Prior AuthorizationPrior authorization and provider documentation requirements
- Prior authorization is required for initiation of Tremfya (guselkumab). Providers must submit a prior authorization request with supporting documentation as described in the criteria below. Approvals for initial therapy are generally granted for up to 12 months for plaque psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn's disease when criteria are met. For certain UC requests where response documentation is provided, a 6-month authorization may be granted on a case-by-case basis for the 200 mg every 28 days regimen.
- Documentation-based denials: Requests lacking required documentation (specialist consult or prescribing clinician, disease severity measures, prior therapy trials with durations, TB screening, or rationale for dosing exceptions/induction route) will be denied as not meeting criteria. If prior therapy trials are not documented as inadequate response, intolerance, or contraindication, the request will be denied.
- Quantity limit exceedance: Tremfya SC (100 mg/mL) has a pharmacy quantity limit of 1 prefilled syringe/pen per 56 days; exceptions are allowed for initial loading doses (see dosing block). Tremfya 200 mg/2 mL has a quantity limit of 1 prefilled syringe/pen per 28 days; quantity limit exceptions (e.g., Crohn's induction or psoriasis/psoriatic arthritis loading) require medical rationale and will be reviewed case-by-case. Requests to exceed quantity limits must include clinical justification and documentation of induction needs or inability to receive IV induction where applicable.
- Clinical response documentation: For continuation or for approval of higher doses/frequency, providers must submit clinical data demonstrating achievement or maintenance of remission or clinically meaningful improvement (e.g., stool frequency, rectal bleeding, urgency, CRP, fecal calprotectin, endoscopic appearance, disease activity scores such as UCEIS or Mayo score, or other objective measures). For UC requests for Tremfya 200 mg every 28 days, documentation of inadequate response to lower-dose therapy after at least 24 weeks or documentation of clinically meaningful incremental benefit from prior lower dose is required.
- Exception rationale: If requesting subcutaneous (SC) induction dosing or higher SC dosing in lieu of recommended IV induction, provider must submit medical rationale explaining why IV induction is not possible or appropriate for the patient. Exceptions to step therapy (e.g., Medicare members who received medication within past 365 days) must be noted and supported by records.
- Dose escalation documentation: Requests for increased dose or frequency (including Tremfya 200 mg every 4 weeks) require documentation of inadequate clinical response after the recommended trial period (typically at least 24 weeks) on prior dosing, or documentation of a clinically meaningful incremental benefit with the escalated regimen. For Crohn's disease SC induction higher-dose requests, include rationale and prior attempt or inability to receive IV induction.