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.

Appeal Strategy

Alfred's family, while researching information to help them appeal this denial, came across the MCMC website (www.mcmcllc.com) and read about the MCOP volunteer program. MCOP was contacted for assistance and quickly put together a panel of experts, including specialists in prostate cancer and in interventional radiology. This case turned out to be one of challenging proportions.

The reviewers were in agreement on the absence of randomized controlled clinical trial data evaluating IMRT vs other radiation therapy techniques in this setting. The reviewers agreed that the recent literature on the use of IMRT in prostate cancer and the literature supporting the use of dose escalation with IMRT or 3D-CRT to achieve improved biochemical control with fewer side effects are reflected in the recent revisions of the standard oncology texts.

The bottom line is that even without evidence from gold standard trials, sufficient data have been reported to indicate that the IMRT approach is promising in prostate cancer, reduces toxicity, achieves local control in adenocarcinoma, and improves biochemical control. Empirical evidence of good biochemical control in Alfred's case provided a persuasive showing of benefit.

Resolution

That being said, the health plan's denial was based on the lack of gold standard data and the lack of information demonstrating that the patient would benefit more from IMRT than from 3D conformal radiation therapy alone. The health plan was reluctant to approve this care without such evidence and was particularly concerned about setting a precedent that could be overturned with later data.

The reviewers pointed out that IMRT could be approved in this case based on the empirical evidence of benefit. However, this was not the determinative factor in getting the plan's approval. Alfred and his family did some sleuthing regarding how the health plan handled similar cases and came up with two executive level employees with prostate cancer and high PSAs who had had their IMRT treatment approved at another treatment center. Uneven application of policy provisions always trumps denials!

Lessons Learned

• Health plans require evidence-based decisions for the most part in determining coverage, and prefer to base decisions on randomized trial evidence.
• In those situations where gold standard trials are not in place, if the patient's case is rare so that such trials are highly unlikely ever to be performed, the strength of existing evidence should carry the day.
• Please note that empirical evidence may be persuasive but is not a basis for coverage that most plans would accept unless the impact of coverage can be neutralized in terms of precedent; usually this is by extracontractual coverage for other reasons such as savings (if the intervention requested is cheaper) or an ambiguous provision in the contract interpreted this way because of a strong showing of patient benefit.
• Uneven application of contract coverage and exclusion criteria can always carry the day, but it can be difficult to discover and/or extract this language.