Infliximab (ARCHIVED)

Policy ID: I-9028-005

Section: Injections

Effective Date: April 01, 2022

Revised Date: October 20, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Applies To: Commercial Only

**This policy has been Archived effective December 08, 2024. Click the Archive tab above for more information.**

Policy ID: I-9028-005

Section: Injections

Effective Date: April 01, 2022

Revised Date: October 20, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Archived Date: December 08, 2024

Applies To: Commercial Only

Description

Infliximab is a murine-human chimeric monoclonal antibody, which binds to and neutralizes the effects of tumor necrosis factor alpha (TNF-alpha), a pro-inflammatory cytokine.

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.

Preferred Agents

Non-Preferred Agent

Inflectra (infliximab-dyyb) - Q5103

Renflexis (infliximab-abda) - Q5104

Avsola (infliximab-axxq) - Q5121

Infliximab - J1745

Remicade (infliximab) - J1745

Infliximab or an infliximab biosimilar may be considered medically necessary when an individual meets all of the following criteria:

ONE of the following:
- The requested agent is a preferred agent [i.e., Inflectra (infliximab-dyyb) or Renflexis (infliximab-abda)]; or
- The individual has tried and had an inadequate response to TWO preferred agents [i.e., Inflectra (infliximab-dyyb) and Renflexis (infliximab-abda)] for at least a three (3)-month trial of each (medical records required); or
- The individual has an intolerance or hypersensitivity to TWO of the preferred agents [i.e., Inflectra (infliximab-dyyb) and Renflexis (infliximab-abda)] that is not expected to occur with the requested agent (medical records required); or
- The individual has an FDA labeled contraindication to ALL of the preferred agent(s) [i.e., Inflectra (infliximab-dyyb) and Renflexis (infliximab-abda)] that is not expected to occur with the requested agent (medical records required); and
ONE of the following:
- The prescriber has provided documentation that the individual has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed; or
- ALL of the following:
  - The individual has an FDA labeled indication or an indication that is supported in compendia for the requested agent and route of administration; and
  - ONE of the following:
    - The individual's age is within FDA labeling for the requested indication for the requested agent; or
    - The prescriber has provided information in support of using the requested agent for the individual's age for the requested indication; and
  - ONE of the following:
    - The individual has a diagnosis of moderately to severely active rheumatoid arthritis (RA) AND BOTH of the following:
      - ONE of the following:
        The individual has tried and had an inadequate response to maximally tolerated methotrexate (e.g., titrated to 25 mg weekly) used in the treatment for RA for at least three (3)-months; or
        The individual has tried and had an inadequate response to another conventional agent (e.g., hydroxychloroquine, leflunomide, or sulfasalazine) used in the treatment of RA for at least three (3)-months; or
        The individual has an intolerance or hypersensitivity to ONE of the following conventional agents (i.e., maximally tolerated methotrexate, hydroxychloroquine, leflunomide, and sulfasalazine) used in the treatment of RA; or
        The individual has an FDA labeled contraindication to ALL conventional agents (i.e., methotrexate, hydroxychloroquine, leflunomide, and sulfasalazine) used in the treatment of RA; 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 RA; and
      - ONE of the following:
        The individual will be taking the requested agent in combination with methotrexate or an alternative DMARD (e.g., leflunomide, hydroxychloroquine, sulfasalazine); or
        The individual has an intolerance, FDA labeled contraindication, or hypersensitivity to methotrexate AND ALL alternative DMARDs; or
    - The individual has a diagnosis of granulomatosis with polyangiitis (GPA) (Wegener's granulomatosis) AND ALL of the following:
      - The individual has refractory or treatment-resistant GPA; and
      - ONE of the following:
        The requested agent will be used in combination with a corticosteroid; or
        The individual has an intolerance, FDA labeled contraindication, or hypersensitivity to corticosteroid therapy; and
      - ONE of the following:
        The individual has tried and had an inadequate response to BOTH cyclophosphamide and rituximab for at least three (3)-months; or
        The individual has an intolerance or hypersensitivity to BOTH cyclophosphamide and rituximab used in the treatment of GPA; or
        The individual has an FDA labeled contraindication to BOTH cyclophosphamide and rituximab used in the treatment of GPA; and
      - ONE of the following:
        The individual has tried and had an inadequate response to an alternative immunosuppressive (e.g., azathioprine, methotrexate, mycophenolate mofetil) for at least three (3)-months; or
        The individual has an intolerance or hypersensitivity to an alternative immunosuppressive used in the treatment of GPA; or
        The individual has an FDA labeled contraindication to ALL alternative immunosuppressive therapy used in the treatment of GPA; or
    - The individual has a diagnosis of active psoriatic arthritis (PsA) 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 compendia for the treatment of PsA; or
    - The individual has a diagnosis of chronic severe plaque psoriasis (PS); or
    - The individual has a diagnosis of moderately to severely active Crohn's disease (CD) 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 compendia for the treatment of CD; or
    - The individual has a diagnosis of moderately to severely active ulcerative colitis (UC) 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 compendia for the treatment of UC; or
    - The individual has a diagnosis of active ankylosing spondylitis (AS) AND ONE of the following:
      - The individual has tried and had an inadequate response to two different NSAIDs used in the treatment of AS for at least a 4-week total trial; or
      - The individual has an intolerance or hypersensitivity to TWO different NSAIDs used in the treatment of AS; or
      - The individual has an FDA labeled contraindication to ALL NSAIDs used in the treatment of AS; 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 AS; or
    - The individual has another FDA labeled indication for the requested agent and route of administration not mentioned previously; or
    - The individual has another indication supported in compendia for the requested agent and route of administration not mentioned previously; 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 the requested agent in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors); or
- The individual will be using the requested agent in combination with another immunomodulatory agent AND BOTH of the following:
  - The prescribing information for the requested agent 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).

