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Special Section on Implications of CATIE   |    
Special Section on Implications of CATIE: NAMI Perspective on CATIE: Policy and Research Implications
Kenneth Duckworth, M.D.; Michael J. Fitzpatrick, M.S.W.
Psychiatric Services 2008; doi: 10.1176/appi.ps.59.5.537

The Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) was designed to assess effectiveness of antipsychotic medication for people with schizophrenia. The authors, who are administrators of the National Alliance on Mental Illness (NAMI), discuss CATIE and related policy and research studies and their implications. CATIE has answered some important questions for consumers and their families and raises many more. The prevalence of medical risk factors in the population with schizophrenia is an important part of advancing prevention. Poor adherence to medications randomly prescribed by CATIE physicians in a blinded procedure is also a key finding and points to the need for individually tailoring medication regimens. Policy makers may be tempted to oversimplify the results of CATIE by restricting access to the costlier second-generation medications. However, doing so will hurt clinical care, and any savings to state and community mental health programs may be illusory. Policy can be constructed to focus on clinical outcomes and not merely restrict access to medications on the basis of cost. Research is urgently needed on a new generation of medications with benign side effects and greater efficacy than their predecessors for people with schizophrenia. (Psychiatric Services 59:537—539, 2008)

Abstract Teaser
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Dr. Duckworth is medical director and Mr. Fitzpatrick is executive director of the National Alliance on Mental Illness, Colonial Place Three, 2107 Wilson Blvd., Suite 300, Arlington, VA 22201 (e-mail: ken@nami.org). This article is part of a special section on the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) and its implications. Marvin S. Swartz, M.D., served as guest editor of the special section.

From the perspective of the National Alliance on Mental Illness (NAMI), the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) addressed some important questions and raised many more. NAMI is the nation's largest family and consumer advocacy organization for persons with serious mental illnesses. Improving access to the best treatment, rehabilitation services, and support is a core NAMI value. Although perhaps not representative of all families and consumers affected by severe mental illness, the NAMI perspective is an important starting point for family and consumer reflections on the CATIE study.

Concerns about access to medication are of particular concern because of the general poor organization and financing of integrated comprehensive treatment for persons with schizophrenia. The 2003 report of the President's New Freedom Commission on Mental Health observed that the mental health care system is a "system in shambles" (1). In 2006 NAMI published Grading the States: A Report on America's Health Care System for Serious Mental Illness (2), which had 39 specific grading criteria and found the national average grade to be a D. Given these troubling deficits in treatment, for many persons with schizophrenia, antipsychotic medications may be the sole form of treatment that is consistently provided.

We know from our NAMI members that access to the best medicine for the individual is an essential building block for recovery. We have first-hand information from them that "one size does not fit all" when it comes to antipsychotics and other medications. In CATIE, random and blinded assignment of antipsychotic medications to people chronically ill with schizophrenia was associated with poor treatment adherence and suboptimal outcomes. This finding suggests that treatment needs to be optimally tailored to the individual. It also reminds us that we need to focus research on improving treatment adherence across treatment regimens.

From the CATIE study it is also clear that medications can have different and troublesome side effects. This is essential information to share with consumers and family members. NAMI does not endorse specific medicines or courses of treatment but firmly believes that individuals should get the best treatment they can. We now recognize a troubling tradeoff between tardive dyskinesia—more prevalent with first-generation antipsychotics—and metabolic risks, which are most prominently associated with many of the newer medications. The metabolic risks of second-generation antipsychotics are alarming and require urgent action and research. Diabetes and obesity compound the cardiac risks inherent in the population with severe and persistent mental illness. And elevated levels of smoking, inadequate medical care, and depression all increase the risk of early cardiac problems.

An overlooked finding in the CATIE study is its confirmation that the prevalence of medical risk factors is very high among persons who live with schizophrenia. NAMI has advocated for years for integrated medical care, better access to prevention of cardiovascular disease, and healthy lifestyle promotion. In 2002 NAMI developed its Hearts and Minds program (www.nami. org/heartsandminds). Along with a recent study by the National Association of State Mental Health Program Directors (3) on early mortality, CATIE has advanced awareness of the serious medical risks associated with living with a mental illness. We need a culture that attends to mind and body alike, in preventive and integrated ways. NAMI Walks, a fundraising walk to raise public awareness, promotes a culture of activity across the nation, and NAMI presses the states on health disparities and promotion in its Grading the States report. The field of mental health services has a long way to go in these areas.

CATIE has fueled an ongoing national policy debate about access to medications. Formularies often restrict access, restrictions limit pharmacy costs (although often not other costs), and first-generation antipsychotics cost less than newer agents. Although CATIE has found that patients may adhere to a first-generation medication regimen just as poorly as a second-generation one, the fact remains that there are individual differences among patients. Antipsychotic medications are not interchangeable. Unfortunately, instead of considering that patients differ in individual needs, preferences, and physical health status, policy makers who are under financial pressure may be tempted to impose restrictions on medication access simply on the basis of media accounts that have oversimplified the CATIE findings.

