MAFIxekizumab (Taltz) Prefilled Pen 80 mg/mL
1) Treatment of adult patients with ankylosing spondylitis
Additional Clinical Criteria
Ankylosing spondylitis (Initial)
The patient on initial application for AS:
• 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'.
Ankylosing spondylitis (Renewal)
The patient on subsequent reapplication for AS:
• 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 adult patients with psoriatic arthritis with axial involvement
Additional Clinical Criteria
Psoriatic arthritis with axial involvement (Initial)
The patient on initial application for PsA:
• 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'.
Psoriatic arthritis with axial involvement (Renewal)
The patient on subsequent reapplication, fulfils two of the following and no worsening of any measure:
• tender or swollen joint count improvement of at least 30% from baseline; or
• patient global improvement by one point on a five point Likert scale from baseline; or
• physician global improvement by one point on a five point Likert scale 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 psoriatic arthritis with peripheral involvement
Additional Clinical Criteria
Psoriatic arthritis with peripheral involvement (Initial)
The patient on initial application:
• has >= 3 swollen and >= 3 tender joints/ digits/ entheses; and
• has failed 2 conventional synthetic DMARD regimens at optimal doses (unless limited by documented significant toxicity) for >= 3 months each.
The above criteria is valid for 6 months. To continue treatment, please reapply under 'Renewal'.
Psoriatic arthritis with peripheral involvement (Renewal)
The patient on subsequent reapplication, fulfils two of the following and no worsening of any measure:
• tender or swollen joint count improvement of at least 30% from baseline; or
• patient global improvement by one point on a five point Likert scale from baseline; or
• physician global improvement by one point on a five point Likert scale from baseline.
Reassessment should be conducted every 6 months and treatment continued only if there is clear evidence of ongoing clinical benefit.
4) 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.