Abstract

The objective of this study was to develop a conceptual framework to estimate potential consequences of IRP reforms by estimating the impact if a European country was to include Turkey into the set of countries that it uses to establish the reference price. Phase 1 consisted of obtaining evidence on the IRP countries using a literature review from 2011 to 2013 (WHO/HAI Systematic Review - May 2011) based on ECONLIT, MEDLINE and grey literature. Phase 2 consisted of developing a conceptual framework and model database to summarize IRP designs, reference baskets, methods and updates. Model inputs for the product included prices, volume, and launch phase. Phase 3 consisted of building and testing the model from a manufacturer perspective with a variable time horizon up to 5 years. Products from the epidermal growth factor receptor (EGFR) class were selected to estimate the potential effects of including Turkey into the reference basket used by EU countries to calculate reference rules. Four peer-reviewed and a number of websites and white papers were identified discussing IRP related issues. A conceptual framework was designed considering 1) database of IRP country rules, 2) product data, and 3) model input interface to conduct one-way sensitivity analysis of a simulated IRP reform. Inclusion of Turkey into the reference basket of various EU markets lead to large negative financial impacts for companies with EGFR products. The countries that lead to the largest impact were Romania and Greece. The second order effects such as countries that re-referenced Greece and Romania were larger over the 5-year time frame compared with the primary effects. The proposed conceptual framework may offer another tool to estimate the impact of IRP reforms as we found that even small changes to reference baskets used in IRP can lead to large negative financial impacts for pharmaceutical manufactures.

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