CATIE was not designed to address important policy issues, such as treatment for patients experiencing their first psychotic episode, people with co-occurring substance abuse disorders, and the importance of psychosocial interventions—such as assertive community treatment—in adherence and outcomes. The study did not address issues of matching compounds to alleviate individual side effects, satisfy individual preferences, or account for family histories of response to their family member's mental illness.

Untested policies, such as drug formulary restrictions, may create illusory savings, as found in Kentucky (4), and cost shifting to emergency services and hospitals, as found in New Hampshire (5). For many states, the long-term cost savings from restrictions on medication access may be considerably less than hoped for.

NAMI endorses cost-saving strategies that are intended to address medication choices in clinically informed ways. For example, Massachusetts instituted a prior-authorization procedure for two situations: the simultaneous use of two second-generation antipsychotic medications and for the fifth psychiatric medicine prescribed (6). Feedback to physicians about their prescription patterns appeared to save money and improve care, although more definitive evaluations of such programs are urgently needed.

Similar results were achieved in Missouri, where a mental health-Medicaid partnership of state agencies has collaborated with a private company called Comprehensive NeuroSciences in a voluntary program for doctors. The company organizes data on physician prescriptions to identify outliers and incidents of duplicate prescribing. The state communicates with physicians by letter and can even provide consultation to some physicians. The program was reputed to have saved $7.4 million annually and to have reduced inpatient hospitalization by 50% (7), but additional evaluations of this and similar programs are under way.

If research on the effectiveness of medications is still in its infancy, then knowledge about the impact of cost-management strategies is even less developed. For example, there is little empirical literature about the impact of restricted formularies on clinical outcomes, such as when and under what circumstances prior-authorization policies are both clinically and economically sound. Given this uncertainty, the guidance from the federal Centers for Medicaid and Medicare Services has warned against simple fail-first strategies, wherein patients must fail an initial, typically less costly regimen to receive a more expensive one (8).

Very few quantitative or qualitative studies have evaluated the impact of recent decisions from individual states about access to medications—particularly in state Medicaid programs. NAMI urges states to conduct such studies in order to develop a body of literature that can inform states nationwide—and help confront rising costs through best practices in public policy.

When states make changes in policies regarding access to medications without seeking intensive consumer and family participation, we know that the system change may not work, as occurred in Michigan's early prior-authorization program. For example, the state implemented formulary restrictions without a stakeholder consensus and later reversed the decision. NAMI strongly believes that traditional "policy takers"—consumers and family members—need to be at the table when all access issues are discussed, including pharmacy decisions. Decisions need to be grounded in realities of personal experience to achieve a truly consumer- and family-driven system.

"Choice" and "access" are words that people living with schizophrenia have rarely heard spoken. That is a mistake. Medications represent a foundation for many consumers to create and enhance a recovery. Consumer knowledge, experience, and preferences must be considered.

Policy makers should always keep in mind that the effects of medication, good or bad, and the consequences of public policy affect the lives of consumers and family members every day. Simplistic fail-first policies and other unsophisticated restrictions ultimately are expensive in terms of simple human suffering and do not support a vision of personalized medicine.

CATIE has confirmed another core concern: persons with severe mental illness need a new generation of medications and interventions to improve adherence to treatment. There is an urgent need for medications that have benign side effects but powerful effects on the positive and negative symptoms of schizophrenia, as well as cognition. Fortunately the National Institute of Mental Health has increasingly been aligning its funding stream to address the public health burden of major mental illnesses. But there is still a long way to go, and current funding trends at the National Institutes of Health overall are troubling and dramatically impede this important quest.

CATIE has underscored the need for long-term studies, although we acknowledge that they are expensive and difficult to mount. People live with schizophrenia for decades—if they are fortunate. A long-term study that lasts 18 months, which CATIE represents, will not pick up most of the cases of tardive dyskinesia and will not tell us the outcomes of cases of diabetes developed while taking antipsychotic medications. There is an urgent need to follow a large cohort of individuals with severe mental illness over time, as done with the Framingham Heart Study. We need to study long-term disabling illnesses over decades in order to better understand predictors of both recovery and early death.

CATIE also reflects the importance of research on medication adherence. Schizophrenia presents special challenges. About half of people with the disorder are not likely to be adherent using ordinary strategies, because they cannot and do not recognize that they are ill. We urgently need studies on how adherence may be improved through reduced side effects, assertive community treatment programs, creative forms of outreach, clinician alliances, leverage strategies, and, when absolutely needed, the best practices of involuntary outpatient commitment. These are crucial questions that affect people's everyday lives.

