
Province: Saskatchewan
Indication: ankylosing spondylitis
Medication: golimumab (Simponi®)
Listing Status: Listed—CBC
Listing Criteria:
For treatment of ankylosing spondylitis (A.S.) according to the following criteria:
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Initial Application for a 12-week medication trial:
- For patients who have already been treated conventionally with two or more non-steroidal anti-inflammatory drugs (NSAIDs) taken sequentially at maximum tolerated or recommended doses for four weeks without symptom control. AND
- Satisfy New York diagnostic criteria: a score > 4 on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) AND a score of > 4 cm on the 0-10cm spinal pain visual analogue scale (VAS) on two occasions at least 12 weeks apart without any change of treatment.
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Second Application (following the initial 12 week approval, requests will be considered for a one year approval timeframe):
- Adequate response to treatment assessed at 12 weeks defined as at least 50% reduction in pre-treatment baseline BASDAI score or by > 2 units AND a reduction of > 2 cm in the spinal pain VAS.
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Subsequent Annual Renewal Applications (beyond the first 15 months, requests are to be submitted annually for consideration of ongoing approval on a yearly basis):
- The BASDAI score does not worsen (i.e. remains within two units of the second assessment) AND at least two units less than the initial application's BASDAI score.
Notes:
- Coverage will not be provided when a patient switches to another anti-TNF agent if the patient fails to respond or if there is a loss of response to the first agent.
- Requests for coverage for this indication must be made by a rheumatologist.
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