Ivacaftor / Lumacaftor: 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
G-BA (Germany), HAS (France) and NYE METODER (Norway), among others, recommended or restricted ivacaftor / lumacaftor, while AOTMIT (Poland) and CONITEC (Brazil) did not recommend it.
Assessment has run over 8.2 years, from 13 May 2016 at ZIN (Netherlands) to 24 Jul 2024 at AWMSG (Wales).
ZIN (Netherlands) changed its position: not recommended on 13 May 2016, restricted by 30 Apr 2019, after a resubmission.
No assessment is on file from CIPM (Spain), which is among the eight highest-volume agencies here.
The file is active: 8 of 25 records date from 2023 or later.
3 distinct indication wordings are recorded for ivacaftor / lumacaftor by the agencies that label one in English (AWMSG, PBAC and SMC).
3 of these 25 records carry a year of decision but no day, so any interval quoted here is approximate to within a year.
ZIN (Netherlands) was first to assess ivacaftor / lumacaftor, on 13 May 2016; AWMSG (Wales) did not open a file until 24 Jul 2024 — an unusually long tail of 8.2 years between the earliest and latest system to look at it.
The record arrives in waves: 6 separate years each carry two or more decisions, spread across 8 years in total.
7 of the 11 agencies here assessed ivacaftor / lumacaftor more than once, ZIN (Netherlands) most often at 5 entries — repeat review is the norm for this molecule rather than the exception.
11 of the 18 agencies in this archive hold a record for ivacaftor / lumacaftor.
The full ledger for ivacaftor / lumacaftor reads 10 recommended, 6 not recommended, 4 restricted and 4 advice, with 1 in other categories.
Decisions on file
| Agency | Date | Indication as recorded | Outcome | Source |
|---|---|---|---|---|
| SMC (Scotland) | 24 Jul 2024 | treatment of cystic fibrosis (CF) in patients aged 1 year and older (granules in sachet) or 6 years and older (film-coated tablets) who are homozygous for the F508del mut… | accepted | source |
| AWMSG (Wales) | 24 Jul 2024 | Orkambi tablets are indicated for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who are homoz… | excluded, NICE appraised | source |
| NYE METODER (Norway) | 26 May 2024 | Granulat til behandling av cystisk fibrose hos pasienter >1 år som er homozygote for F508 delmutasjonen i CTFR-genet. | introduced | source |
| G-BA (Germany) | 18 Jan 2024 | Orkambi — benefit assessment §35a | added benefit: non-quantifiable (hint) | source |
| ZIN (Netherlands) | 11 Dec 2023 | GVS-advies uitbreiding vergoedingsvoorwaarden lumacaftor/ivacaftor (Orkambi®) voor de behandeling van cystische fibrose | advice published (GVS) | source |
20 further decisions for ivacaftor / lumacaftor, across 9 agencies, are not shown here. They link to 18 further source documents.
Related molecules
- ivacaftor — same ATC class R07A — Other respiratory
- elexacaftor / ivacaftor / tezacaftor — same ATC class R07A — Other respiratory
- ivacaftor / tezacaftor — same ATC class R07A — Other respiratory
- empagliflozin — also decided by SMC in 2024Q3
- ivosidenib — also decided by SMC in 2024Q3
- lenacapavir — also decided by SMC in 2024Q3
Coverage: 25 decisions for ivacaftor / lumacaftor from 11 agencies, 2016 to 2024. Data to 7 Sep 2026. ATC class R07A — Other respiratory. How this page is produced. Compiled by Altima Partners; queries: sales@altimapartners.co.uk.