Pembrolizumab denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for services as recommended by Jonathan Goldman, MD including hold osimertinib, start carboplatin/pemetrexed with or without pembrolizumab followed by maintenance pemetrexed with or without pembrolizumab, dexamethasone prior to initiation, folic acid 1 mg tablet, megestrol 40 mg/mL suspension, cyanocobalamin 1000 mcg/mL inject 1000 mcg, and central nervous system (CNS) involvement, including a complete metabolic work-up for treatment of the enrollee’s epidermal growth factor receptor (EGFR) positive metastatic adenocarcinoma of the lung. Findings: The physician reviewer found that this is a patient with metastatic NSCLC who has been treated with chemotherapy and radiation therapy. Several studies have shown that systemic chemotherapy can prolong survival compared to best supportive care.

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for pembrolizumab (Keytruda®). The National Comprehensive Cancer Network (NCCN) guidelines for the management of breast cancer deem triple negative breast cancer (TNBC), stage II to stage III, as high risk. Researchers report that the U.S. Food and Drug Administration (FDA) approves the use of pembrolizumab in combination with chemotherapy for neoadjuvant treatment and then continued as a single agent for adjuvant therapy following surgery for patients with high-risk, early-stage triple-negative breast cancer. The NCCN further notes that adjuvant pembrolizumab may be individualized for high-risk, stage II to stage III TNBC patients. In this case, the patient was not offered neoadjuvant pembrolizumab.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for pembrolizumab. Metastatic ovarian and fallopian cancers are rarely cured by current therapies, although the disease may respond to a diverse group of agents. The National Comprehensive Cancer Network (NCCN) stipulates that typical indications for the use of pembrolizumab in ovarian cancer are for tumors that exhibit defective deoxyribonucleic acid (DNA) repair, namely deficient mismatch repair (dMMR). While current medical literature supports the use of pembrolizumab as safe in the population of recurrent ovarian cancer patients, its activity appears modest. In this case, given the absence of typical indications such as dMMR and a high v, the use of pembrolizumab is not likely to be more beneficial than other available standard therapies.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for pembrolizumab (Keytruda). Pembrolizumab (Keytruda) is U.S. Food and Drug Administration (FDA) approved for the treatment of recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma in patients whose tumors express programmed death-ligand 1 (PD-L1), who have disease progression after two or more prior lines of therapy, including fluoropyrimidine-containing and platinum-containing chemotherapy, and if appropriate, HER2/neu-targeted therapy. The National Comprehensive Cancer Network (NCCN) guidelines recommend pembrolizumab for second-line therapy in patients with microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) tumors or for third-line or subsequent lines in PD-L1 positive tumors.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Pembrolizumab, then check the rights and deadlines that apply to your plan.