Bevacizumab 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 bevacizumab (Avastin) treatment of the enrollee’s lung cancer. Findings: All Three physician reviewers found that The physician reviewer found there are currently no standard regimens for use in this patient’s clinical setting. However, Avastin has been shown to prolong survival in patients when given in combination with paclitaxel/carboplatin in first-line therapy (Sandler, et al). It has also been combined effectively with docetaxel or pemetrexed. As demonstrated by Herbst and colleagues, Avastin was combined with single agents and showed an advantage in terms of one year survival rates. Some recent abstracts presented at the American Society of Clinical Oncology also support other combinations with Avastin that show significant response.

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for bevacizumab (Zirabev) and atezolizumab (Tecentriq). The treatment of patients with advanced hepatocellular carcinoma has changed quite dramatically over the last few years. Data support sorafenib, a multi-kinase inhibitor, or lenvatinib, an inhibitor of VEGFR, FGFR, PDGFR, and other signaling kinases for the treatment of patients with hepatocellular carcinoma. The records provided for review document that this patient was initially treated with lenvatinib. However, due to disease progression, the patient was moved on to tremelimumab and durvalumab. This combination therapy was investigated in a phase 3 study where it showed an overall survival benefit above the tyrosine kinase inhibitor sorafenib.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for irinotecan and bevacizumab. The National Comprehensive Cancer Network (NCCN) guidelines do not include irinotecan and bevacizumab in their recommendations for the treatment of this patient’s metastatic cholangiocarcinoma. In addition, the combination of infusional 5-fluorouracil (5-FU) with irinotecan and bevacizumab produced some responses in five of 13 patients. However, this is not the same regimen requested for this patient, as infusional 5-FU is not included. Further, the current data is from small studies with limited follow-up.

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Nivolumab (Opdivo) 240 mg intravenous (IV) every two weeks and bevacizumab (Avastin) 2.5 mg/kg IV every two weeks. The U.S. Food and Drug Administration (FDA) has not approved the combination of Opdivo, Avastin, trametinib, and lapatinib for the treatment of metastatic cholangiocarcinoma. Moreover, there is a lack of medical literature or guidelines to support the safety and effectiveness of this therapeutic regimen. Further, Avastin and Opdivo are not within the standard of care for the treatment of metastatic cholangiocarcinoma as noted by the National Comprehensive Cancer Network (NCCN) guidelines. The records indicate that this patient has been treated with some of these medications with positive response.

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