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On the surface, these efforts may appear to make economic sense. But the risks are great to the health of millions of Americans who have severe mental illnesses, and to the welfare of society overall. Moreover, such measures could produce even greater economic burdens. Stopping the Threat to Recovery In the face of this very real threat, the National Alliance for the Mentally Ill (NAMI) is calling for an end to unnecessary restrictions on medications that treat severe mental illness. Throughout the country, NAMI consumer and family members are alerting state legislators, healthcare payers, the media, and the general public about the dangers inherent in such restrictions. NAMI members believe that professional judgment and informed consumer choice should determine the choice of medications to treat mental illnesses. Choice should be based on current knowledge of effectiveness and potential side effects and should be consistent with existing treatment guidelines.
Why the Newer Medications Matter As a physician and someone who has bipolar disorder, I know one size does not fit all. Individuals and their treatment partners must have the flexibility to find the particular medication and the specific dose that works for them. Suzanne Vogel-Scibilia, M.D. Severe mental illnesses are brain disorders that profoundly disrupt a person’s ability to think, feel, and relate to others and their environment. Left untreated, mental illnesses can have terribly destructive and costly effects, including unemployment, poverty, homelessness, criminalization, social isolation, and premature death. First-generation antipsychotic drugs, or "conventional" antipsychotic medications, were as revolutionary when they were discovered nearly 50 years ago as insulin was for diabetes or antibiotics were for infectious diseases. Drugs such as Thorazine and Haldol greatly eased psychotic, or positive, symptoms, such as hallucinations and delusions. These drugs allowed hundreds of thousands of patients to leave psychiatric hospitals and return to their communities. Limitations of these drugs, however, were significant. The older drugs didn’t help a range of serious problems, including the negative (apathy, withdrawal, lack of emotion), cognitive (comprehension, judgment, memory, and reasoning), and mood (depression) symptoms of severe mental illnesses. Side effects were a major problem. Many of these drugs triggered debilitating neurological side effects that were painful, humiliating, stigmatizing, and frequently permanent. More than half of the patients taking these older drugs had side effects ranging from uncontrollable muscle movements to total rigidity and difficulty swallowing. For many, the medication side effects were worse than the actual illness. A new generation of antipsychotic medications, called "atypicals," have been developed during the past 10 years. These medications have helped many people feel better and recover to an extent that had hardly been thought possible. Life became easier for many people with schizophrenia and other psychotic illnesses. The newer medications also work better on aspects of schizophrenia that do not respond well to the older medications, such as lack of motivation or problems with concentration. Finally, the side effects of the new medications are much easier to live with for most people than those of the older medications.
Cost Controls at the Expense of Mental Illness Recovery The cheapest medication may not offer the best value, especially if it means losing my job, ending up back in the hospital, or even dying. The total cost of care needs to be considered. Jim McNulty, President Concerned with escalating costs, both private and public-sector health plans have developed a variety of ways to restrict access to medications. Sometimes these policies may be appropriate to avoid the inappropriate use of drugs or to encourage the use of generic equivalents. But often the limitations are designed to discourage the use of more expensive medications, which are often the most effective. The two major cost-cutting measures used by health plans are restrictive drug formularies and fail-first policies
Restrictive drug formularies A drug formulary is a list of specific medications covered by a health plan. If a drug is not included on a health plan’s formulary, an individual can’t get it unless he or she pays for it out of pocket.
Other formulary considerations:
Fail-first policies Fail-first policies, also known as "step therapy," require a person to first take an older, less expensive medication. Only after failing on that drug, which might trigger a serious relapse, may that person be approved for a newer, more expensive—but more effective—medication. Controlling costs through fail-first approaches conflicts with most clinical treatment guidelines for mental illnesses. It is poor clinical care to delay the start of effective treatment and expose a person with mental illness to increased risks. As someone with schizophrenia, finding the right medication has been a critical component of my recovery. It’s a modern form of torture to give a medication with irreversible side effects when alternatives are available. Moe Armstrong, M.A., M.B.A.
