GRADE EVIDENCE TO DECISION (EtD) FRAMEWORK FOR COVERAGE DECISIONS

Abstract

Objectives: Coverage decisions are decisions by third party payers about whether and how much to pay for technologies or services, and under what conditions. Given their complexity, a systematic and transparent approach is needed. The DECIDE (Developing and Evaluating Communication Strategies to Support Informed Decisions and Practice Based on Evidence) Project, a GRADE (Grading of Recommendations Assessment, Development and Evaluation) Working Group initiative funded by the European Union, has developed GRADE Evidence to Decision (EtD) framework for different types of decisions, including coverage ones. Methods: We used an iterative approach, including brainstorming to generate ideas, consultation with stakeholders, user testing, and pilot testing of the framework. Results: The general structure of the EtD includes formulation of the question, an assessment using twelve criteria, and conclusions. Criteria that are relevant for coverage decisions are similar to those for clinical recommendations from a population perspective. Important differences between the two include the decision-making processes, accountability, and the nature of the judgments that need to be made for some criteria. Although cost-effectiveness is a key consideration when making coverage decisions, it may not be the determining factor. Strength of recommendation is not directly linked to the type of coverage decisions, but when there are important uncertainties, it may be possible to cover an intervention for a subgroup, in the context of research, with price negotiation, or with restrictions. Conclusions: The EtD provides a systematic and transparent approach for making coverage decisions. It helps ensure consideration of key criteria that determine whether a technology or service should be covered and that judgments are informed by the best available evidence. Coverage decisions are decisions by third party payers (public or private health insurers) about whether and how much to pay for drugs, tests, devices, or services and under what conditions. These decisions are made at national, regional, or local levels, depending on the type of interventions and the way health services are paid for in a country. Often, committees or panels that may include policy makers, managers, clinicians, from the Italian Ministry of Health ( Keywords: GRADE, Coverage decisions

Using GRADE methodology to assess innovation of new medicinal products in Italy

“…The AIFA's approach helps to ensure that the panel members consider all the important factors for making a decision, providing a concise summary of the best available evidence about each criterion to inform their judgements, helping them to structure and document discussion, and identify reasons for disagreements. As the EtD frameworks strengthens the credibility of decisions by documenting the evidence‐based decision‐making process, in the AIFA's approach, decisions flow from judgments about relevant criteria in a structured and transparent manner, while making the users aware of the rationale (justification) for their decisions.…”

GRADE Guidelines: 16. GRADE evidence to decision frameworks for tests in clinical practice and public health

“…Ideally, decisions, such as those about health recommendations, that involve tests should be informed by evidence that directly addresses all the important effects of both testing and subsequent management strategies. When such direct evidence is available, EtD frameworks for clinical or public health recommendations or for coverage decisions can be used [4][5][6]. Unfortunately, evidence from randomized trials or well-done non-randomized studies M A N U S C R I P T…”

“…The GRADE Evidence to Decision (EtD) criteria for clinical recommendations, public health or coverage decisions about health interventions apply to tests [3,4]. However, tests by themselves usually affect outcomes indirectly rather than directly [4][5][6]. Tests should not be applied without carefully considering the intended and unintended consequences, including the presumptive management strategies and outcomes that follow from applying a test [7][8][9][10].…”

The GRADE Evidence to Decision (EtD) framework for health system and public health decisions

“…There may be limited or no available economic analyses, nor resources available to conduct one [ 34 , 35 ]. As with clinical recommendations and coverage decisions, the greater the budget impact and the more uncertainty there is about the resources required and cost effectiveness, the less likely a panel is to recommend or decide to implement a health system or public health option [ 11 , 13 ]. Conversely, the greater the savings, the more appealing an option becomes.…”