Last Review Date: 10/03/2024

Date of Origin: 08/29/2017

Dates Reviewed: 08/2017, 04/2018, 08/2018, 08/2019, 08/2020, 08/2021, 08/2022, 08/2023, 10/2024

1. Length of Authorization

Ulcerative Colitis:

Initial coverage will be provided for 11 weeks (for 3 intravenous doses) as induction therapy.

2. Dosing Limits

A. Quantity Limit (max daily dose) [NDC Unit]:

• Tremfya 200 mg single-dose vial: 1 vial at weeks 0, 4, & 8

B. Max Units (per dose and over time) [HCPCS Unit]:

   Tremfya IV

   Ulcerative Colitis

• 200 mg at weeks 0, 4, & 8

3. Initial Approval Criteria ¹

Coverage is provided in the following conditions:

• Patient is at least 18 years of age; AND
• Physician has assessed baseline disease severity utilizing an objective measure/tool; AND
• Patient is up to date with all age-appropriate vaccinations, in accordance with current vaccination guidelines, prior to initiating therapy; AND

Universal Criteria ¹

• Patient has been evaluated and screened for the presence of latent tuberculosis (TB) infection prior to initiating treatment and will receive ongoing monitoring for the presence of TB during treatment; AND
• Patient does not have an active infection, including clinically important localized infections; AND
• Patient will not receive live vaccines during therapy; AND
• Patient is not on concurrent treatment with another biologic therapy (e.g., IL-inhibitor, TNF inhibitor, integrin receptor antagonist, T cell costimulation modulator, etc.) or targeted synthetic therapy (e.g., apremilast, abrocitinib, tofacitinib, baricitinib, upadacitinib, deucravacitinib, ritlecitinib, ruxolitinib, etrasimod, ozanimod, etc.); AND

Ulcerative Colitis (UC) † ^1,35-38,42

• Documented moderate to severe active disease; AND

• Documented failure or ineffective response to a minimum 3-month trial of conventional therapy [aminosalicylates, corticosteroids, or immunomodulators (e.g., azathioprine, 6-mercaptopurine, methotrexate, etc.)] at maximum tolerated doses, unless there is a contraindication or intolerance to use; OR
• Documented failure, contraindication, or ineffective response at maximum tolerated doses to a minimum 3-month trial of a TNF modifier such as adalimumab, golimumab, or infliximab; OR
• Patient is already established on a biologic or targeted synthetic therapy for the treatment of UC

      † FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria ¹

Coverage cannot be renewed.

5. Dosage/Administration ¹

   Indication	Dose
   Ulcerative Colitis	Induction: Administer 200 mg intravenously at Week 0, Week 4, and Week 8.

6. Billing Code/Availability Information

HCPCS Code(s):

• J1628* - Injection, guselkumab, 1 mg: 1 billable unit = 1 mg

(*Note: CMS generally creates codes for products themselves, without specifying a route of administration in the code descriptor, as there might be multiple routes of administration for the same product. Drugs that fall under this category should be billed with either the JA modifier for the intravenous infusion of the drug or billed with the JB modifier for subcutaneous injection of the drug.)

NDC(s):

• Intravenous
  • Tremfya 200 mg/20 mL (10 mg/mL) single-dose vial: 57894-0650-xx

7. References

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Appendix 1 – Covered Diagnosis Codes

Tremfya (J1628) Intravenous

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A