Tarceva denials in California external review

What the reviewers wrote

Where the denial was overturned

The patient is a 50-year-old woman who presented with an explosive course of bronchoalveolar adenocarcinoma and respiratory failure. She had a dramatic response to treatment with Iressa. When she later reached a plateau on Iressa, she was switched to Tarceva. The Health Plan indicates it will not authorize Tarceva because it is not considered medically necessary unless it follows failed treatment with a platinum-based chemotherapy.When this patient initially presented, she was too sick for chemotherapy. She was treated with Iressa, an EGFR-targeted treatment, and had a remarkable response. Although Tarceva’s current indication is for second line treatment, it is another EGFR-targeted treatment that is routinely being used for subsets of patients with a high likelihood of benefit.

SummaryThe patient is a 60-year-old male with cancer of the pancreas. He is requesting authorization to be treated with Gemzar and Tarceva. The Health Plan denied authorization on the basis that Tarceva is not medically necessary. The physician who reviewed the case concluded that the requested medication is medically necessary for treatment of the patient’s condition and the Health Plan denial should be overturned.Analysis and FindingsClinical Facts: The patient was diagnosed with cancer of the pancreas in March 2005. At that time he underwent a Whipple procedure and was then treated with pre-radiation Gemzar, followed by radiation therapy along with infusion 5-FU. He then was well until he was diagnosed with recurrent and inoperable cancer in October 2006.

Where the denial was upheld

A 20-year-old male enrollee has requested combination chemotherapy with Avastin and Tarceva for treatment of his hepatocellular carcinoma. Findings: The physician reviewer found that hepatocellular carcinoma (HCC) is generally is not responsive to chemotherapy. One drug, Nexavar, has demonstrated a survival benefit and has been approved for use in this cancer. This particular young patient has been treated with a variety of past treatments including Nexavar and now has progressive disease, for which there is no known standard treatment likely to be of benefit. Two studies have been published demonstrating some degree of efficacy of Avastin. The first, by Cid and colleagues, studied 12 patients with Avastin who had previously received Nexavar and found a 50% rate of clinical benefit and median overall survival of 9.5 months.

The patient is a 54-year-old female who was diagnosed with glioblastoma in February 2006, at which time she was found to have a left hemispheric high grade glioma, not amenable to surgery. She was treated with radiation and concurrent temozolomide. Follow-up imaging with MRI in September 2006 showed enhancement outside the field of radiation involving the cerebral peduncle and pons, which was felt to be consistent with tumor progression. With regard to the patient’s functional status, she is unable to speak, though comprehension remains intact. Her KPS is reported at 70%. At issue is whether Tarceva (erlotinib) is medically necessary for treatment of the patient’s recurrent glioma.Gliomas are the most common of CNS tumors with over 50% being of the most virulent type, glioblastoma multiforme (GBM). Apart from resection and radiotherapy, chemotherapy has afforded only a modest benefit.

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