Country adaptation of a health economic model: The case for roflumilast in The Netherlands

BACKGROUND: The phosphodiesterase-4 enzyme (PDE4) inhibitor roflumilast is a new treatment that targets the underlying inflammation associated with COPD. When approved, roflumilast will be registered as an add-on to bronchodilator treatment in adult patients with severe COPD, with a history of frequent exacerbations. a health economic (HE) micro-simulation Markov model was used to support its submission in the United Kingdom (UK). Pharmaceutical companies can save significantly on the process of HE evidence development, if models can be adapted for use in more than one country. OBJECTIVES: To transfer an existing UK HE model to the The Netherlands in order to calculate the cost-effectiveness (CE) of roflumilast in patients with severe COPD from a societal perspective. METHODS: The model structure was adapted to include production loss using the friction cost method, and to separate heterogeneity from parameter uncertainty. All input parameters on health care use, costs, utilities, and COPD epidemiology were obtained from Dutch sources, except for the case-fatality rate of an exacerbation-related hospitalization. a direct comparison was made between a combination of a long-acting |32 agonist (LABA) plus roflumilast (ROFLU) and LABA alone. a second, indirect comparison was between LABA + ROFLU and LABA plus an inhaled corticosteroid (ICS). One-way and probabilistic sensitivity analyses were performed. RESULTS: From a societal perspective, the incremental CE ratio (ICER) for LABA + ROFLU compared with LABA alone, was €7900. The ICER of LABA + ROFLU versus LABA + ICS was €10,000. The probability that LABA + ROFLU was cost-effective when compared with LABA alone at a threshold of €20,000 versus LABA was 97%. Compared with LABA + ICS this probability was 68.3%. CONCLUSIONS: The original UK model was suitable for adaptation to the Dutch setting. The ICERs of roflumilast were below commonly referred threshold values of a QALY.