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 C alifornia's Medicaid program, known as Medi-Cal, which is responsible for d elivery of medical care to an unusually large population of mentally ill in dividuals in the context of a culturally diverse environment. To meet the c hallenge, Medi-Cal has instituted a formal process for technology assessmen t of new and existing pharmaceutical products known as the Therapeutic Clas s Review (TCR). OBJECTIVE. The purpose of this paper is to describe the information produce d for Medi-Cal in the TCR process for antidepressant medications and the in dividual petition review of antipsychotic medications, and to synthesize ou r 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 s ubstantive body of new evidence regarding the needs of Medi-Cal recipients, the quality of current treatment, and prospects regarding the cost-effecti veness of introducing newer treatments. CONCLUSION. Medi-Cal has a formal process for evaluating new medicines. Thi s process allows researchers to understand the needs of those who make cove rage decisions. We recommend increasing routine epidemiologic surveillance, including service use, and clinical trials that include aspects of usual m edical care early in the drug development process.