Insulin GlargineOptisulin
Treatment of type 1 and type 2 diabetes mellitus. A biosimilar brand of insulin glargine for patients requiring basal insulin therapy.
Decisions on record
- Meeting Mar 2019 Not recommended INSULIN GLARGINE with LIXISENATIDE is indicated in combination with metformin for the treatment of adults with type 2 diabetes mellitus to improve glycaemic control when this has not been provided by
- Meeting Mar 2019 Not recommended Indication not stated
- Meeting Jul 2018 Recommended Unrestricted (indicated for diabetes mellitus)
- Meeting Nov 2015 Recommended Diabetes
- Meeting Jul 2015 Recommended Diabetes
- Meeting Mar 2015 Recommended Diabetes mellitus
- Meeting Mar 2007 Recommended Diabetes no PSD
Access path
- TGA registered · Optisulin
TGA label narrower than the PBS population
- Jul 2005Not recommended
Uncertain overall benefit in insulin-dependent diabetic population as a whole, uncertain and unacceptably high…
- ↻ resubmittedMar 2006Recommended
Evidence: RCT → Meta-analysis, Registry
- Mar 2006Recommended
Evidence: RCT → Meta-analysis, Registry
- Mar 2015Recommended
Comparator changed: insulin NPH → Lantus (insulin glargine reference product)
- Jul 2015Recommended · restricted
Comparator changed: Lantus (insulin glargine reference product) → insulin glargine 100…
- Nov 2015Recommended · restricted
Comparator changed: insulin glargine 100 units per mL (U100) → insulin glargine (Lantus)
- Jul 2018Recommended
Comparator changed: insulin glargine (Lantus) → Lantus (reference brand of insulin…
- PBS listing · Unrestricted
From the public summary
6.1 The PBAC recommended listing the biosimilar brand of insulin glargine (Semglee) on the General Schedule (Section 85) as an unrestricted benefit.PSD · Jul 2018
6.2 In making this recommendation, the PBAC noted the TGA CER on Semglee® concluded that the TGA was satisfied that Semglee® was bioequivalent to the reference product, Lantus and was non-inferior in terms of both efficacy and safety.PSD · Jul 2018
6.26 Cost-minimisation analysis for T1DM: The submission estimated that U300 40.46 units daily and U100 34.12 units daily were equi-effective (i.e. 1 unit of U300 is equivalent to 0.84 units of U100). The equi-effective doses were based on the mean doses at 6 months in EDITION IV. The equi-effective doses differed for morning versus evening dosing. For patients dosed in the morning, 1 unit of U300 was equivalent to 0.90 units of U100.PSD · Jul 2015
6.27 In EDITION IV, at month 6 the mean daily mealtime insulin dose was higher for patients randomised to U300 compared with U100 (28.66 vs 27.11 units). The cost of mealtime insulin was not included in the T1DM economic analysis. Including the cost of mealtime insulin reduces the cost-minimisation ex-manufacturer price for U300 from $'''''''''''''' to approximately $''''''''''''' per 450 unit pen.PSD · Jul 2015
6.20 For the treatment of T1DM the submission describes U300 as non-inferior in terms of comparative effectiveness and comparative safety over U100. The ESC considered this claim was adequately supported.PSD · Jul 2015
6.21 The PBAC considered that the claim of non-inferior comparative effectiveness was reasonable.PSD · Jul 2015
The PBAC noted and welcomed the input from individuals (2) and health care professionals (4) via the Consumer Comments facility on the PBS website. The comments described a range of benefits of treatment with U300 including: less nocturnal hypoglycaemia; smaller volumes of insulin required will be more convenient for patients with T2DM with severe insulin resistance requiring large doses of insulin and may mean better compliance; and insulin expected to …PSD · Jul 2015
Cost-effectiveness
Cost-minimisation analysis. This was a minor submission; no cost-effectiveness analysis with ICER was conducted. The submission was based on demonstrated biosimilarity to the reference product and price reduction.
The minor submission estimated a net save to the PBS of $10 - $20 million in Year 6 of listing with a total net save to the PBS/RPBS of $30 - $60 million over the first 6 years in listing. PSD · 2018
Decision context
PopulationAdults with type 1 and type 2 diabetes mellitus requiring basal insulin therapy, as demonstrated in the INSTRIDE 1 and INSTRIDE 2 trials comparing Semglee to Lantus.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2018 | Recommended | Lantus (reference brand of insulin glargine) | — | RCT · Efficacy and safety non-inferiority |
| Nov 2015 | Recommended · restricted | insulin glargine (Lantus) | — | RCT · Cost-minimisation |
| Jul 2015 | Recommended · restricted | insulin glargine 100 units per mL (U100) | — | RCT · HbA1c |
| Mar 2015 | Recommended | Lantus (insulin glargine reference product) | — | RCT · HbA1c (non-inferiority) |
| Mar 2006 | Recommended | insulin NPH | — | Meta-analysis, Registry · Hypoglycaemic events |
| Mar 2006 | Recommended | insulin NPH | $200k | Meta-analysis · ARR |
| Jul 2005 | Not recommended | insulin NPH | — | RCT · Reduction in hypoglycaemic events (symptomatic, major, severe) compared to insulin NPH; HbA1c reduction as secondary measure of effectiveness. |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| INSTRIDE 1 | Ph 3 | 558 | Change in HbA1c From Baseline to 24 Weeks | completed |
| INSTRIDE 2 | Ph 3 | 560 | Change in HbA1c From Baseline to 24 Weeks | completed |
Consumer voice
No consumer comments were received for this item.
The PBAC noted that no consumer comments were received for this item. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to adults requiring basal insulin therapy, excluding children covered by TGA label.