Typical questions that arise in today’s health care policy environment include, inter alia, a broad range of issues of a more general nature, specific problems from a health care policy makers’ view, and a set of challenges from the perspectives of providers – researchers, manufacturers, and health care professionals:
- What is the “value” of health care programs, and how should it be assessed?
- Which perspective is really the appropriate one for value assessment?
- Are there contextual variables (and if any, which are those) that impact the value assessment of health care interventions?
- What is the appropriate perspective for determining the opportunity cost of accepting a given health care program for reimbursement?
- Are we always consistent in choosing the perspectives for benefit and cost measurement?
- What should be the appropriate budget constraint (individual versus societal)?
- What, then, is the potential societal value of a new health care “technology”?
- What exactly is the relationship between individual and social preferences, or for that matter between individual and social willingness-to-pay?
- What might be the future role of “empirical ethics” in this context, and (how) might it be possible to engage in a fruitful multi-stakeholder dialogue about these issues in the face of conflicting interests (/objectives)?
- (How) Can we determine an appropriate price for (new and established) health technologies?
- (When) Should we divest established technologies, i.e., exclude them from future reimbursement in a publicly financed health scheme?
- (How) Should we address (and quantify) the uncertainty surrounding health outcomes and cost benefit evaluations in a meaningful way?
- (How) Can the conventional economic evaluation paradigm be integrated into Health Technology Assessment (HTA) processes in a useful way?
- (How) Can the logic of cost effectiveness using health-adjusted life years (HALYs) as ‘the’ measure of health-related outcomes be amended to meet fairness objectives?
- Are there viable alternatives to the currently prevailing health economic evaluation paradigm?
- (How) Can we incorporate the phenomenon of dynamic efficiency in the evaluation of new technologies?
- (How) Might we achieve international harmonization of Health Technology Assessments (HTAs)?
- How much resources should be dedicated to an effective and efficient HTA process?
- What kind of monitoring and quality assurance processes should be established for HTAs?
- (How) Should we formally address uncertainty at the time of evaluation, including gaps in knowledge that require further research?
- What might be an appropriate role for managed entry schemes in this context (such as “coverage with evidence development” agreements)?
- (How) Should the implementation of decisions based on Health Technology Assessments be fostered and quality of health care monitored?
Specifically, from the perspectives of providers –
researchers, manufacturers, and health care professionals:
- (How) Can we anticipate whether it is worthwhile to invest into research and development (R&D) of a given technology platform?
- (How, then) Can we determine an optimal portfolio of research and development (R&D) projects?
- (How) Can the value of health care interventions be identified, proven, quantified, and communicated?
- Which of the currently available “validated” Health-Related Quality of Life (HRQoL) instruments might be most appropriate (”sensitive”) to demonstrate the impact of an intervention in a given context?
- (How) Can we effectively develop a core value proposition and build compelling evidence in support of it?
- What is the most promising international strategy to accomplish early market access for and fair reimbursement of a new technology?
- (How) Can the cost benefit ratio of a new product or technology be established in a meaningful and internationally accepted way, hereby minimizing redundancy and duplication of effort in a heterogeneous regulatory environment?
- What can be done to maximize the credibility of value propositions and cost benefit ratios?
- What are the implications of the economics of research & development (“innovation”) for international pricing and reimbursement policies, and (how) can these be demonstrated, measured, and effectively communicated?
This list of challenges is not a complete one; it is in fact far from comprehensive. InnoValHC is committed to support decision-makers, particularly those concerned with the field of health care or related areas, in finding optimal, not merely defensible, answers to these and related issues. Or, in other words, as the Institute’s founders put it as early as at the time of inception of InnoValHC in 2005:
“[Our] raison-d'être […] is to contribute to the understanding of the trade-offs inevitably associated with diagnostic and therapeutic decisions.”
This implies analyses and research into the
- methods and normative foundations of health economic evaluations;
- mechanisms of financing and delivery of health care, and their impact on outcomes, quality, and efficiency
- (e)valuation of innovative and established technologies, procedures, and products;
- acceptability of technologies based on the degree of confidence in their effectiveness as well as their social value, which may be assessed by cost-benefit, cost-effectiveness, or social utility analysis;
- utilization of specific health care programs, including quality of service provision, real-world effectiveness and budgetary impact;
- decision analytic tools to support effective health care and value-driven research & development;
- mechanisms of market access, reimbursement and pricing for new and established products and procedures, which reflect the goals of collectively funded health care systems or privately financed health insurance in the best possible way.
As also declared from the very start of the Institute, “a fundamental principle of all InnoValHC projects is adherence to rigorous methodological standards and strict separation of evidence (factual knowledge; in the context of HTAs, sometimes referred to as ‘assessment’) and interpretation (opinion; or in the context of HTAs, ‘appraisal’).”