MAFGolimumab (Simponi) Prefilled Syringe 50 mg/0.5 mL, 100 mg/mL
1) Treatment of adult patients with rheumatoid arthritis
Additional Clinical Criteria
Rheumatoid arthritis (Initial)
The patient on initial application:
• has at least moderate disease activity as measured by a DAS28 score >= 3.2 and >= 6 swollen and/or tender joints; and
• has failed >= 2 combinations of non-biologic DMARDs at optimal doses for >= 3 months unless contraindicated by documented significant toxicity;
The above criteria is valid for 6 months. To continue treatment, please reapply under 'Renewal'.
Rheumatoid arthritis (Renewal)
The patient on subsequent reapplication:
• demonstrates at least a moderate EULAR response from baseline:
• Present DAS28 <= 3.2 and good response (DAS28 improvement > 1.2); or
• Present DAS28 <= 3.2 and moderate response (DAS28 improvement > 0.6 and <= 1.2); or
• Present DAS28 > 3.2 to <= 5.1 and moderate response (DAS28 improvement > 0.6); or
• Present DAS28 > 5.1 and moderate response (DAS28 improvement >1.2).
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 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.
3) Treatment of adult patients with psoriatic arthritis
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 for PsA:
• 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.
4) 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.
5) Treatment of adult patients with ulcerative colitis
Additional Clinical Criteria
Ulcerative colitis (Initial)
The patient on initial application:
• has moderately to severely active Ulcerative Colitis (UC) confirmed by a gastroenterologist; AND
• has failed to achieve an adequate response*, or is intolerant to prior systemic therapy including:
• a tapered course of steroids over 6 weeks, with either azathioprine or 6-mercaptopurine for >= 3 months.
AND/OR
• adequate induction and/or maintenance doses of one or more of the following: anti-TNFα (infliximab and adalimumab)
Reassessment should be conducted 12 weeks after initiation of treatment.
*Failure to achieve adequate response defined as:
1. Failure to achieve:
• Clinical and patient-reported outcome (PRO2) remission, defined as resolution of rectal bleeding and diarrhoea/altered bowel habit, assessed at a minimum of 3 months during active disease; AND
• Endoscopic remission - resolution of friability and ulceration at flexible sigmoidoscopy or colonoscopy, assessed at 3-month interval during active disease;
AND/OR
2. Assessed clinically as requiring surgery as the next therapeutic option, in the absence of treatment with a biologic
Ulcerative colitis (Renewal)
The patient on subsequent reapplication:
• Achieved clinical remission defined as PRO2 (rectal bleeding=0 and stool frequency=0) or partial Mayo (<3 and no score >1) OR
• has improvement in intestinal inflammation documented by:
• improvement/normalisation of CRP or faecal calprotectin; and/or
• evidence of endoscopic improvement in disease activity and/or mucosal healing as demonstrated by flexible sigmoidoscopy or colonoscopy.
Reassessment should be conducted every 6 months and treatment continued only if there is clear evidence of ongoing clinical benefit.