Guselkumab (Tremfya)

Policy ID: I-9039-002

Section: Injections

Effective Date: June 01, 2023

Revised Date: May 08, 2024

Revision Effective Date: July 01, 2024

Last Reviewed: May 14, 2024

Applies To: Commercial and Medicaid Expansion

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.

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

ONE of the following:
- The individual is receiving guselkumab (Tremfya) for training and education purposes; OR
- The individual's primary insurance requires medical claim processing; OR
- A medical reason is provided as to why an individual cannot self-administer (i.e., physical disability, anxiety/panic attack, previous severe reaction to the hemophilia product; OR
- The individual is hospitalized; AND
ONE of the following:
- The individual has a diagnosis of active Psoriatic Arthritis (PsA); and
  - 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) for the individual's age; and
    - ONE of the following:
      - The individual has tried and had an inadequate response to ONE conventional agent (i.e., cyclosporine, leflunomide, methotrexate, sulfasalazine) used in the treatment of PsA for at least three (3)-months; or
      - The individual has an intolerance or hypersensitivity to ONE of the conventional agents used in the treatment of PsA; or
      - The individual has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of PsA; or
      - The individual has severe active PsA (e.g., erosive disease, elevated markers of inflammation [e.g., ESR, CRP] attributable to PsA, long-term damage that interferes with function [i.e., joint deformities], rapidly progressive); or
      - The individual has concomitant severe psoriasis (PS) (e.g., greater than 10% body surface area involvement, occurring on select locations [i.e., hands, feet, scalp, face, or genitals], intractable pruritus, serious emotional consequences); or
      - The individual's medication history indicates use of another biologic immunomodulator agent OR Otezla that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence, or NCCN compendium recommended use of 1 or 2a for the treatment of PsA; or
- The individual has a diagnosis of moderate to severe Plaque Psoriasis (PS); and
  - 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) for the individual's age; and
    - ONE of the following:
      - The individual has tried and had an inadequate response to ONE conventional agent (e.g., acitretin, anthralin, calcipotriene, calcitriol, coal tar products, cyclosporine, methotrexate, pimecrolimus, PUVA [phototherapy], tacrolimus, tazarotene, topical corticosteroids) used in the treatment of PS for at least three (3)-months; or
      - The individual has an intolerance or hypersensitivity to ONE conventional agent used in the treatment of PS; or
      - The individual has an FDA labeled contraindication to ALL conventional agents used in the treatment of PS; or
      - The individual has severe active PS (e.g., greater than 10% body surface area involvement, occurring on select locations [i.e., hands, feet, scalp, face, or genitals], intractable pruritus, serious emotional consequences); or
      - The individual has concomitant severe psoriatic arthritis (PsA) (e.g., erosive disease, elevated markers of inflammation [e.g., ESR, CRP] attributable to PsA, long-term damage that interferes with function [i.e., joint deformities], rapidly progressive); or
      - The individual's medication history indicates use of another biologic immunomodulator agent OR Otezla that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence, or NCCN compendium recommended use of 1 or 2a for the treatment of PS; 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) in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors; or
- The individual will be using guselkumab (Tremfya) in combination with another immunomodulatory agent AND BOTH of the following:
  - The prescribing information for guselkumab (Tremfya) 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 use of guselkumab (Tremfya) 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

Reauthorization Criteria

Continuation of therapy with guselkumab (Tremfya) may be considered medically necessary when the following criteria are met:

ONE of the following:
- The individual is receiving guselkumab (Tremfya) for training and education purposes; OR
- The individual's primary insurance requires medical claim processing; OR
- A medical reason is provided as to why an individual cannot self-administer (i.e., physical disability, anxiety/panic attack, previous severe reaction to the hemophilia product; OR
- The individual is hospitalized; AND
The individual has been previously approved for guselkumab (Tremfya) through the Blue Cross Blue Shield of North Dakota's precertification process; and
The individual has had clinical benefit with guselkumab (Tremfya); 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) in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors; or
- The individual will be using guselkumab (Tremfya) in combination with another immunomodulatory agent AND BOTH of the following:
  - The prescribing information for guselkumab (Tremfya) 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).

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

L40.0

L40.50

L40.51

L40.52

L40.53

L40.59

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)

Litfulo (ritlecitinib)

Nucala (mepolizumab)

Olumiant (baricitinib)

Omvoh (mirikizumab-mrkz)

Opzelura (ruxolitinib)

Orencia (abatacept)

Otezla (apremilast)

Remicade (infliximab)

Renflexis (infliximab-abda)

Riabni (rituximab-arrx)

Rinvoq (upadacitinib)

Rituxan (rituximab)

Rituxan Hycela (rituximab/hyaluronidase human)

Ruxience (rituximab-pvvr)

Siliq (brodalumab)

Simlandi (adalimumab-ryvk)

Simponi (golimumab)

Simponi ARIA (golimumab)

Skyrizi (risankizumab-rzaa)

Sotyktu (deucravacitinib)

Spevigo (spesolimab-sbzo)

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

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.

Policy ID: I-9039-001

Section: Injections

Effective Date: June 01, 2023

Last Reviewed: May 23, 2023

Archived Date: June 30, 2024

Applies To: Commercial and Medicaid Expansion

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.

