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

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44 ICER Thresholds KCE Reports 100 3.5.3 Canada cc In this paragraph, it is stated that no precise ICER threshold value is used for decision making but that rather a threshold range is defined, based on the ICERs of currently funded health interventions. This means that, while the Appraisal Committee is clear about not wanting to use a single threshold value for funding decisions, it nevertheless chooses to follow a certain guiding principle with respect to decisions about interventions in relation to their ICERs. The guiding principles are as follows: • For interventions with an ICER < £20 000/QALY gained, decisions will primarily be guided by cost-effectiveness considerations. In principle, the recommendation will be to provide this intervention, unless there are major doubts about the plausibility of and/or certainty around the estimated ICER. Thus, account is taken of the results of the sensitivity analysis and potential limitations to the generalizability of the findings regarding effectiveness. • For interventions with an ICER between £20 000/QALY gained and £30 000/QALY gained, NICE takes account of the following factors: o The degree of (un)certainty about the ICER. o Whether there are strong reasons to indicate that the assessment of the HRQoL has inadequately captured, and may therefore misrepresent, the health utility gained. o The innovative nature of the technology, specifically where the innovation adds benefits of a substantial nature compared with available alternatives which may not have been captured in the QALY measure. • For interventions with an ICER > £30 000/QALY gained the same factors will be taken into account. A stronger case is needed on these factors to approve such interventions. These guiding principles suggest that ‘additional elements’, are only explicitly considered in the decision making process by the Appraisal Committee if the ICER exceeds £20 000/QALY. For interventions with ICERs below £20 000/QALY the only additional element considered is the uncertainty around the estimate of the ICER. Recently, a report has been published on the relative societal value of health gains (QALYs) to different population groups in the UK. 44 The study identified attributes that determine societal preferences for the allocation of health gains and estimated equity weights for QALYs based on data from 688 interviews in people from the general public. bb In Canada, cost-effectiveness data are formally required for all new outpatient medications since 1996. 94 Given this long-standing requirement for economic evidence in Canada, it might be expected that the role of ICERs and ICER threshold values is well established in that country. Despite the formal requirement for cost-effectiveness evidence from the Canadian Agency for Drugs and Technologies in Health (CADTH), no information was found on how this economic evidence is used for decision making, neither from the CADTH published guidelines 154 , nor from the other websites consulted. bb Before the interviews in the general public were performed, relevant attributes for societal preferences were identified through focus groups with 57 members of the general public and from a survey of 172 NHS employees. cc Website consulted, accessed autumn 2008: the Canadian Agency for Drugs and Technologies in Health (http://www.cadth.ca), including the Common Drug Review that conducts rigorous reviews of the clinical and cost effectiveness of drugs, and provides formulary listing recommendations to the publicly funded drug plans in Canada (except Québec).
KCE reports 100 ICER Thresholds 45 In the Canadian literature, Laupacis et al. 155 suggested in 1992 that evidence for adoption of a new intervention in Canada was strong with an ICER below CAN$20 000/QALY (CAN$ of the year 1990), moderate with an ICER between CAN$20 000/QALY gained and CAN$100 000/QALY gained, and weak if the ICER exceeds CAN$100 000/QALY gained. Laupacis et al. 155 acknowledged however that these lower and upper boundaries were arbitrary. Furthermore, there is no formal evidence that any of these boundaries has been accepted or used by any Canadian decision making institution. 94 Recently, Rocchi et al. 94 reviewed the published (September 2003 to March 2007) drug reimbursement recommendations generated by the advisory board of the Common Drug Review (CEDAC – Canadian Expert Drug Advisory Committee) in order to identify the role of economic evaluations and indicate whether an implicit threshold was used. Of the 62 files reviewed, ICERs were considered in less than half of the cases (40%, 25 files), including 12 negative recommendations and 13 positive recommendations. Medications with a positive recommendation ranged from dominant to CAN$80 000/QALY. Medications with a negative recommendation ranged from CAN$32 000/QALY gained to CAN$137 000/QALY gained. From this, Rocchi et al. 94 concluded that these implicit thresholds did not act as a clear demarcation line, because the ICER range for medications with a positive recommendation overlapped with the ICER range for medications with a negative recommendation. They also suggested that the resulting inconsistency in which ICERs lead to a positive recommendation may be due to the fact that other factors are considered in the context of a specific review. 3.5.4 The Netherlands dd The Dutch Health care Insurance Board (CVZ, College voor Zorgverzekeringen) examines the basic package of care to which all Dutch patients have access. They provide the Ministry of Health, Welfare and Sport (VWS, Volksgezondheid Welzijn en Sport,) with advice about what care should be added or removed. The Pharmaceutical Aid Committee is an expert committee within the CVZ that assists in assessing whether new medicines need to be included in the basic package and be reimbursed. To be considered for reimbursement, manufacturers are formally required to provide costeffectiveness data of all new drugs for which they claim an added-value. With this respect, CVZ has edited the “Dutch Guidelines for Pharmacoeconomic Research” since 1999, with an updated version published in April 2006. 16 Those guidelines do not mention how the pharmacoeconomic information is used for making decisions about the reimbursement of drugs in the Drug Reimbursement System. The Council for Public Health and Health Care (Raad voor de Volksgezondheid en Zorg) is an independent body advising the government on public health and health care. At the end of June 2006, the Council published the report “Zinnige en Duurzame Zorg” (“Sensible and Sustainable Care”) that addresses issues such as which criteria should be applied in order to identify priorities for the funding of care from collective resources. The Council divides the process of deciding which forms of care should or should not be funded from collective resources into four phases: • Agenda-setting (scoping): defining the priorities for the decision making process (urgency principle) • Assessment (quantifiable criteria): disease burden, efficacy and costeffectiveness • Appraisal (non-quantifiable criteria): community review of the outcome of the assessment phase, principles of fairness and solidarity • Implementation: ensuring the forms of care that have been identified as warranting funding from collective resources are indeed funded in this way, and that other forms of care are not dd Websites consulted, accessed autumn 2008: the Health Care Insurance Board (http://www.cvz.nl/), Ministry of Health, Welfare and Sport (http://www.minvws.nl/en/), the Council for Public Health and Health Care (http://www.rvz.net/)
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