Are Countries Using ATC Classification and Defined Daily Dose for Pricing and Reimbursement Decisions of Pharmaceuticals?

OBJECTIVES: The World Health Organisation (WHO) Anatomic Therapeutic Chemical (ATC) and Defined Daily Dose (DDD) systems serve as a tool for drug utilization monitoring with the aim of improving quality of drug use. The systems are also used by payers in market access and reimbursement. This study aimed to identify how ATC/DDD classification is utilized in the EU5 and the Netherlands for pricing and reimbursement decisions.

METHODS: Health Technology Assessment (HTA) guidelines and publications from HTA authorities were examined in the EU5 and the Netherlands to understand if ATC and/or DDD were involved in HTA appraisals. Pricing and reimbursement legislation were reviewed to confirm if the use of ATC/DDD in HTA appraisals was supported by local legislation. Drug utilization studies were examined to validate if countries are using this system for drug utilization monitoring.

RESULTS: Germany uses DDD for reference pricing calculations. In France, ATC classification is included in HTA reports of pharmaceuticals. In Spain, ATC is used to assign pharmaceuticals to a group after patent expiry and DDD is used to calculate the reference price for that group. In Italy, payback percentages are based on ATC groups and the DDD defines the reimbursement level of those groups; any price changes, clawbacks and other cost-containment measures can be ATC-based. In the Netherlands, the Medicines Reimbursement System, formed by 500 clusters, is based on the ATC/DDD classification. The United Kingdom does not use ATC/ DDD for pricing and reimbursement. All countries use ATC/DDD systems to report drug utilization.

CONCLUSIONS: ATC classification and DDD impact pricing and reimbursement decisions in all the countries in scope, except in the UK. While DDD can be used to define the reimbursement level of reference price groups in Germany, Spain and Italy, ATC classifications are used in Italy as a basis for price changes, clawbacks and other cost-containment measures.