SUMMARY

The main aim of this article is to show the advantages that using Pharmacoeconomics as one of the criteria for reimbursement and pricing decisions on pharmaceuticals would have for the Spanish National Health Service.
The rise of the pharmaceutical expenditure led to many countries to apply pharmaceutical policies based on cost contention measures. Some examples of that type of measures are price controls or payback clauses when revenue targets are exceeded. The failure of those policies has motivated that an increasing number of countries are using pharmacoecnomics as a tool to make decisions about public financing of new medicines (reimbursement). This practice is known as the fourth hurdle.

In this paper we review some of the most developed fourth hurdle systems in the world. We try to infer from those international experiences some useful lessons for the public regulation of the Spanish pharmaceutical market. This market suffers from several chronic problems like, for example, a high volume of prescriptions, a small market share for generics, and also a fall of effective copayment by users.
The set of strategies implemented by the Spanish regulator in order to solve those problems has been based on price and expenditure controls. On the contrary, aspects like the selective financing of new drugs (reimbursement policy) and the provision of prescription guidelines (proxy-demand side) have been forgotten. The effect of the approach applied until recent years has been only successful in the short term, with the pharmaceutical expenditure showing a tendency to increase as soon as the initial impact of the measures implemented is assumed by the market. Nevertheless it seems that the rate at which the expenditure is growing has been contained for the last three years.

The analysis of six countries (the United Kingdom, Finland, Australia, Canada, the Netherlands, Sweden) in which the fourth hurdle is a compulsory requirement for pharmaceutical producers provides some insights for the Spanish case. Specifically, we suggest that Spain, as it is actually done in the UK, could apply the fourth hurdle only to those new medicines selected because they can have a strong effect in terms of potential health benefits and budgetary impact. The Spanish body that regulates the pharmaceutical market (Agencia Española de Medicamentos y Productos Sanitarios) could base their reimbursement decisions on the reports made by a committee of experts in pharmacoeconomics. In addition to that, as it occurs in Australia, reimbursement recommendations based on cost-effectiveness evidence could also help to set the initial price of new drugs. Moreover, guidelines including pharmacoecomics evidence could be useful to avoid moral hazard if, as it is usual in the UK, adherence to those guidelines would be supervised by a public body. Lastly, health technology committees in hospitals could also use pharmacoeconomics recommendations in order to make decisions on what new pharmaceuticals should be acquired.

Pharmacoeconomics can be a useful tool for priority setting in pharmaceutical policy. It is an approach quite different from those based on cost containment targets only, and its purpose is to influence on the supply and demand of pharmaceuticals in a permanent way. Furthermore, it seems a more appealing approach to manage with so-called “pharmaceutical problem”: the difficult balance between the budgetary constraints of governments and the profit prospects of the pharmaceutical industry.