Appeal type: Experimental/Investigational
Decision: Overturned

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 overturned. 

This is a male patient who has been previously diagnosed mediastinal B-cell lymphoma stage two A (IIA). The documentation indicated the patient had a Deauville response to 6 cycles of DA-R-EPOCH (dose adjusted rituximab, etoposide, prednisolone, vincristine, cyclophosphamide, doxorubicin). The submitted documentation indicated it was recommended the patient undergo consolidative radiation therapy (RT). The documentation indicated comparative treatment planning was performed utilizing institutional standard techniques. The physician also indicated based on analysis of comparative planning, proton therapy was recommended in order to reduce the risk of perioperative complication from thoracic radiotherapy. Proton therapy was recommended to reduce radiation dose to the heart, lungs, and nontarget normal tissues. 

The current version of National Comprehensive Cancer Network (NCCN) guidelines state that "advanced radiation therapy technologies such as proton therapy may offer significant and clinically relevant advantages in specific instances to spare organs at risk such as the heart, lungs, spinal cord, esophagus." The consensus recommendation from the 2018 guidelines from the International Lymphoma Radiation Oncology Group regarding mediastinal lymphoma state:

 "Lymphoma patients who can greatly benefit from proton therapy include (1) patients with mediastinal disease that spans below the origin of the left main stem coronary artery and is anterior to, posterior to, or on the left side of the heart; (2) young female patients for whom proton therapy can reduce breast dose and risk for secondary breast cancer; and (3) heavily pretreated patients who are at higher risk for radiation-related toxicity to the bone marrow, heart, and lungs. When using proton therapy, treating physicians should (1) demonstrate by calculation that it provides greater benefit to the patient compared with optimally planned photon therapy; (2) document the medical necessity of proton therapy, including consideration of issues for long-term survivors and the risks for radiogenic late effects; (3) understand the complexities of lymphoma proton planning, including the need to manage uncertainties, and the evolving nature of the technology with the development of pencil beam scanning, in-room volumetric imaging, and robustness optimization; and (4) use deep inspiration breath hold (DIBH) when it further minimizes doses to the OARs [organs at risk], with an understanding of the increased complexity of using DIBH with proton therapy compared with photon therapy."

Proton therapy has final approval from the appropriate regulatory bodies for this diagnosis.

Proton therapy is the best available treatment for this patient at this time.

The requested procedure is likely to be more beneficial than any other existing standard health service. Proton therapy is likely to be more beneficial than the standard intensity-modulated radiation therapy (IMRT) treatment using photons.

There are no increased adverse risks compared with other radiation modalities.  The justification in this case is that there are decreased adverse risks with proton therapy.

The carrier's denial of 45 treatments of simple with compensation, intermediate complex proton beam radiotherapy should be overturned.