Juvenile Spondyloarthritis or Enthesitis-related Arthritis
Adalimumab
Brand(s)
- Humira (Only for those approved for biosimilar exemptions)
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
Etanercept
Brand(s)
- Enbrel (Only for those approved for biosimilar exemptions)
Dosage Form/Strength
- 25 mg/vial
- 50 mg prefilled syringe for subcutaneous injection
Infliximab
Brand(s)
- Remicade (Only for those approved for biosimilar exemptions)
Dosage Form/Strength
- 100 mg/vial
Indications for Treatment
For the treatment of juvenile spondyloarthritis (JSpA) or enthesitis-related arthritis (ERA) in patients who meet the following criteria for either axial or peripheral disease:
Axial Disease
- Age of disease onset ≤ 16 years; AND
- Low back pain and stiffness for > 3 months that improve with exercise and not relieved by rest; AND
- Failure to respond to or documented intolerance to adequate trials of 2 nonsteroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND
- BASDAI score of ≥ 4 after at least 4 weeks of standard NSAID therapy; AND
- Imaging evidence of severe active disease by X-ray, CT scan, or MRI
Details of imaging reports for severe active disease must provide the following:
- 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” or “erosion” of the SI joint.
Actual imaging reports must be submitted with the request. If the imaging reports do not specify the above findings, the request will be reviewed by external medical experts. The imaging interpretation report from the radiologist or rheumatologist may be submitted along with radiographic report.
- Renewal: Considered for patients with objective evidence of at least a 50% reduction in BASDAI score or ≥ 2 absolute point reduction in BASDAI score.
- For renewals beyond the second year: Objective evidence of preservation of treatment effect must be provided.
Peripheral Disease
- Age of disease onset ≤ 16 years; AND
- ≥ 5 active sites of inflammation attained by a combination of swollen/active joints and/or enthesitis sites (tenderness or swelling at entheseal insertion); AND
- Failure or intolerance to at least one DMARD
- (sulfasalazine 50 mg/kg/day, maximum 2 grams, or methotrexate 15 mg/m²/week, maximum 25 mg per week)
- for at least 3 months.
Renewals will be considered for patients with objective evidence of at least a 20% reduction in active sites over the previous year. There should also be an improvement in the number of enthesitis sites.
- For renewals beyond the second year: Objective evidence of preservation of treatment effect must be provided.
- Requests that do not meet these criteria: Undergo external review.
Approved Dosage
The planned dosing regimen for the requested biologic should be provided.
The recommended dose for the treatment of JSpA/ERA is as follows:
- Etanercept:
- 0.4 mg/kg (max 25 mg) twice weekly OR
- 0.8 mg/kg (max 50 mg) once weekly
- Infliximab:
- 5 mg/kg/dose at weeks 0, 2, and 6
- Followed by maintenance therapy of up to 5 mg/kg/dose every 6-8 weeks
- Adalimumab:
- If < 30 kg: 20 mg SC every 2 weeks
- If ≥ 30 kg: 40 mg SC every 2 weeks
- Requests for higher doses will be considered on a case-by-case basis.
Duration of Approval
- Initial Approval and Renewals: 1 Year
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 JSpA/ERA and whether there has been a reduction in pain medication since initiating the biologic (if applicable).
- The planned dosing regimen for the requested biologic should be provided.
