Health technology assessment (HTA) has become a critical basis for pricing and reimbursement decision-making worldwide. In some countries, extensive requirements for data are set out in guidances or regulation and apply to all new prescription medicines; in others, HTA is required of industry or performed by payers only for therapies expected to be particularly costly. Although the effect of HTA on spending for prescription medicines is studied often, far less attention is given to its effects on decisions about research and development in the biopharmaceutical industries.
Australia was the first, in 1993, to make economic evaluation an important component of its decisions about reimbursement of drugs. Since then, several jurisdictions have followed suit. Decision-making authorities (e.g., ministries of health or health technology assessment agencies) usually issue methodological guidelines for the conduct of studies of economic value. Similarities across countries in the sets of guidelines likely are greater than the differences, especially among those guidelines that have been developed in the context of formal decision-making procedures.
The authors point out that biopharmaceuticals are more complex agents than conventional chemical entities and therefore are more difficult to replicate after patent expiry. Off-patent versions of the originator product, moreover, cannot rely on a simple demonstration of chemical comparability; they are best described as ‘biosimilar’. These differences mean that biosimilar markets will evolve in a more complex way than traditional, small molecule, chemical generics markets.
In 2008, the European Commission published a proposal for a Directive on the application of patients’ rights in cross-border health care. This followed two 1998 landmark rulings of the European Court of Justice (ECJ) that appeared to affirm the right of patients to obtain reimbursement from their own health care systems for health care that they purchased from another EU Member State, without prior authorization.
This Briefing reports the discussions of a group of experts at an OHE workshop on the benefit-risk assessments of drugs. The objective was to identify how particular tools and methods used in economic analysis and the decision sciences might improve the methodologies that regulatory authorities apply to evaluate drug benefit and risk.
In June 2006, a conference entitled Better Analysis for Better Decisions: Bridging the Gap Between Economic Evaluation and Healthcare Decision-Making was held at McMaster University in honour of the late Bernie O’Brien. The papers presented by leading health economists were reviews of the use of economic evaluation in the UK, Canada and USA, and more methodologically focused contributions.
The reviews of the experience in the three countries suggest that economic analysis is playing an increasingly important role in health sector decision making.
This Briefing discusses, inter alia, the role of the Office of Fair Trading (OFT) in competition cases affecting the pharmaceutical industry. It does so in the context of a discussion of “ex ante” versus “ex post” approaches to regulation. This refers to the balance of reliance in a market on competition, sector specific regulation, and general competition law to deliver efficient outcomes.
Health care decision makers are becoming increasingly concerned with obtaining value for money and therefore with the use of economic evidence, particularly as a criterion for the reimbursement of new pharmaceuticals. There are a range of countries in which economic considerations have been introduced into the decision making process together with some of the associated policy applications.
Towse, A., Fenn, P., Gray, A., Rickman, N. and Salinas, R.
The UK government hopes that the proposals in the report of the Department of Health’s Chief Medical Officer "Making Amends" (CMO, 2003) will make its NHS safer whilst ensuring that patients who are harmed get compensation more quickly and more efficiently than at present. The Making Amends proposals seek to achieve this by setting up administrative mechanisms for compensating patients. These will provide an alternative to the existing court based "tort" system, whereby patients sue doctors and hospitals for negligence in order to get compensation. These changes should be helpful.