Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Brain Metastases.
Treatment:  Proton Beam Radiation Therapy.

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

The patient is a male with a diagnosis of stage IV lung cancer, status post multiple courses of systemic therapy.  The patient subsequently developed leptomeningeal disease.  Craniospinal radiation therapy was recommended, and proton therapy was requested.

The initial request for proton therapy was denied by the health plan, because per eviCore guideline, they posit that proton therapy is not clinically superior to other types of radiation therapy for this patient's indication.

Yes, the proton beam radiation therapy is medically necessary.

The requested proton therapy has been shown in clinical trials to reduce dose to the surrounding critical structures when craniospinal irradiation is being utilized.  In this case, a proton/IMRT (intensity-modulated radiation therapy) comparison plan was done, and the proton plan was able to significantly reduce dose to the heart and bowel bag.

Therefore, given the above, the proton beam radiation therapy is medically necessary.

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

Proton beam radiation therapy has been shown to be safe and effective for any CNS (central nervous system) lesions that are adjacent to critical structures such as optic nerve, base of skull, brain stem or spinal cord, and is considered medically necessary per most guidelines.

In this patient's case, because of extensive volume or radiation required including craniospinal irradiation and that the target is in close proximity to critical structures such as cochlea, brainstem and temperal lobes, conventional radiation techniques can result in adverse effects on vision, hormone, and neurocognitive functioning in this young patient. In addition, proton therapy can also help reduce the risk of injury to heart, lung, thyroid, GI (gastrointestinal) tract and reproductive organs. Furthermore, studies have shown that there is a potential reduction of the incidence of radiation induced secondary cancer by using proton beam radiation.

Other types of radiation therapy such as photon IMRT (intensity-modulated radiation therapy) or tomotherapy has also been used to treat this disease, however, they are not the optimal modalities for this patient.

A study by Brown et al. evaluated 40 adult patients with meduloblastoma treated with proton therapy, the authors concluded that "Patients treated with p-CSI (proton craniospinal irradiation) experienced less treatment-related morbidity including fewer acute gastrointestinal and hematologic toxicities."

In addition, the NCCN (National Comprehensive Cancer Network) states, "Considering protons over photons (if available) for craniospinal irradiation in adults is reasonable."

In this case, a proton/IMRT photon comparison plan was done. The mean heart dose was 6.92Gy (Gray) with IMRT (intensity-modulated radiation therapy) and 0.03Gy (Gray) with proton therapy. The proton plan was also able to significantly reduce dose to the bowel bag and other structures. Because of the special "Bragg peak" characteristic, proton beam radiation therapy therefore, is the most appropriate treatment for this patient at this time.