The long and winding road to general reimbursement of glitazones in treatment of type 2 diabetes patients in Denmark

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Slide 1 : The long and winding road to general reimbursement of glitazones in treatment of type 2 diabetes patients in Denmark H. Vondeling (1), P.B. Iversen (2) 1 Department of Health Economics, University of Southern Denmark, Odense, Denmark 2 Roche A/S, Hvidovre, Denmark
Slide 2 : How can reimbursement decisons with regard to glitazones by the Danish health authorities be explained?What are the consequences of these decisons in terms of public expenditure and access?
Slide 3 : Introduction Diabetes mellitus Chronic disease About 125.000 patients in Denmark 90% type 2 diabetes patients Glitazones Insulin sensitisers, rosiglitazone and pioglitazone Introduced in EU in 2000 Two reimbursement systems in Denmark Individual reimbursement and general reimbursement 2000 Glitazones: individual reimbursement Early 2006 General reimbursement for rosiglitazone Late 2006 General reimbursement for pioglitazone
Slide 4 : Methods Matching evidence with criteria for decision making Criteria for reimbursement Danish Medicines Agency Sources of evidence on safety, effectiveness and cost-effectiveness of glitazones Literature (Medline and Embase) Danish Medicines Agency Ministry of Health Danish Institute for Rational Pharmacotherapy Danish Centre for Evaluation and Health Technology Assessment Clinical guidelines for diagnosis and treatment of diabetes patients Comparison of availability of evidence, its quality and its actual use in reimbursement decision making
Slide 5 : (? = unclear; n.a. = not applicable, - = irrelevant). Table 1. Overview of evidence on glitazones and its application to criteria for general reimbursement by the Danish Health Authorities in 2000 Added ’unofficial’ criterion: budget impact
Slide 6 : Summary of reimbursement decision making in 2000 Ten criteria for general reimbursement 9 operationalised, 6 applicable to glitazones, evidence on five criteria, evidence used on three criteria (in italics) There is a high probability of widening of indications, for which there is insufficient evidence There is insufficient evidence on effectiveness There is a risk that the pharmaceutical will inappropriately become ’first choice’ Added ’unofficial’ criterion: budget impact of glitazones
Slide 7 : Figure 1. Monthly public spending on glitazones in Denmark in the period August 2000 -December 2001 (DKR). (1 Euro = 7.42 DKR). (Source: Danish Medicines Agency)
Slide 8 : Summary of reimbursement decision making in 2006 Early 2006 Rosiglitazone no longer prevented from general reimbursement because three criteria were judged no longer to apply Limited supportive evidence used in the first two criteria (in italics) There is a high probability of widening of indications, for which there is insufficient evidence There is insufficient evidence on effectiveness The price of the product is unreasonable compared with its (additional) therapeutic benefit
Slide 9 : Summary of reimbursement decision making in 2006 Late 2006 Pioglitazone no longer prevented from general reimbursement because one criterion was judged no longer to apply The price of the product is unreasonable compared with its (additional) therapeutic benefit The manufacturer of pioglitazone had reduced the price level of this product to the price level of rosiglitazone after it had been granted general reimbursement
Slide 10 : Figure 2. Annual public spending on glitazones in Denmark in the period 2000-2006 (DKR x 1000). (1 Euro = 7.42 DKR). A combination tablet of metformin and rosiglitazone was introduced late 2003. (Source: Danish Medicines Agency)
Slide 11 : Conclusions and discussion At present both rosiglitazone and pioglitazone are subject to the general reimbursement scheme The process from individual to general reimbursement has taken a long time (6-7 years) Increasing evidence of different safety profiles Overall reimbursement process Mainly driven by considerations of therapuetic benefit and budget impact Not all criteria for general reimbursement are explicit and/or explicitly applied No formal demands for and use of evidence on cost-effectiveness
Slide 12 : Conclusions and discussion Individual reimbursement can primarily be regarded as a mechanism for controlled introduction of new pharmaceuticals Cons Likely inequalities in access ’Rationing by administrative inconvenience’ Pros Limiting public expenditure Generalisability More than 30 pharmaceuticals in 19 categories of disease are individually reimbursed
Slide 13 : Further reading H. Vondeling, P. B. Iversen. Reimbursement of glitazones in treatment of type 2 diabetes patients in Denmark in the context of a voluntary system for submitting pharmacoeconomic studies. European Journal of Health Economics 2004(5):263-69. P. B. Iversen, H. Vondeling. Reimbursement decision-making and prescription patterns of glitazones in treatment of type 2 diabetes mellitus patients in Denmark. Health Care Analysis 2006(14):79-89.

 


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