COVERED USES:

FDA Approved Indications:

1. Rheumatoid Arthritis: For reducing signs and symptoms, including major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis. May be used in combination with methotrexate or alone.
2. Severe Polyarticular Juvenile Rheumatoid Arthritis - For reducing signs and symptoms of moderately to severely active polyarticular - course rheumatoid arthritis in patients who have had an inadequate response to one or more DMARDs.
3. Psoriatic Arthritis - For reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with psoriatic arthritis. May be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone.
4. Ankylosing spondylitis
5. Plaque Psoriasis - Treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Unless otherwise stated in this policy, requests for a non-FDA approved (off-label) uses of this medication will be considered on case-by-case subject for evaluation of the prescriber's medical rationale, formulary alternatives, the available published evidence-based research and whether the proposed use is determined to be experimental/investigational.

AGE RESTRICTIONS:

NA

PRESCRIBER RESTRICTIONS:

For diagnosis of rheumatoid arthritis, must be prescribed by or in consultation with a rheumatologist.

For diagnosis of chronic plaque psoriasis, must be prescribe by or in consultation with a rheumatologist or a dermatologist.

REQUIRED MEDICAL INFORMATION:

For initiation of treatment, a prior authorization form and relevant chart notes documenting medical rationale are required and for continuation of therapy, ongoing documentation of successful response to the medication may be necessary.

CRITERIA:

For Rheumatoid Arthritis (including Juvenile Rheumatoid Arthritis) the following criteria must be met:

• Documented failure (6-12 week trial) of methotrexate and one of the following: sulfasalazine or leflunomide.
• Dosing must be within Package Insert guidelines for each medication.

For Psoriatic Arthritis:

• Must have trial and failure (6-12 week trial) or contraindication to methotrexate (may be used in combination with methotrexate after initial trial with methotrexate monotherapy)

For Chronic Plaque Psoriasis the following criteria must be met:

• Documented failure of at least two alternative conventional treatments such as topical steroids or other topical agents such as calcipotiene, tazarotene, and coal tar or medical rational why these cannot be tried.

For all diagnoses, dosing must be consistent with drug labeling.

Reauthorization will require documentation of adequate response to the medication for all diagnoses.

EXCLUSION CRITERIA:

NA

COVERAGE DURATION:

Initial authorization will be for up to six months. Reauthorization for up to one year.