Reauthorization Criteria

Reauthorization of infliximab or an infliximab biosimilar may be considered medically necessary when the following criteria are met:

ONE of the following:
- The requested agent is a preferred agent [i.e., Inflectra (infliximab-dyyb) or Renflexis (infliximab-abda)]; or
- The individual has tried and had an inadequate response to TWO preferred agents [i.e., Inflectra (infliximab-dyyb) and Renflexis (infliximab-abda] for at least a three (3)-month trial of each (medical records required); or
- The individual has an intolerance or hypersensitivity to TWO of the preferred agents [i.e., Inflectra (infliximab-dyyb) and Renflexis (infliximab-abda] that is not expected to occur with the requested agent (medical records required); or
- The individual has an FDA labeled contraindication to ALL of the preferred agents [i.e., Inflectra (infliximab-dyyb) and Renflexis (infliximab-abda] that is not expected to occur with the requested agent (medical records required); and
The individual has been previously approved for infliximab or an infliximab biosimilar through the Blue Cross Blue Shield of North Dakota's precertification process; and
The individual has had clinical benefit with infliximab or an infliximab biosimilar; 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 the requested agent in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors); or
- The individual will be using the requested agent in combination with another immunomodulatory agent AND BOTH of the following:
  1. The prescribing information for the requested agent does NOT limit the use with another immunomodulatory agent; and
  2. The prescriber has provided information in support of combination therapy (submitted copy required, e.g., clinical trials, phase III studies, guidelines required).

Infliximab or an infliximab biosimilar 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 Codes

J1745

Q5103

Q5104

Q5121

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 or National Comprehensive Cancer Network (NCCN) 1 or 2a recommended use

NOTE: The infliximab dose requested should NOT exceed 10 mg/kg every 4 weeks.

