Indication: ankylosing spondylitis
Medication: golimumab (Simponi®)
Listing Status: Listed—CBC
For treatment of ankylosing spondylitis (A.S.) according to the following criteria:
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.
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.
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.
- 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.