HTA Regulation: PICO simulation exercises done by the EU HTA Coordination Group
In order to test and improve the draft content of the Guidance on the scoping process, six PICO (Population Intervention Comparator Outcome) exercises were carried out by the JCA subgroup in the Spring of 2024: three for Medicinal Products (MPs) and three for Medical Devices (MDs).
They were carried out on MPs that had already received a positive CHMP opinion and on MDs that had received a scientific opinion from the expert panels on MDs and in vitro diagnostic devices. Please note that the PICO exercises do not fully reflect the final (i.e. endorsed) version of the guidance, which was drawn up after the exercises. Therefore, no conclusions regarding standardisation should be drawn from the exercises.
They are published here for transparency purposes.
Round 1
Imfinzi (durvalumab) for advanced or unresectable hepatocellular carcinoma had 13 consolidated PICOs and six comparators.
EASEE system as an adjunctive therapy to antiepileptic medication had five consolidated PICOs and four comparators.
Round 2
Krazati (adagrasib) as monotherapy for advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation and disease progression had 13 consolidated PICOs and 10 comparators.
Edwards EVOQUE Tricuspid Valve Replacement System for severe tricuspid regurgitation had one PICO and one comparator.
Round 3
Hemgenix (etranacogene dezaparvovec) for severe and moderately severe haemophilia B had 7 PICOs and 7 comparators.
Transcatheter patent ductus arteriosus (PDA) stenting procedure with a bioresorbable stent for cyanotic congenital heart defects requiring temporary palliation had three consolidated PICOs and three comparators.
