Valeurs seuils pour le rapport coût-efficacité en soins de santé - KCE

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48 ICER Thresholds KCE Reports 100 3.5.8 Finland hh 3.5.9 Sweden ii • Another reason for not having a fixed ICER threshold value is that the spending on community pharmaceuticals is required to be kept within a fixed budget within a given year. Given the binding nature of this constraint and all things being equal, what is and is not considered ‘costeffective’ varies with the amount of funding available (not just in terms of the total budget each year, but the available budget at any point in time, as explained in 2.5.3: a fixed budget requires a variable ICER threshold value). Pritchard et al. 93 speculated that PHARMAC’s decisions are broadly consistent with an implicit threshold of NZ$20 000/QALY (NZ$ of the year 2000). The authors did not, however, perform a systematic analysis of PHARMAC’s decision reports. The Finnish ‘guidelines for preparing a health economic evaluation’ are published as an annex to the Decree by the Ministry of Social Affairs and Health on applications for a reasonable wholesale price, on special reimbursement status for a medicinal product, and on the documentation to be attached to the application (decree 1111/2005). Despite the formal requirement to provide health economic evaluations for new chemical entities in Finland, we could not identify the use of any explicit ICER threshold value, neither from the websites consulted (including the legislation of the institutions), nor from the Finnish pharmacoeconomic guidelines. In 2003, the Swedish Pharmaceutical Benefits Board published general guidelines for conducting economic evaluations. 161 The English version of those guidelines does not contain information about the use of an ICER threshold value for decision making. The main task of the Pharmaceutical Benefits Board in Sweden is to ascertain if a pharmaceutical or medical device is to be included in the pharmaceutical benefits scheme and be reimbursed by society. The Pharmaceutical Benefits Board weighs three criteria (‘principles’) when making its decisions: • The human value principle; which underlines the respect for equality of all human beings and the integrity of every individual. • The need and solidarity principle; which says that those in greatest need take precedence when it comes to reimbursing pharmaceuticals. In other words, people with more severe diseases are prioritised over people with less severe conditions. • The cost-effectiveness principle; which states that the cost for using a medicine should be reasonable from a medical, humanitarian and socialeconomic perspective. Cost-effectiveness thus appears to be a central concern in the Swedish reimbursement system, 162 but a threshold value under which a treatment is considered cost-effective does not appear to be explicitly stated. Other factors, besides cost-effectiveness, are also weighed in the decision making process of the Pharmaceutical Benefit Board. hh Websites consulted, accessed autumn 2008: the Finnish Office for Health Technology Assessment (http://finohta.stakes.fi), the Finnish Ministry of Social Affairs and Health (http://www.stm.fi), the Pharmaceuticals Pricing Board (the body responsible for pricing decision and operating under the control of the Ministry of Social Affairs and Health), the Social Insurance Institution (the body responsible for the reimbursement of pharmaceuticals, http://www.kela.fi). ii Websites consulted, accessed autumn 2008: the Swedish Council on Technology Assessment in Health Care (http://www.sbu.se), the Centre for Medical Technology Assessment (http://www.cmt.liu.se), the Swedish Pharmaceutical Benefits Board (http://www.lfn.se/), the National Centre for Priority Setting in Health Care (http://e.lio.se/prioriteringscentrum)
KCE reports 100 ICER Thresholds 49 3.5.10 Norway jj The Norwegian Medicines Agency approves medicines and monitors their use, and ensures efficient, effective and well-documented use of medicines. On its website, the Norwegian Medicines Agency has published guidelines for pharmacoeconomic analysis in connection with applications for reimbursement in 2005. 163 Those guidelines do not inform on when an intervention is considered cost-effective. From the websites consulted, no explicit threshold value could be identified in Norway. 3.5.11 Denmark kk The Health Technology Assessment Handbook published in 2007 reports the views of DACEHTA (the Danish Centre for Health Technology Assessment) on when to consider a technology cost-effective. 164 They state that when two technologies do not dominate one another and an incremental cost-effectiveness ratio (ICER) is calculated for those two interventions, whether we should accept the new (or old) technology as being cost-effective ultimately depend upon the maximum price that the decision maker is willing to pay for the extra effect. DACEHTA further reports that there are no generally applicable limits concerning what can be considered a reasonable QALY price. Table 3: Explicit, implicit and assumed ICER threshold values in other countries Country Authors ICER threshold Explicit ICER threshold range UK NICE151 £20 000 - £30 000 per QALY Implicit ICER threshold values or ranges based on past allocation decisions Australia Henry et al. and the AU$69 900 per QALY PBAC 95 New Zealand Pritchard et al. and PHARMAC 93 Canada Rocchi et al. and the CDR 94 NZ$20 000 per QALY ICER threshold values or ranges proposed by individuals or institutions USA Weinstein 140 $50 000 per QALY Range of acceptance: dominant to CAN$80 000 per QALY Range of rejection: CAN$31 000 to CAN$137 000 per QALY USA Braithwaite et al. 96 $109 000 - $297 000 per QALY The The Council for Public Netherlands Health and Health Care156 €80 000 per QALY Canada Laupacis et al. 155 CAN$20 000 to CAN$100 000 per QALY No ICER threshold values or ranges identified Finland, Sweden, Norway, Denmark CDR: Common Drug Review; NICE: National Institute for Health and Clinical Excellence; PBAC: Pharmaceutical Benefits Advisory Committee; PHARMAC: Pharmaceutical Management Agency. jj Websites consulted, accessed autumn 2008: The Norwegian Medicines Agency (http://www.legemiddelverket.no), the Norwegian Knowledge Centre for the Health Services (http://www.nokc.no, this website is in Norwegian only), The Ministry of Health and Care Services (http://www.regjeringen.no/), The Norwegian Labour and Welfare Organisation (responsible for reimbursement and medical benefits, http://www.nav.no). kk Websites consulted, accessed autumn 2008: the Danish Centre for Evaluation and Health Technology Assessment (http://www.dacehta.dk), the Danish Institute for Health Services Research (http://www.dsi.dk), the Danish medicine agency (http://www.dkma.dk/)
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