Colon Cancer denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for proton beam radiation therapy. Overall, the utilization of proton beam radiation therapy remains an area of debate. Proton beam radiation therapy has unique properties compared to standard photon or x-ray beam in its ability to deposit radiation dose and can potentially result in fewer areas of low scattered radiation dose. Proton beam is also beneficial in cases of re-irradiation when there was radiation exposure to adjacent tissues. In this patient’s case, the primary organs at risk in treating the colon are the adjacent normal liver tissue as well as nearby bowel and kidney. This patient’s colon cancer is near the hepatic flexure, meaning that it is located very close to the liver.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Zelboraf (vemurafenib). Findings: The physician reviewer found that The request for Zelboraf is medically necessary for treatment of the patient’s medical condition. BRAF is an important signal transduction protein that signals within the same pathway as KRAS and EGFR, which are frequently overexpressed or mutated in colon cancer. Zelboraf is a specific inhibitor active against the BRAF V600E mutant protein that was present in this patient. Although there was not much single agent activity in phase II studies, the studies did show efficacy when combined with chemotherapy . A study of 86 patients where the progression-free survival (PFS) on regimen selected by molecular profiling was compared to PFS on the last chemotherapy regimen.

Where the denial was upheld

Physician 1: This patient is a 50-year-old woman first diagnosed with colon cancer in 2003. At that time she had positive lymph nodes and was treated with chemotherapy, the Folfox-4 regimen. In May 2005 she was found to have recurrent disease, and she was started on Folfiri with Avastin. She elected to stop this treatment and sought treatment with an out-of-network provider who offered her low dose chemotherapy and insulin potentiation therapy. The Health Plan has denied coverage for this therapy on the basis it is considered experimental for the treatment of colon cancer.Insulin potentiation therapy is an unproven treatment for cancer. It consists of giving insulin in a method that supposedly makes the cancer cells susceptible to lower doses of chemotherapy. The chemotherapy drugs used are a variety of standard chemotherapy drugs.

Nature of Statutory Criteria/Case Summary: An enrollee requested reimbursement for FoundationOne comprehensive cancer genomic panel for evaluation of the enrollee’s colon cancer. Findings: 2/3 of the physician reviewers found that the physician reviewer found that this patient had recurrent colon cancer. At the time the test was ordered and performed, she had not had treatment for her recurrent, metastatic cancer. The treatment did not depend on the results of FoundationOne testing. The National Comprehensive Cancer Network guidelines recommend routine testing of the primary cancers for mismatch repair and microsatellite instability. There is no pathology report submitted from her original cancer surgery to determine that testing for microsatellite instability and mismatch repair were done at that time.

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 colon cancer, then check the rights and deadlines that apply to your plan.