Guselkumab (Tremfya) (ARCHIVED)

Policy ID: I-9039-004

Section: Injections

Effective Date: June 01, 2023

Revised Date: November 18, 2024

Revision Effective Date: December 31, 2024

Last Reviewed: November 19, 2024

Applies To: Commercial Only

**This policy has been Archived effective December 31, 2024. Click the Archive tab above for more information.**

Policy ID: I-9039-004

Section: Injections

Effective Date: June 01, 2023

Revised Date: November 18, 2024

Revision Effective Date: December 31, 2024

Last Reviewed: November 19, 2024

Archived Date: December 31, 2024

Applies To: Commercial Only

Description

Guselkumab (Tremfya®) is a human monoclonal IgG1λantibody that selectively binds to the p19sub-unit of interleukin 23 (IL-23) and inhibits its interaction with the IL-23 receptor.

The intravenous formulation may be covered under the medical benefit; please refer to pharmacy policies for coverage of the subcutaneous formulation.

Policy Application

All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Guselkumab (Tremfya) IV may be considered medically necessary and payable through the medical benefit when the following criteria are met:

Ulcerative Colitis (UC)

The individual has a diagnosis of moderately to severely active UC; and
ONE of the following:
- Information has been provided that indicates the individual has been treated with guselkumab (Tremfya) IV (starting on samples is not approvable) within the past 90 days; or
- The prescriber states the individual has been treated with guselkumab (Tremfya) IV (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed; or
- BOTH of the following:
  - ONE of the following:
    - The individual is 18 years of age or older; or
    - The prescriber has provided information in support of using guselkumab (Tremfya) IV for the individual's age; and
  - ONE of the following:
    - The individual has tried and had an inadequate response to one (1) conventional agent (i.e., 6-mercaptopurine, azathioprine, balsalazide, corticosteroids, cyclosporine, mesalamine, sulfasalazine) used in the treatment of UC for at least a three (3)-month duration of therapy; or
    - The individual has severely active ulcerative colitis; or
    - The individual has an intolerance or hypersensitivity to one (1) of the conventional agents used in the treatment of UC; or
    - The individual has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of UC; or
    - The individual's medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in compendia for the treatment of UC; and
The prescriber is a specialist in the area of the individual's diagnosis, or the prescriber has consulted with a specialist in the area of the individual's diagnosis; and
ONE of the following:
- The individual will NOT be using guselkumab (Tremfya) IV in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors; or
- The individual will be using guselkumab (Tremfya) IV in combination with another immunomodulatory agent AND BOTH of the following:
  - The prescribing information for guselkumab (Tremfya) IV does NOT limit the use with another immunomodulatory agent; and
  - The prescriber has provided information in support of combination therapy (submitted copy required, e.g., clinical trials, phase III studies, guidelines required).

Other

The individual has another FDA labeled indication for guselkumab (Tremfya) IV; or
The individual has another indication supported in compendia for the requested agent and route of administration; and
If the individual has an FDA approved diagnosis, ONE of the following:
- The individual's age is within FDA labeling for the requested indication for guselkumab (Tremfya) IV; or
- The prescriber has provided information in support of using guselkumab (Tremfya) IV for the individual's age for the requested indication; and
The prescriber is a specialist in the area of the individual's diagnosis or the prescriber has consulted with a specialist in the area of the individual's diagnosis; and
ONE of the following:
- The prescribing information for guselkumab (Tremfya) IV does NOT limit the use with another immunomodulatory agent; and
- The prescriber has provided information in support of combination therapy (submitted copy required, e.g., clinical trials, phase III studies, guidelines required).
- The individual will NOT be using guselkumab (Tremfya) IV in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors; or
- The individual will be using guselkumab (Tremfya) IV in combination with another immunomodulatory agent AND BOTH of the following:
  - The prescribing information for guselkumab (Tremfya) IV does NOT limit the use with another immunomodulatory agent; and
  - The prescriber has provided information in support of combination therapy (submitted copy required, e.g., clinical trials, phase III studies, guidelines required)

If approved, guselkumab (Tremfya) IV will be allowed as three (3) intravenous infusions over twelve (12) weeks.

