MI Profile panel test by Caris Life Sciences (multi-gene panel test).

The insurer denied the Genetic Testing MI Profile panel test by Caris Life Sciences (multi-gene panel test).

The denial was overturned.

This is a female patient with a prior history of triple negative breast cancer and a recent diagnosis of advanced stage ovarian cancer diagnosed at the end of 2019. The patient received neoadjuvant chemotherapy in early 2020 who underwent a diagnostic laparoscopy, exploratory laparotomy, total abdominal hysterectomy, bilateral salpingo-oophorectomy, omentectomy, and radical tumor debulking.  The patient had a negative BRCA 12 test.  The patient had not had a full panel. The treating provider ordered genomic profiling on the tumor via CARIS laboratories.

Genetic Testing MI Profile panel test by Caris Life Sciences is considered medically necessary for this patient. The use of actionable mutations identified within the tumor in ovarian cancer is the subject of many clinical trials at the time being.  With that being said, the literature as acknowledged by the National Comprehensive Cancer Network (NCCN) (2020) guidelines has identified the corresponding mutations and their appropriate targeted agents and are identified as appropriate options within the NCCN guidelines: Pembrolizumab for Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors; Olaparib for patients with deleterious germline BRCA-mutated (as detected by an FDA-approved test or other validated test performed in a Clinical Laboratory Improvement Amendments (CLIA)-approved facility) advanced ovarian cancer who have been treated with three or more lines of chemotherapy.  OR in patients who are BRCA positive after achieving complete or partial response after primary chemotherapy for ovarian/primary peritoneal or fallopian tube cancer as primary maintenance therapy; Rucaparib for patients with deleterious germline and/or somatic BRCA mutated (as detected by an FDA-approved test or other validated test performed in a CLIA-approved facility) advanced ovarian cancer who have been treated with two or more lines of chemotherapy. 

According to Lim et al (2017), "Germline BRCA mutation (gBRCAmut) has been established as a strong predictor of response rate, progression-free survival (PFS), and overall survival (OS) with PARPi. Olaparib (Lynparza; AstraZeneca, Wilmington, DE, USA) first gained approval in Europe for maintenance following complete response to third line or greater platinum-based chemotherapy and in the USA for 4th treatment or greater, both indications limited to gBRCAmut carriers.  However, somatic mutations were also postulated to predict PARPi sensitivity, and in fact, rucaparib broadened the indications for PARPi when it was approved in the USA for 3rd line or greater treatment in women with either germline or somatic BRCA mutations.  
The health plan did not act reasonably with sound medical judgment, and in the best interest of the patient.                                                               

The carrier's denial of coverage for the Genetic Testing MI Profile panel test by Caris Life Sciences (multi-gene panel test) should be overturned.  The medical necessity is substantiated.