MethotrexateARX-METHOTREXATE
Recommended RheumatologyAuthority RequiredNot applicable line 💬 consumer voice
Severe active rheumatoid arthritis or severe psoriasis (when oral methotrexate is unsuitable, and psoriasis must not have adequately responded to topical treatment).
3
Submissions
2 resub
2016–18
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
- TGA registered · ARX-METHOTREXATE
- Mar 2016Not recommended
vs methotrexate 50 mg/2 mL vials for injection
- ↻ resubmittedMar 2017Recommended · restricted
Comparator changed: methotrexate 50 mg/2 mL vials for injection → parenteral methotrexate…
- Jul 2018Recommended · restricted
Comparator changed: parenteral methotrexate (methotrexate 50 mg in 2 mL glass vials for…
- PBS listing · Authority Required
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
5.1 The PBAC recommended the Authority Required (STREAMLINED) listing of five new forms of subcutaneous methotrexate (7.5 mg/0.3 mL, 10 mg/0.4 mL, 15 mg/0.6 mL, 20 mg/0.8 mL, 25 mg/1 mL) for the same indications as the currently PBS listed brand of subcutaneous methotrexate, Trexject®.PSD · Jul 2018
5.2 The PBAC noted that Methoblastin PFS was considered bioequivalent to Trexject® by the TGA.PSD · Jul 2018
Economic analysis
6.24 The resubmission presented a cost-minimisation analysis versus methotrexate glass vials including drug, injection and administration costs (a cost-analysis). This included reduced healthcare visits for weekly self-administration of methotrexate.PSD · Mar 2017
Table 6 summarises the key differences compared with the previous submission. 13PSD · Mar 2017
Clinical claim
6.21 The resubmission described SC methotrexate pre-filled syringes as non-inferior and bioequivalent in terms of comparative effectiveness and non-inferior in terms of comparative safety over methotrexate glass vials injected intramuscularly. The PBAC had previously accepted the claim of non-inferior comparative effectiveness over IM methotrexate and the new clinical data supported the PBAC’s previous conclusion.PSD · Mar 2017
6.22 The PBAC considered that the claim of non-inferior comparative safety was reasonable, and viewed that the resubmission had adequately addressed the PBAC’s previous concerns about the safety of methotrexate self-injection outside the clinic setting.PSD · Mar 2017
Consumer comments
6.2 The PBAC noted and welcomed the input from individuals (21), health care professionals (29) and organisations (3) via the Consumer Comments facility on the PBS website. The comments described a range of benefits of treatment with SC methotrexate pre-filled syringes including improved dosing accuracy, ease of administration, lack of wastage compared to vials, improved compliance and enhanced quality of life.PSD · Mar 2017
6.3 The comments from Creaky Joints Australia and the Young Women’s Arthritis Support Group also highlighted that the pre-filled syringes provided convenience in the administration of methotrexate, particularly as patients with RA may have limited dexterity and be unable to administer other forms of injectable methotrexate. The PBAC welcomed the patient comments compiled by Creaky Joints Australia.PSD · Mar 2017
Cost-effectiveness
Cost-minimisation; no ICER calculated. Minor submission with expected cost-neutral impact to Government.
The resubmission presented a cost-minimisation analysis that compared SC methotrexate with other parenteral methotrexate. PSD · 2017
Cost-effectiveness accepted
Decision context
PopulationAdults with severe active rheumatoid arthritis or severe psoriasis who are unsuitable for oral methotrexate administration.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2018 | Recommended · restricted | Trexject® | — | Cost-minimisation · Cost-minimisation |
| Mar 2017 | Recommended · restricted | parenteral methotrexate (methotrexate 50 mg in 2 mL glass vials for intramuscular injection) | — | RCT · Bioequivalence |
| Mar 2016 | Not recommended | methotrexate 50 mg/2 mL vials for injection | — | RCT · Other |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| NCT01737944 | Ph 1, PHASE2 | 38 | Bioequivalence Based Upon Dose-Normalized AUC[0-Inf] for MTX | completed |
Consumer voice
Three individuals provided consumer comments focused on the effectiveness of methotrexate in treating psoriasis.
treatment effectivenesspsoriasis management