BARRIERS IN ACCESS TO MULTI-INDICATION MEDICINES DRIVING INEQUITABLE ACCESS ACROSS THERAPY AREAS
Author(s)
Tom Atkins, N/A, Adele Schulz, MSc.
Sanofi, Reading, United Kingdom.
Sanofi, Reading, United Kingdom.
OBJECTIVES: Multi-indication medicines (MIMs) represent a high proportion of NICE technology appraisals (TA) yet face disproportionate reimbursement barriers despite the 2021 NHS England Commercial Framework. This study quantified NICE termination, negative and optimised recommendation trends for MIMs, assessed therapy area dependencies, and estimated patient impact.
METHODS: NICE TA guidance (2001 and July 2025) was extracted from the NICE database (n=867 published; n=300 in development). Appraisals were classified as single-, first-, or follow-on indication, including guidance in development. Patient populations were derived from NICE resource impact templates, GlobalData, and Clarivate healthcare intelligence databases. Recommendations for MIMs versus single-indication products were assessed across therapy area, MIM pathway types and population size.
RESULTS: MIMs represented 70.4% of appraisals (2019-2025) yet accounted for 76.3% of combined terminations and negative recommendations. Not recommended rates were 29% for MIMs versus 21.4% for single-indication products. When approved, MIMs were more frequently optimised (53.5% versus 42%), suggesting systemic pricing could be a factor driving failures. In therapy areas with high termination rates, a high proportion of these terminations are for multi-indication medicines. For example, ENT, oncology, ophthalmology and rheumatology showed heavy MIM dependence (>60% follow-on indications). This means these therapy areas are disproportionately impacted. An estimated 888,000 patients were affected by terminated/negative appraisals in 2024-2025, with 83% attributable to follow-on indications despite only representing 55% of evaluations.
CONCLUSIONS: MIMs face persistent access barriers despite representing the majority of new treatments in several therapy areas. The growing share of follow-on indications means this inequity will affect an increasing number of patients. This pattern has persisted despite the introduction of NHS England Commercial Framework, suggesting the stringent criteria for ISP remain a barrier to access for MIMs. Reform is needed to address treatment access inequity in MIM-dependent therapy areas.
METHODS: NICE TA guidance (2001 and July 2025) was extracted from the NICE database (n=867 published; n=300 in development). Appraisals were classified as single-, first-, or follow-on indication, including guidance in development. Patient populations were derived from NICE resource impact templates, GlobalData, and Clarivate healthcare intelligence databases. Recommendations for MIMs versus single-indication products were assessed across therapy area, MIM pathway types and population size.
RESULTS: MIMs represented 70.4% of appraisals (2019-2025) yet accounted for 76.3% of combined terminations and negative recommendations. Not recommended rates were 29% for MIMs versus 21.4% for single-indication products. When approved, MIMs were more frequently optimised (53.5% versus 42%), suggesting systemic pricing could be a factor driving failures. In therapy areas with high termination rates, a high proportion of these terminations are for multi-indication medicines. For example, ENT, oncology, ophthalmology and rheumatology showed heavy MIM dependence (>60% follow-on indications). This means these therapy areas are disproportionately impacted. An estimated 888,000 patients were affected by terminated/negative appraisals in 2024-2025, with 83% attributable to follow-on indications despite only representing 55% of evaluations.
CONCLUSIONS: MIMs face persistent access barriers despite representing the majority of new treatments in several therapy areas. The growing share of follow-on indications means this inequity will affect an increasing number of patients. This pattern has persisted despite the introduction of NHS England Commercial Framework, suggesting the stringent criteria for ISP remain a barrier to access for MIMs. Reform is needed to address treatment access inequity in MIM-dependent therapy areas.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HPR13
Topic
Health Policy & Regulatory
Topic Subcategory
Pricing Policy & Schemes, Reimbursement & Access Policy