AACP Newsletter, Volume 10,
Number 3, Summer 1996
Principles for Formulary Management in Public Sector Managed Care
Formulary management of psychotropic medication can be a highly effective method of controlling unnecessary over-utilization of expensive or marginally effective medications that might otherwise deplete limited public sector pharmacy budgets. Formulary management should not, however, employ policies or protocols which unnecessarily restrict the practice of good psychopharmacology, and thereby increase the likelihood of poor outcome. The purpose of this document is to establish general principles to guide the establishment of formulary management procedures in public sector mental health settings.
- In any locale formulary management protocols should be derived from community standards of psychopharmacological practice and usage - not just from FDA-approved indications - and must be reviewed and approved for clinical appropriateness by a psychiatric organization which has governance over the intended purview of the protocols (e.g., a state psychiatric society for a statewide public sector managed care program or a state hospital medical staff organization).
- Formulary restrictions should ideally be based on documented evidence that a particular pharmacologic strategy is both less costly and equally effective. Cost - effectiveness data should be based on total per episode cost, not just pharmacy cost, including costs associated with dosage titration, drug discontinuation due to side effects, and non-compliance due to complexity of dosing regimen (e.g., frequency of dosing and numbers of medications).
For example, there is ample evidence that, in most instances, generic drugs are equally effective and less costly than proprietary drugs. However, selective serotonin reuptake inhibitors, while more expensive per dose than tricyclic antidepressants, are less expensive per successfully treated patient than tricyclics due to faster dose titration, faster onset of action, and reduced side effects, resulting in less frequent drug discontinuation and reduced incidence of hospitalization.
Cost effectiveness data should also be based on savings associated with reduction of other health care costs due to improved outcome and enhanced compliance. For example, newer antipsychotics, such as clozapine and risperidone, are more expensive, but have been associated with reduced utilization of more costly mental health services for persons who had previously been less responsive to treatment.
- Formulary restrictions may also include defined protocols for utilization of newer more expensive drugs which are likely to be more effective than less expensive standard drugs (e.g., clozapine and risperidone) or which are adjunctive to standard treatment (e.g., naltrexone for alcohol dependence). Such protocols may require evidence of lack of adequate response to standard treatments prior to authorization of newer drugs.
- Formulary restrictions may also include defined protocols for ongoing prescription of controlled substances (e.g., benzodiazepines or stimulants) to psychiatric patients, requiring documentation of diagnosis or clinical indication for continued use.
- Formulary restriction should not be based on preferential manufacturer discounts for a particular drug.
- Formularies should not restrict or exclude utilization of psychotropic or side effect medications simply because those drugs have more common medical indications (e.g., carbemazepine, valproic acid, diltiazem, thyroid supplements, and propranolol). Psychiatrists should be permitted to order laboratory tests that are relevant to the clinical management of psychiatric patients without prior authorization.
- When there is a lack of research data to support a particular formulary restriction, but there is a possibility that such restriction may be valid, there should be an initial trial period of data collection in order to assess the value of the proposed restriction.
- In all possible instances, formulary protocols should, whenever possible, permit physicians to order a more costly or less preferred alternative medication by supplying written documentation attached to the prescription (which can be subject to retrospective review) rather than requiring prior authorization requests which delay or disrupt treatment.
- In any situation, denial of a medication request should only be done by a psychiatrist. Reasons for denial should be documented in writing and sent to the prescriber, who should be given the opportunity to appeal the denial.
March 31, 2003 - Web Editor's Note: The contact information at the head of this article is outdated. The current contact information for the American Association of Community Psychiatrists is:
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AACP c/o Frances M. Roton PO Box 570218 Dallas, TX 75228-0218 |
Phone: 972-613-0985 Fax: 972-613-5532 Email: frda1@airmail.net (frda-ONE) |
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