ARE ANTIBIOTIC POLICIES AND REIMBURSEMENT DECISIONS ALIGNED?
Author(s)
Schey C1, Connolly M2
1University of Groningen, St Prex, Switzerland, 2University of Groningen, Groningen, The Netherlands
OBJECTIVES According to the World Health Organisation, the emergence of resistant organisms has rendered antibiotics ineffective in some settings (1). In an attempt to address current and future unmet needs in this area innovative antibiotics are being developed. We conducted a review of recent HTA evaluations for antibiotics to investigate whether policy initiatives to promote advances in antibiotics are reflected in reimbursement decisions. METHODS The guidance directories of the Scottish Medicines Consortium (SMC), All Wales Medicines Strategy Group (AWMSG) and the National Institute for Health and Care Excellence (NICE) were reviewed for assessments of antibiotics, from 2000 until May 2014. Data relating to each assessment were extracted. A simple scoring system for the reimbursement decisions by the SMC and AWMSG was adopted: where a “positive” reimbursement decision scored 3, “Restricted use” scored 1, “Not yet reviewed” scored 0 and “Rejected” scored -1. Results were plotted to show the positioning of reimbursement decisions of AWMSG in relation to SMC. RESULTS A total of 18 antibiotics were identified as having been assessed by either SMC or AWMSG. Of these 18 products, only 2 were assessed by NICE, and a further 2 were the subjects of “Evidence Review Summaries”, product overviews that are not legally binding. Of the 18 antibiotics identified, only 3 and 2 received “Positive” reimbursement decisions by the SMC and AWMSG, respectively. Four antibiotics were “Not Recommended” by both SMC and AWMSG, of which several rejections were due to pharmaceutical companies not submitting dossiers to the regulatory body. Scatterplots of SMC and AWMSG scores featured six antibiotics in the top right quadrant. CONCLUSIONS This study demonstrates the different assessment approaches by each regulatory body for antibiotics. Moreover, the low number of antibiotics reviewed highlights that the dearth of new, innovative antibiotics are not in keeping with policies to develop innovative antibiotics.
Conference/Value in Health Info
2014-11, ISPOR Europe 2014, Amsterdam, The Netherlands
Value in Health, Vol. 17, No. 7 (November 2014)
Code
PIN120
Topic
Health Policy & Regulatory
Topic Subcategory
Reimbursement & Access Policy
Disease
Infectious Disease (non-vaccine)