Insulin DegludecTresiba
Recommended EndocrinologyRestricted 💬 consumer voice
Treatment of type 1 diabetes mellitus in patients aged 1 year or older requiring basal insulin therapy.
2
Submissions
1 resub
2013–25
On the record
—
ICER range
Cost-min
Cost basis
Decision on record
- Meeting Jul 2025 Recommended Type 1 diabetes mellitus
Access path
- TGA registered · Tresiba
TGA label narrower than the PBS population
- Mar 2013Recommended
vs insulin glargine
- Jul 2025Recommended · restricted
Comparator changed: insulin glargine → insulin glargine 100 IU/mL
- PBS listing · Restricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
7.1 The PBAC recommended the General Schedule Restricted Benefit listing of insulin degludec for the treatment of type 1 diabetes mellitus (T1D). The PBAC’s recommendation for listing was based on, among other matters, its assessment that the cost-effectiveness of insulin degludec would be acceptable at the price proposed in the resubmission. The PBAC advised that the small, proposed price difference relative to insulin glargine 100 IU/mL was reasonable.PSD · Jul 2025
7.2 The PBAC noted that insulin detemir is scheduled for discontinuation from the Australian market towards the end of 2026 and that the consumer comments received on this submission stated that people living with T1D value having a choice of insulin treatments. The PBAC noted that not all patients do well on insulin glargine and that some patients living with T1D have issues with nocturnal hypoglycaemia.PSD · Jul 2025
Economic analysis
The resubmission presented a simple cost consequences analysis, listing the comparative per-unit costs of insulin degludec 100 IU/mL versus insulin glargine 100 IU/mL, and the potential advantages of insulin degludec to the target population of T1D patients, if insulin degludec were listed on the PBS.PSD · Jul 2025
OFFICIAL Public Summary Document – July 2025 PBAC Meeting Guidelines V5.0, p64). The evaluation and the ESC considered that use of a cost consequences analysis was not adequately justified in the resubmission.PSD · Jul 2025
Clinical claim
6.46 The resubmission described insulin degludec as non-inferior in terms of effectiveness and safety compared with insulin glargine 100 IU/mL, with potentially important clinical advantages in nocturnal hypoglycaemia, basal and total insulin doses, flexibility of administration times and use in critical early childhood and pregnancy.PSD · Jul 2025
6.47 The ESC considered that the therapeutic conclusions presented in the resubmission were adequately supported by the evidence presented in the resubmission in terms of non-inferior efficacy and safety, but that the claimed clinical advantages were not supported for the following reasons:PSD · Jul 2025
Consumer comments
6.3 The PBAC noted that the most important clinical need for people living with T1D, according to the consumer organisations, is to have a choice of treatments. The consumer organisations indicated that choice of treatment is particularly important for people who experience nocturnal hypoglycaemia.PSD · Jul 2025
Cost-effectiveness
Cost consequences analysis was performed instead of cost-effectiveness analysis; no ICER was calculated.
The base case ICERs were all less than $10,000 per quality adjusted life year (QALY) for type 1 basal bolus, type 2 basal oral, type 2 basal bolus, all type 2 weighted and type 1 and 2 weighted. PBAC · 2013
ICER uncertainICER / price too highEconomic model disputed
Decision context
PopulationAdults and children aged 1 year or older with type 1 diabetes mellitus requiring basal-bolus insulin therapy, excluding patients with type 2 diabetes.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2025 | Recommended · restricted | insulin glargine 100 IU/mL | — | RCT · Glycaemic control; hypoglycaemia episodes |
| Mar 2013 | Recommended | insulin glargine | — | RCT · HbA1c |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| HypoDeg | Ph 4 | 149 | Symptomatic nocturnal hypoglycaemia | completed |
| NN1250-3583 | Ph 3 | 629 | Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks o… | completed |
| NN1250-3579 | Ph 3 | 1,030 | Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks o… | completed |
Consumer voice
Consumer organisations emphasised the importance of treatment choice for people with type 1 diabetes, particularly those experiencing nocturnal hypoglycaemia, and highlighted that insulin degludec offers safety in pregnancy, more consistent blood glucose management, and quality of life benefits compared to existing insulins.
The most important clinical need for people living with T1D, according to the consumer organisations, is to have a choice of treatments. Consumer comments · PSD
treatment choiceunmet needquality of lifesafety in pregnancynocturnal hypoglycaemiahypoglycaemia risk reduction
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to type 1 diabetes only, excluding type 2, and specifies basal or basal-bolus insulin therapy requirements.