Appeal type: Drugs
Decision: Favorable

We decided that the Plan has to pre-approve Keytruda (pembrolizumab) 1MG injection (CPT Code J9271).
You asked the Plan to pre-approve the medication. You say that the medication is necessary. The Plan denied your request. The Plan says that the medication is not necessary.
The Plan must follow Medicare rules. The rules say that Medicare may pay for unlabeled uses for anti-cancer drugs if they are medically accepted as safe and effective or appropriate for the particular use. We asked our physician reviewer to carefully review the case file and apply the relevant Medicare rules to determine if the Plan was correct in denying the request to pre-approve the medication. physician reviewer found the review indicates that the enrollee is with Stage IB NSCLC, SCC type, in October 2019. The enrollee has undergone radiation to the lung mass, and now presents with weight loss, dyspnea on exertion, cough and PET/CT with interval disease progression/probable metaastaic disease. The enrollee's Oncology provider has requested Keytruda (pembrolizumab) 1MG injection (CPT Code J9271). In October 2015, a second PD-1 inhibitor, pembrolizumab (Keytruda), was FDA approved for metastatic NSCLC. Approval of pembrolizumab was based in part on data from the KEYNOTE-001 trial, in which pembrolizumab produced an overall response rate of nearly 20% in 495 previously treated and treatment-naive patients with advanced or metastatic NSCLC. The overall response rate was much higher, at 45.2%, in a cohort of patients with NSCLC that showed high expression of PD-L1. The median duration of response exceeded 1 year (12.5 months) in all responders, regardless of the degree of PD-L1 expression. Median overall survival was 12.0 months (95% confidence interval [CI], 9.3-14.7 months) for all patients, 9.3 months (95% CI, 8.4-12.4 months) for previously treated patients, and 16.2 months (95% CI, 16.2 months-not reached) for previously untreated patients. In October 2016, pembrolizumab was approved as monotherapy for first-line treatment of patients with metastatic NSCLC whose tumors have high PD-L1 expression (Tumor Proportion Score [TPS] =50%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. This expanded approval was based on results from the KEYNOTE-024 trial, which showed significantly longer PFS and OS and fewer adverse events with pembrolizumab than with platinum-based chemotherapy. Median PFS was 10.3 months (95% CI, 6.7 to not reached) in the pembrolizumab group compared with 6.0 months (95% CI, 4.2 to 6.2) in the chemotherapy group (hazard ratio for disease progression or death, 0.50; 95% CI, 0.37 to 0.68; P< 0.001). [The above indication was expanded in April 2019 to include patients with stage III NSCLC who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC, and whose tumors express PD-L1 (TPS =1%) with no EGFR or ALK genomic tumor aberrations. In this case, the enrollee has progressive/metastatic disease as demonstrated by PET scanning. The requested use of Keytruda (pembrolizumab) 1MG injection (CPT Code J9271) is FDA-approved for the enrollee's diagnosis. We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that Medicare rules for coverage of the medication have been met. Therefore, we decided that the Plan has to pre-approve Keytruda (pembrolizumab) 1MG injection (CPT Code J9271).