Evidence of comparative efficacy should have a formal role in European drug approvals

Despite methodological concerns, comparative efficacy evidence should be required at the time of drug approval, says Corinna Sorenson and colleagues, to allow patients, clinicians, and other healthcare decision makers to determine whether a new drug is superior, equivalent, or inferior to its existing alternatives

Toward effective health technology regulation

New health technologies offer both challenges and opportunities. Regulation is one mechanism to help balance the benefits and risks of new health technologies. This thesis examines the extent to which ‘good’ health technology regulation is achieved and the effectiveness of the policy measures regulators (and others) employ to meet such aims. To accomplish these objectives, a conceptual framework of ‘good regulation’ based on the academic and practitioner literatures was developed and its various dimensions considered and explored across eight different studies. Taken together, the studies provide an analysis of the roles, processes, policies, and performance of the regulators responsible for the market authorisation and coverage and reimbursement of pharmaceuticals and medical devices in Europe and the US; the role and use of technology assessment in health technology regulation and its impact on attaining good regulation; and, the factors that impact regulatory performance. The thesis demonstrates that attaining good health technology regulation is complex and challenging, because of the inherent uncertainty regarding the benefits and risks of new technologies, their growing diversity and complexity, the limitations of existing study designs and assessment methods, the increased demands placed on regulators to meet sometimes conflicting objectives, and the underlying political nature of making decisions about public access to and financing of new health technologies. Regulators have made progress on addressing these challenges. However, additional improvements are needed to improve health technology regulatory performance. Like much of health care policy, movement toward achieving the various criteria of good regulation will be incremental, especially considering the often step-wise nature of technological innovation

Medical technology as a key driver of rising health expenditures: disentangling the relationship

Health care spending has risen steadily in most countries, becoming a concern for decision-makers worldwide. Commentators often point to new medical technology as the key driver for burgeoning expenditures. This paper critically appraises this conjecture, based on an analysis of the existing literature, with the aim of offering a more detailed and considered analysis of this relationship. Several databases were searched to identify relevant literature. Various categories of studies (eg, multivariate and cost-effectiveness analyses) were included to cover different perspectives, methodological approaches, and issues regarding the link between medical technology and costs. Selected articles were reviewed and relevant information was extracted into a standardized template and analyzed for key cross-cutting themes, ie, impact of technology on costs, factors influencing this relationship, and methodological challenges in measuring such linkages. A total of 86 studies were reviewed. The analysis suggests that the relationship between medical technology and spending is complex and often conflicting. Findings were frequently contingent on varying factors, such as the availability of other interventions, patient population, and the methodological approach employed. Moreover, the impact of technology on costs differed across technologies, in that some (eg, cancer drugs, invasive medical devices) had significant financial implications, while others were cost-neutral or cost-saving. In light of these issues, we argue that decision-makers and other commentators should extend their focus beyond costs solely to include consideration of whether medical technology results in better value in health care and broader socioeconomic benefits

Use of comparative effectiveness research in drug coverage and pricing decisions: a six-country comparison

Comparative effectiveness research (CER) has assumed an increasing role in drug coverage and, in some cases, pricing decisions in Europe, as decision-makers seek to obtain better value for money. This issue brief comparatively examines the use of CER across six countries—Denmark, England, France, Germany, the Netherlands, and Sweden. With CER gaining traction in the United States, these international experiences offer insights and potential lessons. Investing in CER can help address the current gap in publicly available, credible, up-to-date, and scientifically based comparative information on the effectiveness of drugs and other health interventions. This information can be used to base coverage and pricing decisions on evidence of value, thereby facilitating access to and public and private investment in the most beneficial new drugs and technologies. In turn, use of CER creates incentives for more efficient, high-quality health care and encourages development of innovative products that offer measurable value to patients