Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Carcinoma of the larynx.
Treatment: Proton beam radiation therapy.
The insurer denied coverage for proton beam radiation therapy.
The denial is overturned. 

This patient is a female who has been diagnosed with carcinoma of the larynx. The documentation indicated the patient has been recommended to undergo proton beam therapy in order to spare the patient's critical structures due to the location of disease.  The documentation indicated she likely has stage cT4aN0/1M0 based on outside imaging performed in November 2020.  She has been recommended to undergo a total laryngectomy with postoperative radiotherapy (RT). The physician indicated concurrent chemo RT with the goal of larynx preservation is a reasonable approach and the patient strongly prefers larynx preservation. Given the location of the target or sensitive structures in the head and neck it was recommended she undergo proton beam therapy (PBRT) to reduce radiation dose. The attending physician is considering delivery of a definitive dose to the tumor, which is located near the base of skull and other critical structures, including remaining salivary glands and brain stem.  

Proton radiation is generally accepted as medically necessary for the following conditions: 1. intracranial arteriovenous malformations (AVMs); 2. Ocular tumors, including intraocular/uveal melanoma (includes the iris, ciliary body, and choroid); or 3. Skull-based tumors (e.g., chordomas or chondrosarcomas). All other clinical situations are generally either medically unnecessary or investigational. National Comprehensive Cancer Network (NCCN) Guidelines version 2.2021 for Head & Neck Malignancies describes appropriate postoperative radiation as IMRT photons or other conformal techniques, including proton therapy.  This update indicates that for proton beam therapy achieving highly conformal dose distributions is especially important for patients whose primary tumors are periocular in location and/or invade the orbit, skull base and/or cavernous sinus; extend intracranially or exhibit extensive perineural invasion; and who are being treated with curative intent and or will have long life expectancies following treatment. Proton beam therapy is also to be used to treat patients with the most challenging disease, for which other RT options are not felt to be safe or of any benefit.  The guidelines further indicate that there are a few randomized and single institution reports and systemic comparisons demonstrating safety and efficacy of proton beam therapy in the above-mentioned specific clinical scenarios.  This patient falls into the category described above.  She has disease, located in a specific anatomical area such as base of skull, spinal cord or previously treated regions that requires extremely specific and conformal dosing. 

The ASTRO Report on Emerging Technologies indicates the proton beam therapy for head and neck tumors while not necessarily a standard of care currently may be considered in appropriate situations.  The 2014, June update indicates that for sites other than those listed above, there is a continued need for clinical evidence development and comparative effective analysis for appropriate use of proton beam therapy for these various disease sites.  The records do indicate an improvement of proton therapy over photon therapy. Regarding medical necessity, while proton therapy may not have been a standard of medical practice, it is becoming more of a standard in certain above noted situations and it may be safe and effective and may be considered more effective than standard photon therapy for this patient's condition. The AP has indicated that for a photon plan they are concerned with tolerances of the tissues near the tumor, including base of brain, brain stem and spinal cord, oral cavity, contralateral parotid, and submandibular glands.  The proton plan could also lower the dose to the oral cavity, pharyngeal constrictor muscles and larynx and inferior mediastinal structures also within reasonable limits for tolerance.  Current Guidelines indicate that protons can reduce short term toxicity and reduce significant long-term side effects.  The AP at this time has provided a comparison of proton versus photon plans.  The comparison showed a significant advantage for the proton plan. It shows that proton beam plan will be better preserving tolerance to the spinal cord and brain stem, neurocognitive function, and swallowing function. The dose distribution is superior compared to photons plan such that there is no exit dose resulting in much reduced acute and chronic side effects, such as xerostomia compared to photon treatment.  The potential for dysgeusia, mucositis, nausea and pharyngitis are significantly reduced for the proton plan.  This will result in less longer-term issues and side effects, including improved neurocognitive function.  As she is expected to have a significant five-year survival, this will be important.   She has a long-life expectancy where consideration of reduction or potential elimination of long-term treatment effects will be critical. The photon plan also fails to meet constraints for the left parotid gland and the constrictor muscles.  The comparison shows the proton plan meets all the criteria listed from the Astro report and per NCCN guidelines that it can be used over photon therapy in this situation.

It is an appropriate level of service that can be safely provided, better than a photon plan for protecting critical structures. For these reasons, included from the clinical information provided, the NCCN and ASTRO guidelines, proton beam therapy, for this patient with a tumor in the larynx/ head and neck region with an indication for definitive radiation treatment of her current disease can be approved by the health plan.

The insurer's denial of coverage for Phase 1: 35 fractions (treatment sessions) of Proton Beam Therapy, Image Guided Radiation Therapy is overturned.  Medical necessity is substantiated.