Appeal type: Experimental/Investigational
Decision: Upheld

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 patients 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). The response to the drug has not necessarily correlated with the presence of EGFR in the tumor. Erbitux has been approved for use in certain situations in metastatic colon cancer, and just recently, a study demonstrated its value, along with radiation therapy, in the treatment of squamous cell carcinoma of the head and neck.Submitted with the appeal are three abstracts relating to the use of Erbitux in head and neck cancer. It appears that all of the patients in these studies had squamous cell cancer, the most common type of head and neck cancer. This reviewer is unaware of any meaningful data on the use of Erbitux in adenoid cystic carcinoma, the type of cancer this patient has.  For this reason, Erbitux would be considered investigational in this setting and of unknown medical benefit.  Based upon the information set forth above, I have determined that the requested medication is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.Physician 2: The patient is a 74-year-old female with adenoid-cystic carcinoma, originating in the nasopharynx. Previous treatments included surgery and radiation therapy. Chemotherapy does not typically work with this type of tumor. The patient has requested authorization and coverage of Erbitux. The Health Plan has denied her request based upon a determination that the medication is considered experimental/investigational for the treatment of her condition.It appears the patients provider has recommended treatment with Erbitux based on favorable data on the use of the drug in combination with radiation therapy or as a single agent for treatment of squamous carcinoma of the head and neck. The patients EGFR determination was positive, providing additional support for the recommendation.  Adenoid cystic carcinoma is rare and indolent; therefore indirect evidence is all that is available.  Although the research cited involved squamous carcinoma, there is sufficient indirect evidence to support Erbitux for this patient along with radiation therapy.   Therefore, I have determined that the requested medication is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned.Physician 3: The patient is a 74-year-old female with recurrent nasopharyngeal adenoid cystic carcinoma along with a cervical mass and pulmonary metastases. She is requesting approval for Erbitux treatment along with her radiation therapy. The Health Plan considers the Erbitux experimental/investigational in this clinical context and has denied coverage.Data supporting the use of Erbitux in the treatment of nasopharyngeal carcinoma is very limited.  I am aware of a Phase II, single arm study, conducted outside of the United States, but not of proper clinical trials within the country. As such, this drug is considered experimental for the treatment of the patients nasopharyngeal adenoid cystic carcinoma and is not likely to be more beneficial for treatment of her medical condition than any available standard therapy. The Health Plans denial should be upheld.