Methotrexate (As Sodium)
Recommended RheumatologyUnrestrictedNot applicable line
New formulation of methotrexate (as sodium) 2.5 mg and 10 mg tablets for listing under the same circumstances as the currently PBS-listed methotrexate tablets, including treatment of patients requiring doses greater than 20 mg per week.
1
Submissions
2024–24
On the record
—
ICER range
Cost-min
Cost basis
Decisions on record
- Meeting Jul 2024 Recommended Chemotherapy and inflammatory conditions
- Meeting Sep 2023 Recommended Rheumatological conditions management no PSD
- Meeting Dec 2022 Recommended Juvenile idiopathic arthritis (JIA) no PSD
- Meeting Jul 2018 Recommended Severe active rheumatoid arthritis; Severe psoriasis
- Meeting Mar 2017 Recommended Rheumatoid arthritis and psoriasis
- Meeting Mar 2016 Not recommended Rheumatoid arthritis or psoriasis
- Meeting Mar 2008 Recommended Anti-metabolite no PSD
Access path
- Jul 2024Recommended
vs methotrexate (current formulation)
- PBS listing · Unrestricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
6.1 The PBAC recommended a General Schedule (Unrestricted Benefit) listing of a new formulation of methotrexate, (methotrexate as sodium) 2.5 mg and 10 mg tablets (Methoblastin®) (MTX (as sodium)) under the same circumstances as the PBS-listed methotrexate 2.5 mg and 10 mg tablets (Methoblastin®) (MTX).PSD · Jul 2024
6.2 The PBAC also recommended a new maximum quantity of 10 units and 5 repeats for the listing of MTX (as sodium) 10 mg 10-unit pack. The PBAC considered that the new maximum quantity of 10 units with 5 repeats for MTX (as sodium) 10 mg appropriately aligned with the existing listing of 15 units with 3 repeats.PSD · Jul 2024
Clinical claim
5.4 The TGA considered MTX (as sodium) and MTX to be bioequivalent (pg 7, TGA evaluation of responses).PSD · Jul 2024
5.5 The PBAC considered that the claim of non-inferior comparative effectiveness was reasonable.PSD · Jul 2024
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated as the submission involved bioequivalent formulation with equivalent pricing.
The PBAC noted that its recommendation was on a cost-minimisation basis and advised that, because MTX (as sodium) is not expected to provide a substantial and clinically relevant improvement in efficacy, or reduction of toxicity, over MTX, 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 · 2024
Decision context
PopulationPatients with indications for methotrexate therapy, including those requiring doses greater than 20 mg per week (for the 50-unit pack listing).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2024 | Recommended | methotrexate (current formulation) | — | Cost-minimisation · Cost-minimisation |
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both texts authorize methotrexate for patients with indications requiring methotrexate therapy, including high-dose regimens above 20 mg/week.