Reimbursement of glitazones in treatment of type 2 diabetes patients in Denmark in the context of a voluntary system for submitting pharmacoeconomic studies.

In 1998, guidelines for pharmacoeconomic evaluation were issued in Denmark. It was left to the discretion of the industry for which products to submit a pharmacoeconomic study. The impact of this voluntary system is illustrated by a case study on reimbursement of two types of glitazones. A review is presented of the evidence on safety, effectiveness and cost-effectiveness of glitazones that was available in the public domain at the time of reimbursement decision making, which was matched to the Danish criteria for general reimbursement of new pharmaceuticals. The study concludes that the voluntary system has not supported the inclusion of efficiency considerations in reimbursement decision making on glitazones. The decision-making process may be improved by mandatory pharmacoeconomic evaluations for selected products such as glitazones, which potentially represent a benefit to patients and potentially improve the cost-effectiveness of care, while at the same time having a considerable budget impact.