Inefficiencies in Developing UK and Irish HTA Submissions and How to Streamline the Process
Author(s)
Samuel E. Taylor, PhD1, Brenda Dooley, MSc2, Carl Prescott, MSc1.
1AXIS - The Reimbursement Experts, London, United Kingdom, 2AXIS - The Reimbursement Experts, Dublin, Ireland.
1AXIS - The Reimbursement Experts, London, United Kingdom, 2AXIS - The Reimbursement Experts, Dublin, Ireland.
OBJECTIVES: When to submit to UK and Irish Health Technology Assessments (HTAs) is a balance. Too soon, and you will duplicate effort and miss key learnings from ongoing HTA decisions. Too late, and there is a missed opportunity for potential revenue, and risk clinical trial data, systematic literature reviews (SLRs), and relevant comparators being outdated. Here, we propose an optimised timeline for UK and Irish HTA submissions, outlining the key decision points and considerations for each HTA agency.
METHODS: A hypothetical sequential timeline for NICE, SMC, and NCPE HTA submissions, including the development of materials and HTA review/decision times, was first plotted. Next, periods of ‘down-time’ were highlighted, demonstrating where time can be saved in a streamlined approach. Similar HTA submission requirements were also highlighted as potential duplications of effort. Finally, the sequential HTA timelines were segmented, and re-organised.
RESULTS: The typical time from development to recommendation decision for recent NICE, SMC, and NCPE is 14 , 10, and 22 months, respectively; a total of 46 months in a sequential submission approach. Dealing with several HTA bodies, who have differing regulators and differing approaches to processes, methods, timeliness, transparency, backlogs etc, can be complex to navigate. However, carefully overlapping HTA submissions in a streamlined approach can reduce both time to recommendation in each region, and resource burden of submissions .
CONCLUSIONS: Balancing UK and Irish HTA submissions scheduling is complex. A sequential approach allows for a more straightforward timeline, however, is often less efficient and embedded with duplication in both time and resources. Proactively scheduling of NICE, SMC, and NCPE HTA submissions as one overarching project, instead of three individual projects, allows for a more cohesive approach. However, this approach comes with additional challenges, balancing each submissions needs and timings, to achieve a faster overall time to reimbursement across three regions.
METHODS: A hypothetical sequential timeline for NICE, SMC, and NCPE HTA submissions, including the development of materials and HTA review/decision times, was first plotted. Next, periods of ‘down-time’ were highlighted, demonstrating where time can be saved in a streamlined approach. Similar HTA submission requirements were also highlighted as potential duplications of effort. Finally, the sequential HTA timelines were segmented, and re-organised.
RESULTS: The typical time from development to recommendation decision for recent NICE, SMC, and NCPE is 14 , 10, and 22 months, respectively; a total of 46 months in a sequential submission approach. Dealing with several HTA bodies, who have differing regulators and differing approaches to processes, methods, timeliness, transparency, backlogs etc, can be complex to navigate. However, carefully overlapping HTA submissions in a streamlined approach can reduce both time to recommendation in each region, and resource burden of submissions .
CONCLUSIONS: Balancing UK and Irish HTA submissions scheduling is complex. A sequential approach allows for a more straightforward timeline, however, is often less efficient and embedded with duplication in both time and resources. Proactively scheduling of NICE, SMC, and NCPE HTA submissions as one overarching project, instead of three individual projects, allows for a more cohesive approach. However, this approach comes with additional challenges, balancing each submissions needs and timings, to achieve a faster overall time to reimbursement across three regions.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HTA1
Topic
Economic Evaluation, Health Technology Assessment, Organizational Practices
Topic Subcategory
Systems & Structure
Disease
No Additional Disease & Conditions/Specialized Treatment Areas