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.

The patient is a man with stage III cT4N2M0 HPV positive squamous cancer of left tonsillar fossa. Proton beam therapy is being request for definitive concurrent chemo-radiation therapy.  

Currently, there is insufficient published long-term clinical outcome evidence of proton beam RT (radiation therapy) relative to photon IMRT (intensity-modulated radiation therapy) for head and neck cancer. It is, therefore, not possible to draw any conclusions on the benefits of proton beam RT compared to photon IMRT, which has demonstrated high locoregional control rate for the tonsillar cancer, as in this patient's case. The long-term clinical outcome evidence on the safety and efficacy of proton beam RT compared to IMRT for tonsillar has not been published in peer-reviewed journals. 

Proton RT for head and neck cancer is being investigated in clinical trials to study its clinical outcomes (local control, toxicity, survival) compared to photon IMRT before it is used as standard therapy in routine clinical practice. Proton radiation treatment for head and neck cancer is currently under study in phase 2 and phase 3 clinical trials. 
NCCN guideline on Head and Neck Cancer states that IMRT or other conformal techniques (3D conformal RT, helical TomoTherapy, volume modulated arc therapy (VMAT), and proton Beam Therapy (PBT)) may be used as appropriate depending on the stage, tumor location, physician training/experience, and available physics support.
The requested service is not likely to be more beneficial. 
The updated 2017 ASTRO Proton Beam Therapy Model Policy states that Proton beam therapy is an advanced type of external-beam radiation therapy...
Based on new evidence published since the original policy was issued in 2014, the updated model policy outlines two categories of appropriate clinical indications, or diagnoses, for proton beam therapy. For indications in Group 1, coverage is recommended; for Group 2, coverage is recommended if additional requirements (outlined below) are met. Disease sites were assigned to one of the two categories based on evidence in published clinical data and current Medicare coverage.
...
The policy recommends coverage for Group 2 indications if the patient is enrolled in either an Institutional Research Board (IRB)-approved study or in a multi-institutional registry adhering to Medicare requirements for Coverage with Evidence Development (CED). 

These indications also represent the disease sites for which evidence is accumulating and may support future Group 1 coverage. While the policy specifies that no indications are deemed inappropriate for CED, it also specifies several systems for Group 2 indications:
1) Non-T4 and resectable head and neck cancers (previously all head and neck malignancies*). 2) Non-metastatic prostate cancer (previously grouped with genitourinary carcinomas*). 3) Breast cancer*. 4) Thoracic malignancies, including non-metastatic primary lung and esophageal cancers. 5) Abdominal malignancies, including non-metastatic primary pancreatic, biliary and adrenal cancers. 6) Pelvic malignancies, including non-metastatic rectal, anal, bladder and cervical cancers.

Medical documents do not indicate that the requested proton beam RT is provided as part of an NCI-approved clinical trial or registry trial. 

Therefore, proton beam RT in this case does not  meet the 2017 ASTRO policy for proton beam therapy.