Billie Pettersson and Frank R. Lichtenberg - SNS

2. Background2.1. Determinants influencing the use of new medicinesPharmaceuticals represent around 15% of overall health expenditure in the OECDcountries, and increasing expenditures have led to the introduction of different policiesaimed at controlling costs and improving the efficiency of drug use [4]. These policieshave important implications for the access, rate of uptake and use of new medicines.Danzon et al. observed that only 23−27% of products launched between 1995−2005were available in countries (such as Sweden) with pricing and reimbursement (P&R)control, compared to 63.8% in the US, where access to the market is generally notrestricted by P&R decisions [5].Use of new medical technology varies widely between countries but also betweendifferent disease areas within a country [6]. The causes for variation in diffusion of newdrugs could be differentiated into three broad groups, macro- or system-leveldeterminants, service organization determinants and clinical practice determinants [7].These categories are interrelated. For example, a readiness among clinicians to adoptinnovations in clinical practice is determined, to some degree, by the ease with whichaccess to innovation is provided at the system level. The relative importance of thesefactors will vary depending on the disease area in question and the system context.In explaining the potential causes of international variation found in the studymentioned above [6], a number of common themes emerges: (1) health technologyassessment (HTA) processes and outcomes can have a significant impact on levels ofusage; (2) service planning, organization and direction-setting play an important role inenabling or restricting usage; and (3) clinical culture and attitudes towards treatmentremain important determinants of levels of acceptance. These themes often work incombination, so, for example, the impact of HTA can either be mitigated or amplifiedby issues relating to service organization or clinical culture, where the main issues arethe availability of or access to specialists.2.2. Pharmaceutical policies in SwedenDuring the past two decades, increasing pharmaceutical expenditures led to theintroduction of a variety of mainly demand-side policies aimed at restricting theescalation [8−10]. These policies were designed to promote the rational and costeffectiveuse of drugs at national as well as regional levels. Two of the most importantpolicies were the devolution of the pharmaceutical budget to the county councils in1998 and implementation in 2002 of a new system for pricing and reimbursement(P&R) according to value-based pricing (VBP). There are indications that the policiesintroduced might have had a restrictive impact on the use of (new) medicines inSweden.The prior P&R scheme was replaced by the current VBP system, where HTA became afoundation for P&R decision-making. HTA has emerged as an important foundation forguiding decision-making and allocating resources in health care by TLV, Sweden’sDental and Pharmaceutical Benefits Agency for making P&R decisions. VBP meansthat a drug’s value, i.e. cost-effectiveness, is evaluated and a price premium over its oneor more pre-defined comparators may be determined and used to set the price of that11