The cost of medicines has been a matter of specific concern to Member States since the concepts of national drug policies and essential medicines were first introduced in 1975 (11, 14-16). Questions about the use of cost and cost-effectiveness information in the selection of essential medicines were also raised by several reviewers who took part in the 2001 consultation process (section 3.1), including:
- whether the high cost of a medicine could prevent its inclusion in the Model List even if it satisfied the selection criteria on grounds of need (i.e. it was needed to treat a priority health problem), effectiveness (when compared with other medicines used to treat the same condition) and safety;
- whether worldwide comparisons of the cost-effectiveness of different medicines in treating specific conditions would be meaningful, given the wide cost variations and the dynamic nature of prices for the same medicine.
During the open session, it was stressed that price information needs to be collected and used with care and that price information can quickly become out of date. It was recognized that for the selection of essential medicines only indicative price information is needed, with a focus on price comparisons within therapeutic categories. In addition, the comment was made that information about current prices is not always easy to obtain.
With regard to the selection criteria, the new procedures specify that:
- the absolute cost of a medicine will not be a reason to exclude it from the Model List if it meets the stated selection criteria;
- cost-effectiveness comparisons must be made among medicines within the same therapeutic group (e.g. for identifying the most cost-effective medicine treatment to prevent mother-to-child transmission of HIV).
This approach is in line with WHO’s practice of including cost considerations in the development of public health recommendations.
The Committee noted that the impact of cost variations on estimates of cost-effectiveness could be addressed through the use of information on indicative prices of medicines that are already available within the United Nations system, and through the rigorous identification of sources of cost information. Where available, cost-effectiveness analyses and systematic reviews could also be used. The Committee expressed its hope that, with time, Member States’ experiences in using cost-effectiveness analysis would lead to further refinements and improvements in the new procedures.