Insulin Glargine: 6 agencies, 2002–2026
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
No agency in this archive has refused insulin glargine: all 18 decisive outcomes across 6 agencies were positive or positive with restrictions.
The file has been open for more than a decade: 23.6 years separate the first record, 4 Oct 2002 at SMC (Scotland), from the most recent, 26 May 2026 at TLV (Sweden).
AWMSG (Wales) changed its position: recommended on 22 Mar 2013, restricted by 10 Dec 2015.
No assessment is on file from CIPM (Spain) and G-BA (Germany), each among the eight highest-volume agencies here.
7 distinct indication wordings are recorded for insulin glargine by the agencies that label one in English (AWMSG, PBAC and SMC).
1 of these 26 records carries a year of decision but no day, so any interval quoted here is approximate to within a year.
SMC (Scotland) was first to assess insulin glargine, on 4 Oct 2002; PBAC (Australia) did not open a file until 2018 — an unusually long tail of 15.8 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 14 years in total.
Restriction is doing real work here: 6 of 18 decisive outcomes narrowed insulin glargine to a subgroup rather than accepting or refusing it outright, at AWMSG (Wales), SMC (Scotland) and TLV (Sweden).
5 of the 6 agencies here assessed insulin glargine more than once, HAS (France) most often at 11 entries — repeat review is the norm for this molecule rather than the exception.
6 of the 18 agencies in this archive hold a record for insulin glargine.
The full ledger for insulin glargine reads 12 recommended, 6 restricted, 6 other and 2 not assessed.
Decisions on file
| Agency | Date | Indication as recorded | Outcome | Source |
|---|---|---|---|---|
| HAS (France) | 10 Jun 2020 | Indication extension | SMR substantial · ASMR V | source |
| AWMSG (Wales) | 12 Feb 2020 | Treatment of diabetes mellitus in adolescents and children from the age of 6 years | outside AWMSG criteria | source |
| PBAC (Australia) | 2018 | Unrestricted (indicated for diabetes mellitus) | The PBAC recommended the unrestricted listing the biosimilar brand of insulin glargine (Se… | source |
| SMC (Scotland) | 7 Sep 2015 | For the treatment of type 1 or type 2 diabetes mellitus in adults aged 18 years and above | accepted (restricted) | source |
| TLV (Sweden) | 2 Dec 2009 | Vi beslutar att Lantus ska ingå i högkostnadsskyddet med begränsning | restricted subsidy | source |
21 further decisions for insulin glargine, across 5 agencies, are not shown here. They include the most recent record on file, 26 May 2026 from TLV (Sweden); its outcome is in the subscriber dataset. They link to 16 further source documents.
Related molecules
- insulin detemir — divergent outcome (recommended vs restricted) on a shared indication
- insulin aspart — same ATC class A10A — Diabetes
- insulin degludec — same ATC class A10A — Diabetes
- insulin lispro — same ATC class A10A — Diabetes
- insulin glulisine — same ATC class A10A — Diabetes
- insulin glargine / lixisenatide — same ATC class A10A — Diabetes
Coverage: 26 decisions for insulin glargine from 6 agencies, 2002 to 2026. Data to 7 Sep 2026. ATC class A10A — Diabetes. How this page is produced. Compiled by Altima Partners; queries: sales@altimapartners.co.uk.