Keytruda denials: what the review data shows

Where the denial was overturned

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for the medication (Keytruda) regimen including, as needed: diphenhydramine HCL injection, injection famotidine 20 mg, ondansetron HCL injection, dexamethasone sodium phosphate, paclitaxel injection, injection heparin sodium per 10 Units, lidocaine injection, alteplase recombinant, normal saline solution infusion, and injection pembrolizumab (Keytruda). The mainstay of soft tissue sarcoma therapy is surgical resection. There are many diverse subtypes of soft tissue sarcoma, including epithelioid angiosarcoma. There are phase 2 clinical trials evaluating paclitaxel and/or pembrolizumab (Keytruda) in the treatment of patients with advanced sarcoma.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for combination therapy with Padcev (enfortumab vedotin) and Keytruda (pembrolizumab). This patient has undergone treatment with a clinical course that is considered the standard care in bladder cancer therapy. The patient now presents with metastatic disease, for which he requires treatment with different systemic therapy. The U.S. Food and Drug Administration (FDA) has approved Padcev for use in locally advanced metastatic, urothelial cancer, in patients who have previously received a PD1 or PDL1 inhibitor and a platinum-containing chemotherapy, as in this patient’s case. Padcev gained FDA approval in 2019 based on multiple studies in patients that were in eligible to receive cisplatin or who had progressed after platinum-based therapy.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Keytruda immunotherapy.Findings: The physician reviewer found that The records provided for review document that this patient presents with a history of metastatic small cell lung cancer (SCLC) status post suboccipital craniectomy for resection of cerebellar metastases. The provider documented that the patient was treated with topotecan monotherapy due to the findings of progressive disease. The provider has recommended treatment with pembrolizumab (Keytruda). As noted in the peer-reviewed medical literature, Keytruda is supported for the treatment of patients with SCLC that is extensive and staged 1-3. Moreover, the National Comprehensive Cancer Network (NCCN) guidelines endorse Keytruda for use in patients who have metastases, as in this patient’s case.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Keytruda infusions (pembrolizumab). This patient presents with thyroid cancer, for which the standard of care includes dabrafenib and trametinib based on the presence of a BRAF V600E mutation (Subbiah, et al.). The provider recommended the addition of Keytruda in combination with the BRAF targeted therapy. Keytruda is U.S. Food and Drug Administration (FDA) approved for various tumor indications. The National Comprehensive Cancer Network (NCCN) guidelines support treatment with Keytruda for patients with microsatellite instability-high or mismatch repair deficient cancer. This patient underwent testing to assess for BRAF mutations. However, the patient’s tumor mutational burden was not quantified or reported.

These are outcomes from California’s external review program — an independent physician panel that binds the insurer. Every state has an equivalent process, and internal appeals succeed even more often. Cite the outcome record for Keytrudawhen you appeal: reviewers routinely find that denials like yours didn’t hold up.