MAFEtanercept (Enbrel) Prefilled Syringe 25 mg/0.5 mL, 50 mg/mL
1) Treatment of adult patients with non-radiographic axial spondyloarthritis (axSpA).
Additional Clinical Criteria
Non-radiographic axial spondyloarthritis (Initial)
The patient on initial application for nr-axSpA:
• has active disease (BASDAI >= 4 or ASDAS-CRP >= 2.1); and
• has failed 2 sequential NSAIDs (including COX-2 inhibitor) at maximal tolerated doses for a total of >= 4 weeks (unless contraindicated to or intolerant of NSAIDs).
The above criteria is valid for 6 months. To continue treatment, please reapply under 'Renewal'.
Non-radiographic axial spondyloarthritis (Renewal)
The patient on subsequent reapplication for nr-axSpA:
• demonstrates an improvement of at least 2 points on the BASDAI or 1.1 points on the ASDAS-CRP from baseline.
Reassessment should be conducted every 6 months and treatment continued only if there is clear evidence of ongoing clinical benefit.
2) Treatment of juvenile idiopathic arthritis
Additional Clinical Criteria
Juvenile idiopathic arthritis (Initial)
The patient on initial application:
• has failed methotrexate at optimal doses.
The above criteria is valid for 6 months. To continue treatment, please reapply under 'Renewal'.
Juvenile idiopathic arthritis (Renewal)
The patient on subsequent reapplication:
• demonstrates a continuing decrease in active joint count and ESP/CRP from baseline.
Reassessment should be conducted every 6 months and treatment continued only if there is clear evidence of ongoing clinical benefit.
3) Treatment of adult patients with chronic plaque psoriasis
Additional Clinical Criteria
Chronic plaque psoriasis (Initial)
The patient on initial application has erythrodermic presentation; OR fulfils the criteria below:
• has chronic plaque psoriasis (> 6 months) and PASI > 10; and
• has active disease causing significant impact on their QOL with a DLQI of > 10; and
• has had an inadequate (failed) response, or is contraindicated to all of the following: topical treatment, phototherapy for at least 3 months, methotrexate for at least 3 months, acitretin for at least 3 months, cyclosporine for at least 2 months.
The above criteria is valid for 6 months. To continue treatment, please reapply under 'Renewal'.
Chronic plaque psoriasis (Renewal)
The patient on subsequent reapplication:
• has a significant improvement in QOL with DLQI >= 5 improvement from baseline; and
• has a >= 50% improvement in the PASI score or body surface area affected from baseline.
Reassessment should be conducted every 6 months and treatment continued only if there is clear evidence of ongoing clinical benefit.