Cancer Rx denials in California external review

What the reviewers wrote

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 combination therapy of BRAFTOVI (encorafenib) and MEKTOVI (binimetinib). A researcher explains that craniopharyngiomas are rare tumors of embryonic tissue left over from human development. They occur in the brain, sometimes near the hypothalamus and optic nerves. Pathology can show infiltrative growth patterns near vital structures, precluding full surgical resection. Schweizer and colleagues note that papillary subtypes of craniopharyngiomas have the activating BRAF V600E mutation in 90% of cases. In this respect, the clinical situation resembles the rare pathologic subtypes of gliomas with BRAF mutations, such as xanthoastrocytomas.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for abemaciclib (Verzenio). Researchers report, “Patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer who have received two or more previous therapies for advanced disease have few effective treatment options. The monarcHER trial aimed to compare the efficacy of abemaciclib plus trastuzumab with or without fulvestrant with standard-of-care chemotherapy of physician's choice plus trastuzumab in women with advanced breast cancer.” The authors found that at a median follow-up of 19 months, the median progression-free survival (PFS) was 8.3 months in the abemaciclib/fulvestrant/trastuzumab group, versus 5.7 months in the other two groups. Overall response rates were 33 % with abemaciclib/fulvestrant/trastuzumab, and 14 % in each of the other arms.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Exkivity (mobocertinib). The use of next-generation sequencing (NGS) panel testing as a means to select anti-cancer therapy in advanced cancer has been advancing over the past few years and is an area of active research with ongoing studies including Targeted Agent and Profiling Utilization Registry (TAPUR) and Molecular Analysis for Therapy Choice (MATCH). The concept of this approach is that all cancers are unique and that each cancer has a specific individual molecular driver which can be identified using this testing. Once identified, specific therapy can be given to the patient that directly treats their tumor.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Tibsovo. The use of next-generation sequencing (NGS) panel testing as a means of selecting anti-cancer therapy in advanced cancer has been progressing over the past few years and is an area of active research with ongoing studies. The concept of this approach is that all cancers are unique and that each cancer has a specific individual molecular driver which can be identified using this testing. Once identified, specific therapy can be given to the patient that directly treats their tumor. In this case, the patient was originally diagnosed with anaplastic astrocytoma. Notes dated 6/28/22 reported that the patient had a recurrence that was categorized as glioblastoma, World Health Organization (WHO) grade IV.

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 Cancer Rx, then check the rights and deadlines that apply to your plan.