HTA STATUS OF BIOSIMLARS ACROSS THE UK AND IRELAND
Author(s)
Mildred M, Davies K
Boehringer Ingelheim Ltd, Bracknell, UK
OBJECTIVES: Biosimilars have the potential to revolutionise the healthcare landscape by realising cost savings over originator biologics and thus increasing access to innovative medicines. The biosimilars marketplace in the UK and Ireland is relatively new, however the landscape is rapidly developing. The objective of this analysis was to map the HTA status of biosimilars in the UK and Ireland to provide insight for stakeholders involved in the assessment of new biosimilars. METHODS: The HTA status of all EMA authorised biosimilars was identified by searching the websites of all four HTA agencies in the UK and Ireland, namely, NICE, the SMC, the AWMSG, and the NCPE. All previously assessed medicines and on-going technology appraisals were screened for the inclusion of biosimilars using the non-proprietary (common name) and proprietary (brand) names. RESULTS: Sixteen (84%) of the nineteen biosimilars submitted to the EMA have been authorised, eleven of which (69%) have been considered by HTA agencies. The SMC has approved 100% of the biosimilars it has considered (n=7); the largest positive reimbursement rate amongst all HTA agencies considered. The AWMSG has considered the largest number of biosimilars (n=11), of which five, (45%) received a positive reimbursement status. Both NICE and the NCPE have approved one biosimilar, however three additional biosimilars are currently being considered by NICE. CONCLUSIONS: The reimbursement status of biosimilars in the UK and Ireland is not consistent across HTA agencies. The timing of HTA submissions to different HTA agencies may play an important factor in the reimbursement status of biosimilars given that this landscape is relatively new and assessment processes vary. Marketing authorisation holders for biosimilars may want to consider the strategic importance of submitting evidence to each of the HTA agencies in the UK and Ireland, and the impact timing may have on the uptake of their biosimilar.
Conference/Value in Health Info
2014-11, ISPOR Europe 2014, Amsterdam, The Netherlands
Value in Health, Vol. 17, No. 7 (November 2014)
Code
PHP157
Topic
Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes, Reimbursement & Access Policy
Disease
Multiple Diseases