Chapter I Table of Contents Chapter III

Access and Utilization of New Antidepressant and Antipsychotic Medications

Chapter II. Principal Findings

As discussed in the introduction, the present study was guided by three principal questions about the status of pharmaceutical benefits for psychotherapeutic medications. We consider each of these questions in turn.

What are the formal policies and procedures implemented by health care payers that affect consumer access to and utilization of psychiatric medications? Are these policies and procedures different for psychiatric medications than for other medication classes?

The present research indicates that psychotherapeutics are covered on an equal basis with pharmaceuticals of other classes. No evidence of selective application of more restrictive utilization controls, prior authorization requirements, or restrictive formularies was found. These problems appear to have existed in the past, but the policies have been changed in recent years. A few health care payers require that a psychiatrist prescribe psychotherapeutic drugs. Usually this restriction, where it exists, applies only to antipsychotic medications.

How does the implementation of these policies and procedures affect access to and utilization of these medications?

The assertion that access to newer psychotherapeutics is impeded by the implementation of managed care policies and procedures is difficult to substantiate. The evidence from analysis of pharmaceutical claims suggests that, as a group, new generation antidepressant and antipsychotics have diffused into common use at approximately the same rate as have new generation pharmaceuticals in other classes.

However, few healthcare payers have implemented programs to pro-actively facilitate the diagnosis and treatment of mental illness. Fewer still have attempted to measure the outcomes of mental health interventions. The modest programs to support these goals may suggest that the implementation of policies and procedures acts to inhibit access to and utilization of psychotherapeutic medications by consumers who would benefit from them in a more general way. This problem is not specific to the utilization of pharmaceuticals, but reflects a general need for more efforts in providing mental health services.

Do policies, procedures, and modes of implementation (regardless of whether they differ for mental health) create barriers to adequate mental health care even if similar policies, procedures, and modes of implementation do not create similar barriers for adequate care for other conditions?

The concerns of consumers, advocates, and providers suggests that the barriers that are in place to regulate utilization of medications of all classes may be too burdensome for mental health consumers and their providers to navigate effectively. Consumers requiring mental health care may have greater difficulty than some others in asserting their needs and entitlements within complex administrative systems. However, it is possible that a number of other consumer populations with long-term, debilitating conditions would find utilization controls imposed by health care payers difficult to navigate as well. However, the degree to which the mental health services system is burdensome to its consumers has not been compared in any systematic way to the burden imposed by physical health systems on patients with other long-term debilitating conditions.

The impact of pharmaceutical utilization controls or cost-sharing requirements on mental health consumers who may have concurrent physical illnesses is likely to be more severe than it is for consumers without mental illnesses. Mental health consumers are more likely to exceed quantity limits and incur higher dollar amounts in cost-sharing than are other consumers for this reason. This may force the consumer or provider to make a choice between filling a prescription to treat the physical illness and filling a prescription to treat the mental illness. This problem is compounded because providers of mental and physical health services may not be fully aware of all concurrent medications the patient requires. The lack of coordinated care increases the potential for adverse drug interactions, even as it may increase the complexity of how to coordinate care to assure that the patient receives all necessary treatments. This problem is an interesting area for possible exploration.

A. Access to Newer Antidepreseant and Antipsychotic Medications

  1. Pharmaceutical Benefits

    Pharmaceutical benefits are commonly available for psychotherapeutic agents.

    Limits on prescription coverage and cost sharing requirements apply equally to all classes of medications.

  2. Patients are not routinely forced to change medications when the transitioning between treatment settings (e.g., inpatient to outpatient) because of formulary restrictions, or when transferring among payers.

    Credentialling of prescribers is relatively rare and operates almost exclusively in the private sector.

  3. Formularies

    Manufacturers, providers and consumers concur that formularies are no longer restricting access to newer psychotherapeutic agents

    The concept of "open, closed, or restricted" formulary is changing in meaning and is not an accurate depiction of access.

    Plans with closed formularies may take active steps to enforce the formulary. These may include:

    Effectiveness and cost are the most frequently cited barriers to formulary approval. The relative importance of each of these factors depends on the class of drugs and particular interest of an individual health plan.

    Newer antidepressant and antipsychotic medications have attained formulary status in most of the programs surveyed in this study.

  4. Prior Authorization
  5. Provider and consumer associations interviewed report that prior authorization and paperwork requirements are now the primary barrier to access.

    Antipsychotics no longer require prior authorization as a matter of policy. However there are some restrictions at the facility (community) level. PA may be more common for antidepressants.

  6. Step Care

    Traditional step care protocols, whereby patients are required to try an older generation agent prior to obtaining approval for reimbursement of a newer one, have largely disappeared.

    Currently, it is more common for payers to designate one or two preferred pharmaceuticals chosen from the newer agents. Patients must first experience a treatment failure on a preferred agent prior to being reimbursed for a non-preferred agent.

