Metastatic Colon Cancer denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested panitumumab (Vectibix) injection therapy for treatment of the enrollee’s metastatic colon cancer. Findings: The physician reviewer found that as noted in the medical literature, cetuximab and Vectibix are monoclonal antibodies directed against the epithelial growth factor receptor (EGFR) protein on the surface of colon adenocarcinomas. Both medications have been demonstrated to be effective and safe in treating patients with colorectal cancer and are approved by the U.S. Food and Drug Administration (FDA) for use in metastatic colorectal cancer. Cetuximab is approved in combination with FOLFIRI as first-line treatment. FOLFIRI is an active regimen that has shown efficacy in stage IV colorectal cancer in combination with cetuximab or Vectibix (Peeters, et al; Van Cutsem, et al).

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for Comprehensive genomic profiling test (FoundationOne CDx). As noted in the medical literature, the standard of care for patients with metastatic colon cancer includes testing for KRAS, NRAS, BRAF, HER2, and microsatellite instability (MSI). Per the National Comprehensive Cancer Network (NCCN) guidelines, this testing can be performed individually or as part of next-generation sequencing, which has the ability to detect actionable mutations. The American Society of Clinical Oncology (ASCO) recommends genetic testing on colon cancer tumors. Next-generation sequencing offers the advantage of identifying markers known to have targeted therapy as well as potential clinical trials. Given this patient’s metastatic disease, comprehensive molecular profiling was appropriate.

Where the denial was upheld

Physician 1The patient is a 74-year-old man who was initially diagnosed with colon cancer in 1999. His initial treatment is unknown. He has recently been found to have three very small lung nodules, which have not been biopsied. The patient’s oncologist believes they represent metastases to the lung, but feels that there is no advantage to instituting chemotherapy at this point in time. He has recommended the use of high dose Celebrex in an effort to control the metastases. The Health Plan has denied authorization for Celebrex indicating that its use is considered investigational for treatment of the patient’s medical condition.Celebrex is a COX-2 inhibitor, which has found wide use in many rheumatologic conditions. It also purportedly has anti-angiogenic properties; therefore, there is interest in its potential usefulness in cancer.

Physician 1The patient is 67-year-old man with chemo-refractory metastatic colon cancer. The patient wishes to undergo a combination of insulin potentiation therapy and additional chemotherapy. The Health Plan has denied authorization for insulin potentiation therapy indicating that the efficacy of the requested procedure has not been shown.There is not adequate data in support of insulin potentiation therapy. The proposed treatment is not part of a clinical trial in a Food and Drug Administration-approved protocol. This modality has not been tested in rigorous trials with favorable results and is not likely to result in any improvement in the patient’s condition. Therefore, I have determined that the requested therapy is not likely to be more beneficial for treatment of the patient’s medical condition than any available standard therapy.

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