by ecancer reporter Janet Fricker

Changes to the Medicare reimbursement policy were associated with reduction in use of androgen-deprivation therapy (ADT) among men in whom the benefits were unclear, reports an article in the New England Journal of Medicine.

Androgen deprivation therapy, through orchiectomy or use of gonadotropin-releasing hormone (GnRH) agonists, has been the mainstay of palliation for men with prostate cancer. The US Government Accountability Office reported that physicians acquired GnRH agonists at an average of 82 % of the average wholesale practice, allowing considerable profits to be made.

The result was that during the 1990s overall use of ADT doubled, and by 1999 nearly half of all patients with prostate cancer received the therapy. The increase occurred principally among patients for whom therapy had unproven benefit. In 2004, however, introduction of the Medicare Modernization Act, led to changes in Medicare’s drug reimbursement policy that resulted in reimbursement being reduced to 85% of the average wholesale price.

Vahankn Shahinian and colleagues, from the University of Michigan, University of Texas, and University of Florida, hypothesized that given such drastic cuts in reimbursement; use of ADT would decline markedly for indications where there was limited evidence of efficacy.

Using the Surveillance, Epidemiology, and End Results (SEER) Medicare database, the investigators identified 54,925 men who had received a diagnosis of prostate cancer between 2003 and 2005.

The men were divided into three groups according to the strength of the indication for ADT use: defined as inappropriate use (consisting of scenarios where there was no reasonable expectation of benefit) appropriate use (consisting of scenarios where treatment was considered to be necessary on the basis of efficacy and limited alternative options) and discretionary use (where treatment was either of uncertain benefit because of insufficient evidence or based on evidence but with reasonable alternatives ).

Results showed that the rate of inappropriate use of ADT declined from 38.7% in 2003, to 30.6% in 2004, to 25.7% in 2005. Furthermore results showed between 2003 and 2005 a 28 % reduction in use of inappropriate ADT treatment.

There was, however, no decrease for appropriate use of adjuvant ADT (OR 1.01; 95% CI, 0.86 to 1.19), while there was a significant decline in discretionary use in 2005, but not in 2004.

“We found a substantial decline in the use of ADT in close association with reductions in reimbursement for GnRH agonists in 2004 and 2005,” wrote the authors, adding that financial incentives are most likely to have an effect on physicians’ behaviour in cases in which medical uncertainty exists, as opposed to cases in which care is life saving.

“..Reimbursement policies should be carefully considered to avoid providing incentives for care for which no clear benefit has been established. The extreme profitability of the use of GnRH agonists during the 1990s probably contributed to the rapid growth in the use of ADT for indications that were not evidence based,” wrote the authors.

Other influences that could have influenced prescribing, they added, included practice guidelines being published during the study period, ongoing clinical trials involving ADT, and increased recognition of the adverse effects of ADT.

Commenting on the story Dr Giovanni Codacci-Pisanelli from the European Institute of Oncology said: "On the face of it this article may be of less interest to European oncologists, not involved in Medicare, but the data it provides is certainly of interest. Reducing the financial incentive of drug use results in a reduction in improper prescriptions; the administration to patients more likely to benefit, on the other hand, is not affected.

This indication should be considered by European regulatory agencies: even on this side of the Atlantic.drug prescription sometimes seems to derive more from rewards to oncologists than from benefit to patients. Removing such incentives seems to have remarkable efficacy, and is apparently free from negative side effects."

Reference

V B Shahinian, YF Kuo and S M Gilbert. Reimbursement Policy and Androgen Deprivation Therapy for Prostate Cancer. N Engl J Med 2010; 363: 1822-32