
The past decade has seen an outpouring of new drugs introduced for the treatment of mental disorders. New medications for the treatment of depression and schizophrenia are among the achievements stoked by research advances in both neuroscience and molecular biology.
U.S. Surgeon General Report on Mental Health 1
Since 1990, remarkably effective medications have become available for the treatment of mental illnesses. The introduction of these medications represents an unprecedented turning point for the more than five million Americans who have severe mental illnesses and for their families.
New medications offer exciting new possibilities for full and productive lives for people with schizophrenia, bipolar disorder, major depression, and other severe mental illnesses. These treatments can mean the difference between hope and despair, recovery and struggle, even life and death.
Improved Effectiveness, Reduced Side Effects
The newer medications offer a number of advantages over the older drugs. For example, the "atypical antipsychotics" often produce superior outcomes by treating a broader range of schizophrenia symptoms. These medications also have a better side-effect profile and are less likely to cause serious movement disorders. Similarly, the newer antidepressants are equally effective in treating depression, treat a broader range of illnesses, are generally safer if taken in overdose, and have different side effects than the older drugs.
In short, access to the newer medications is vital to high quality care and mental illness recovery.
A Looming Crisis
Despite the newer medications’ promise of unparalleled recovery, an insidious tragedy is unfolding in this country. Far too many people with chronic mental illnesses are denied the newer, life-changing treatments.
States are stepping up efforts to restrict access to the newer medications. From coast to coast, state Medicaid agencies and their managed care agents have implemented or are considering cost-cutting measures that deny or delay access to the newer, most effective medications for treating serious mental illnesses.
|
A Dangerous Policy As doctors later acknowledged in reports related to the shooting [in Utah], Mellaril has strong side effects, and Ms. Duy suffered from increased agitation as well as rapid involuntary movement of her arms and legs. Besides, the medicine did not stop the voices, and so she often quit taking it. The New York Times, April 11, 2000 2 The older agents such as haloperidol or the phenothiazines will have to be the mainstay for most conditions, regardless of their higher incidence of side effects. Utah State Department of Health 3 |
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.
|
People with mental illnesses want sound medication decisions to be based on:
|
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.
Director, Beaver County Psychiatric Services, Beaver, PA
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.
|
Treatment Works Although far from being a cure, the newer medications have become a critical cornerstone of the illness-recovery process. Treatment Success Rates: 4
|
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
Manic-Depressive and Depressive Association of Rhode Island
Bristol, RI
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
|
Penny Wise, Pound Foolish A federally financed independent study concluded that formularies succeed at preventing access to excluded medications, but these savings "are usually more than offset by increases in spending experiences by other service sectors as a result of excluding an effective drug from coverage." 5 |
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.
Director, Consumer & Family Affairs
Vinfen Corporation, Cambridge, MA
|
Managed Care Restrictions Forty percent of managed care organizations use closed formularies. percent of managed care organizations use fail-first policies. 7 |
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
|
Federal Government Supports Access The U.S. Health Care Financing Administration now recommends that state Medicaid programs provide access to the newer, atypical antipsychotic drugs. 20 |
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
|
Thus, as a whole, there is evidence that the newer antipsychotics are more clinically advantageous than the older ones due the combination of their effective treatment of positive (and perhaps negative) symptoms, their treatment of ancillary symptoms such as anxiety and depression, and their more favorable side effect profile. U.S. Surgeon General Report On Mental Health 26 |
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
Breakthroughs in Antipsychotic Medications
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.
|
NAMI’s Blueprint for Recovery To stop the tide of neglect and discrimination toward individuals with severe mental illnesses, NAMI (the National Alliance for the Mentally Ill) has launched a national initiative to encourage state policymakers to replicate evidence-based interventions essential to recovery. The Omnibus Mental Illness Recovery Act (OMIRA) is model legislation that can make an immediate difference in the lives of individuals and families and in communities in every state throughout the nation. If fully implemented, this NAMI initiative will close the gap between what we know about treating severe mental illnesses and end the discriminatory policies that dismiss individuals with such disorders as second-class citizens and abandon them to prolonged and unnecessary suffering. |
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 Nation’s Voice on Mental Illness
Colonial Place Three
2107 Wilson Blvd., Suite 200
Arlington, VA 22201-30421
703/524-7600
NAMI HelpLine: 1(800) 950-NAMI [6264]
www.nami.org
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.
41 Ibid.
42 Ibid.
43 Ibid.
Copyright © 1996 - 2009 NAMI. All Rights Reserved.