Insulin AspartFiasp
Treatment of diabetes mellitus. Truvelog is a biosimilar to the reference brand NovoRapid, indicated for use under the same circumstances as existing NovoRapid formulations.
Decisions on record
- Meeting Nov 2024 Noted Diabetes mellitus no PSD
- Meeting Jul 2023 Noted Diabetes mellitus no PSD
- Meeting Jul 2022 Noted Diabetes mellitus no PSD
- Meeting Nov 2021 Recommended Diabetes mellitus
- Meeting Nov 2018 Recommended Diabetes Mellitus
Access path
- TGA registered · Fiasp
TGA label narrower than the PBS population
- Nov 2018Recommended
vs insulin aspart (NovoRapid)
- Nov 2021Recommended
Comparator changed: insulin aspart (NovoRapid) → NovoRapid
- PBS listing · Unrestricted
From the public summary
6.1 The PBAC recommended the listing of a new biosimilar brand of insulin aspart in the form of 100 IU/mL cartridge (Truvelog) and 100 IU/mL pre-filled pen (Truvelog Solostar) under the same circumstances as the PBS-listed reference brands NovoRapid Penfill and NovoRapid Flexpen.PSD · Nov 2021
6.2 The PBAC advised that the equi-effective doses are: Truvelog 100 IU/mL cartridge = NovoRapid Penfill 100 IU/mL cartridge and Truvelog Solostar 100 IU/mL pre-filled pen = NovoRapid Flexpen 100 IU/mL pre-filled pen.PSD · Nov 2021
6.25 Consistent with its clinical claim of non-inferiority, the submission presented a cost- minimisation analysis comparing the daily treatment cost of Fiasp and NovoRapid. Key components and assumptions of the cost-minimisation analysis are summarised in Table 5.PSD · Nov 2018
Table 5: Key components and assumptions of the cost-minimisation analysis Component Claim or assumption Based on evidence presented in the submission, effectiveness is assumed to be non- Therapeutic claim: effectiveness inferior.PSD · Nov 2018
5.6 The submission claimed that Truvelog was biosimilar to NovoRapid.PSD · Nov 2021
5.7 The PBAC considered that the claim of non-inferior comparative effectiveness and safety was adequately supported by the data. Pricing considerationsPSD · Nov 2021
6.2 The PBAC noted and welcomed the input from a health care professional (1) and an organisation (1) via the Consumer Comments facility on the PBS website. The comments described the positive impact on target blood glucose levels obtained through an insulin product that can be administered with, rather than prior to, a meal.PSD · Nov 2018
6.38 No risk sharing arrangements were proposed in the submission. However consistent with Clause 5.7.6 of the Strategic Agreement, the sponsor accepted that it may be required to enter into a Deed of Agreement reflecting the proposed staged pricing.PSD · Nov 2018
Cost-effectiveness
Cost-minimisation basis; no ICER calculated as biosimilar is equi-effective to reference brand.
Decision context
PopulationAdult patients with diabetes mellitus using insulin glargine.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2021 | Recommended | NovoRapid | — | RCT · Safety and efficacy |
| Nov 2018 | Recommended | insulin aspart (NovoRapid) | — | RCT · HbA1c |
Consumer voice
A healthcare professional and an organisation provided input welcoming an insulin product that can be administered with rather than prior to meals, noting positive impacts on blood glucose levels and faster insulin action in Type 1 Diabetes Management.
The comments described the positive impact on target blood glucose levels obtained through an insulin product that can be administered with, rather than prior to, a meal. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to adult patients already using insulin glargine, whereas TGA label covers all diabetes mellitus patients.