Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Malignant neoplasm of parotid gland
Treatment: Proton beam therapy
The insurer denied the Proton beam therapy.
The denial is overturned.

The patient is a male with a diagnosis of stage T2N0M0 (larger than 2 centimeters but no larger than 4 centimeters) high grade mucoepidermoid of the right parotid gland status post right parotidectomy. Adjuvant radiation therapy was recommended, and proton therapy was requested.

The prior denial reason was that it was considered not medically necessary per plan guideline, and that IMRT (intensity-modulated radiation therapy) is the recommended technique. The reason for the appeal is that proton therapy is medically necessary because proton/IMRT comparison plan showed that the IMRT plan would exceed surrounding tissue dose tolerance.

Yes, the requested proton beam therapy is medically necessary.

There are a few studies showing that proton therapy is safe and effective for the
treatment of head and neck cancer. Proton therapy also has been shown to reduce
toxicity and reduce dose to surrounding critical structures compared to photon-based therapy.

An MD Anderson Cancer Center study evaluated 15 head and neck cancer patients
treated with proton therapy. The authors concluded that "All 15 patients were able to complete treatment with MFO-IMPT [multifield optimization intensity-modulated proton therapy], with no need for treatment breaks and no hospitalizations. There were no treatment-related deaths, and with a median follow-up time of 28 months (range, 20-35 months), the overall clinical complete response rate was 93.3% [percent]."

Another study from Lewis, et al evaluated ten patients with nasopharyngeal carcinoma for whom IMPT (Intensity-Modulated Proton Beam Therapy) was planned; 9 patients also had a comparison photon-based IMRT plan generated. Dosimetric comparison of mean radiation dose to 29 adjacent OAR (organs at risk) was performed. There were significant differences in mean doses in 15 of the 29 OAR; 13 OAR received lower mean dose with proton-based plans. Two-year locoregional control was 100% and the 2-year overall survival was 88.9%.

A more recent 2016 study from Memorial Sloan Kettering Cancer Center evaluated
patients with head and neck cancer treated with either IMRT or proton therapy. IMRT plans had a greater dose to the brainstem, spinal cord, oral cavity and contralateral
parotid gland. Proton therapy had significantly lower rates of grade 2 or greater acute dysgeusia (5.6% vs. 65.2%), mucositis (16.7% vs. 52.2%), and nausea (11.1% vs. 56.5%). The authors concluded that "The unique properties of PBRT [proton beam radiation therapy] allow greater normal tissue sparing without sacrificing target coverage when irradiating the ipsilateral head and neck. This dosimetric advantage seemingly translates into lower rates of acute treatment-related toxicity."

In this patient's case, a proton therapy/IMRT comparison plan was done. The proton plan was able to significantly reduce dose to the surrounding critical structures, especially the right (remaining) parotid gland. Proton therapy would be able to help reduce significant radiation related side effects and late complications, and is therefore, considered medically necessary.

A proton/IMRT comparison plan was done. The mean right (remaining) parotid dose was 35Gy (Grey) with IMRT. IMRT exceeded tolerance per Quantec limit. The proton therapy plan was 16Gy, which was within tolerance. If non-proton therapy technique such as IMRT was utilized, the patient would have a high risk of developing permanent significant xerostomia. The proton therapy technique was able to reduce the parotid dose to an acceptable level, reducing the risk of severe xerostomia. The requested proton therapy, therefore, is medically necessary.