OBJECTIVES: Requirements for a Health Technology Assessment (HTA) submission vary within the UK (England and Wales [National Institute for Health and Clinical Excellence (NICE)], Scotland [Scottish Medicines Consortium (SMC)], and Wales [All Wales Medicines Strategy Group (AWMSG)]) and the Republic of Ireland (National Centre for Pharmacoeconomics [NCPE]). The objective of this study is to determine whether the likelihood of reimbursement in these markets is linked to HTA submission requirements.
METHODS: Dossier requirements issued by NCPE, NICE, SMC and AWMSG were compared, and a checklist of requirements compiled. We investigated 20 interventions most recently reviewed by the NCPE, and recorded the recommendations for these compared with those issued by NICE, SMC and AWMSG.
RESULTS: Economic analysis is key for an NCPE submission, although there are no specific requirements or template for the clinical data. Requirements for NICE are the most stringent; SMC and AWMSG have similar requirements. Of 20 interventions reviewed by NCPE, 11 (55%) were reimbursed under the Community Drugs Scheme. Of these, 2 treatments were reimbursed after a price reduction, 2 were borderline, and 1 treatment was cost-effective under the General Medical Services scheme but not the Drugs Payment Scheme. Of the 11 products reimbursed by NCPE, 5 were recommended by NICE (45%), 6 by SMC (55%) and 1 by AWMSG (9%). Not all of the 11 treatments were reviewed by NICE, SMC and/or AWMSG. Furthermore, 2 of the 11 treatments have been withdrawn in Scotland, England and Wales. Limited clinical/economic data was the reason for the one non-recommendation by the SMC. a more detailed analysis will be presented.
CONCLUSIONS: Although requirements for HTA submissions vary between countries, demonstrating cost-effectiveness is a key factor for reimbursement in all markets investigated.
