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Findings from 2 pivotal government-funded studies of comparative antipsychotic effectiveness undermine assumptions about the marked superiority of the more expensive second-generation “atypical” medications in comparison to the less expensive first-generation “typical” drugs. Because this assumption was the basis for the almost universal recommendation that these newer antipsychotics be used preferentially resulting in a 10-fold increase in state governmental expenditures on this class of medications over the past decade, a reassessment of policy is called for. To address the issue, the Medical Directors Council of the National Association of State Mental Health Program Directors critically reviewed findings of these studies in the context of other data and considered policy implications in the light of the obligations of state government to make available best possible and individually optimized treatment that is cost-effective. The Medical Directors Council unanimously adopted a set of recommendations to promote appropriate access, efficient utilization, and best practice use. We present our policy statement, in which we provide a succinct background, articulate general principles, and describe a set of 4 broad recommendations. We then summarize our understanding of the current state of knowledge about comparative antipsychotic effectiveness, best antipsychotic practice, and considerations for state policy that represent the basis of our position statement.
Over the past decade, there has been a significant change in patterns of antipsychotic practice, with the newer, more costly, and believed-to-be-more effective “atypical” agents replacing the older “typical” antipsychotic medications. While all these medications are Food and Drug Administration (FDA) approved for the treatment of schizophrenia in adults, where their use has been best studied, they are often utilized “off-label” for treatment of a wide variety of other conditions. (Some agents have additionally received FDA approval for other indications and/or populations). Although our review focuses on the use of antipsychotics in schizophrenia, many observations may also be relevant to the use of these agents in other conditions.
The recent publication of the findings of 2 major government-funded studies (Clinical Antipsychotic Trials of Intervention Effectiveness [CATIE], Cost Utility of the Latest Antipsychotic Drugs in Schizophrenia Study) of comparative antipsychotic effectiveness in schizophrenia has caused uncertainty among patients, clinicians, and policy makers about the relative utility of atypical and typical antipsychotic agents. To address the issue, National Association of Mental Health Directors (NASMHPD) medical directors critically reviewed the findings of these studies in the context of other data. Over the past 2 years, the Medical Directors Council repeatedly reviewed the evolving evidence, sought to understand the studies’ findings, and discussed policy implications. The principal investigator of CATIE (Jeffrey Lieberman, MD) participated in a full-day discussion of CATIE in July 2006. Subsequently, findings and implications were discussed at monthly medical directors’ conference calls and 3 additional NASMHPD Medical Directors Council meetings (October 2006, May 2007, and December 2007). Review drafts were provided to psychiatry researchers active in the field and their input considered and incorporated. Observations were also presented to the NASMHPD Commissioners in July 2006 and December 2007. It should be noted that the findings and recommendations are solely those of the NASMHPD Medical Directors Council, and nothing in this report should be construed as recommending a particular medication for use by individual patients. In our statement, we utilize commonly used colloquial terms (typicals and atypicals) for these first- and second-generation classes of antipsychotic medications.
Based on our review, we present the following summary of findings and set of recommendations. We first enumerate broad principles that should guide policy approaches to antipsychotic utilization and then discuss specific policy recommendations.
The following policy recommendations should be considered in light of the complexity of antipsychotic prescribing in clinical practice and the expectation for individualized treatment; they are not to be considered specific practice guidelines.
Antipsychotic medications should be available and utilized as clinically appropriate on an individualized basis. Efficacy, safety, tolerability, personal preferences and vulnerabilities, and cost considerations should guide antipsychotic selection. Given significant individual variability in response, ultimately all marketed antipsychotic medications should be available to patients who require treatment with them.
The cost of antipsychotic medications is an important factor, and controlling this cost will help to protect access. Cost-effective utilization of antipsychotic medications can be promoted in the context of an unrestricted “open formulary” or in the context of a preferred drug list (PDL); both these approaches have strengths and weaknesses.
