A regulatory governance perspective on Health Technology Assessment (HTA) in Sweden

Reimbursement Decisions for Pharmaceuticals in Sweden: The Impact of Disease Severity and Cost Effectiveness

“…The TLV also explicitly states that, jointly, these criteria imply that the accepted cost per QALY should be allowed to vary depending on the severity of the disease. For pharmaceuticals, the TLV has direct decision-making power over prescription drugs, whereas the 21 regional county councils are independently responsible for reimbursement decisions for hospital/in-patient drugs [7].…”

A regulatory governance perspective on health technology assessment (HTA) in France: The contextual mediation of common functional pressures

“…In order to avoid unnecessary repetition of already published material, readers are encouraged to consult the fuller descriptions of our methods available elsewhere [1,2] In France, ten interviews were conducted with a wide range of stakeholders reflecting different perspective and interests, including senior government officials identified through their membership in the relevant committees. These institutions included: the Ministry of Health, the department for Social Security (DSS) and the Department for Public Health (DGS) The High Health Authority (HAS), the Health Product Agency (AFSSAPS, now MSNA) the General National health Insurance fund (CNAM), the Health Economics and Outcomes Research Organisation (URC-ECO) and a relevant pharmaceutical company.…”

“…The introductory sections of the paper draw upon work in other papers published by this research group [1,2,3]. This is due to the fact that we have conducted this research together and have developed and applied the theoretical framework for analysis jointly.…”

“…Today, individual nation states are among the largest buyers in pharmaceutical markets. Accordingly, there is more scope for variation in national regulatory arrangements for health technologies than in arrangements for sectors like banking, finance and aviation, which require unified regulatory regimes towards the construction of which nation states, private enterprises and third sector organisations necessarily collaborate [2,7]. And certainly, in terms of institutions, processes and evidential requirements for HTA, national states exhibit significant differences and divergences, which limits opportunities for policy learning across states.…”

“…Indeed, by using the right cases-studies, analysts may even increase the potential for policy learning and transference. For example, in the case of Sweden, some national environments, notably Spain which has a similarly structured health care system, may be more relevant to reflecting on and potentially improving the Swedish approach than other national models [2].…”