Tremfya (guselkumab) — Medica
Plaque psoriasis
Initial criteria
- EITHER (age > 6 to < 17 years AND weight > 40 kg) OR age ≥ 18 years
- EITHER tried ≥ 1 traditional systemic agent for psoriasis for at least 3 months unless intolerant (e.g., methotrexate, cyclosporine, acitretin, or PUVA) OR contraindication to methotrexate OR has previously tried a biologic other than requested drug
- prescribed by or in consultation with a dermatologist
Reauthorization criteria
- patient has been established on requested drug for at least 3 months
- beneficial clinical response defined as improvement from baseline in at least one of: estimated body surface area, erythema, induration/thickness, or scale of areas affected by psoriasis
- improvement in at least one symptom such as decreased pain, itching, or burning
Approval duration
initial 3 months, reauth 1 year