Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Prostate Cancer
Treatment: Proton Beam Therapy, pre-service
The insurer denied the Proton Beam Therapy, pre-service
The denial is upheld.

The patient is a male with a diagnosis of stage T1c (nonpalpable prostate cancer diagnosed by needle biopsy), intermediate risk prostate cancer, GS (Gleason score) 7, PSA (prostate specific antigen) 13. Definitive radiation therapy was recommended, and proton therapy was requested.

Coverage for the request for proton therapy was initially denied by the health plan, because it was not considered medically necessary and does not meet health plan criteria for coverage. This denial is being appealed.

No, the requested proton beam therapy is not medically necessary.
There is emerging data showing that proton beam radiation therapy is safe and effective for the treatment of prostate cancer. However, there is insufficient clinical peer-reviewed literature that showed that proton therapy is safer or more effective than the standard therapies, which include IMRT (intensity-modulated radiation therapy), prostate brachytherapy, surgery or combined modality. In fact, several studies have concluded that additional studies are necessary with proton beam radiation therapy for the treatment of prostate cancer.

In a study, Mayahara and associates evaluated 287 patients with prostate cancer treated with proton beam radiation therapy. They concluded that "additional follow-up is warranted to elucidate the long-term safety and efficacy of proton therapy for prostate cancer."

Another study by Zietman et. al. investigated 393 patients with prostate cancer treated with a combination of photon and proton beam radiation therapy and concluded, "While the trial validates the use of proton-beam therapy, it did not test whether this modality is more or less efficacious than other more commonly available conformal techniques, brachytherapy or surgery."

Another systematic review by Allen et al. concluded that there is evidence for the efficacy of proton beam therapy for treating prostate cancer but no suggestion that it is superior to photon based approaches.

A recent study from University of Florida evaluated 1327 men with prostate cancer treated with proton therapy. The 5-year freedom from biochemical progression rates were 99%, 94%, and 74% in low-risk, intermediate-risk, and high-risk patients, respectively. The authors concluded that, "Image guided PT [proton therapy] provided excellent biochemical control rates for patients with localized prostate cancer," but, "Prospective clinical studies are needed to determine the comparative effectiveness of PT [proton therapy] and other radiation treatment strategies."

Another study from Massachusetts General Hospital evaluated proton versus photon-based radiation therapy for prostate cancer. The authors concluded that, "Present data have demonstrated that proton beam therapy is safe and effective compared with the standard treatment options for prostate cancer. While dosimetric studies suggest lower whole-body radiation dose and a theoretically higher relative biological effectiveness in prostate cancer compared with photons, no studies have demonstrated a clear benefit with protons."

In addition, American Society for Radiation Oncology (ASTRO) states that, "While proton beam therapy is not a new technology, its use in the treatment of prostate cancer is evolving. ASTRO (American Society for Radiation Oncology) strongly supports allowing for coverage with evidence development for patients treated on clinical trials or within prospective registries." However, it also concludes that, "The comparative efficacy evidence of proton beam therapy is still being developed."

NCCN (National Comprehensive Cancer Network) guidelines also state that proton therapy is an option for prostate cancer, but no clear benefit over the existing therapy of intensity-modulated radiation therapy has been demonstrated. IMRT (intensity-modulated radiation therapy) with photon therapy is the standard of care for patients with prostate cancer that wish to undergo external beam radiation therapy.

Therefore, given the above, proton beam radiation therapy is not considered medically necessary in this patient's case due to availability of other available treatment modalities and non-superiority of proton beam radiation therapy compared to other standard options.

Yes, the health plan did act reasonably, with sound medical judgment, and in the best interest of the patient.
In this case, there was no proton/photon IMRT (intensity-modulated radiation therapy) comparison plan provided showing that the IMRT (intensity-modulated radiation therapy) plan is inadequate in sparing the surrounding critical structures. IMRT (intensity-modulated radiation therapy) photon therapy is the standard of care for patients with prostate cancer that wish to undergo external beam radiation therapy. Proton beam radiation therapy is not considered medically necessary due to availability of other available treatment modalities and non-superiority of proton beam radiation therapy compared to other standard options.