The above policy recommendations should not be construed as support for policies of:
Differences in treatment outcomes are as dependent on how antipsychotic medications are prescribed and patient adherence to the medication as on differences between medications. Because actual clinical use of antipsychotic medications diverges widely from evidence-based practice, states should systematically promote best psychopharmacological treatment practices by utilizing a combination of approaches such as
Improving prescribing practices should be the major focus of any program to manage the utilization of antipsychotic medications. It has been our experience that improving the quality of antipsychotic prescribing saves funding that can then be redirected to other treatment needs.
There is often a significant lag between the identification of an important clinical question and the implementation of a well-designed study to address that question. In addition, there are often significant lags between conclusion of clinical trials and complete dissemination of all its findings and between the publication of important clinical trials and the translation of findings of that research into practice. There is a great need for independent, well-designed trials that address clinically relevant questions that can guide best practice regarding the use of psychiatric medications. The states, as guarantors of the public good and as the biggest payer for antipsychotic medications, have an obligation to ensure the timely conduct of pertinent clinical trials, independent of the pharmaceutical industry, that can guide the efficient and effective use of pharmacotherapy to promote individual recovery. Because existing mechanisms for research into these questions are inadequate, NASMHPD, in conjunction with Substance Abuse and Mental Health Services Administration, Centers for Medicare and Medicaid Services, National Institute of Mental Health, and other groups, should develop such a mechanism. It should be noted that the federal government and states collectively spend about 9 billion dollars per year on antipsychotic medications; we believe that it would be wise to invest a small percentage of that amount in ongoing, well-designed and impartial research on the appropriate use of these medications, including ways to maximize the principles put forth here.
Members of the NASMHPD Medical Directors Council—Stan Ardoin, MD; Alan Brevik, MD; Mary Brunette, MD; Howard Burley, MD; Charles Carlisle, MD; Kathleen Crapanzano, MD; Mary E. Diamond, DO; Ron Diamond, MD; Robert Eilers, MD; James Evans, MD; Mary E. Foti, MD; Elsie Freeman, MD; Gerard Gallucci, MD; Alexis Giese, MD; Thomas Gray, MD; Brian Hepburn, MD; Duane Hopson, MD; Roger Jackson, MD; Gayle Jordan-Randolph, MD; Penny Knapp, MD; Mike Lancaster, MD; Kenneth Marcus, MD; Shahid Masood, MD; Edward Maxwell Jr, MD; Andrew J. McLean, MD; William McMains, MD; Art Merrell, MD; Laurence Miller, MD; Laura Nelson, MD; Mary B. Ostrom, MD; Joseph Parks, MD; George Parker, MD; Richard Powers, MD; Alan Radke, MD; Brenda Ratliff, MD; Estelita Redding, MD; Stephen Robinson, MD; Patricia W. Singer, MD; Lloyd Sederer, MD; Blaine Shaffer, MD; William Sheehan, MD; Richard Spencer, MD; Steven Steury, MD; Dale Svendsen, MD; Rajiv Tandon, MD; Victor Torano, MD; James Vilt, MD; and Richard L. Wagner, MD. Parks is a consultant to and/or has received speakership honoraria from Comprehensive Neuroscience Inc, Eli Lilly Pharmaceuticals, Bristol Myers-Squibb, Jannsen, and Solvay Pharmaceuticals. None of the other authors report any relevant conflicts of interests within the past year. The senior author Tandon has, however, received speakership honoraria from and/or has provided consultation to Astra-Zeneca, Bristol-Myers Squibb, Eli Lilly, Janssen Pharmaceuticals, and Pfizer Pharmaceuticals within the past 5 years. This document was independently developed by the NASMHPD Medical Directors Council without any external funding or influence. The findings are solely those of the members of the NASMHPD Medical Directors Council and do not purport to represent the state governments that employ them or NASMHPD and its Board of Directors. The principles of practice and strategies for treatment contained in this document are not intended to define the standard of practice or care. The ultimate analysis and decisions regarding the specific course of treatment for any patient must consider all appropriate circumstances and factors, including the patient's condition, his or her diagnosis, the treatment resources available, and other relevant considerations, in order to reach an informed and individualized treatment decision.