Omalizumab: 12 agencies, 2006–2026
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
The file has been open for more than a decade: 20.5 years separate the first record, 13 Mar 2006 at TLV (Sweden), from the most recent, 30 Sep 2026 at DMC (Denmark).
CONITEC (Brazil) changed its position: not recommended on 3 Apr 2013, recommended by 3 Feb 2025, after a resubmission.
No assessment is on file from G-BA (Germany), which is among the eight highest-volume agencies here.
Not every gap is a refusal: for omalizumab, 1 submission was never made and 1 was withdrawn or terminated before a decision — an outcome set by the company rather than the assessor.
The file is active: 14 of 43 records date from 2023 or later.
The programme is broad: 17 distinct indication wordings are recorded for omalizumab by the agencies that label one in English (AWMSG, NICE, PBAC and SMC).
12 of these 43 records carry a year of decision but no day, so any interval quoted here is approximate to within a year.
TLV (Sweden) was first to assess omalizumab, on 13 Mar 2006; DMC (Denmark) did not open a file until 30 Sep 2026 — an unusually long tail of 20.5 years between the earliest and latest system to look at it.
The record arrives in waves: 12 separate years each carry two or more decisions, spread across 17 years in total.
9 of the 12 agencies here assessed omalizumab more than once, PBAC (Australia) most often at 12 entries — repeat review is the norm for this molecule rather than the exception.
omalizumab has been through 12 of the 18 agencies in this archive — among the most widely assessed molecules on file.
The full ledger for omalizumab reads 25 recommended, 5 other, 4 restricted and 3 not recommended, with 6 in other categories.
Decisions on file
| Agency | Date | Indication as recorded | Outcome | Source |
|---|---|---|---|---|
| PBAC (Australia) | 2026 | Uncontrolled severe asthmaUncontrolled severe allergic asthmaSevere chronic spontaneous urticaria | Recommended | source |
| CIPM (Spain) | 17 Jun 2026 | Indicación terapéutica autorizada: Asma alérgica Omlyclo está indicado en adultos, adolescentes y niños (de 6 a <12 años… | financed by the SNS · art. 92 a, d | source |
| TLV (Sweden) | 28 Oct 2025 | Omlyclo ingår i högkostnadsskyddet | restricted subsidy | source |
| ZIN (Netherlands) | 5 Aug 2024 | Advies - vergoed omalizumab (Xolair®) voor de behandeling van ernstig astma | reimbursed | source |
| CONITEC (Brazil) | 8 Jul 2016 | Asma alérgica grave | not incorporated | source |
38 further decisions for omalizumab, across 11 agencies, are not shown here. They include the most recent record on file, 30 Sep 2026 from DMC (Denmark); its outcome is in the subscriber dataset. They link to 19 further source documents.
Related molecules
- mepolizumab — same ATC class R03D — Obstructive airway diseases
- benralizumab — same ATC class R03D — Obstructive airway diseases
- tezepelumab — same ATC class R03D — Obstructive airway diseases
- montelukast — same ATC class R03D — Obstructive airway diseases
- depemokimab — same ATC class R03D — Obstructive airway diseases
- roflumilast — same ATC class R03D — Obstructive airway diseases
Coverage: 43 decisions for omalizumab from 12 agencies, 2006 to 2026. Data to 7 Sep 2026. ATC class R03D — Obstructive airway diseases. How this page is produced. Compiled by Altima Partners; queries: sales@altimapartners.co.uk.