Ivacaftor: where the agencies disagree
This page collects every recorded health technology assessment decision for one molecule across the agencies in our archive, and compares them. The comparison is the point: each agency publishes its own verdict, none publishes how that verdict sits against the others.
What the record shows
AIFA (Italy), CONITEC (Brazil) and G-BA (Germany), among others, recommended or restricted ivacaftor, while AOTMIT (Poland) and SMC (Scotland) did not recommend it.
On the same population the two systems disagree outright: PBAC (Australia) recorded recommended for “Cystic fibrosis (CF) with the CF transmembrane conductance regulator (CFTR) gene mutation”, while SMC (Scotland) recorded not recommended for “For the treatment of patients with cystic fibrosis (CF) aged 18 years and older who have an R117H mutation in the CF transmembrane conductance regulator (CFTR) gene.”.
PBAC (Australia) has been easier on ivacaftor than on its own caseload: it refused 0 of 5 decisive submissions here (0%), against a base rate of 24% across everything it has assessed.
The file has been open for more than a decade: 13.2 years separate the first record, 7 Nov 2012 at HAS (France), from the most recent, 25 Feb 2026 at CIPM (Spain).
PHARMAC (New Zealand) changed its position: restricted on 21 Feb 2019, recommended by 5 Sep 2022.
No assessment is on file from TLV (Sweden), which is among the eight highest-volume agencies here.
The file is active: 17 of 79 records date from 2023 or later.
5 distinct indication wordings are recorded for ivacaftor by the agencies that label one in English (AWMSG, PBAC and SMC).
8 of these 79 records carry a year of decision but no day, so any interval quoted here is approximate to within a year.
HAS (France) was first to assess ivacaftor, on 7 Nov 2012; AWMSG (Wales) did not open a file until 24 Jul 2024 — an unusually long tail of 11.7 years between the earliest and latest system to look at it.
The record arrives in waves: 10 separate years each carry two or more decisions, spread across 13 years in total.
10 of the 12 agencies here assessed ivacaftor more than once, G-BA (Germany) most often at 21 entries — repeat review is the norm for this molecule rather than the exception.
ivacaftor has been through 12 of the 18 agencies in this archive — among the most widely assessed molecules on file.
The full ledger for ivacaftor reads 41 recommended, 13 not recommended, 12 no benefit and 9 restricted, with 4 in other categories.
Decisions on file
| Agency | Date | Indication as recorded | Outcome | Source |
|---|---|---|---|---|
| CIPM (Spain) | 25 Feb 2026 | Indicaciones terapéuticas autorizadas: KALYDECO 75 MG GRANULADO EN SOBRE, 56 (4 x 14) sobres (multipack) (C.N. 711571) K… | not financed by the SNS · art. 92 d | source |
| AIFA (Italy) | 6 Aug 2025 | KAFTRIO, in regime di associazione con KALYDECO, è indicato nel trattamento della fibrosi cistica (FC) in pazienti pedia… | fully innovative, since expired | source |
| HAS (France) | 18 Dec 2024 | Listing (Transparency Committee) | SMR insufficient · ASMR II | source |
| NYE METODER (Norway) | 8 Dec 2024 | Monoterapi til barn 1-4 måneder (fra 3 kg) med cystisk fibrose, som har en av følgende mutasjoner i CFTR-genet: R117H, G… | introduced | source |
| PBAC (Australia) | 2016 | Cystic fibrosis | The PBAC deferred making a recommendation regarding listing ivacaftor granules for the tre… | source |
74 further decisions for ivacaftor, across 12 agencies, are not shown here. They include the most recent record on file, 25 Feb 2026 from CIPM (Spain); its outcome is in the subscriber dataset. They link to 51 further source documents.
Related molecules
- elexacaftor / ivacaftor / tezacaftor — same ATC class R07A — Other respiratory
- ivacaftor / lumacaftor — same ATC class R07A — Other respiratory
- ivacaftor / tezacaftor — same ATC class R07A — Other respiratory
- dydrogesterone — also decided by CIPM in 2026Q1
- vutrisiran — also decided by CIPM in 2026Q1
- damoctocog alfa pegol — also decided by CIPM in 2026Q1
Coverage: 79 decisions for ivacaftor from 12 agencies, 2012 to 2026. Data to 7 Sep 2026. ATC class R07A — Other respiratory. How this page is produced. Compiled by Altima Partners; queries: sales@altimapartners.co.uk.