Information needs for medication coverage decisions in a state Medicaid program.

Background: Health plans commonly face the conflicting demands of trying to provide access to novel technologies, including new classes of medications, while trying to contain costs. These demands are particularly acute for California's Medicaid program, known as Medi-Cal, which is responsible for delivery of medical care to an unusually large population of mentally ill individuals in the context of a culturally diverse environment. To meet the challenge, Medi-Cal has instituted a formal process for technology assessment of new and existing pharmaceutical products known as the Therapeutic Class Review (TCR).
Objective: The purpose of this paper is to describe the information produced for Medi-Cal in the TCR process for antidepressant medications and the individual petition review of antipsychotic medications, and to synthesize our experience in a series of policy recommendations designed to improve the quality of coverage decisions.
Outcome: A collaborative process between Medi-Cal and Lilly resulted in a substantive body of new evidence regarding the needs of Medi-Cal recipients, the quality of current treatment, and prospects regarding the cost-effectiveness of introducing newer treatments.
Conclusion: Medi-Cal has a formal process for evaluating new medicines. This process allows researchers to understand the needs of those who make coverage decisions. We recommend increasing routine epidemiologic surveillance, including service use, and clinical trials that include aspects of usual medical care early in the drug development process.