This Briefing summarises the results of a roundtable convened by OHE to discuss using HTA to assess biosimilars – including which methods are most appropriate in specific situations. Participating were ten experts: leading academics and representatives from the UK medicines regulatory agency, the three UK HTA entities, and the UK industry trade association. Background for discussion at the meeting included an OHE literature review and ABPI’s 2013 position paper on biosimilar medicines.
This Briefing extends to 2007 Thomas McKeown’s well-known analysis of changes in life expectancy in England during 1901-1971. It finds that mortality continued to decline after 1971, but that the causes of death have changed.
This study compares pricing and reimbursement (P&R) policy for 43 orphan medicinal products (OMPs) across seven EU Member States: France, Germany, Italy, The Netherlands, Spain, Sweden and the UK. Examined in particular are the standards of evidence and the criteria for P&R decisions, the availability of access before full licensing approval, and requirements for studies after the drug is available on the market.
Johannesson, M., Jonsson, B., Jonsson, L., Kobelt, G. and Zethraeus, N.
In this Briefing, five leading European experts in health economics provide a comprehensive international review of changes in health economic evaluation and the reasons for them. The authors express concern that the basis for health care decision making today has evolved away from the societal perspective of cost benefit analysis to the payer perspective of cost-effectiveness analysis. Most voluntary and mandatory guidelines for evaluating medical innovation now encourage or require this narrower, budget-based payer perspective. As a result, they argue, decisions often ar
Written while Labour Government policies still were in force, this Briefing clearly and thoroughly examines non-discretionary cost differences between public and independent providers that may have a serious impact on the effectiveness of competition. Four key differences are identified: corporation tax, value added tax, pension costs and cost of capital. Critical barriers to implementing the competition policy are reviewed.
In the UK and elsewhere, choices about how to allocate health care resources are guided not only by economic calculations, but also by social value judgments such as those relating to equity and fairness. Factors such as uncertainty around key values, operational feasibility and stakeholder interests also need to be considered. The question of how to combine these inputs is central to the field of health care decision making.
Coined by the French historian Alexis de Tocqueville in the early nineteenth century, the term ’American exceptionalism’ refers to the idea that the US is different from other developed nations because of its unique origins, evolution, and institutions.
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.