A Clear Case for Newer Antipsychotic Medications In some parts of the country, we understand that healthcare systems will not routinely allow new patients to be started on atypical antipsychotic medications until they have failed a course of the standard (less expensive generic) antipsychotic medications. We see no scientific justification [emphasis added] for such a practice and consider it particularly ill advised since, for many people with schizophrenia, their first exposure to antipsychotic medication may have life-long implications for compliance with treatment. Steven E. Hyman, M.D., director, National Institute of Mental Health 8 First Choice of Medical Experts Most psychiatric treatment guidelines established by the nation’s leading medical societies recommend the newer atypical antipsychotic medications as the drugs of first choice in most situations for most consumers. 9,10 The reasons are two-fold:
It should be noted, however, that when someone has been clinically stable on an older antipsychotic medication for an extended period of time, the risks of changing his or her medication may outweigh the potential benefits of switching to a new one. Effective Management of Symptoms Medical doctors prefer to prescribe the newer medications because, overall, they do a better job of comprehensive symptom management and offer more hope for recovery. Multiple scientific studies back up this practice:
Furthermore, access to atypical antipsychotic medications is particularly important when the response to older antipsychotic medications has been unsatisfactory. 15,16 Less Troublesome Side Effects The side effects of the newer, atypical antipsychotic medications are generally less severe than those of the older drugs, so it is less likely that someone will stop treatment because of sedation, stiffness, abnormal movements, or lack of energy and interest. 17 Perhaps the most important aspects of this side-effect profile is the reduced risk of tardive dyskinesia, an irreversible and severely disabling movement disorder, and neuroleptic malignant syndrome, a potentially fatal side effect which is much less common with the atypical antipsychotic medications. 18,19
Greater Fiscal Sense Medications represent only a small part of the total treatment cost of serious mental illness. For example, in Michigan, drug therapy is only two percent of the direct medical costs for treating schizophrenia. 21 Over and above that, the newer medications are proving to be extremely cost effective. 22
Newer Antidepressant Medications Over the past decade, the selective serotonin reuptake inhibitor (SSRI) class of antidepressants has largely replaced the older and more problematic tricyclic antidepressants, based in large part on safety and side effect considerations. Steven E. Hyman, M.D., director, National Institute of Mental Health 27 First choice of medical experts. As with the atypical antipsychotic medications, it is widely recommended in clinical treatment guidelines that the newer antidepressant medications should be the drug of first choice in most situations for most consumers, or that at least both older and newer antidepressants be available as first-choice drugs. 28,29 Better or equal management of symptoms. Ample evidence exists that newer antidepressant medications are equally effective in treating depression as older antidepressant agents.30,31 In fact, many recent studies have demonstrated clear advantages of the newer antidepressant medications. For example:
Better side-effect profile. The side effects of the newer, atypical antidepressant medications are different and generally less troubling to the consumer than those of the older drugs. 36 Economic impact. In actual practice, the total treatment costs of newer antidepressants and older antidepressants are similar. Medication costs are higher, but costs of office visits and other medical care are reduced because dosage adjustment is simpler and side effects are less problematic. 37 Ensuring a Lifeline to Recovery People do so much better with these newer medications. Several years ago, I never would have dreamed we would be seeing the results and the recovery we are now witnessing with these remarkable advances in treatment. Peter J. Weiden, M.D., Co-Author People with severe mental illnesses and their families know—perhaps, better than anyone—that being denied recovery-enhancing medications can quickly unravel their lives, which depend on the best that science and medicine can offer. To ensure that these people are given the best hope for recovery, the National Alliance for the Mentally Ill (NAMI), through its Omnibus Mental Illness Recovery Act initiative, is calling for an end to unnecessary medication restrictions, an end to yet another form of discrimination against people with mental illnesses.
A Call To Action Specifically, NAMI is seeking national and state legislation that would require:
Beyond Formularies In addition to fighting restrictive drug formularies, NAMI is working to ensure access to critical medications denied in other ways:
Quality-of-care Concerns Continue While actively confronting medication restrictions, NAMI also is advocating for improved medical care with regard to medications. Major national studies highlight the disparity between treatment standards and actual medical practice.
