Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Locally advanced nasopharyngeal cancer.
Treatment: Proton Radiation Therapy.

The insurer denied the Proton Radiation Therapy.  The denial is overturned.

The patient is a male with a diagnosis of locally advanced nasopharyngeal cancer. Definitive chemotherapy and radiation therapy was recommended, and proton therapy was requested.

Yes, the requested proton therapy is medically necessary.

There are several studies showing that proton therapy is safe and effective for the treatment of nasophageal 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 (MFO-IMRT [multifield optimization intensity-modulated radiation 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%."

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 (intensity-modulated radiation therapy) 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 (organs at risk); 13 OAR (organs at risk) 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 study from Memorial Sloan Kettering Cancer Center evaluated patients with head and neck cancer treated with either IMRT (intensity-modulated radiation therapy) or proton therapy. IMRT (intensity-modulated radiation therapy) 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% versus. 65.2%), mucositis (16.7% versus. 52.2%), and nausea (11.1% versus. 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."

The request for proton therapy was initially denied coverage by the health plan, because it was deemed not medically necessary. This is the subject of this appeal.

No, the health plan did not act reasonably, with sound medical judgment, and in the best interest of the patient.

In this case, a proton/photon comparison plan was done. The brainstem Dmax (maximum dose) was 60.3Gy (gray) with photon therapy (which exceeded tolerance) and 52.7Gy (gray) with proton therapy (within tolerance). The spinal cord Dmax (maximum dose) was 50.8Gy (gray) with photon therapy (exceed tolerance) and 37.3Gy (gray) with proton therapy (within tolerance). The mean parotid gland dose was 35Gy (gray) with photon therapy (exceeded tolerance) and 19Gy (gray) with proton therapy (with tolerance). If a non-proton technique was utilized, there is a significant risk of injury to the brainstem, spinal cord and the parotid glands. The requested proton therapy, therefore, is medically necessary.