Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Left Sided Tonsillar Mass
Treatment: Outpatient Proton Bean Therapy Treatments (Codes 77263, 77300, 77331, 77427, 77301, G6002, 77014, 77336, 77523, 77334, 77525, 77370, 77530, 77520, 77333, 77470, 77387, 77522)
The insurer denied the Outpatient Proton Bean Therapy Treatments (Codes 77263, 77300, 77331, 77427, 77301, G6002, 77014, 77336, 77523, 77334, 77525, 77370, 77530, 77520, 77333, 77470, 77387, 77522).
The denial is upheld.

The health plan should not cover the proposed treatment.

It is unclear if proton therapy is likely to be more beneficial compared to photon IMRT (intensity-modulated radiation therapy).

The patient is a male with a diagnosis of carcinoma of the tonsil.  Definitive chemotherapy and radiation therapy was recommended, and proton beam radiation therapy was requested. 

In this case, the patient is a male with a diagnosis of carcinoma of the tonsil.  Definitive chemotherapy and radiation therapy was recommended, and proton beam radiation therapy was requested.  However, based upon and in conclusion of the review above, the requested proton therapy is not considered medically appropriate.

Proton beam radiation therapy is a type of very precise external radiation treatment in which protons are used to treat cancer and other conditions.  Compared to photon, a proton beam that is delivered with sufficient energy has a low "entrance dose." A proton beam also has a high-dose "Bragg peak" region, which is designed to cover the entire tumor and there is no "exit dose" beyond the tumor involved in proton radiation therapy.  Because of this unique property, proton beam therapy is highly successful in minimizing damage to normal tissue and surrounding organs, resulting in fewer side effects.  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.  It has also been shown to be a very useful procedure when re-irradiation is required, or when sparing of the surrounding critical structures cannot be done adequately with other types of radiation therapy.  It is an FDA-approved procedure and it is not subject to IRB (institutional review board) review.  For the treatment of head and neck cancer with proton beam radiation therapy, there are ongoing phase II/III studies being conducted.

Although there are single institutional trials and case series showing that proton therapy for head and neck cancer is safe and effective, there is insufficient clinical data in the medical literature showing that it is equivalent or superior to photon IMRT for the treatment of head and neck cancer.  A reference was provided by AP which showed that the rate of feeding tube dependency is reduced by proton therapy.  However, the authors also acknowledged that "Prospective multicenter randomized trials are needed to validate such findings" (10).  There are ongoing clinical trials (including a phase III trial) still evaluating the role of proton therapy for head and neck cancer.  IMRT photon radiation therapy has been shown to be safe and effective for the treatment of head and neck cancer, and is currently the standard of care.  Proton beam therapy is, therefore, not considered medically appropriate because it has not been shown in well-conducted randomized trials to be clinically superior to photon IMRT in this patient's clinical scenario.