Criteria

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

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

ONE of the following:
- The individual is receiving guselkumab (Tremfya) for training and education purposes; OR
- The individual's primary insurance requires medical claim processing; OR
- A medical reason is provided as to why an individual cannot self-administer (i.e., physical disability, anxiety/panic attack, previous severe reaction to the hemophilia product; OR
- The individual is hospitalized; AND
ONE of the following:
- The individual has a diagnosis of active Psoriatic Arthritis (PsA); and
  - 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) for the individual's age; and
    - ONE of the following:
      - The individual has tried and had an inadequate response to ONE conventional agent (i.e., cyclosporine, leflunomide, methotrexate, sulfasalazine) used in the treatment of PsA for at least three (3)-months; or
      - The individual has an intolerance or hypersensitivity to ONE of the conventional agents used in the treatment of PsA; or
      - The individual has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of PsA; or
      - The individual has severe active PsA (e.g., erosive disease, elevated markers of inflammation [e.g., ESR, CRP] attributable to PsA, long-term damage that interferes with function [i.e., joint deformities], rapidly progressive); or
      - The individual has concomitant severe psoriasis (PS) (e.g., greater than 10% body surface area involvement, occurring on select locations [i.e., hands, feet, scalp, face, or genitals], intractable pruritus, serious emotional consequences); or
      - The individual's medication history indicates use of another biologic immunomodulator agent OR Otezla that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence, or NCCN compendium recommended use of 1 or 2a for the treatment of PsA; or
- The individual has a diagnosis of moderate to severe Plaque Psoriasis (PS); and
  - 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) for the individual's age; and
    - ONE of the following:
      - The individual has tried and had an inadequate response to ONE conventional agent (e.g., acitretin, anthralin, calcipotriene, calcitriol, coal tar products, cyclosporine, methotrexate, pimecrolimus, PUVA [phototherapy], tacrolimus, tazarotene, topical corticosteroids) used in the treatment of PS for at least three (3)-months; or
      - The individual has an intolerance or hypersensitivity to ONE conventional agent used in the treatment of PS; or
      - The individual has an FDA labeled contraindication to ALL conventional agents used in the treatment of PS; or
      - The individual has severe active PS (e.g., greater than 10% body surface area involvement, occurring on select locations [i.e., hands, feet, scalp, face, or genitals], intractable pruritus, serious emotional consequences); or
      - The individual has concomitant severe psoriatic arthritis (PsA) (e.g., erosive disease, elevated markers of inflammation [e.g., ESR, CRP] attributable to PsA, long-term damage that interferes with function [i.e., joint deformities], rapidly progressive); or
      - The individual's medication history indicates use of another biologic immunomodulator agent OR Otezla that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence, or NCCN compendium recommended use of 1 or 2a for the treatment of PS; 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) in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors; or
- The individual will be using guselkumab (Tremfya) in combination with another immunomodulatory agent AND BOTH of the following:
  - The prescribing information for guselkumab (Tremfya) 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).

Procedure Codes

J1628

Reauthorization Criteria

Continuation of therapy with guselkumab (Tremfya) may be considered medically necessary when the following criteria are met:

ONE of the following:
- The individual is receiving guselkumab (Tremfya) for training and education purposes; OR
- The individual's primary insurance requires medical claim processing; OR
- A medical reason is provided as to why an individual cannot self-administer (i.e., physical disability, anxiety/panic attack, previous severe reaction to the hemophilia product; OR
- The individual is hospitalized; AND
The individual has been previously approved for guselkumab (Tremfya) through the Blue Cross Blue Shield of North Dakota's precertification process; and
The individual has had clinical benefit with guselkumab (Tremfya); 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) in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors; or
- The individual will be using guselkumab (Tremfya) in combination with another immunomodulatory agent AND BOTH of the following:
  - The prescribing information for guselkumab (Tremfya) 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).

Procedure Codes

J1628

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (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

L40.0

L40.50

L40.51

L40.52

L40.53

L40.59

Professional Statements and Societal Positions Guidelines

Agents NOT to be used Concomitantly (subject to change)

Adbry (tralokinumab-ldrm)

Actemra (tocilizumab)

Amjevita (adalimumab-atto)

Arcalyst (rilonacept)

Avsola (infliximab-axxq)

Benlysta (belimumab)

Cibinqo (abrocitinib)

Cimzia (certolizumab)

Cinqair (reslizumab)

Cosentyx (secukinumab)

Dupixent (dupilumab)

Enbrel (etanercept)

Entyvio (vedolizumab)

Fasenra (benralizumab)

Humira (adalimumab)

Ilaris (canakinumab)

Ilumya (tildrakizumab-asmn)

Inflectra (infliximab-dyyb)

Infliximab

Kevzara (sarilumab)

Kineret (anakinra)

Nucala (mepolizumab)

Olumiant (baricitinib)

Opzelura (ruxolitinib)

Orencia (abatacept)

Otezla (apremilast)

Remicade (infliximab)

Renflexis (infliximab-abda)

Riabni (rituximab-arrx)

Rinvoq (upadacitinib)

Rituxan (rituximab)

Rituxan Hycela (rituximab/hyaluronidase human)

Ruxience (rituximab-pvvr)

Siliq (brodalumab)

Simponi (golimumab)

Simponi ARIA (golimumab)

Skyrizi (risankizumab-rzaa)

Sotyktu (deucravacitinib)

Stelara (ustekinumab)

Taltz (ixekizumab)

Tezspire (tezepelumab-ekko)

Tremfya (guselkumab)

Truxima (rituximab-abbs)

Tysabri (natalizumab)

Xeljanz (tofacitinib)

Xeljanz XR (tofacitinib extended release)

Xolair (omalizumab)

Zeposia (ozanimod)

ND Committee Review

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

Adopted medical policy

Medical Policies Quick Search

Guselkumab (Tremfya)

Description

Policy Application

Criteria

Reauthorization Criteria

Diagnosis Codes

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer

Description

Criteria

Reauthorization Criteria

Diagnosis Codes

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer