Guselkumab (Tremfya) — coverage criteria for IV and SC administration
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Defines medical necessity, site-of-care, dosing limits, and documentation requirements for guselkumab (Tremfya) IV and SC administration across FDA-approved indications (psoriasis, psoriatic arthritis, ulcerative colitis, Crohn's disease); affects prescribers, infusion centers, and prior authorization reviewers.
Allowance added for patients currently established on a biologic or systemic immunomodulator agent for the requested indication who have had positive clinical benefit from that agent.
For CD and UC, removed required trial/failure of conventional therapy and replaced with requirement to demonstrate moderately to severely active disease using symptoms plus objective evidence of active inflammation or other specified criteria.
Expanded pediatric eligibility for PS and PsA to patients >=6 years who weigh at least 40 kg and updated UC induction dosing to include IV or SC options per FDA label.
Coverage and Medical Necessity Criteria
Initial Therapy (by indication)
Covered when ALL of the following are met for the requested indication (each indication has its own nested rules):
Psoriasis (PS) initial therapy
- Age/Weight: Patient is >=6 years AND weighs >=40 kgsee age/weight thresholds
- Prior therapy or exceptions: ONE of: (1) inadequate response to ONE conventional agent used for >=3 months (documentation required); OR (2) intolerance/hypersensitivity to ONE conventional agent (documentation required); OR (3) FDA-labeled contraindication to ALL conventional agents (documentation required); OR (4) severe active PS (e.g., >10% BSA, select locations, intractable pruritus, serious emotional consequences) (documentation required); OR (5) concomitant severe PsA; OR (6) currently established on an FDA-approved biologic/systemic immunomodulator for PS with documented positive clinical benefit (documentation required)
Psoriatic Arthritis (PsA) initial therapy
- Age/Weight: Patient is >=6 years AND weighs >=40 kg
- Prior therapy or exceptions: ONE of: (1) inadequate response to ONE conventional agent (e.g., cyclosporine, leflunomide, methotrexate, sulfasalazine) for >=3 months (documentation required); OR (2) intolerance/hypersensitivity to ONE conventional agent (documentation required); OR (3) FDA-labeled contraindication to ALL conventional agents (documentation required); OR (4) severe active PsA (examples provided) (documentation required); OR (5) concomitant severe PS; OR (6) currently established on an FDA-approved biologic/systemic immunomodulator for PsA with documented positive clinical benefit (documentation required)
Ulcerative Colitis (UC) initial therapy
- Age: Patient is >=18 years
- Evidence of active disease: ONE of: (A) BOTH symptoms consistent with active UC AND objective evidence of active inflammation on endoscopy (e.g., MES, UCEIS) (documentation required); OR (B) Evidence of active inflammation on intestinal ultrasound (IUS) (documentation required); OR (C) Biomarker evidence of inflammation (e.g., elevated FC, CRP, ESR, low albumin) (documentation required); OR (D) Presence of >=1 poor prognostic factor (documentation required); OR (E) corticosteroid-dependence or refractory to oral corticosteroids (documentation required); OR (F) patient currently established on an FDA-approved biologic/systemic immunomodulator for UC with documented positive clinical benefit (documentation required)
Crohn's Disease (CD) initial therapy
- Age: Patient is >=18 years
- Evidence of active disease: ONE of: (A) Symptoms consistent with active CD AND objective evidence of active inflammation on cross-sectional imaging, IUS, or pelvic MRI (e.g., bowel wall thickening, ulceration, fistula, abscess) (documentation required); OR (B) Biomarker evidence of inflammation (e.g., elevated FC, CRP, ESR, low albumin) (documentation required); OR (C) Significant extent of disease or upper GI involvement identified on radiographic or endoscopic assessment (e.g., large/deep mucosal lesions, fistulas, strictures, ileal involvement >40 cm, pancolitis, prior bowel resection) (documentation required); OR (D) corticosteroid-dependence or refractory to oral corticosteroids (documentation required); OR (E) patient currently established on an FDA-approved biologic/systemic immunomodulator for CD with documented positive clinical benefit (documentation required)
Site of Care Medical Necessity Criteria
Site of Care criteria determine whether hospital outpatient/inpatient administration is medically necessary; otherwise administration should occur in home or physician office settings.
Use of guselkumab (Tremfya) in combination with another biologic immunomodulator agent, Otezla, or Zeposia is prohibited. The prescriber must ensure the patient will NOT be using guselkumab in combination with these agents as a condition of medical necessity determinations.
Requests that exceed the maximum units allowed for the duration of approval will not meet criteria. Per the dosing table, the maximum units are PS/PsA: 800 units; UC/CD: 3,200 units, and the requested quantity must not exceed these limits. Additionally, requests that do not meet indication-specific objective disease activity criteria (for IBD indications) or other required clinical criteria are not considered medically necessary.
Billing Codes and Eligibility
| J1628 | Guselkumab (Tremfya) HCPCS code as listed |
Provider Requirements, Prior Authorization, and Documentation
Prior Authorization Required
Prior authorization is required for guselkumab (Tremfya®). Dosing and maximum units will be verified at the time of request (HCPCS J1628). Standard approval duration is 365 days (1 year).
- Dosing: PS & PsA — 100 mg SC at weeks 0 and 4, then every 8 weeks thereafter
- Dosing: UC — Induction: 200 mg IV at weeks 0, 4, and 8; OR 400 mg SC at weeks 0, 4, and 8
- Maximum units: PS 800; PsA 800; UC 3,200; CD 3,200
Step Therapy and Exceptions
Step therapy requirements apply for plaque psoriasis (PS) and psoriatic arthritis (PsA). Exceptions are allowed for patients who are currently established on another FDA‑approved biologic or systemic immunomodulator for the requested indication and have documented positive clinical benefit.
- PS & PsA: Trial and inadequate response to ≥1 conventional agent for at least 3 months is required unless exception criteria met
- Exception: Current use of an FDA‑approved biologic/systemic immunomodulator with documented benefit — medical record documentation required
- Conventional agents examples for PS: acitretin, anthralin, calcipotriene, calcitriol, coal tar products, cyclosporine, methotrexate, pimecrolimus, phototherapy (PUVA or UVB), tacrolimus, tazarotene, topical corticosteroids
- Conventional agents examples for PsA: cyclosporine, leflunomide, methotrexate, sulfasalazine
Quantity and Combination Restrictions
Requests that exceed the documented maximum units for the approved duration or that combine guselkumab (Tremfya®) with another biologic immunomodulator or specified agents are not allowed.
- Combination use with another biologic immunomodulator, Otezla® (apremilast), or Zeposia® (ozanimod) is not permitted
- Requests exceeding maximum units for the duration of approval will be denied
- Site of care rules apply for inpatient or outpatient hospital administration requests
Definitions and Site-of-Care Justification
Clinical Background
Guselkumab (Tremfya) is an anti–IL‑23 monoclonal antibody available as an intravenous infusion or subcutaneous injection. It is FDA‑approved for plaque psoriasis (PS) and psoriatic arthritis (PsA) in patients aged ≥ 6 years who weigh at least 40 kg, and for ulcerative colitis (UC) and Crohn’s disease (CD) in patients aged ≥ 18 years. Dosing varies by indication (for example, PS and PsA: 100 mg SC at weeks 0 and 4, then every 8 weeks; UC induction: 200 mg IV at weeks 0, 4, and 8 or 400 mg SC at weeks 0, 4, and 8).
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