GemcitabineDBL Gemcitabine Injection
Multiple oncology indications including locally advanced or metastatic non-small cell lung cancer, adenocarcinoma, pancreatic cancer, bladder cancer, breast cancer (in combination with paclitaxel), and ovarian cancer (in combination with carboplatin).
Decisions on record
- Meeting Mar 2025 Recommended Various cancers
- Meeting Nov 2011 Recommended Anti-cancer drug no PSD
- Meeting Jul 2009 Recommended Anti-cancer drug no PSD
- Meeting Mar 2009 Recommended Anti-cancer drug no PSD
- Meeting Mar 2009 Recommended Anti-cancer drug no PSD
Access path
- TGA registered · DBL Gemcitabine Injection
TGA label narrower than the PBS population
- Mar 2025Recommended · restricted
vs DBL Gemcitabine (1 g/26.3 mL injection and 2 g/52.6 mL…
- PBS listing · Unrestricted
From the public summary
5.1 The PBAC recommended Section 100 (Efficient Funding of Chemotherapy Program) Unrestricted Benefit listings of two new forms of gemcitabine (1 g/25 mL injection and 2 g/50 mL injection), hereafter referred to as Gemcitabine Sandoz, under the same conditions and on a cost-minimisation basis to the existing gemcitabine listing (1 g/26.3 mL injection and 2 g/52.6 mL injection), hereafter referred to as DBL Gemcitabine. 4PSD · Mar 2025
5.2 The PBAC noted that the TGA found both Gemcitabine Sandoz and DBL Gemcitabine to be bioequivalent to the reference product, gemcitabine (as hydrochloride) powder for injection (Gemzar), which is no longer PBS-listed.PSD · Mar 2025
4.3 The submission did not present a formal economic analysis.PSD · Mar 2025
4.4 The submission requested the same approved ex-manufacturer price (AEMP) for Gemcitabine Sandoz as the existing listing for DBL Gemcitabine (as of 1 February 2025, the AEMPs are $24.31 for 1 g/26.3 mL injection and $38.74 for 2 g/52.6 ml injection).PSD · Mar 2025
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated as this is a substitutional listing with equivalent efficacy.
The PBAC noted that its recommendation was on a cost-minimisation basis and advised that, because Gemcitabine Sandoz is not expected to provide a substantial and clinically relevant improvement in efficacy, or reduction of toxicity, over DBL Gemcitabine, or not expected to address a high and urgent unmet clinical need given the presence of an alternative therapy, the criteria prescribed by the National Health (Pharmaceuticals and Vaccines – Cost Recovery) Regulations 2022 for Pricing Pathway A were not met. PBAC · 2025
Decision context
PopulationPatients with oncology indications approved for gemcitabine (locally advanced or metastatic non-small cell lung cancer, adenocarcinoma, pancreatic cancer, bladder cancer, breast cancer, and ovarian cancer) treated in public or private hospitals.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2025 | Recommended · restricted | DBL Gemcitabine (1 g/26.3 mL injection and 2 g/52.6 mL injection) | — | Cost-minimisation · Cost-minimisation |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients treated in public or private hospitals; TGA label contains no such care setting restriction.