VP34 Impact Of Adverse Events On Reimbursement Recommendations

Abstract

Introduction

European agencies evaluate the adverse events (AEs) of asthma drugs in studies. The impact of these evaluations on reimbursement decisions remains unclear.

Methods

Adult asthma evaluations were accessed from initial regulatory decision by the European Medicines Agency (EMA) through reimbursement evaluations. Omalizumab and reslizumab were chosen for the comparison of an older with a newer asthma drug. A timeline was then constructed to evaluate the effect of AEs on reimbursement recommendations. Evaluations from the United Kingdom (NICE) were not used because their documents are not as complete or in depth, including those from Sweden (TLV) and Germany (IQWIG).

Results

Omalizumab was first approved as add-on therapy to improve asthma control in October 2005. Of the 6 decisions made between 2006 and 2012, safety information was found in 4 of them, all from 2006 and evaluated by either Scotland (SMC) or France (HAS). These desicions all received either a ‘Do not recommend’ or a ‘Recommend with restrictions’ decision. Reslizumab was first approved as add-on therapy for patients with severe eosinophilic asthma in August 2016. Of the 9 decisions made in 2017, safety information was found in 5 decisions evaluated by IQWiG, Germany (G-BA), HAS, or SMC, which gave them a Do not recommend, Recommend with restrictions, or Recommend decision. Of the Do not recommend decisions, both the omalizumab and reslizumab safety evaluations mentioned common AEs (worsening asthma) and less common AEs (malignant tumors). Of the Recommend with restrictions decisions, the same AEs were seen. Only reslizumab had Recommended decisions. In the safety evaluation, there were no specific AEs named.

Conclusions

The impact of AEs on reimbursement decisions could not be detected when comparing omalizumab and reslizumab reviews, as other factors may contribute to the decisions. Further research should be conducted to explore this issue.