Is the UK’S Ilap Process Delivering Its Intended Benefits? a Review of Access to Orbis Designated Oncology Products within the UK
Author(s)
Gaultney J, McDonald K, Mushtaq S
IQVIA Ltd, London, UK
Presentation Documents
OBJECTIVES:
The UK’s Innovative Licensing Access Pathway (ILAP) provides manufacturers opportunity to engage early with UK stakeholders with the ambition to improve patient access to innovative medicines. Little is known about the benefits as there is no publicly available documentation on the products accepted into ILAP, though Orbis-designated oncology products must also qualify for ILAP. HTAs by NICE and SMC for Orbis-designated products were reviewed to assess if they receive the benefits of the ILAP scheme.METHODS:
A search of an international database of extracted HTAs (HTA Accelerator) was conducted in June 2023 to identify NICE and SMC HTAs of products that received Orbis-designation. Data extractions included the evidence under assessment, agency critique, outcome, and time to recommendation.RESULTS:
As of March 2023, 16 products received Orbis designation. The majority (n=9; 56%) were indicated for non-small cell lung cancer (NSCLC). From NICE, 58% received positive recommendations (+/-restrictions), 21% were negative and 21% did not submit. From SMC, 50% received positive recommendations (+/-restrictions), 14% were negative and 36% did not submit. In two instances, SMC and NICE appraisal decisions outcomes were divergent. Median and mean time to decision was 82 and 67 days longer for NICE compared to SMC, respectively [NICE: 244 or 268 days; SMC: 149 or 179 days]. Mean time to availability was 240 days in England vs 208 days in Scotland, which in comparison to the 2021 EFPIA Patient WAIT survey for oncology products, was similar for NICE (240 vs 241) but faster for SMC (208 vs 374).CONCLUSIONS:
Timelines for HTA approval for products in Project Orbis are similar to non-Orbis oncology products in England, although faster in Scotland. Regulator and HTA decisions are not always aligned. Products in Project ORBIS are not necessarily representative of ILAP more generally but other information is currently not available.Conference/Value in Health Info
2023-11, ISPOR Europe 2023, Copenhagen, Denmark
Value in Health, Volume 26, Issue 11, S2 (December 2023)
Code
HPR31
Disease
No Additional Disease & Conditions/Specialized Treatment Areas