B. Utilization of Antidepressant and Antipsychotic Medications

  1. Treatment Guidelines and Preferred Medications

    HCFA(now known as CMS) does not instruct States on the choice of appropriate medications for use in specific illnesses. However, HCFA(now known as CMS) did request that States make atypical antipsychotics available for first-line treatment of schizophrenia if requested by physicians.

    State Medicaid and State Mental Health programs have not widely adopted treatment guidelines for depression or schizophrenia. This situation has begun to change somewhat with the advent of Medicaid Managed Care.

    There is no consensus on the best first line agents for the treatment of schizophrenia or depression among private payers.

  1. Clinical Development and Marketing

    Manufacturers express no bias against developing a new drug for mental health indications in comparison with physical health indications.

    The MCOs and PBMs interviewed reported that traditional clinical trials are of relatively short duration and measure outcomes using instruments not readily translatable into regular clinical practice, such as standardized psychiatric rating scales.

    Manufacturers devote considerable effort to marketing psychotherapeutics to physicians and patients, although tactics vary. The extent to which marketing efforts affect sales success has not been quantified.

    Although it is generally assumed that manufacturer contracts and rebates may affect drug utilization, no data exists to support this idea, largely because such data are considered trade secrets.

  2. Utilization Management

    All of the payers interviewed maintain some form of drug utilization review (DUR) program.

    Monitoring of psychotropic medications occurs no differently than for other classes of pharmaceuticals and tracks duplication, overuse, under-use and possible drug interactions.

  3. Provider and Patient Compliance

    Programs that monitor patients for compliance with therapy or providers for compliance with treatment guidelines are in their infancy.

The patient-targeted programs that do exist do not generally take into account cultural differences in populations that may affect the success of these programs.

The management of patients who become severely mentally ill is not uniform across service sectors. There are few special programs for these patients.

C. Utilization of Newer Antidepressant and Antipsychotic Medications by State Medicaid Programs 1995-1998

New generation antipsychotics and antidepressants have been accepted into common use within Medicaid programs.

The introduction of atypical antipsychotics and new-generation antidepressants has been accompanied by a growth in the total market for antipsychotics and antidepressants in Medicaid. Antidepressants and antipsychotics account for nearly 9% of Medicaid pharmaceutical prescriptions and nearly 19% of Medicaid pharmaceutical reimbursements. New-generation antidepressants and antipsychotics have been accepted into common use by Medicaid programs at about the same rate and to the same extent as other innovator drugs.

  1. Utilization of Antipsychotics

    In 1998, 51% of all Medicaid prescriptions for antipsychotics were for atypical antipsychotics. Expenditures on atypicals accounted for 89% of total spending on antipsychotics.

    The use of atypical antipsychotics in Medicaid has grown dramatically since 1995. Concomitantly, the use of antipsychotics as a class has grown by 20% since 1995.

    Expenditures on antipsychotics have vastly outpaced the growth in number of prescriptions.

    In several high-volume States (FL, IL, MA, MD, MI, PA) risperidone has become the most frequently prescribed class of antipsychotic, outpacing the national averages.

    The uptake of newer antipsychotic agents into Medicaid immediately post-launch has been rapid.

  2. Utilization of Antidepressants

    In 1998, 62% of antidepressant prescriptions were for new-generation, branded antidepressants.

    The use of new-generation antidepressants in Medicaid grew dramatically between 1995 and 1998. As with antipsychotics, the growth in use of newer antidepressants rapidly outpaced the replacement of older agents.

    Medicaid expenditures for antidepressants outpaced the rate of growth in number of prescriptions between 1995 and 1998.

  3. Comparison of Psychotherapeutic Utilization with Utilization of Other Drug Classes

    New-generation antidepressants and antipsychotics have been accepted into common use by Medicaid programs at about the same rate and to the same extent as other innovator drugs.

D. Cost-Effectiveness of Newer Antidepressant and Antipsychotic Medications

  1. Cost-Effectiveness of Newer Antidepressants

    Published cost-effectiveness literature shows no clear differences in total treatment costs associated with the use of different antidepressant agents, although individual studies have claimed that one particular agent is superior to another.

    The clearest result from these studies is that patient compliance with the newer antidepressants is considerably better than with TCAs. For this reason, the newer antidepressants may be more cost-effective than the older antidepressants.

    These studies indicate that reliance on older generation antidepressants as preferred therapy is unlikely to realize any cost-savings if total health-systems costs are to be included. As a result the exclusion of new generation antidepressants on cost grounds cannot be justified.

  2. Cost-Effectiveness of Newer Antipsychotics

    Evidence from the pharmacoeconomic literature shows that treatment using the new antipsychotics exhibits economic advantages over treatment using the older antipsychotics. This evidence for olanzapine and clozapine is superior to the corresponding evidence for risperidone.

    The results of numerous studies together provide strong evidence of clozapine's superior cost-effectiveness relative to older, typical antipsychotics in treatment resistant schizophrenia.

    The paucity of well-designed studies precludes drawing any conclusions regarding relative pharmacoeconomic differences among atypical antipsychotics.

 

References


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Last updated August 20, 2000