Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Breast cancer

Treatment: Proton beam radiation therapy (PBRT)

The insurer denied coverage for proton beam radiation therapy (PBRT)
The denial is overturned

According to the clinical documentation provided for review, the patient is a female with the medical diagnosis of synchronous bilateral (b/l) breast cancer (CA). The patient has been seen and treated for synchronous bilateral (b/l) breast cancer (CA). 

The 2017 ASTRO (American Society for Radiation Oncology) Proton Beam Therapy Model Policy states that Proton beam therapy is an advanced type of external-beam radiation therapy that uses proton rather than photon beams to deliver radiation doses to a tumor. Proton therapy offers a high degree of precision, which allows radiation oncologists to target an escalated dose of radiation directly on a tumor and spare nearby healthy tissue. Proton therapy is particularly beneficial for patients with tumors that are near critical structures, such as lung tumors near the heart.

"The authors concluded that the conventional planning approaches were suboptimal in target volume coverage compared to protons. In addition, protons provided a superior sparing of the cardiopulmonary structures for the cases they studied. One obvious question is why the authors chose to compare the protons with conventional photons and/or electrons-photons instead of comparing them with multiportal inverse-planned (intensity modulated radiation therapy [IMRT]) and volumetric arc therapy (VMAT) approaches that allow ways to optimize the dose delivery within the planning target volume and spare the critical structures." (Mihailidis, 2014).

"The toxicity of radiotherapy is a key issue when analyzing the eligibility criteria for patients with breast cancer. In order to obtain better results, proton therapy is proposed because of the more favorable distribution of the dose in the patient's body compared with photon radiotherapy. Scientific groups have conducted extensive research into the improved efficacy and lower toxicity of proton therapy for breast cancer. Unfortunately, there is no complete insight into the potential reasons and prospects for avoiding undesirable results. Cardiotoxicity is considered challenging; however, researchers have not presented any realistic prospects for preventing them. We compared the clinical evidence collected over the last 20 years, providing the rationale for the consideration of proton therapy as an effective solution to reduce cardiotoxicity. We analyzed the parameters of the dose distribution in organs at risk, such as the heart, blood vessels, and lungs, using the following two irradiation techniques: whole breast irradiation and accelerated partial breast irradiation. Moreover, we presented the possible causes of side effects, taking into account biological and technical issues. Finally, we collected potential improvements in higher quality predictions of toxic cardiac effects, like biomarkers, and model-based approaches to give the full background of this complex issue." (Musielak, et al., 2021). 

"Conclusion: Proton therapy reduces mean heart dose in breast cancer irradiation, probably reducing late cardio-vascular toxicity. Large clinical studies will likely confirm a clinical benefit of proton therapy." (Kammerer, et al., 2018).                                                          

The health plan did not act reasonably with sound medical judgment in the best interest of the patient.

The insurer's denial of coverage for Proton Beam Radiation Therapy (PBRT) is overturned. Medical Necessity is substantiated.