Our work with policymakers and managers focused on the development of strategies to help decision makers go from evidence to coverage decisions. Coverage decisions are defined as decisions by third party payers (public or private health insurers) about whether and how much to pay for drugs, technologies, tests, devices or services and under what conditions. They can take place at national, regional or local levels, depending on the type of interventions and the way health services are paid for in a country. Our target audience included members of commissions or panels, like policymakers, managers and support staff, researchers and healthcare professionals, that are usually involved in these type of decision. Our main product was the development of a conceptual framework (Evidence to Decision framework – EtD), which includes criteria identified as necessary to inform the process that goes from the assessment of evidence to coverage decisions.
Coverage decisions and clinical recommendations share some common features. Both require formulation of a question, an assessment and conclusions. The question details require similar considerations. However, whereas guideline panels can make clinical recommendations from the perspective of an individual patient, coverage decisions are always made from a population perspective. The factors that affect a decision (criteria) are similar, but there are some important differences in relation to panels’ judgements about how much people value the main outcomes, equity, acceptability and feasibility. A coverage decision is subject to the judgment of a population of relatively well informed stakeholders, vested interests and social representatives, and here the political standing of the decision maker is at stake, depending on volatile criteria of opinion consensus. Accountability is a strength for the coverage decision-making process as it confers openness and the chance for motivated disagreement.
The DECIDE EtD framework summarises in a logical and transparent way all the elements of a complex decision-making process. From the perspective of clinicians and patients affected by coverage decisions, use of the EtD framework can help to ensure that decisions are fair. The EtD allows a consistent use of appropriate criteria for assessing interventions linked to explicit judgments and to the evidence available to inform each of them. It can facilitate identification of reasons for disagreements and the collection of feedbacks on a draft decision prior to making a final one.
More information about the development of the EtD and its structure may be retrieved here
Examples of practical use of the EtD
1) Use of trans-catheter aortic valve implantation (TAVI) for patients with severe aortic stenosis in Lazio Regional Health Service in Italy [Ref. 2-5]: the EtD was used to inform a real-life coverage decision about trans-catheter aortic valve implantation (TAVI) for patients with severe aortic stenosis in Lazio Regional Health Service in Italy. Two EtD frameworks were prepared comparing TAVI vs traditional surgery and vs medical therapy. They were presented and discussed with a panel of regional health system representatives that involve both regional decision makers as well as clinicians. The EtD was then included in a final regulatory document of the Lazio Region about the appropriate use of the intervention
2) Developing a conceptual framework to support coverage decisions for vaccines adoption in Lombardy (Italy) [Ref. 6-7]: this research project aims to develop a transparent and comprehensive standard framework for the inclusion and prioritization of new vaccines in the regional immunization program. The framework should act as a guide to consistently inform policy makers in the Region of Lombardy. This project is conducted by the University of Milan in collaboration with WP2 of the DECIDE Project and supported by a grant from the Region of Lombardy.
The research consists of three phases:
- Phase 1: aimed at reviewing and cataloguing the relevant current frameworks, taxonomies and dimensions on vaccines and connect these to the DECIDE Evidence to Decision framework (EtD).
- Phase 2: aimed at sharing and validating the framework proposed using a Delphi method. We generated a comprehensive list of items to consider when completing the framework to support vaccine coverage decisions. Finally, we developed a multi-dimensional framework conceived from the DECIDE - Evidence to decision Framework (EtD framework).
- Phase 3: validate the framework by conducting a real data and evidence set collection on varicella vaccination and tested it with a multidisciplinary group.