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ATC codes: L04AX03
EMLc
Indication
Psoriasis of unspecified type ICD11 code: EA90.Z
INN
Methotrexate
Medicine type
Chemical agent
List type
Complementary (EML)
(EMLc)
Formulations
Oral > Solid > tablet: 2.5 mg (as sodium salt) ; 10 mg (as sodium salt)
EML status history
First added in 2023 (TRS 1049)
Sex
All
Age
Also recommended for children
Therapeutic alternatives
The recommendation is for this specific medicine
Patent information
Patents have expired in most jurisdictions
Summary of evidence and Expert Committee recommendations
The Expert Committee acknowledged the global burden of psoriasis and the public health need for effective treatments. Until now, only topical therapies for psoriasis have been included on the Model Lists. The Committee recommended the inclusion of oral methotrexate on the complementary list of the EML and EMLc for the new indication of psoriasis, based on a favourable balance of desirable to undesirable effects. The Expert Committee did not recommend the inclusion of sub-cutaneous injection formulations of methotrexate on the EML and EMLc for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis and arthritic psoriasis and Crohn disease in patients not responding to maximum tolerable doses of oral methotrexate. The Committee noted that methotrexate is one of the mainstays of treatment for these conditions, but that data on clinical efficacy and safety of subcutaneous methotrexate compared to oral or intramuscular formulations are limited and are based mostly on studies in patients with rheumatoid arthritis. Overall, the Committee considered the possible benefits of subcutaneous compared to oral methotrexate were unclear, and with limited available evidence suggesting only modest benefits in a small proportion of patients, at a considerably higher price.