Ankylosing Spondylitis (AS)/Spondyloarthropathy (SpA)
Ankylosing Spondylitis Drugs
Adalimumab
- See Formulary for funded biosimilars
- Brand(s): Humira and formulary listed biosimilars
- Dosage Form/Strength:
- 40 mg/0.8 mL prefilled syringe
- 40 mg/0.8 mL and 20 mg/0.2 mL prefilled pens for subcutaneous injection
Certolizumab
- Brand(s): Cimzia
- Dosage Form/Strength:
- 200 mg/mL prefilled syringe and autoinjector
Etanercept
- See Formulary for funded biosimilars
- Brand(s): Enbrel and formulary listed biosimilars
- Dosage Form/Strength:
- 25 mg/vial
- 50 mg prefilled syringe for subcutaneous injection
Golimumab
- Brand(s): Simponi
- Dosage Form/Strength:
- 50 mg/0.5 mL prefilled syringe and autoinjector
Infliximab
- See Formulary for funded biosimilars
- Brand(s): Remicade and formulary listed biosimilars
- Dosage Form/Strength:
- 100 mg/10 mL intravenous infusion
Secukinumab
- Brand(s): Cosentyx
- Dosage Form/Strength:
- 150 mg/mL prefilled syringe and 150 mg/mL prefilled pen
Indications for Treatment
For the treatment of ankylosing spondylitis (AS) OR psoriatic spondylitis (PS) in patients who have severe active disease with:
- Age of disease onset: 50 years of age or younger; AND
- Low back pain and stiffness: For greater than 3 months that improves with exercise and not relieved by rest; AND
- Failure to respond to or documented intolerance to adequate trials of 2 non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND
- BASDAI score: ≥ 4 for at least 4 weeks while on standard therapy; AND
- A list of current concomitant medications related to the AS/PS, including pain medications (if relevant) with dosing regimens provided.
Note: NSAIDs include coxibs; use of DMARDS instead of NSAIDs not acceptable.
Submission Requirements
The information submitted with the request must include the following:
- Current Concomitant Medications:
- Related to AS/PS, including pain medications (if relevant).
- Include dosing regimens.
- Details of Review of Radiographic Reports for Severe Active Disease:
- X-ray or CT scan report stating the presence of “SI joint fusion” or “SI joint erosion” OR
- MRI report stating the presence of “inflammation” or “edema” of the SI joint.
- Actual radiographic reports must be submitted with the request. If the radiographic reports do not specify the above, the request will be reviewed by external medical experts.
- Additional Information (if applicable):
- Schober measurement and chest expansion measurement.
- Evidence of restricted spinal mobility.
- If the patient has AS/PS with predominantly peripheral joint involvement, additional information pertaining to trials of DMARDs must be provided, and these requests will be reviewed by external medical experts.
Duration of Approval
- Initial Approval: 1 year
- Renewals:
- First Renewal: 1 year
- Second and Subsequent Renewals: 5 years
Renewal Criteria:
- For Renewals Beyond the Second Year:
- Objective evidence of preservation of treatment effect.
- General Renewal Requirements:
- For patients with objective evidence of at least a 50% reduction in BASDAI score or ≥ 2 absolute point reduction in BASDAI score.
- Provide an update on concomitant medications for AS/PS and whether there has been a reduction in pain medication for AS/PS since initiating the biologic (if applicable).
- The planned dosing regimen for the requested biologic should be provided.
Recommended Dosing Regimens for AS/PS
- Adalimumab:
- 40 mg every two weeks.
- Certolizumab:
- 400 mg at weeks 0, 2, and 4.
- Followed by maintenance therapy of 200 mg every 2 weeks or 400 mg every 4 weeks.
- Etanercept:
- 25 mg twice weekly or 50 mg once weekly.
- Golimumab:
- 50 mg once a month.
- Infliximab:
- 3-5 mg/kg/dose at weeks 0, 2, and 6.
- Followed by maintenance therapy of up to 5 mg/kg/dose every 6 to 8 weeks.
- Secukinumab:
- 150 mg subcutaneously at weeks 0, 1, 2, and 3.
- Followed by monthly maintenance dosing starting at week 4.