PemetrexedTevatrexed
Patients with malignant pleural mesothelioma or locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.
Decisions on record
- Meeting Mar 2023 Recommended Mesothelioma; locally advanced or metastatic non-small cell lung cancer
- Meeting Mar 2016 Recommended Locally advanced or metastatic non-small-cell lung cancer and mesothelioma
- Meeting Mar 2016 Recommended Locally advanced or metastatic non-small-cell lung cancer and mesothelioma
Access path
- TGA registered · Tevatrexed
TGA label narrower than the PBS population
- Nov 2007Recommended · restricted
vs cisplatin
- Mar 2009Recommended · restricted
Comparator changed: cisplatin → gemcitabine in combination with cisplatin
- Mar 2010Not recommended
unacceptably high and uncertain cost-effectiveness ratio, uncertain inclusion of patients with 'unknown or other…
- ↻ resubmittedMar 2016Recommended
Evidence: RCT, cost-minimisation analysis → Other
- Mar 2016Recommended
Evidence: RCT, cost-minimisation analysis → Other
- Mar 2023Recommended · restricted
Evidence: Other → Cost-minimisation
- PBS listing · Unrestricted
From the public summary
6.1 The PBAC recommended the Section 100 EFC program listing of three new forms of pemetrexed (Pemetrexed Ever Pharma) 100 mg/4 mL, 500 mg/20 mL and 1000 mg/40 mL solutions for injection as unrestricted benefits under the same circumstances as the currently listed brands of pemetrexed powder for I.V. infusion.PSD · Mar 2023
6.2 The PBAC noted that the derived price of pemetrexed 100 mg/4 mL, 500 mg/20 mL and 1000 mg/40 mL solutions for injection was consistent with the other strengths of pemetrexed and considered this was appropriate.PSD · Mar 2023
4.5 The submission requested an ex-manufacturer price of $3,119.70, in line with the same price per mg to the 100 mg and 500 mg vials currently listed on the PBS.PSD · Mar 2016
4.4 The submission requested an ex-manufacturer price of $3,119.70, in line with the same price per mg as the 100 mg and 500 mg vials currently listed on the PBS.PSD · Mar 2016
5.4 The submission estimated that 25% of patients currently using the 100 mg, 500 mg and 1000 mg powders for injection would switch to Pemetrexed Ever Pharma. No evidence was provided to support this assumption.PSD · Mar 2023
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated as pemetrexed solutions for injection are not expected to provide a substantial and clinically relevant improvement in efficacy or reduction of toxicity over currently listed forms.
The PBAC noted that its recommendation was on a cost-minimisation basis and advertised that, because pemetrexed solutions for injection are not expected to provide a substantial and clinically relevant improvement in efficacy, or reduction of toxicity, over the currently listed forms of pemetrexed, or not expected to address a high urgent unmet clinical need given the presence of an alternative therapy, the criteria prescribed by the National Health (Pharmaceuticals and Vaccines – Cost Recovery) Regulations 2009 for Pricing Pathway A were not met. PBAC · 2023
Decision context
PopulationPatients with malignant pleural mesothelioma or locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology, currently treated with pemetrexed powder for injection.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2023 | Recommended · restricted | pemetrexed powder for injection (100 mg, 500 mg, and 1000 mg) | — | Cost-minimisation · Cost-minimisation |
| Mar 2016 | Recommended | — | — | Other |
| Mar 2016 | Recommended | — | — | Other |
| Mar 2010 | Not recommended | gemcitabine | $15k–75k | RCT, cost-minimisation analysis · OS |
| Mar 2009 | Recommended · restricted | gemcitabine in combination with cisplatin | $45k–75k | RCT · OS | PFS |
| Nov 2007 | Recommended · restricted | cisplatin | $45k–75k | RCT · OS |
Consumer voice
Lung Foundation Australia provided consumer input supporting the listing of new forms of pemetrexed, describing benefits including greater access to treatment options for patients.
The PBAC noted the consumer comment received from Lung Foundation Australia supporting listing of new forms of pemetrexed and describing a range of benefits including greater access to treatment options for patients. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients currently treated with pemetrexed powder for injection; TGA label has no such treatment history requirement.