Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Mucoepidermoid carcinoma, intermediate grade.

Treatment: Radiation Therapy for Head/Neck Cancer Phase 1: 33 fractions (treatment sessions) of Proton Beam Therapy.

The insurer denied coverage for Radiation Therapy for Head/Neck Cancer Phase 1: 33 fractions (treatment sessions) of Proton Beam Therapy. 

The denial is upheld. 

This is a male patient with a medical history of mucoepidermoid carcinoma, intermediate grade. He underwent excisional biopsy and parotidectomy of a left parotid mass and was evaluated for re-excision. After discussion with the surgeon and tumor board, proton beam radiotherapy (PBRT) was recommended. This is the subject of the review.

Currently, there is no clinical data in the medical literature to suggest that treatment with proton beam radiation offers a clinical benefit compared to conventional radiation therapy techniques for head and neck cancer. In this setting, there is no published literature that compares clinical outcomes of proton beam radiotherapy compared to standard photon techniques. In the majority of cases, the standard approach to treat this malignancy is with standard photon techniques. The American Society for Radiation Oncology (ASTRO) emerging technology committee report on proton therapy specifically states that there is insufficient data to recommend proton beam therapy for routine head and neck radiation therapy outside of clinical trials.

Although with intensity-modulated radiation therapy (IMRT), dose to certain critical structures may be higher, it is still considered acceptable to use IMRT in this setting and the difference between the two plans may not be considered clinically significant. Currently, there is insufficient clinical data to discern whether treatment with proton beam radiation offers a clinical benefit compared to conventional radiation therapy techniques in this setting. The provider has not provided a significant justification for why proton therapy should be utilized over standard photon radiation. Consensus group guidelines do not support the use of proton therapy in this setting. Also, there is no level I evidence to support the use of proton therapy for the treatment of head and neck cancer. Based on these reasons, proton beam therapy is not deemed medically necessary.

Per the National Comprehensive Cancer Network (NCCN) guidelines, radiation therapy (RT) "can be administered either as primary, preoperative, or postoperative treatment.  Total RT doses are always determined based on the tissue tolerance. Newer RT techniques such as brachytherapy, intraoperative RT (IORT), and intensity-modulated RT (IMRT) have led to the improvement of treatment outcomes in patients with STS [soft tissue sarcoma]. The main advantage of IMRT is its ability to more closely contour the high-dose radiation to the surrounding normal tissues. Additionally, image-guided techniques may allow for reduced target volumes, further minimizing toxicity."

The health care plan acted reasonably and with sound medical judgment and in the best interest of the patient.                                                

The carrier's denial of coverage for Radiation Therapy for Head/Neck Cancer Phase 1: 33 fractions (treatment sessions) of Proton Beam Therapy is upheld. The medical necessity is not substantiated.