The prevalence of medical risks associated with treatment of schizophrenia is a devastating truth that patients and their families face. CATIE has helped to draw attention to this research vacuum. There is a profound need for research into ways to prevent metabolic side effects, integrate medical care, and foster better lifestyles for people with psychotic disorders.

Finally, matching to the individual the many compounds now available to create tailored intervention is a long way off. Genomic information—predicting who may develop what side effects—is a novel tool of compelling interest but is hardly well developed. There is an urgent need for science-based information about tailoring medication to the individual.

Despite CATIE's shortcomings, its findings sharpen our medical vision. More research is needed. We need genomic knowledge, long-term studies, keys to greater adherence, better medications, and reduction of risks associated with medication. These are all critical keys to helping people recover from the profound challenge that is schizophrenia.

CATIE was supported by grant N01-MH-90001 from the National Institute of Mental Health. A list of study locations and principal investigators can be found at www.catie.unc.edu/schizophrenia/locations.html.

The authors report no competing interests.

Achieving the Promise: Transforming Mental Health Care in America. Pub no SMA-03-3832. Rockville, Md, Department of Health and Human Services, President's New Freedom Commission on Mental Health, 2003
 
Honberg R, Duckworth K, Carolla B, et al: Grading the States: A Report on America's Health Care System for Serious Mental Illness. Arlington, Va, National Alliance on Mental Illness, 2006. Available at www.nami.org/grades
 
Parks J, Svendsen D, Singer P, et al: Morbidity and Mortality in People With Serious Mental Illness. Alexandria, Va, National Association of State Mental Health Program Directors, Program Directors Council, Oct 2006. Available at www.nasmhpd.org/generalfiles/publications/meddirectorspubs/technical%20report%20on%20morbidity%20and%20mortaility%20-%20final%2011-06.pdf
 
Talbert J: Impact of Prior Authorization for Zyprexa: Kentucky Medicaid Program. Lexington, Ky, University of Kentucky, Martin School of Public Policy and College of Pharmacy, Nov 2003
 
Soumerai S, McLaughlin TJ, Ross-Degnan D, et al: Effects of a limit on Medicaid drug reimbursement benefits on the use of psychotropic agents and acute mental health services by patients with schizophrenia. New England Journal of Medicine 331: 650—655, 1994
 
Duckworth K, Hanson A: Using a clinical and evidenced-based strategy to preserve access to psychiatric medications. Psychiatric Services 53:1231—1232, 2002
 
Silver and Bronze Achievement Awards. Psychiatric Services 57:1527—1529, 2006
 
Psychotropic Medications: Addressing Cost Without Restricting Access. Technical Assistance Paper. Baltimore, Centers for Medicare and Medicaid Services, Aug 20, 2004. Available at www.cms.hhs.gov/promisingpractices/downloads/psychotropicmeds.pdf
 
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References

Achieving the Promise: Transforming Mental Health Care in America. Pub no SMA-03-3832. Rockville, Md, Department of Health and Human Services, President's New Freedom Commission on Mental Health, 2003
 
Honberg R, Duckworth K, Carolla B, et al: Grading the States: A Report on America's Health Care System for Serious Mental Illness. Arlington, Va, National Alliance on Mental Illness, 2006. Available at www.nami.org/grades
 
Parks J, Svendsen D, Singer P, et al: Morbidity and Mortality in People With Serious Mental Illness. Alexandria, Va, National Association of State Mental Health Program Directors, Program Directors Council, Oct 2006. Available at www.nasmhpd.org/generalfiles/publications/meddirectorspubs/technical%20report%20on%20morbidity%20and%20mortaility%20-%20final%2011-06.pdf
 
Talbert J: Impact of Prior Authorization for Zyprexa: Kentucky Medicaid Program. Lexington, Ky, University of Kentucky, Martin School of Public Policy and College of Pharmacy, Nov 2003
 
Soumerai S, McLaughlin TJ, Ross-Degnan D, et al: Effects of a limit on Medicaid drug reimbursement benefits on the use of psychotropic agents and acute mental health services by patients with schizophrenia. New England Journal of Medicine 331: 650—655, 1994
 
Duckworth K, Hanson A: Using a clinical and evidenced-based strategy to preserve access to psychiatric medications. Psychiatric Services 53:1231—1232, 2002
 
Silver and Bronze Achievement Awards. Psychiatric Services 57:1527—1529, 2006
 
Psychotropic Medications: Addressing Cost Without Restricting Access. Technical Assistance Paper. Baltimore, Centers for Medicare and Medicaid Services, Aug 20, 2004. Available at www.cms.hhs.gov/promisingpractices/downloads/psychotropicmeds.pdf
 
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