Friday, October 21, 2005

APA Concerned About Formulary Restrictions

In this week's Psychiatric News:

Widespread misinterpretation of the results of the National Institute of Mental Health's Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) has led to concern that the study results could be used to restrict the availability of antipsychotic medications in Medicare or Medicaid formularies.

Data from the first phase of CATIE, which compared the effectiveness of four newer, more expensive second-generation antipsychotic drugs and an older, first-generation medication available in cheaper, generic formulations, were published in the September 22 New England Journal of Medicine (see story beginning on page 1). Reports in major daily newspapers across the country noted that the four newer medications compared with the first-generation antipsychotic, perphenazine, were found to be "no more effective or better tolerated." In fact, the study found significant differences in efficacy of one drug in particular, as well as differences in the tolerability of the five drugs studied.

The issue of restricted formularies in entitlement programs is particularly timely because the new Medicare Part D prescription drug benefit begins on January 1, 2006. Currently, Part D will pay for all of the newer, more expensive antipsychotics (Psychiatric News, July 15), and most state Medicaid programs have included open access to all antipsychotics. However, cost-control mechanisms have increasingly been used in the last three years. "From a public policy perspective, it would be a dire mistake to conclude that restricting access to any of the currently available antipsychotic medications, either by formulary limitations or by other means such as tiered pricing and `must fail' policies, is in the best interest of patients," said APA Medical Director James H. Scully Jr., M.D., in a letter to Mark McClellan, M.D., Ph.D., administrator of the Centers for Medicare and Medicaid Services (CMS).

"APA is concerned that some of CATIE's early findings have been erroneously interpreted and reported in the press as grounds for a restrictive formulary and utilization-review policy of medications based on cost rather than medical judgment," Scully wrote. "Critical facts have been lost," he continued. "The study demonstrated that all of these medications have substantial benefit, but none is without side effects." The study also showed, he added, that four times as many patients on the older, cheaper drug discontinued their medication because of extrapyramidal symptoms, compared with those taking newer medications. Indeed, Scully told McClellan, CATIE validated "clinicians' belief that to offer the greatest benefit and the least-adverse side effects for the individual patient, it is often necessary to try two or more medications." He concluded, "APA strongly urges CMS to continue to allow physicians and patients to work together to select a treatment plan that is most beneficial for the individual patient and not restrict access to the full range of medications based on arbitrary concerns and questionable reporting of data."

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