Access to Effective Medications: A Critical
Link to Mental Illness Recovery

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.

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.
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.

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

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.

• Closed formulary. A closed formulary is a plan that denies reimbursement for specific drugs or requires higher enrollee copayments for specific drugs, but not all drugs.

• Open formulary. An open formulary is a health-plan list that includes all FDA-approved drugs.⁶ Although "open," these formularies often include other cost-control measures to encourage the use of less expensive medications. For example, a plan may require a lower out-of-pocket payment (co-payment) by the enrollee for a generic drug than for a brand drug.

Other formulary considerations:

• Prior-approval requirement. As part of their formulary policies, health plans also may require pre-approval before an enrollee can get specific drugs.

• Appeals. Health plans may permit a formal appeal. The enrollee must convince the plan administrators to make an exception to approve a medication not included on the formulary. Depending on the plan, the process may be rapid and straightforward—or it may be convoluted, time-consuming, and futile.

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

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:

• The newer medications have been shown to be more effective in treating symptoms in some individuals.

• The side effects of the newer medications may cause fewer short-term and long-term problems.

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:

• The newer, atypical antipsychotic medications are at least as effective in treating the so-called "positive" symptoms of schizophrenia (such as hallucinations and delusions), when compared with older antipsychotic agents. ¹¹

• The newer, atypical antipsychotic medications are more effective in treating the "negative" symptoms of schizophrenia when compared with older antipsychotic agents. ¹² Cognitive functions also may improve to a greater degree on these newer medications.^13,14

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

• Decrease in clinical-care costs. The greater initial cost of atypical antipsychotic medications is more than recovered in the decreased costs of clinical care, particularly of fewer days of inpatient hospitalization.²³ In one study on treatment costs with the newer drugs, the net savings in total cost of care was $8,702 per patient per year.²⁴

• Greatest cost savings with most severe cases. For state health plans covering individuals with the most severe and persistent mental illnesses, providing the newer antipsychotics in combination with supportive community services results in the greatest cost containment, driven primarily by reduced hospitalizations. ²⁵

• No cost increases shown. Studies with different patient populations taking the newer antipsychotics show different levels of cost savings, but none show increased total costs of treatment.

• Decrease in indirect costs. Above and beyond the reduction in direct costs of care, there are significant financial benefits from returning previously disabled individuals to work through treatment with atypical antipsychotics.

• Potential, but costly, liability issues. Given the scientific evidence now available, denying access to newer medications may also present another major financial issue. A potential, but significant, legal cost looms when individuals, who started on the older drugs, develop persistent tardive dyskinesia or neuroleptic malignant syndrome. Presumably only one or two lawsuits of this sort could offset the difference between the cost of older antipsychotics and the newer atypical medications.

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:

• Newer antidepressant medications may be particularly important when the response to older antidepressant medications has been unsatisfactory.^32,33

• Newer antidepressant medications are more effective than classic antidepressants in treating other specific psychiatric disorders, including atypical depression, borderline personality disorder, obsessive-compulsive disorder, and certain other anxiety disorders than older antidepressant agents.³⁴

• The newer antidepressants are especially useful in the treatment of late-life depression because these agents are reported to have fewer anti-cholinergic (dry mouth, blurred vision, constipation) and cardiovascular side effects than the older medications. ³⁵

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.

A Call To Action

Specifically, NAMI is seeking national and state legislation that would require:

• Health plans to offer unrestricted access to all effective and medically appropriate medications and not to deny access to specific medications for mental illness.
• Health plans that use formularies to allow exceptions when a non-formulary alternative is medically indicated.
• Health plans to establish procedures for members to quickly appeal a medication-prescription decision and receive a prompt reconsideration.
• Health-plan medication appeals to comply with mandated third-party, independent, clinical review appeals procedures.
• Maintenance on an enrollee’s previously prescribed medication until the entire appeals process is completed. Further, health plans would not be permitted to require enrolled individuals to switch from medications that have been effective for them.
• Health plans to inform the public and potential enrollees about the plan’s pharmacy benefit, restrictions that may apply to the pharmacy benefit, and any other plan procedure that affects access to medications—prior to anyone enrolling in or renewing a health plan.

Beyond Formularies

In addition to fighting restrictive drug formularies, NAMI is working to ensure access to critical medications denied in other ways:

• Capitation rates. In agreement with the U.S. Department of Health and Human Services Office of the Inspector General, NAMI believes that combining a pharmacy managed care capitation with a mental illness treatment capitation should be prohibited.³⁸ Almost all capitations are inadequately financed. Combining the two, forces a trade off: medication, other clinical care, or support services. Such a trade off frequently results in treatment failure.

• Pharmacy-assistance programs. NAMI strongly endorses the enactment of state government pharmacy-assistance programs. Currently 17 states have these programs, but only seven offer assistance to non-elderly persons with disabilities. These programs are targeted to non-Medicaid-eligible persons, which eliminates a vast number of people with mental illnesses who will go without medication without such assistance.

• Burdensome co-payments. Where the law permits, NAMI seeks to ensure that co-payment obligations do not interfere with access to needed medications.

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.

• Only one-third of individuals with schizophrenia are receiving appropriate doses of medication. ³⁹

• Forty percent of depressed patients receive sub-therapeutic doses of medication. ⁴⁰

• Too few medical-management visits occur. ⁴¹

• Long-term medication monitoring is inadequate. ⁴²

• Substantial variation exists (by geographic location and between academic-based psychiatrists and non-academic-based psychiatrists) in prescribing practices for identical psychiatric disorders. ⁴³

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.

|

|