Appeal type: Surgery
Decision: Unfavorable

We decided that the Plan does not have to pre-approve proton beam radiation therapy (PBRT) for treatment of
prostate cancer.

You asked the Plan to pre-approve the requested PBRT. You say that PBRT would be preferable to other
radiation treatments because it reduces radiation exposure to nearby tissues which leads to better outcomes.
The Plan denied your request. The Plan says the literature does not clearly support that PBRT leads to better
outcomes for prostate cancer patients over standard IMRT.

The Plan must follow Medicare rules. Medicare rules say that items and services that are not medically
necessary are not covered.

We asked our physician reviewer to carefully review the case file and apply the relevant Medicare rules to
determine if the Plan was correct in denying the request to pre-approve the requested PBRT. Our reviewer says
that the requested items/services are not considered medically reasonable and necessary in this case. Our
physician reviewer found whether proton therapy (in general) affords any benefit over conventional radiation
therapy is a heated issue, with quite disparate opinions among experts in the field. Specifically, for prostate
cancer, there is controversy regarding the claim that PBRT would always lead to less radiation toxicity to the
rectum. In fact, a study published in Journal of the American Medical Association shows that proton therapy
has resulted in a greater risk of gastrointestinal toxicity versus intensity-modulated radiation therapy (IMRT).
Another study based on a Medicare database compared prostate IMRT with proton therapy; they concluded that
"there was no difference in toxicity in a comprehensive cohort of Medicare beneficiaries with prostate cancer at
12 months post-treatment."

Some assert that that proton therapy could lower the risk of second, radiation-associated, malignancies. IMRT
does result in a greater deposition of low dose to normal tissue, which theoretically increases the risk of second
malignancies. While proton therapy reduces the low dose deposition, proton therapy results in a greater dose
rate and appreciably more neutron exposure (compared to essentially none with IMRT), and thus the benefit of
protons over IMRT in reducing radiation-associated malignancies is controversial. In a study examining dose
delivered to a phantom (i.e., model of a patient), in which only 5 prostate cancer cases were analyzed, the
authors concluded that the "estimated secondary cancer risk using scattering mode in proton therapy is either
significantly lower than the cases in IMRT treatment or, at least, does not exceed the risk induced by
conventional IMRT." In another study of 1116 patients (matched pair of 558 patients treated with proton
therapy) the risks of 2nd malignancies in prostate cancer survivors was not greater among those treated with
proton therapy, and a decreased risk was not seen (for which longer follow-up was needed to ascertain).

The American Society of Radiation Oncology (ASTRO) released guidelines regarding the use of PBRT for
prostate cancer in which it indicates that it should not be routinely recommended outside of clinical trials, and
states that "there is no clear evidence that proton beam therapy for prostate cancer offers any clinical advantage
over other forms of definitive radiation therapy. Clinical trials are necessary to establish a possible advantage
of this expensive therapy."

Overall, any potential benefit or detriment of proton therapy over standard IMRT is an investigational question.
Other treatment approaches (IMRT +/- image-guided radiotherapy (IGRT)) are also highly effective and well
tolerated. Thus, whether proton therapy affords a benefit over other standard approaches (IMRT/IGRT) for
prostate cancer is an area of investigation and remains controversial. To date, there are no compelling data to
suggest that proton therapy is superior to or more beneficial than IMRT/IGRT. The generally accepted standard
of care for prostate cancer is to only offer proton beam therapy on clinical trials, and to not routinely offer it to
patients. As such, the requested PBRT would not be considered reasonable and necessary in this case.

We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that
Medicare rules for coverage of the requested PBRT have not been met. Therefore, we decided that the Plan
does not have to pre-approve proton beam radiation therapy (PBRT) for treatment of prostate cancer.