adalimumab products — Medica
Spondyloarthritis, other subtypes (including undifferentiated arthritis, non-radiographic axial spondyloarthritis, reactive arthritis [Reiter’s disease], or arthritis associated with inflammatory bowel disease)
Initial criteria
- age > 18 years
- Patient meets one of the following: (a) Both of the following [(1) and (2)]: (1) Patient has arthritis primarily in the knees, ankles, elbows, wrists, hands, and/or feet; AND (2) Patient has tried at least one conventional synthetic DMARD (e.g., methotrexate, leflunomide, or sulfasalazine); OR (b) Patient has axial spondyloarthritis with objective signs of inflammation defined as at least one of the following: (1) C-reactive protein elevated beyond the upper limit of normal for reporting laboratory; OR (2) Sacroiliitis reported on MRI
- Medication is prescribed by or in consultation with a rheumatologist
Reauthorization criteria
- Patient has been established on therapy for at least 6 months
- Patient meets at least one of the following: (a) When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples: Ankylosing Spondylitis Disease Activity Score [ASDAS], C-reactive protein, erythrocyte sedimentation rate); OR (b) Compared with baseline, patient experienced an improvement in at least one symptom (e.g., decreased pain or stiffness, or improvement in function or activities of daily living)
Approval duration
Initial: 6 months; Reauth: 1 year