Proton Beam Therapy (PBT) is a form of external beam radiation therapy (EBRT) also known as charged particle therapy. PBT provides the opportunity of achieving dose escalation and decreasing toxicity by delivering physical dose to a narrowly defined region, while avoiding normal tissue. The potential benefit is to improve local control, improve survival, and decrease toxicity.
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.
Coverage is subject to the specific terms of the member’s benefit plan.
PBT may be considered medically necessary for the treatment of the following tumors:
- Chordomas and chondrosarcomas of the base of the skull, localized and in the postoperative setting
- Uveal melanoma, when PBT is considered preferential compared to brachytherapy
- Select cases of localized unresectable hepatocellular carcinoma (HCC)
- Stage IIA seminoma
- Pediatric tumors (18 years and younger)
- Malignancies requiring Craniospinal Irradiation (CSI)
- Astro Guidelines are used in the determination of proton radiation therapy for other indications. Indications considered for potential coverage include:
- Instances where sparing the surrounding normal tissue cannot be adequately achieved with photon-based radiotherapy and is of added clinical benefit to the individual. Examples of such an advantage might be:
- The target volume is in close proximity to one or more critical structures and a steep dose gradient outside the target must be achieved to avoid exceeding the tolerance dose to the critical structure(s).
- The same or an immediately adjacent area has been previously irradiated, and the dose distribution within the paient must be sculpted to avoid exceeding the cumulative tolerance dose or nearby normal tissue.
Documentation Requirements must include:
- Documentation stating one or more medical necessity requirements outlined in this policy.
- A comprehensive list of therapies and medications used in the member’s cancer treatment, including chemotherapy history and/ or history of previous radiation therapy to same or an immediately adjacent area.
- A treatment prescription that defines the goals of the treatment plan, including specific dose-volume parameters for the target and nearby critical structures as well as pertinent details of beam delivery, such as method of beam modulation, field arrangement and expected positional and range uncertainties.
In addition, PBT is not typically supported by the following clinical scenarios:
- Where PBT does not offer an advantage over photon-based therapies that otherwise deliver good clinical outcomes and low toxicity,
- Spinal cord compression, superior vena cava syndrome, malignant airway obstruction, poorly controlled malignant bleeding and other scenarios of clinical urgency.
- Inability to accommodate for organ motion.
- Palliative treatment in a clinical situation where normal tissue tolerance would not exceeded in previously irradiated areas.
PBT delivered in an ablative manner is considered experimental/investigational and therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.
PBT in combination with photon therapy for any tumor is considered experimental/investigational and therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.