Diagnosis: Stage two A (IIA) primary mediastinal B-cell lymphoma.

Treatment: 45 treatments of simple with compensation, intermediate complex proton beam radiotherapy.

The insurer denied coverage for 45 treatments of simple with compensation, intermediate complex proton beam radiotherapy.

The denial is upheld.

This is a male patient with a history of stage two A (IIA) primary mediastinal B cell lymphoma. The patient is status post induction dose adjusted rituximab etoposide prednisolone vincristine cyclophosphamide doxorubicin (DA-R-EPOCH) systemic chemotherapy achieving a Deauville 4 response after six cycles. The patient has been recommended to proceed with a course of consolidative external beam radiotherapy with curative intent. The treating provider is requesting plan approval for treatment with proton beam radiation therapy (RT).

The patient has no extenuating circumstances that would necessitate the use of proton radiation, example, prior receipt of radiation to an overlapping and/or abutting area or presence of a comorbid and/or genetic disorder, which increases his risk for normal tissue radio sensitivity. The American Society for Radiation Oncology (ASTRO) Model Policy for proton radiation does not support its use in the management of thoracic malignancies such as this, outside the context of a prospective clinical trial. Therefore, proton therapy is not the best available treatment for this patient at this time.

"Among adult lymphoma survivors, radiation treatment techniques that increase the excess radiation dose to organs at risk (OARs) put patients at risk for increased side effects, especially late toxicities. Minimizing radiation to OARs in adult patients with Hodgkin and non-Hodgkin lymphomas involving the mediastinum is the deciding factor for the choice of treatment modality. Proton therapy may help to reduce the radiation dose to the OARs and reduce toxicities, especially the risks for cardiac morbidity and second cancers" (Dabaja, et al., 2018).

Proton radiation is not likely to be more beneficial than any of the standard treatments and/or procedures for this patient.

The provider has not shown that the patient cannot be treated safely and/or effectively with the use of photon-based intensity-modulated radiation therapy (IMRT). The provider has not supplied a detailed slice by slice proton and/or photon plan comparison in color format for review.

The adverse risks are not increased over standard treatment and/or services.

The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcome.

There are currently insufficient high quality clinical outcomes published in the peer reviewed medical literature to allow definitive conclusions to be made regarding the relative safety and/or efficacy of proton beam radiotherapy in the patient's setting, as compared to standard of care photon-based radiotherapy.

Proton therapy does have final approval from the appropriate regulatory bodies for this diagnosis. Proton radiation is Food and Drug Administration (FDA) approved in the member's setting.

While this patient is a candidate for proton therapy, the provider has not shown that the patient cannot be treated safely and/or effectively with the use of photon-based IMRT.

Proton therapy is not the best available treatment for this patient at this time. The carrier's denial of 45 treatments of simple with compensation, intermediate complex proton beam radiotherapy should be upheld.