Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1:  The patient is a 52-year-old male diagnosed with adenocarcinoma of the prostate, Gleason grade 3+3=6/10, PSA 16.8, and clinical stage T1c, based on the August 2006 consultation. Two of four cores from the right side of the prostate were positive involving 10% to 12% of the biopsy specimen.  The pathology report did not indicate any other conditions such as benign prostatic hypertrophy (BPH) or chronic prostatitis. The metastatic workup included an MRI scan, bone scan, and CT scan of the pelvis with contrast. All were negative for evidence of metastatic disease. The consulting radiation oncologist recommended the combined treatment of photon and proton radiation. The Health Plan denied the patients request for referral to the facility offering proton beam radiation indicating there is insufficient evidence that this therapy is superior to traditional management of prostate cancer.The patients PSA, Gleason score and clinical stage would indicate an intermediate risk of recurrence. The NCCN Guidelines for intermediate risk patients with a life expectancy of greater than 10 years recommend either radical prostatectomy or radiation therapy (3D-CRT  brachytherapy). The principles of radiation therapy included in the Guidelines state that for improved PSA-assessed disease control, 3D conformal or IMRT techniques should be employed with a dosage between 75 Gy and 80 Gy. In this case, the non-Plan consultants recommendation was to start treatment with five weeks of conformal beam irradiation followed by a boost using proton beam irradiation. Current NCCN Guidelines do not include proton beam irradiation as the standard of care. Therefore, I have determined that the requested therapy is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.Physician 2:  This patient is a 52-year-old male who presented with a PSA of 16.82 and was diagnosed with prostate cancer in May 2006. Biopsy indicated a Gleason score of 6 (3+3) from the right side of the prostate and it was staged as T2 NX M0. The patient was started on Lupron in July 2006 and has continued with this medication. A metastatic work up that included a bone scan was negative; however both MRI and CT indicated prominence of the seminal vesicles. The patient has explored various treatment options and has selected photon radiation therapy in combination with proton beam radiation therapy as his treatment of choice. The Health Plan denied his request for authorization based upon a determination that proton beam radiation therapy is an experimental/investigation treatment.This patient has a 15% chance of pelvic lymph node involvement by Mac Roachs formula and an over 16% likelihood of involvement using Partins Table. Radiographic imaging did not exclude the possibility of seminal vesicle involvement. With due consideration of these facts, the non-Plan consultant has proposed external photon irradiation (25 treatments) to the entire pelvis followed by a proton beam boost (19 treatments) to the prostate. The record does not include current physical findings or a PSA level.  Nonetheless, external radiation to the pelvis with the option of an intensity modulated radiation therapy (IMRT) boost to the prostate should offer the patient as good a chance for cure as any other means including proton beam therapy. The dosages delivered with IMRT and proton beam therapy are generally the same.Based upon the information set forth above, I have determined that the requested therapy is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.Physician 3:  The patient is a 52-year-old male who was recently diagnosed with localized intermediate-risk adenocarcinoma of the prostate. He was seen by several specialty providers and was offered various options for treatment. The patient would like to pursue a combination of photon beam and proton beam radiation therapy as recommended by a consulting radiation oncologist at the non-Plan academic medical center. His request for authorization was denied by the Health Plan citing the experimental/investigational nature of the therapy.The patient was evaluated by multiple specialty physicians and advised as to the available treatment alternatives. He has requested treatment which includes proton beam radiation therapy in the hope that this therapy will increase tumor control and decrease his treatment related morbidity. A review of the literature showed no increase in tumor control with proton treatment and a higher incidence of late rectal complications. Currently, dose escalation can be accomplished using intensity modulated radiation therapy (IMRT). Image-guided radiation therapy (IGRT) using implanted markers can also improve the preciseness of the treatment. Thus, the available data does not establish that proton beam radiation therapy is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.