Tildrakizumab-asmn (Ilumya)

Policy ID: I-9199-004

Section: Injections

Effective Date: May 01, 2021

Revised Date: November 14, 2023

Revision Effective Date: January 01, 2024

Last Reviewed: November 15, 2023

Applies To: Commercial Only

Description

Tildrakizumab-asmn (Ilumya ^TM ) is a humanized IgG1/k monoclonal antibody that selectively and specifically binds to the p19 subunit of interleukin-23 (IL-23) and inhibits its interaction with the IL-23 receptor. IL-23 is a naturally occurring cytokine that is involved in inflammatory and immune responses. Tildrakizumab (Ilumya) inhibits the release of proinflammatory cytokines and chemokines.

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.

Tildrakizumab (Ilumya)

Tildrakizumab (Ilumya) may be considered medically necessary when an individual meets the criteria for ANY ONE of the following:

Plaque Psoriasis (PS)

The individual has a diagnosis of moderate to severe PS; and
ONE of the following:
- Information has been provided that indicates the individual has been treated with tildrakizumab (Ilumya) (starting on samples is not approvable) within the past 90 days; or
- The prescriber states the individual has been treated with tildrakizumab (Ilumya) (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 tildrakizumab (Ilumya) for the individual's age; and
  - ONE of the following:
    - The individual has tried and had an inadequate response to one (1) 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 (1) 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 tildrakizumab (Ilumya) in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors; or
- The individual will be using tildrakizumab (Ilumya) in combination with another immunomodulatory agent AND BOTH of the following:
  - The prescribing information for tildrakizumab (Ilumya) 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 tildrakizumab (Ilumya); 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 tildrakizumab (Ilumya); or
- The prescriber has provided information in support of using tildrakizumab (Ilumya) 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 tildrakizumab (Ilumya) 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 tildrakizumab (Ilumya) in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors; or
- The individual will be using tildrakizumab (Ilumya) in combination with another immunomodulatory agent AND BOTH of the following:
  - The prescribing information for tildrakizumab (Ilumya) 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 tildrakizumab (Ilumya) 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

J3245

Reauthorization Criteria

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

The individual has been previously approved for tildrakizumab (Ilumya) through the Blue Cross Blue Shield of North Dakota's precertification process; and
The individual has had clinical benefit with tildrakizumab (Ilumya); 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 tildrakizumab (Ilumya) in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors; or
- The individual will be using tildrakizumab (Ilumya) in combination with another immunomodulatory agent AND BOTH of the following:
  - The prescribing information for tildrakizumab (Ilumya) 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

J3245

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.

NOTE: Compendia allowed are DrugDex 1 or 2a level of evidence and NCCN 1 or 2a recommended use.

Diagnosis Code

L40.0

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)
Simponi (golimumab)
Simponi ARIA (golimumab)
Skyrizi (risankizumab-rzaa)
Sotyktu (deucravacitinib)
Stelara (ustekinumab)
Taltz (ixekizumab)
Tezspire (tezepelumab-ekko)
Tremfya (guselkumab)
Truxima (rituximab-abbs)
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 3-17-2021 Adopt policy, was previously policy number I-199

Internal Medical Policy Committee 3-23-2022

Added Zeposia as a contraindicated drug; and
Added list of agents contraindicated as concomitant therapy

Internal Medical Policy Committee 11-29-2022 - Effective January 01, 2023

Updated combination therapy criteria, and
Removed latent tuberculosis criteria from the policy, and
Removed FDA labeled contraindications criteria from the policy, and
Updated Agents NOT to be used Concomitantly list, and
Updated experimental/investigational statement

Internal Medical Policy Committee 11-15-2023 Effective January 01, 2024

Added Other criteria
Updated Agents NOT to be used Concomitantly list

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-9199-003

Section: Injections

Effective Date: May 01, 2021

Revised Date: November 22, 2022

Revision Effective Date: January 01, 2023

Last Reviewed: November 29, 2022

Archived Date: December 31, 2023

Applies To: Commercial Only

Description

Tildrakizumab-asmn (Ilumya^TM) is a humanized IgG1/k monoclonal antibody that selectively and specifically binds to the p19 subunit of interleukin-23 (IL-23) and inhibits its interaction with the IL-23 receptor. IL-23 is a naturally occurring cytokine that is involved in inflammatory and immune responses. Tildrakizumab (Ilumya) inhibits the release of proinflammatory cytokines and chemokines.

Criteria

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

Tildrakizumab (Ilumya)

Tildrakizumab (Ilumya) may be considered medically necessary when an individual meets the criteria for ANY ONE of the following:

Plaque Psoriasis (PS)

The individual has a diagnosis of moderate to severe PS; and
ONE of the following:
- Information has been provided that indicates the individual has been treated with tildrakizumab (Ilumya) (starting on samples is not approvable) within the past 90 days; or
- The prescriber states the individual has been treated with tildrakizumab (Ilumya) (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 eighteen (18) years of age or older; or
    - The prescriber has provided information in support of using tildrakizumab (Ilumya) 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 tildrakizumab (Ilumya) in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors; or
- The individual will be using tildrakizumab (Ilumya) in combination with another immunomodulatory agent AND BOTH of the following:
  - The prescribing information for tildrakizumab (Ilumya) 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

J3245

Reauthorization Criteria

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

The individual has been previously approved for tildrakizumab (Ilumya) through the Blue Cross Blue Shield of North Dakota’s precertification process; and
The individual has had clinical benefit with tildrakizumab (Ilumya); 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 tildrakizumab (Ilumya) in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors; or
- The individual will be using tildrakizumab (Ilumya) in combination with another immunomodulatory agent AND BOTH of the following:
  - The prescribing information for tildrakizumab (Ilumya) 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

J3245

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

Professional Statements and Societal Positions Guidelines

Agents NOT to be used Concomitantly (subject to change)

Adbry (tralokinumab-ldrm)

Actemra (tocilizumab)

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)

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 3-17-2021 Adopt policy, was previously policy number I-199

Internal Medical Policy Committee 3-23-2022

Added Zeposia as a contraindicated drug; and
Added list of agents contraindicated as concomitant therapy

Internal Medical Policy Committee 11-29-2022 - Effective January 01, 2023

Updated combination therapy criteria, and
Removed latent tuberculosis criteria from the policy, and
Removed FDA labeled contraindications criteria from the policy, and
Updated Agents NOT to be used Concomitantly list, and
Updated experimental/investigational statement

Links

References (PDF)

Disclaimer

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