Erbitux denials in California external review

What the reviewers wrote

Where the denial was overturned

A 51-year-old male enrollee has requested chemotherapy using Vectibix, Erbitux and irinotecan for the treatment of his metastatic lung cancer. Findings: Two physician reviewers found that this patient has tried and eventually progressed on several different chemotherapeutic regimens. The patient had a pronounced response to Tarceva, which, as his physician states, is indicative that the tumor is very sensitive to endothelial growth factor receptor (EGFR) inhibition. There is support for the use of EGFR inhibitors (including the monoclonal antibody Erbitux). Butts and colleagues demonstrated benefit from the addition of Erbitux to a chemotherapeutic regimen for patients with advanced localized or metastatic non-small cell lung cancer (NSCLC).

A 64-year-old male enrollee has requested Erbitux, carboplatin and 5-FU, used in combination, or as single agents for treatment of his squamous cell carcinoma with metastatic disease to the liver. Findings: Three physician reviewers found that this patient has metastatic cancer to his liver of unknown primary. In view of the squamous cell histology, it was felt to be most likely of lung or head and neck primary. National Comprehensive Cancer Network guidelines for the treatment of squamous cell carcinoma of unknown primary include two regimens, cisplatin/paclitaxel/5-FU or cisplatin/Taxotere/5-FU. Thus, it is reasonable to conclude that the use of a platinum analogue, with 5-FU, and a taxane, would be acceptable treatments, with some track record of efficacy. He previously responded to carboplatin. Thus, this medication, in combination with 5-FU, is a reasonable alternative.

Where the denial was upheld

Physician 1: This patient is a 42-year-old male with a previous diagnosis of myoepithelial sarcoma of the paranasal sinus. He has apparently been treated with surgery, radiation, and multiple chemotherapeutic agents including Cisplatin, Ifosfamide, Taxol, Carboplatinum, Adriamycin, and Temodar. He has also been treated with Cyberknife radiotherapy. The patient’s tumor was found positive for the epithelial growth factor (EGF) receptor and it is proposed that he be treated with Erbitux. The provider’s request for authorization of Erbitux was denied by the Health Plan citing the experimental nature of the therapy.Erbitux is one of a new class of drugs that inhibits the EGF receptors on a cancer cell and presumably interferes with angiogenesis. Erbitux has been approved by the FDA for use, along with chemotherapy, in the treatment of colon cancer.

Physician 1: The patient is a 74-year-old female who was apparently first diagnosed with adenoid-cystic carcinoma of the nasopharynx in 1999. She was initially treated with radiation therapy and a recurrence in 2001 was also treated with surgery and radiation therapy. She was noted in January of 2004 to have lung metastases. In December of 2004 she was noted to have recurrence in the neck. A biopsy of her disease again revealed adenoid-cystic carcinoma, which was EGFR positive. It is now recommended she be treated with radiation therapy to her neck, along with Erbitux. The patient’s clinician has requested authorization for treatment with Erbitux. The Health Plan has denied the request citing the investigational nature of the medication in this clinical context.Erbitux is a new drug, which acts by inhibiting the epidermal growth factor receptor (EGFR).

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