Insulin Degludec: 7 agencies, 2013–2025
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 degludec: all 9 decisive outcomes across 6 agencies were positive or positive with restrictions.
The file has been open for more than a decade: 12.1 years separate the first record, 24 Jun 2013 at TLV (Sweden), from the most recent, 2025 at PBAC (Australia).
AOTMIT (Poland) changed its position: recommended on 19 Feb 2021, restricted by 9 May 2023.
No assessment is on file from PHARMAC (New Zealand) and CIPM (Spain), each among the eight highest-volume agencies here.
Not every gap is a refusal: for insulin degludec, 1 submission was never made — an outcome set by the company rather than the assessor.
The file is active: 2 of 14 records date from 2023 or later.
3 distinct indication wordings are recorded for insulin degludec by the agencies that label one in English (AWMSG, PBAC and SMC).
1 of these 14 records carries a year of decision but no day, so any interval quoted here is approximate to within a year.
TLV (Sweden) was first to assess insulin degludec, on 24 Jun 2013; PBAC (Australia) did not open a file until 2025 — an unusually long tail of 12.1 years between the earliest and latest system to look at it.
The record arrives in waves: 3 separate years each carry two or more decisions, spread across 11 years in total.
4 of the 7 agencies here assessed insulin degludec more than once, HAS (France) most often at 4 entries — repeat review is the norm for this molecule rather than the exception.
7 of the 18 agencies in this archive hold a record for insulin degludec.
The full ledger for insulin degludec reads 7 recommended, 3 no benefit, 2 restricted and 1 non-submission, with 1 in other categories.
Decisions on file
| Agency | Date | Indication as recorded | Outcome | Source |
|---|---|---|---|---|
| PBAC (Australia) | 2025 | Type 1 diabetes mellitus (T1DM) | Recommended | source |
| AOTMIT (Poland) | 9 May 2023 | Tresiba reimbursement recommendation | recommended conditionally | source |
| AWMSG (Wales) | 3 Oct 2022 | Treatment of diabetes mellitus in adults, adolescents and children from the age of 1 year | recommended (licence extension for paediatric use) | source |
| G-BA (Germany) | 16 May 2019 | Tresiba — benefit assessment §35a | added benefit: not proven | source |
| HAS (France) | 6 Feb 2019 | Re-assessment of ASMR | ASMR IV | source |
9 further decisions for insulin degludec, across 5 agencies, are not shown here. They link to 7 further source documents.
Related molecules
- tirzepatide — divergent outcome (recommended vs not recommended) on a shared indication
- exenatide — divergent outcome (recommended vs not recommended) on a shared indication
- insulin glargine — same ATC class A10A — Diabetes
- insulin detemir — same ATC class A10A — Diabetes
- insulin aspart — same ATC class A10A — Diabetes
- insulin lispro — same ATC class A10A — Diabetes
Coverage: 14 decisions for insulin degludec from 7 agencies, 2013 to 2025. Data to 7 Sep 2026. ATC class A10A — Diabetes. How this page is produced. Compiled by Altima Partners; queries: sales@altimapartners.co.uk.