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

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46 ICER Thresholds KCE Reports 100 3.5.5 USA ee The Council specifies that, for this decision making process to function optimally, the Minister must define an acceptable limit for some parameters, such as the disease burden and the cost-effectiveness value. The Council believes that it is not entitled to define such threshold values and that a democratic discussion has to determine the limit. In order to foster the discussion about this topic, the Council suggests an absolute maximum ICER threshold value of €80 000/QALY gained, provided that the disease severity index exceeds a specific threshold value. 156 The index reflecting disease severity is obtained following the guidelines from the Dutch Health Insurance Board. 157 The measure reflects the health-related quality of life associated with a specific condition and is based on the number of QALYs lost due to the disease relative to the number of QALYs expected without the disease. Therefore, although ICERs are considered in the decision making process of the Council, no explicit ICER threshold value has been defined so far in The Netherlands. Other factors also play an important role in this process. In the USA, the figure of US$50 000/QALY gained has frequently been quoted for many years as being the cost-effectiveness threshold value. 125, 140 Hirth et al. 158 report that this number was originally based on the supposed annual cost per QALY for the Medicare program for patients with chronic renal failure, but they further argue that this standard might have been based on a considerable underestimation of the chronic renal failure program’s true costs. Recently, Braithwaite et al. 96 investigated whether the advocated $50 000/QALY rule is consistent with current resource allocation decisions in the US. They estimated a lower bound for the societal WTP per LYG by calculating the incremental benefits of all medical advances since 1950 in terms of mortality reduction and the associated incremental costs. They simulated the costs and health outcomes in a US birth cohort without the medical advances and the health outcomes and costs with the medical advances. Major assumptions about the mortality reduction and costs attributable to medical advances had to be made. Based on the simulation, they estimated the ICER for ‘modern’ health care. From the empirical observation that most individuals in the US favour expanding the health care budget, they inferred that society’s WTP for health care must exceed the ICER of modern health care and therefore the ICER threshold value must be higher than the estimated lower bound. The estimate of the upper bound for the societal WTP for a LYG was based on observed people’s decisions not to buy unsubsidized insurance even if they are not insured otherwise. The approach assumes that individual’s unwillingness to get insured (even when income is sufficiently high) implies societal unwillingness to pay. The costs and benefits associated with and without unsubsidized insurance are simulated and used to obtain an ICER for insurance. According to Braithwaite et al. the preference not to get insured may point towards an upper-bound estimate for the societal WTP. The base case analysis suggests $183 000/LYG and $264 000/LYG as plausible lower and upper bounds for the ICER threshold value. When both quantity and quality of life were considered, in their sensitivity analysis, the lower and upper bounds became $109 000/QALY and $297 000/QALY respectively. Braithwaite et al. 96 conclude that an ICER threshold value of $50 000/QALY is not consistent with current allocation decisions in the US. As the plausible lower and upper bounds for the ICER are substantially higher than $50 000/QALY, it is very unlikely that this ICER threshold value is consistent with societal preferences in the United States. Despite the existence of such thresholds published in the US literature, so far, the Centers for Medicare and Medicaid Services have avoided the explicit use of costeffectiveness criteria in their coverage decisions and it is unclear to what degree costeffectiveness is used to guide coverage decisions in the private sector. 140 ee Website consulted, accessed autumn 2008: the Centers for Medicare & Medicaid Services (http://www.cms.hhs.gov/), the Academy of Managed Care Pharmacy (http://www.amcp.org/)
KCE reports 100 ICER Thresholds 47 3.5.6 Australia ff In their recent editorial, Weinstein 140 adds that because economic evaluations are not used in any systematic or consistent way in the United States, it should not be surprising that there is no consensus as to the appropriate value of the cost per QALY that should guide health care decisions and policies. 140 Further, in the Format for Formulary Submissions (the suggested template for performing pharmacoeconomic evaluations in the US) published by the Academy of Managed Care Pharmacy in 2005, we found no information about the formal existence of an explicit ICER threshold value. The role of the Pharmaceutical Benefits Advisory Committee (PBAC) in Australia is to recommend to the Minister for Health which drugs and medicinal preparations should be subsidised by the Australian Government under the Pharmaceutical Benefits Scheme. It further advises the Minister and the Pharmaceutical Benefits Pricing Authority about the cost-effectiveness (‘value for money’) of a proposed drug compared with other drugs already listed in the Pharmaceutical Benefits Scheme for the same, or similar, indications. The PBAC has edited Guidelines for Preparing Submissions to the Pharmaceutical Benefits Advisory Committee whose aim is to provide practical information (including guidance for economic evaluations) to the pharmaceutical industry for making a submission to PBAC. 14 The guidelines are also intended to help PBAC assess submissions. When making choices between competing therapeutic modalities, the factors considered by PBAC are cost-effectiveness, but also other important factors which include uncertainty, equity, extent of use and total costs. A threshold under which an ICER is considered attractive by the PBAC is not explicitly specified in the guidelines. Although the PBAC does not appear to work with an explicit threshold value, Henry et al. 95 report that observation of the decisions of the PBAC between 1994 and 2003 point to an apparent threshold of AU$69 900/QALY gained above which reimbursement has been found to be unlikely. There is however no evidence that this implicit threshold is effectively used to guide PBAC’s decisions. 3.5.7 New Zealand gg The role of the Pharmaceutical Management Agency (PHARMAC) in New Zealand is to manage the pharmaceutical budget on behalf of the District Health Boards, and to decide which medicines are funded by the Government. Recently, PHARMAC published an updated version of The Prescription for Pharmacoeconomic Analysis (June 2007) which describes how PHARMAC undertakes its economic evaluations and how it interprets ICERs. 159 As stated in their ‘Prescription for Pharmacoeconomic Analysis’-report, PHARMAC decided not to define an explicit threshold value below which a pharmaceutical is considered ‘cost-effective’. 160 Their justification for this is as follows: • The main reason for this is that cost-effectiveness is only one decision criterion used by PHARMAC. One proposal may be more cost-effective than another but rate poorly on other decision criteria and therefore may not be funded (hence, on ‘successfulness grounds’, it will not be considered cost-effective). ff Websites consulted, accessed autumn 2008: Pharmaceutical Benefits Advisory Committee (http://www.health.gov.au/internet/main/publishing.nsf/Content/Pharmaceutical%20Benefits%20Scheme%2 0(PBS)-1), the Australian Government, Department of Health and Ageing. gg Website consulted, accessed autumn 2008: the Pharmaceutical Management Agency in New Zealand (http://www.pharmac.govt.nz/)
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