Formulary submission guidelines for Blue Cross and Blue Shield of Coloradoand Nevada - Structure, application and manufacturer responsibilities

From 1 January 1999, all requests by pharmaceutical manufacturers and other s to Blue Cross and Blue Shield (BCBS) of Colorado and Nevada for the listi ng of new pharmaceutical products or any proposed change to the formulary s tatus of an existing product must be accompanied by a submission which meet s the informational and analytical standards set out in the BCBS Guidelines for Formulary Submissions for Pharmaceutical Product Evaluation. These sub mission. requirements relate both to the anticipated therapeutic impact of a new product and to claims made as to its anticipated pharmacoeconomic imp act. The guidelines have been developed because BCBS is concerned that decisions to admit a drug to formulary have been based in the past on incomplete inf ormation. In order to rectify this situation land to meet quality control o bjectives), it has been decided that all submissions to BCBS should meet a common information standard that describes both the characteristics of the product and its expected impact in a disease or therapeutic area. Unlike guidelines that have been introduced in countries such as Australia and the Canadian Province of Ontario, these guidelines take an explicit sys tems approach to the case a manufacturer must make before a product is cons idered for formulary listing. While the notion of systems impact requiremen ts is not new, this is the first time that a managed healthcare system in t he US has adopted this explicit perspective and notified manufacturers that traditional pharmacoeconomic evaluations may not meet the information need s of drug purchasers. The purpose of this paper is to describe the BCBS formulary guidelines and to demonstrate how manufacturers are expected to meet the information needs of a systems impact perspective in submissions to the pharmacy and therape utics committee.