About NAMI With more than 210,000 members, NAMI (National Alliance for the Mentally Ill) is the nation’s leading grassroots advocacy organization solely dedicated to improving the lives of families and persons with severe mental illnesses, including schizophrenia, bipolar disorder (manic-depressive illness), major depression, obsessive-compulsive disorder, and severe anxiety disorders. NAMI’s efforts focus on support to persons with serious brain disorders and to their families; advocacy for nondiscriminatory and equitable federal, state, and private-sector policies; research into the causes, symptoms, and treatments for brain disorders; and education to eliminate the pervasive stigma surrounding severe mental illnesses. NAMI has more than 1,200 state organizations and local affiliates in all 50 states, the District of Columbia, Puerto Rico, American Samoa, and Canada. Local NAMI support groups can be found in virtually any community throughout the United States. (Call the NAMI HelpLine for contact information.) NAMI Contact Information For more information about NAMI’s OMIRA initiative, please contact Clarke Ross, D.P.A., NAMI deputy executive director for public policy, at (703) 312-7894 or email clarke@nami.org. For information about access to newer medications, contact Rex Cowdry, M.D., NAMI medical director and deputy executive director for research at (703) 312-7887 or rex@nami.org. Extensive information about medications and related policy issues can be found on the NAMI Web site, www.nami.org. A New Medication Guidebook from NAMI NAMI has published, in partnership with W.W. Norton & Company, Inc., Breakthroughs in Antipsychotic Medications: A Guide for Consumers, Families and Clinicians. Written by four of the nation’s leading medical researchers and healthcare practitioners, this 200-plus-page book presents the most current science-based information about antipsychotic medications in an easy-to-understand format that can be used to help determine the best treatment options for a person with severe mental illness. For complete ordering information, visit the NAMI Web site, www.nami.org. NAMI THE EVIDENCE TO SUPPORT ACCESS * Complete supporting references and citations for published scientific studies marked with an asterisk are available on the NAMI Web site, www.nami.org. 1 U.S. Department of Health and Human Services. Mental Health: A Report of the Surgeon General. U.S. Public Health Service, 1999. 2 Fox Butterfield, "Hole in Gun Control Law Lets Mentally Ill Through," The New York Times, April 11,2000. 3 Duane Parke, DUR Program Manager, Utah Department of Health. July 15, 1999 letter to state's community mental health centers. 4 National Advisory Mental Health Council. Health Care Reform for Americans with Severe Mental Illnesses. National Institute of Mental Health, 1993. 5 The Lewin Group-SAMHSA. Health Plan Benefit Barriers To Access To Pharmaceutical Therapies for Behavioral Health: Findings. October 15, 1998. 6 FDA is the U.S. Food and Drug Administration, the federal agency that must approve the safety of a drug before it becomes legally available to the American public. 7 Newsweek. "Getting the Drug You Need." April 26, 1999. 8 Steven E. Hyman, M.D., Director, National Institute of Mental Health. January 16, 1998 letter to Sally Richardson, Director, Center for Medicaid and State Operations, Health Care Financing Administration. 9 McEvoy, J.P., Scheifler, P.L., Frances, A. Expert Consensus Guideline Series: Treatment of Schizophrenia 1999. Journal of Clinical Psychiatry 60 (suppl. 11): 4-83,1999. 10 Chiles, J.A., Miller, A.L., Crismon, M.L., et al. Development and implementation of the schizophrenia algorithm. Psychiatric Services, 50: 69-74, 1999; and Miller, A.L. et al., The Texas Medication Algorithm Project schizophrenia algorithm. Journal of Clinical Psychiatry (in press). 11 Keck, P.E., McElroy, S.L. The new antipsychotics and their therapeutic potential. Psychiatric Annals 5: 320-331, 1997. 12 Carpenter, W.T. Treatment of negative symptoms: Pharmacological and methodological issues. British Journal of Psychiatry 168 (suppl 29): 17-22, 1996. 13 Buchanan, R.W., Holstein, C., Breier, A. Comparative efficacy and long-term effect of clozapine treatment on neuropsychological test performance. Biological Psychiatry 36: 717-725, 1994. 