Achieve improvements in the relationship between the quantity and quality of life gained and the resources used to obtain such gains requires appropriate health policies, but above all it is about promoting cost-effective clinical decisions. The efficiency of a health system depends essentially on its health care professionals (who take most of the decisions for prevention, diagnosis, treatment, and rehabilitation) having the information and incentives to act in a cost-effective manner.
In recent years several countries (from the European Union and others) have taken measures to incorporate economic assessment in the set of tools which guide strategies for adoption and diffusion of medical innovations. Many also make budget impact studies that should not be interpreted as a conflict between the rules of efficiency and budget, but precisely as how to take into account the opportunity cost for insurers. Each country has adopted different processes in their respective stakes to insert information from the economic evaluation of health technologies in decision making, but what matters is that the evaluating culture from this field has permeated health workers in different areas of decision.
Although an objective and transparent policy for decisions regarding pricing and reimbursement of new drugs is still not very advanced in Spain, the requirement of evidence on cost-effectiveness at international level is already 20 years old. At present, almost half of the countries in the European Union require, in various forms, the results of an economic evaluation to finance and/or put a price on innovation. In other countries, however, this interest for evaluation has been more formal or cosmetic than real.
The introduction of economic assessment for drugs in the practice of European funding or reimbursement decisions has resulted in significant changes affecting the organization of the health system, the procedure itself to obtain the refund, reimbursement decisions and the allocation of resources resulting from these decisions. From observing what has happened in the last two decades in countries around us, I think we can identify eight key dimensions on which to define how each health system wants to adopt the necessary decisions for selective drug financing.
1. The Organization.- The function of an evaluating agency may be regulatory (ruling authority) or limited to an advisory role (make recommendations). The decisions taken on the basis of the results of the evaluation may regard coverage or reimbursement, or also the price. In England and Sweden, agencies perform both the evaluation and assessment of the same so that they have regulatory authority to make decisions. Germany and France have an advisory role on coverage. They generally have more influence on decision making and clinical practice if the agency has a regulatory role.
2. The objectives.- Most agencies tend not to have only the evaluation of the improvement in effectiveness as an objective but also efficiency, using the cost-effectiveness ratio explicitly. Both the recent reforms in France and Germany tend to also introduce the cost-effectiveness ratio in the decision or negotiation of the price of new drugs.
3. The scope of application.- Initially the major European agencies were confined to new drugs. In recent years it has become common to expand the assessment to technologies and almost any health intervention.
4. The procedures.- There are several features that distinguish and differentiate the evaluation procedures used in each country. One is the degree of independence of the evaluating agency; in most cases, there is a certain degree of independence from government and protection against conflicts of interest. The English agency is perhaps the most transparent: it makes almost all documents used in the process public. The Swedish agency publishes the information provided by the industry and not published. The terms of the evaluation procedure should be explicit and must be met. We must allow the possibility that those affected are involved in the process, and there must also be explicit appeal rules as in England and Sweden.
5. Participation.- The participation of the industry, professionals and patients may be an instrument to improve the acceptability, transparency and legitimacy of decisions based on the results of the evaluation.
6. Evaluation methods.- The evaluation should always include clinical effectiveness (incremental or compared) and the incremental cost-effectiveness analysis. The role of the quality-adjusted life-years (QALY) is decisive in England and Sweden, but less important in the process employed in Germany (efficient frontier) and hardly used in France.
7. Decision criteria.- Major European agencies prioritize according to clinical benefit, but for now only the English and Swedish also act on the cost-effectiveness ratio. At this point the debate focusses on the use of explicit or implicit thresholds of maximum willingness to pay for a QALY and adaptation for certain treatments, as is the case in cancer therapies.
8. Implementation.- Although initially outside the scope of interest of the evaluating agencies, they cannot be excluded from how their decisions are put into practice. In England and Sweden financial and non-financial incentives are adopted to encourage the adoption of decisions in clinical practice.
If a more rational path is really wanted so that funding is based on the comparative effectiveness and cost-effectiveness ratio, in light of the European experience, we should not stumble over “who” should evaluate but focus on “what”, “when” and “how” to evaluate. What happens in Spain in the near future, beyond the words and legislation will depend on the option taken regarding known alternatives for each of the above dimensions.