Access and Utilization of New Antidepressant and Antipsychotic Medications. Public Program Guidelines

01/01/2000

The Health Care Financing Administration(now known as Centers for Medicare and Medicaid Services(CMS)) does not in general instruct States on the choice of individual pharmaceutical agents for inclusion in formulary or treatment guidelines. However, HCFA(now known as CMS) has sent a letter to State Medicaid Directors urging the coverage of atypical antipsychotics as first line agents for the treatment of schizophrenia.25

In general, State Medicaid and State Mental Health programs have not adopted treatment guidelines for depression or schizophrenia. This situation has begun to change somewhat with the advent of Medicaid Managed Care. The outstanding example of treatment guidelines in development and implementation are those developed by the Texas Medication Algorithm Project (TMAP), which is being conducted in four phases.34 In Phase I, algorithms for schizophrenia, depression, and bipolar disorder were developed.

The algorithm for the treatment of nonpsychotic depression makes treatment recommendations for six stages of therapy. In Stage I, the algorithm recommends monotherapy with an SSRI, bupropion, nefazadone, venlafaxine or mirtazapine. In Stage II (after partial or nonresponse), the algorithm recommends trying either a different medication from the Stage I list or a TCA. Alternatively, augmentation is recommended after partial response at each stage. In Stage III, the algorithm recommends use of an antidepressant in a class other than one used in Stage I or II. The algorithm also states that the use of a MAOI may be appropriate in Stage III. Stages IV-VII recommend (in this order) lithium augmentation, combination therapy, electroconvulsive therapy (ECT), or any other antidepressant not listed in Stages I-III.35

The TMAP schizophrenia algorithm recommends use in any order of olanzapine, quetiapine or risperidone whether or not the patient has a history of failure on a typical antipsychotic. After non-response to the two remaining atypical agents or to a typical agent (in patients with no history of failure on a typical agent), clozapine is recommended. In the case of non-compliance with the second atypical antipsychotic, haloperidol decanoate or fluphenazine decanoate is recommended. With partial response to clozapine, an augmenting agent is recommended. With non-response or refusal on clozapine, the algorithm recommends either the use of combinations of atypical and/or typical antipsychotics or the combination of an antipsychotic with ECT.35

In Phase II of TMAP, a feasibility trial determined the suitability of the recommendations, as well as strategies and resources necessary for implementation into the public sector. Phase III, a clinical impact study, compares treatment as usual (TAU) to the algorithms. This study will determine whether the algorithms and associated efforts (e.g., patient/family education and increase in clinical staff to implement the algorithms) produce better clinical outcomes and whether they affect service utilization (and therefore cost). Phases II and III provided clinical staff and physicians with continuing education to ensure understanding and use of the algorithms and medications. Preliminary results indicate that the physicians largely followed the algorithms, requested ongoing continuing medical education/information for the new algorithms, and plan to continue use of the algorithms after completion of the study.35 Respondents within the VA and the DoD reported that treatment guidelines have been found useful in the management of patients with mental illness within organizations.

The VA's Medical Advisory Panel (MAP) for Pharmacy Benefits Management recently developed guidelines for the pharmacologic management of major depression as part of a greater effort to standardize and reduce treatment costs for common diseases within the VA. Currently there are no guidelines for the management of schizophrenia at the national level within the VA or the DoD.36

These guidelines for the treatment of depression rely primarily on APA, AHCPR and other evidence-based published guidelines. Guidelines are reviewed and updated routinely. The guidelines are intended to "assist practitioners in clinical decision-making, to standardize and improve the quality of patient care, and to promote cost-effective drug prescribing."

The guidelines focus on pharmacotherapy from a primary care perspective, encouraging monitoring, appropriate dosage, and maintenance therapy, or referral to a psychiatrist if necessary. The guidelines also state that a psychiatrist should immediately evaluate patients who present with depression and suicidal thoughts and/or symptoms of psychosis. Though no one therapy for depression is recognized as clearly superior, SSRIs are recommended as first-line antidepressants due to the lower risk for suicide in overdose. In developing the guidelines, the MAP did not find sufficient evidence to recommend one SSRI over another.