14 Purdon, S.E. Cognitive improvement in schizophrenia with novel antipsychotic medications. Schizophrenia Research 35 (suppl): 51-60,1999; and Purdon, S.E., Jones, B.D.W., Stip, E., et al.: Neuropsychological change in early phase schizophrenia over twelve months of treatment with olanzapine, risperidone, or haloperidol (in press). 15 Kane, J.M., Honigfel, G., Singer, J., Meltzer, H.Y. Clozaril Collaborative Study Group: Clozapine for the treatment-resistant schizophrenic. Archives of General Psychiatry 45: 789-796, 1988. 16 Nine double-blind studies of atypical vs. standard antipsychotic agents in treatment refractory schizophrenia are reviewed in Bradford, D.W., Chakos, M.H., Sheitman, B.B., Lieberman, J.A. Atypical antipsychotic drugs in treatment-refractory schizophrenia. Psychiatric Annals 28: 618-626,1998. 17 Hansen, T.E., Casey, D.E., Hoffman, W.F. Neuroleptic intolerance. Schizophrenia Bulletin 23: 567-582, 1997. 18 Kane, J.M. Tardive dyskinesia. In Bloom, F.E., Kupfer, D.J., eds. Psychopharmacology: The Fourth Generation of Progress. New York: Raven Press, 1995, 1485-1495. 19 Tollefson, G.D., Beasely, C.M., Tamura, R.N. et al. Blind, controlled, long-term study of the comparative incidence of treatment-emergent tardive dyskinesia with olanzapine or haloperidol. American Journal of Psychiatry 154: 1248-1254,1997. 20 Sally K. Richardson, Director, Center for Medicaid and State Operations, HCFA. February 12, 1998 letter to state Medicaid directors. 21 Haveman, James K. "Access to Atypical Antipsychotics: A Public Payer's Perspective," as reported in Behavioral Healthcare Tomorrow, Tiburon, LA: Centralink, August 1998, pages 45-48. 22 Fichtner, C.G., Hanrahan, P., Luchins, D.J. Pharmacoeconomic studies of atypical antipsychotics: Review and perspective. Psychiatric Annals 28: 381-386, 1998. 23 Revicki, D.A. Pharmacoeconomic evaluation of treatments for refractory schizophrenia: Clozapine-related studies. Journal of Clinical Psychiatry 60(suppl. 1): 7-11. 24 Meltzer, H.Y., Cola, P., Way, L., et al. Cost-effectiveness of clozapine in neuroleptic-resistant schizophrenia. American Journal of Psychiatry 150: 1630-1638, 1993. 25 Texas Council of Community MHMR Centers. New Generation Drug Treatment: Upstream Help for Texans with Schizophrenia and Other Severe Mental Illnesses, December, 1988. 26 See endnote #1. 27 See endnote #8. 28 Crisman, M.L., Trivedi, M., Pigott, T.A., et al. The Texas medication algorithm project: Report of the Texas consensus conference panel on medication treatment of major depressive disorder. Journal of Clinical Psychiatry 60(3): 142-156, 1999. 29 Expert Consensus Guideline Series: Treatment of bipolar disorder. Journal of Clinical Psychiatry, 57(suppl 12A): 4-88, 1996. 30 Reviewed in Frazer, A. Antidepressants. Journal of Clinical Psychiatry 58 (suppl. 6): 9-25, 1997. 31 Workman, E.A., Short, D.D. Atypical antidepressants versus imipramine in the treatment of major depression: a meta-analysis. Journal of Clinical Psychiatry 54: 5-12, 1993. 32 Nierenberg, A.A., Feighner, J.P., Rudolph, R., et al. Venlafaxine for treatment-resistant unipolar depression. Journal of Clinical Psychopharmacology 6: 419-423, 1994. 33 Thase, M.E., Keller, M.B., Gelenberg, A.J., et al. Double blind crossover antidepressant study: sertraline versus imipramine. Psychopharmacology Bulletin 31: 535, 1995. 34 Multiple references available on request. 35 See endnote #1. 36 Simon, G.E., VonKorff, M., Heiligenstein, J.H., et al. Initial antidepressant choice in primary care: effectiveness and cost of fluoxetine versus tricyclic antidepressants. Journal of the American Medical Association 275: 1897-1902, 1996. 37 Ibid. 38 U.S. Department of Health and Human Services, Office of the Inspector General. Mandatory Managed Care: Early Lessons Learned by Medicaid Mental Health Programs. U.S. Department of Health and Human Services, January 2000. [OEI-04-97-00343]. 39 Lehman, A., Steinwachs, D., et.al. Patterns of usual care for schizophrenia: Initial results from the Schizophrenia Patient Outcomes Research Team (PORT) client survey. Schizophrenia Bulletin 24: 11-20, 1998. 40 Fallon Healthcare System, ComCare, and Rx Innovations case studies presented at the Institute for Behavioral Healthcare workshop, "Managing Mental Health Pharmaceutical Costs and Risk in Primary Care Settings," November 3, 1998, St. Louis, MO. 41 Ibid. 42 Ibid. 43 Ibid.
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