Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Cancer/Pancreas Cancer
Treatment: Pharmacy/Prescription Drugs
The health plan denied the requested medication as not medically necessary. 
The health plan's determination is overturned.

The patient is a gentleman with history of metastatic pancreatic adenocarcinoma, who was initially treated with neoadjuvant chemotherapy with Folfirinox. Patient was found to have liver metastasis intraoperatively. He subsequently received 5 additional cycles of Folfirinox.
He had undergone germline mutation testing which revealed a 3 VUS mutation noted in genes ATM, PMS2 and PALB2. The patient has completed 10 cycles of Folfirinox regimen. Interval computerized axial tomography (CAT) scan revealed continued treatment response to the chemotherapy regimen.
PARP (protein in cancer cells) inhibitor therapy Rucaparib/Lynparza was prescribed by the treating oncologist as maintenance therapy.
At issue is the medical necessity of the requested medication, Lynparza.

I overturn the health plan's determination of medical necessity, in whole.

Yes, the request is medically necessary for this patient.
Olaparib is approved as maintenance treatment of adult patients with deleterious or suspected deleterious gBRCA (gene) mutated metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. However, more data is now showing such benefit of PARP inhibitor therapy in patients with other HRD (homologous recombination deficient) tumor harboring a mutation such as PALB2.
Although Olaparib is the only Food and Drug Administration (FDA) approved therapy for maintenance treatment for pancreatic cancer with a germline BRCA mutation, accumulating data suggest benefit for maintenance therapy with a PARP inhibitor in patients with advanced pancreatic cancer with HRR (homologous recombination repair) deficiency (such as PALB2 pathogenic variant) after an initial period of platinum-containing chemotherapy.
PARP inhibitor Rucaparib has been studied in patients with HRR deficient pancreatic cancer (such as PALB2 mutations) in a phase II clinical trial. 46 patients were enrolled in the study and these patients were progression free after at least 16-weeks of platinum based systemic chemotherapy. The progression free survival (PFS) rate at 6 months was 60%, median progression free survival (PFS) was 13.1-month, and median overall survival (OS) was 23.5 months. All these values compared favorably with those seen in the POLO trial using Olaparib. Objective response rates were noted to be 41% in those patient with germline BRCA2 mutation and 50% in patients with PALB 2 pathogenic variants.
Based on these findings, PARP inhibitor therapy such as Olaparib or Rucaparib shows promise as maintenance therapy for patient with pancreatic adenocarcinoma harboring germline PALB 2 mutation. National Comprehensive Cancer Network (NCCN) has now updated the guidelines for management of pancreatic adenocarcinoma (version 1.2022) and recommends Rucaparib as maintenance therapy for patients with PLAB2 mutation who are treated with platinum-based chemotherapy.
PARP inhibitors such as Olaparib or Rucaparib should be allowed as maintenance therapy in this particular patient with a PALB2 mutation.