Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Cancer
Treatment: Proton Beam Radiation Therapy (PBRT)
The insurer denied Proton Beam Radiation Therapy (PBRT).
The denial is overturned.

This is an adult male patient with stage T1N0M0 squamous cancer of the nasal septum status post resection. Proton beam therapy is being requested to deliver adjuvant radiation therapy (RT) on a National Cancer Institute (NCI) approved registry trial.

The proposed treatment is medically necessary.

This patient's squamous cancer of the nasal septum is in close proximity to optic nerve/chiasm and brain. Compared to photon beam RT, proton beam radiation therapy can achieve significantly sharper dose gradient due to its Bragg peak patterns of energy release and can deliver a therapeutic high dose to the target with significantly better dose conformity and sparing of adjacent normal tissues such as optic nerve and chiasm. 

Medical documents provide the comparison of proton beam therapy plan and photon radiation therapy plan, which demonstrated that the photon radiation therapy plan exceeded QUANTEC (Quantitative Analysis of Normal Tissue Effects in the Clinic) tolerance dose of right and left optic nerve and optic chiasm and proton beam therapy plan was able to stay within the tolerance dose of both optic nerves and chiasm. Thus, proton radiation therapy in this case can reduce risks of radiation induced blindness and brain necrosis.

The 2017 American Society for Radiation Oncology (ASTRO) model policy for proton beam radiation therapy states that while proton beam therapy (PBT) is not a new technology, there is a need for continued clinical evidence development and comparative effectiveness analyses for the appropriate use of PBT for various disease sites. All other indications not listed in Group 1 are suitable for Coverage with Evidence Development (CED).

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 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: non-T4 and resectable head and neck cancers such as stage T1N0M0 squamous cancer of nasal cavity.

Medical documents indicate that PBT is provided on a multi-center registry trial. Thus, the requested PBT in this case is consistent with the 2017 ASTRO model policy for PBT.

The National Comprehensive Cancer Network (NCCN) guideline on Head and Neck Cancer 2023 states that intensity modulated radiation therapy (IMRT), helical tomotherapy, volume modulated arc therapy (VMAT), image guided radiation therapy (IGRT) and PBT may offer clinically relevant advantages in specific instances to spare important organs at risk and decrease the risks for late normal tissue damage while still achieving the primary goal of local tumor control. The NCCN guideline on Head and Neck Cancer 2022 states that IMRT or other conformal techniques (three-dimensional [3D] conformal radiation therapy), helical tomotherapy, VMAT, and PBT may be used as appropriate depending on the stage, tumor location, physician training/experience, and available physics support.

The requesting facility has physician training/experience, and available physics support. PBT in this case is consistent with the 2017 ASTRO model policy on PBT and the NCCN guideline on head and neck cancer 2022.