Ustekinumab (Stelara®) IV

Ustekinumab (Stelara) IV

Policy ID: I-9037-005

Section: Injections

Effective Date: March 01, 2021

Revised Date: November 14, 2023

Revision Effective Date: January 01, 2024

Last Reviewed: November 15, 2023

Applies To: Commercial Only

Description

Ustekinumab (Stelara®) is a human monoclonal antibody. It is directed against interleukin 12 and interleukin-23, naturally occurring proteins that regulate the immune system and immune-mediated inflammatory disorders. Ustekinumab (Stelara) may be self-administered by subcutaneous injection and is also available as an infusion that may be administered intravenously by a health care professional.

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

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.

Ustekinumab (Stelara) IV

Ustekinumab (Stelara) IV may be considered medically necessary when an individual meets the criteria for ANY ONE of the following:

Crohn's Disease (CD)

The individual has a diagnosis of moderately to severely active CD; 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 ustekinumab (Stelara) 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, corticosteroids [e.g., prednisone, budesonide EC capsule], methotrexate) used in the treatment of CD for at least three (3)-months; or
  - The individual has an intolerance or hypersensitivity to one (1) of the conventional agents used in the treatment of CD; or
  - The individual has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of CD; or
  - The individual's medication history indicates use of another biologic immunomodulator agent 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 CD; 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 ustekinumab (Stelara) IV in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors; or
- The individual will be using ustekinumab (Stelara) IV in combination with another immunomodulatory agent AND BOTH of the following:
  - The prescribing information for ustekinumab (Stelara) 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).

Ulcerative Colitis (UC)

The individual has a diagnosis of moderately to severely active UC; 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 ustekinumab (Stelara) 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 three (3)-months; 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 DrugDex with 1 or 2a level of evidence, or NCCN compendium recommended use of 1 or 2a 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 ustekinumab (Stelara) IV in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors; or
- The individual will be using ustekinumab (Stelara) IV in combination with another immunomodulatory agent AND BOTH of the following:
  - The prescribing information for ustekinumab (Stelara) 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 ustekinumab (Stelara) 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 ustekinumab (Stelara) IV; or
- The prescriber has provided information in support of using ustekinumab (Stelara) 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 ustekinumab (Stelara) 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 ustekinumab (Stelara) IV in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors; or
- The individual will be using ustekinumab (Stelara) IV in combination with another immunomodulatory agent AND BOTH of the following:
  - The prescribing information for ustekinumab (Stelara) 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, ustekinumab (Stelara) IV will be allowed as a single intravenous infusion.

The use of ustekinumab (Stelara) 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

J3358

The subcutaneous formulation of ustekinumab (Stelara) is a pharmacy benefit. Please refer to pharmacy policies for coverage information.

Procedure Code

J3357

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 Codes

Covered Diagnosis Codes for Procedure Code J3358

K50.00

K50.011

K50.012

K50.013

K50.014

K50.018

K50.019

K50.10

K50.111

K50.112

K50.113

K50.114

K50.118

K50.119

K50.80

K50.811

K50.812

K50.813

K50.814

K50.818

K50.819

K50.90

K50.911

K50.912

K50.913

K50.914

K50.918

K50.919

K51.00

K51.011

K51.012

K51.013

K51.014

K51.018

K51.019

K51.20

K51.211

K51.212

K51.213

K51.214

K51.218

K51.219

K51.30

K51.311

K51.312

K51.313

K51.314

K51.318

K51.319

K51.40

K51.411

K51.412

K51.413

K51.414

K51.418

K51.419

K51.50

K51.511

K51.512

K51.513

K51.514

K51.518

K51.519

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)
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 1-19-2021 Adopt policy, was previously policy number I-37

Internal Medical Policy Committee 3-17-2021 Updated criteria for CD and UC

Internal Medical Policy Committee 3-23-2022

Removed sulfasalazine from CD conventional agents; and
Removed steroid suppositories from UC conventional agents; and
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, and
Updated diagnosis code list

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-9037-004

Section: Injections

Effective Date: March 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

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

Criteria

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

Ustekinumab (Stelara) IV

Ustekinumab (Stelara) IV may be considered medically necessary when an individual meets the criteria for ANY ONE of the following:

Crohn’s Disease (CD)

The individual has a diagnosis of moderately to severely active CD; 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 ustekinumab (Stelara) IV 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., 6-mercaptopurine, azathioprine, corticosteroids [e.g., prednisone, budesonide EC capsule], methotrexate) used in the treatment of CD 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 CD; or
  - The individual has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of CD; or
  - The individual’s medication history indicates use of another biologic immunomodulator agent 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 CD; 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 ustekinumab (Stelara) IV in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors; or
- The individual will be using ustekinumab (Stelara) IV in combination with another immunomodulatory agent AND BOTH of the following:
  - The prescribing information for ustekinumab (Stelara) 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).

Ulcerative Colitis (UC)

The individual has a diagnosis of moderately to severely active UC; 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 ustekinumab (Stelara) IV 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., 6-mercaptopurine, azathioprine, balsalazide, corticosteroids, cyclosporine, mesalamine, sulfasalazine) used in the treatment of UC for at least three (3)-months; or
  - The individual has severely active ulcerative colitis; or
  - The individual has an intolerance or hypersensitivity to ONE 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 DrugDex with 1 or 2a level of evidence, or NCCN compendium recommended use of 1 or 2a 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 ustekinumab (Stelara) IV in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors; or
- The individual will be using ustekinumab (Stelara) IV in combination with another immunomodulatory agent AND BOTH of the following:
  - The prescribing information for ustekinumab (Stelara) 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

Compendia Sources

Ustekinumab (Stelara) IV may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.

If approved, ustekinumab (Stelara) IV will be allowed as a single intravenous infusion.

Procedure Codes

J3358

The subcutaneous formulation of ustekinumab (Stelara) is a pharmacy benefit. Please refer to pharmacy policies for coverage information.

Procedure Codes

J3357

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

Covered Diagnosis Codes for Procedure Code J3358

K50.00

K50.011

K50.012

K50.013

K50.014

K50.018

K50.019

K50.10

K50.111

K50.112

K50.113

K50.114

K50.118

K50.119

K50.80

K50.811

K50.812

K50.813

K50.814

K50.818

K50.819

K51.00

K51.011

K51.012

K51.013

K51.014

K51.018

K51.019

K51.20

K51.211

K51.212

K51.213

K51.214

K51.218

K51.219

K51.30

K51.311

K51.312

K51.313

K51.314

K51.318

K51.319

K51.40

K51.411

K51.412

K51.413

K51.414

K51.418

K51.419

K51.50

K51.511

K51.512

K51.513

K51.514

K51.518

K51.519

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)

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)