The WellPoint outcomes based FormularySM: Enhancing the health technology assessment process

Abstract

The purpose of this paper is to present an overview of the evidentiary and analytical standards recommended by WellPoint Pharmacy Management (WPM) in the formulary submission and re-evaluation process for drug products. Given our commitment to The WellPoint Outcomes Based FormularySM , the guidelines emphasise the importance of randomised, active comparator, naturalistic trials in supporting the clinical and cost-effectiveness case for a drug product. In addition, the guidelines emphasise the need to monitor and validate claims made for the product over its life cycle. Whilst modelled cost-effectiveness claims have a place in formulary assessment, any claim must be amenable to empirical evaluation. It is these requirements for naturalistic trials and the assessment of product performance at the health system level that set the WPM guidelines apart. Further, in stating a preference for product performance claims to be expressed in generic cost per quality-adjusted life-year (QALY) terms, WPM is setting a standard for the development of an objective measure to support resource allocation decisions. In the first part of the paper, WPM's commitment to the principles of The WellPoint Outcomes Based FormularySM is reviewed, together with the role of monitoring and validation in the assessment of clinical and modelled cost-effectiveness and system impact claims in formulary evaluation. The second part of the paper details the guidelines' recommendations for new product assessments in terms of: (i) product description and indication; (ii) target population, treatment patterns and place in therapy; (iii) clinical assessment; (iv) cost-outcome assessment and product claims; (v) budget and system impact claims; and (vi) validating and monitoring claims. The third part of the paper details the guidelines' recommendations for product re-evaluation. These recommendations are assessed in terms of: (i) monitoring and validating initial claims for product performance; and (ii) re-evaluating claims for cost-effectiveness and system impact given changes in the competitive landscape for products and procedures in the disease state and the increased awareness of comparative clinical performance of competing products and procedures. © 2005 T&F Informa UK Ltd.