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Empirical Data Used to Gain Coverage for Prostate Ca IMRT

Empirical Data Used to Gain Coverage for Prostate Ca IMRT

ABSTRACT: From the Volunteer Files of the Medical Care and Childhood Cancer Ombudsman Programs (MCOP/CCOP)

Evidence-based medicine is the key factor in gaining health plan approval of medical interventions. However, this is not the only option. This case study illustrates how empirical evidence can help gain approval of coverage for your patients despite a lack of clinical trial evidence. Make sure you cover all the angles in those situations where you, the clinical team, believe strongly that coverage of a certain treatment/service is warranted and is in the best interest of your patients. Remember, you are treading on the health plan's playing field, and in order to be successful, you must play by their rules. This does not mean that you cannot "beat" them at their own game.

Alfred is a 62-year-old gentleman with a long family history of enlarged prostate and prostate cancer. His urologist has followed him closely for an extended period of time, including four biopsies of the prostate over the past several years, all of which were negative. During one of these regular visits, tests disclosed that his prostate-specific antigen (PSA) level had risen to 30 ng/mL. A biopsy was subsequently performed, and adenocarcinoma was discovered. Alfred's highest Gleason score was 7. The staging work-up, which included a bone scan, films, and an MRI, did not show metastases.

After looking at all aspects of his work-up and history, his local oncologist concluded that Alfred fell into a poor-prognosis group requiring treatment. He received 81 Gy of external-beam irradiation in 45 fractions using intensity modulated radiation therapy (IMRT). This type of radiation therapy allows escalation of the radiation dose while sparing healthy surrounding tissue. To date, Alfred has had a good response.

The health plan, in response to a request for preauthorization of coverage, indicated that it would cover conventional radiotherapy or three-dimensional conformal radiotherapy (3D-CRT) for Alfred, but not IMRT, on the basis that it is experimental/investigational. The plan argued that the provider had not demonstrated the following:

1. That the IMRT plan would be superior to a 3D-CRT plan for Alfred.

2. That Alfred is in a subgroup of patients expected to benefit from radiation dose escalation by achieving improved biochemical disease-free survival. A review conducted for the health plan had pointed to study data showing that benefit would be more likely in patients with PSA levels under 10 ng/mL, as opposed to Alfred's PSA of 30 ng/mL.

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