Pns245 Snapshot of Early Access Programmes in Portugal: A New Access Hurdle?

Abstract

Publicly available information on EUnetHTA JAs for individual drugs were identified along with the associated appraisal by NICE, SMC, TLV, HAS, AIFA, SMC, NCPE, ZIN, Medicinradet, AOTM and NOMA (to 12/06/2019). HTA recommendation rates and time to positive appraisal were compared between comparative clinical efficacy (CCE) markets (HAS and Medicinradet) and other (non-CCE) markets (costeffectiveness or budget impact payer archetypes) Results: Eight EUnetHTA JAs were identified, 5/8 were for oncology indications and 2/8 were orphan drugs. Forty-one corresponding national HTA appraisals were identified, ten of which were produced by a CCE market (HAS: seven; Medicinradet: three). Of these 7/10 (70%) received a positive appraisal, which did not significantly differ from non-CCE markets 20/31 (65%). CCE-appraised products had a significantly lower mean delay from ECapproval to national HTA publication in comparison to non-CCE markets (223 days and 324 days respectively; p=0.025) Conclusions: To date, drugs appraised under EUnetHTA JAs have been assessed in a shorter time by CCE markets in comparison to those appraised by non-CCE markets with a similar rate of positive appraisal. This may reflect a greater alignment between the JA clinical framework to CCE market HTA decision-drivers than the non-CCE markets or, may rather reflect natural assessment timelines of the HTA bodies involved. If the pan-clinical HTA proposals come to fruition, their impact may be limited by economic evaluations representing the primary focus of many payer bodies.