Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Malignant neoplasm of cerebral meninges.
Treatment: Proton Beam Therapy / Radiation Therapy for Primary Central Nervous System Neoplasms (Tumors).
The insurer denied the Proton Beam Therapy / Radiation Therapy for Primary Central Nervous System Neoplasms (Tumors).
The denial is overturned.

The patient is a female with a diagnosis of meningioma involving the sphenoid/cavernous sinus with mass effect on optic chiasm status post resection.  Adjuvant radiation therapy to 59.4 gray (Gy) was recommended and proton therapy was requested.

The request was initially denied because it is not considered medically necessary per eviCore guideline.  The appeal was initiated because the attending physician (AP) considers proton therapy medically necessary.

Yes, the proposed proton beam radiation therapy is medically necessary.
Proton beam radiation therapy has been shown to be safe and effective for any central nervous system (CNS) lesions that are adjacent to critical structures such as optic nerve, base of skull, brain stem or spinal cord, and is often considered medically necessary.  In this case, the target location of the lesion in very close proximity to the cranial nerves, optic chiasm and brainstem, and conventional radiation techniques can result in adverse effects on vision, hormone, and neurocognitive functioning.  Proton beam radiation therapy has been shown to be safe and effective for the treatment of central nervous system (CNS) tumors.

Mass General Hospital studied 46 patients with meningioma treated with a combination of photon and proton therapy.  The authors concluded that the survival without severe toxicity was 80% and that "proton therapy is an effective treatment for patients with recurrent or incompletely resected benign intracranial meningiomas".  

Another multi-national study evaluated 110 patients with skull base meningioma treated with particle radiotherapy (104 with proton and six with carbon ion therapy).  Particle radiation therapy (RT) offered excellent overall local control rates with 100% progression-free survival (PFS) after 36 months and 96.6% after 60 months. Median progression free survival (PFS) was not reached due to the small number of events. Overall survival was 96.2% after 60 months and 92.0% after 72 months from therapy.  The authors concluded that "Particle radiotherapy is an excellent treatment option for patients with meningiomas of the skull base and can lead to long-term tumor control with minimal side effects".   

Other types of radiation therapy such as photon intensity modulated radiation therapy (IMRT) or tomotherapy has also been used to treat this disease, however, they are not the optimal modalities for this patient due to the location and extent of the target.  Because of the special "Bragg peak" characteristic, proton beam radiation therapy therefore, is one of the most appropriate treatment for this patient at this time.  It is considered medically necessary.

No, the health plan did not act reasonably, with sound medical judgment and in the best interest of the patient.
A proton/photon comparison plan was done.  The brain stem maximum dose (Dmax) was 56.26 gray (Gy) with photon (which exceeded tolerance) and 50.90 gray (Gy) with proton (within tolerance).  The right optic nerve maximum dose (Dmax) was 51.69 gray (Gy) with photon (exceeded tolerance) and 38.03 gray (Gy) with proton therapy (within tolerance).  The proton plan was also able to significantly reduce dose to the lens, cochlea and brain.  Because the photon plan would result in surrounding critical structures such as the brain stem and optic nerve to exceed tolerance, the risk of radiation complication would be significantly higher with photon radiation.  The requested proton therapy was able to reduce dose to a safe level for all of the surrounding critical structures, and is a medically necessary treatment.