The use of guselkumab (Tremfya) IV for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Code

J1628

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the United States Food and Drug Administration (U.S. FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Diagnosis Codes

K51.00

K51.011

K51.012

K51.013

K51.512

K51.80

K51.811

K51.812

K51.813

K51.814

K51.818

K51.819

K51.90

K51.911

K51.912

K51.913

K51.914

K51.918

K51.919

Professional Statements and Societal Positions Guidelines

Agents NOT to be used Concomitantly (subject to change)

Abrilada (adalimumab-afzb)

Actemra (tocilizumab)

Adalimumab

Adbry (tralokinumab-ldrm)

Amjevita (adalimumab-atto)

Arcalyst (rilonacept)

Avsola (infliximab-axxq)

Benlysta (belimumab)

Bimzelx (bimekizumab-bkzx)

Cibinqo (abrocitinib)

Cimzia (certolizumab)

Cinqair (reslizumab)

Cosentyx (secukinumab)

Cyltezo (adalimumab-adbm)

Dupixent (dupilumab)

Enbrel (etanercept)

Entyvio (vedolizumab)

Fasenra (benralizumab)

Hadlima (adalimumab-bwwd)

Hulio (adalimumab-fkjp)

Humira (adalimumab)

Hyrimoz (adalimumab-adaz)

Idacio (adalimumab-aacf)

Ilaris (canakinumab)

Ilumya (tildrakizumab-asmn)

Inflectra (infliximab-dyyb)

Infliximab

Kevzara (sarilumab)

Kineret (anakinra)

Leqselvi (deuruxolitinib)

Litfulo (ritlecitinib)

Nemluvio (nemolizumab-ilto)

Nucala (mepolizumab)

Olumiant (baricitinib)

Omvoh (mirikizumab-mrkz)

Opzelura (ruxolitinib)

Orencia (abatacept)

Otezla (apremilast)

Pyzchiva (ustekinumab-ttwe)

Remicade (infliximab)

Renflexis (infliximab-abda)

Riabni (rituximab-arrx)

Rinvoq (upadacitinib)

Rituxan (rituximab)

Rituxan Hycela (rituximab/hyaluronidase human)

Ruxience (rituximab-pvvr)

Saphnelo (anifrolumab-fnia)

Selarsdi (ustekinumab-aekn)

Siliq (brodalumab)

Simlandi (adalimumab-ryvk)

Simponi (golimumab)

Simponi ARIA (golimumab)

Skyrizi (risankizumab-rzaa)

Sotyktu (deucravacitinib)

Spevigo (spesolimab-sbzo) subcutaneous injection

Stelara (ustekinumab)

Taltz (ixekizumab)

Tezspire (tezepelumab-ekko)

Tofidence (tocilizumab-bavi)

Tremfya (guselkumab)

Truxima (rituximab-abbs)

Tyenne (tocilizumab-aazg)

Tysabri (natalizumab)

Velsipity (etrasimod)

Wezlana (ustekinumab-auub)

Xeljanz (tofacitinib)

Xeljanz XR (tofacitinib extended release)

Xolair (omalizumab)

Yuflyma (adalimumab-aaty)

Yusimry (adalimumab-aqvh)

Zeposia (ozanimod)

Zymfentra (infliximab-dyyb)

ND Committee Review

Internal Medical Policy Committee 5-23-2023 - Effective June 1, 2023

Adopted medical policy

Internal Medical Policy Committee 5-14-2024 Effective July 01, 2024

Annual review no clinical content change

Internal Medical Policy Committee 11-19-2024 Effective December 01, 2024

Added intravenous formulation and criteria to the policy
Removed subcutaneous formulation and criteria from the policy

Internal Medical Policy Committee 11-19-2024 Effective December 31, 2024

Archived policy

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

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