Diagnosis Codes

D86.0

D86.1

D86.2

D86.3

D86.81

D86.82

D86.83

D86.84

D86.85

D86.86

D86.87

D86.89

D86.9

D89.812

D89.813

H20.041

H20.042

H20.043

H20.049

H44.111

H44.112

H44.113

H44.119

H44.131

H44.132

H44.133

I30.8

I30.9

I40.8

I40.9

J70.2

J70.4

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

K52.1

L40.0

L40.1

L40.2

L40.3

L40.4

L40.50

L40.51

L40.52

L40.53

L40.54

L40.59

L40.8

L40.9

M05.00

M05.011

M05.012

M05.019

M05.021

M05.022

M05.029

M05.031

M05.032

M05.039

M05.041

M05.042

M05.049

M05.051

M05.052

M05.059

M05.061

M05.062

M05.069

M05.071

M05.072

M05.079

M05.09

M05.10

M05.111

M05.112

M05.119

M05.121

M05.122

M05.129

M05.131

M05.132

M05.139

M05.141

M05.142

M05.149

M05.151

M05.152

M05.159

M05.161

M05.162

M05.169

M05.171

M05.172

M05.179

M05.19

M05.20

M05.211

M05.212

M05.219

M05.221

M05.222

M05.229

M05.231

M05.232

M05.239

M05.241

M05.242

M05.249

M05.251

M05.252

M05.259

M05.261

M05.262

M05.269

M05.271

M05.272

M05.279

M05.29

M05.30

M05.311

M05.312

M05.319

M05.321

M05.322

M05.329

M05.331

M05.332

M05.339

M05.341

M05.342

M05.349

M05.351

M05.352

M05.359

M05.361

M05.362

M05.369

M05.371

M05.372

M05.379

M05.39

M05.40

M05.411

M05.412

M05.419

M05.421

M05.422

M05.429

M05.431

M05.432

M05.439

M05.441

M05.442

M05.449

M05.451

M05.452

M05.459

M05.461

M05.462

M05.469

M05.471

M05.472

M05.479

M05.49

M05.50

M05.511

M05.512

M05.519

M05.521

M05.522

M05.529

M05.531

M05.532

M05.539

M05.541

M05.542

M05.549

M05.551

M05.552

M05.559

M05.561

M05.562

M05.569

M05.571

M05.572

M05.579

M05.59

M05.60

M05.611

M05.612

M05.619

M05.621

M05.622

M05.629

M05.631

M05.632

M05.639

M05.641

M05.642

M05.649

M05.651

M05.652

M05.659

M05.661

M05.662

M05.669

M05.671

M05.672

M05.679

M05.69

M05.70

M05.711

M05.712

M05.719

M05.721

M05.722

M05.729

M05.731

M05.732

M05.739

M05.741

M05.742

M05.749

M05.751

M05.752

M05.759

M05.761

M05.762

M05.769

M05.771

M05.772

M05.779

M05.79

M05.7A

M05.80

M05.811

M05.812

M05.819

M05.821

M05.822

M05.829

M05.831

M05.832

M05.839

M05.841

M05.842

M05.849

M05.851

M05.852

M05.859

M05.861

M05.862

M05.869

M05.871

M05.872

M05.879

M05.89

M05.8A

M05.9

M06.00

M06.011

M06.012

M06.019

M06.021

M06.022

M06.029

M06.031

M06.032

M06.039

M06.041

M06.042

M06.049

M06.051

M06.052

M06.059

M06.061

M06.062

M06.069

M06.071

M06.072

M06.079

M06.08

M06.09

M06.0A

M06.1

M06.20

M06.211

M06.212

M06.219

M06.221

M06.222

M06.229

M06.231

M06.232

M06.239

M06.241

M06.242

M06.249

M06.251

M06.252

M06.259

M06.261

M06.262

M06.269

M06.271

M06.272

M06.279

M06.28

M06.29

M06.30

M06.311

M06.312

M06.319

M06.321

M06.322

M06.329

M06.331

M06.332

M06.339

M06.341

M06.342

M06.349

M06.351

M06.352

M06.359

M06.361

M06.362

M06.369

M06.371

M06.372

M06.379

M06.38

M06.39

M06.4

M06.80

M06.811

M06.812

M06.819

M06.821

M06.822

M06.829

M06.831

M06.832

M06.839

M06.841

M06.842

M06.849

M06.851

M06.852

M06.859

M06.861

M06.862

M06.869

M06.871

M06.872

M06.879

M06.88

M06.89

M06.8A

M06.9

M08.00

M08.011

M08.012

M08.019

M08.021

M08.022

M08.029

M08.031

M08.032

M08.039

M08.041

M08.042

M08.049

M08.051

M08.052

M08.059

M08.061

M08.062

M08.069

M08.071

M08.072

M08.079

M08.08

M08.09

M08.0A

M08.1

M08.20

M08.211

M08.212

M08.219

M08.221

M08.222

M08.229

M08.231

M08.232

M08.239

M08.241

M08.242

M08.249

M08.251

M08.252

M08.259

M08.261

M08.262

M08.269

M08.271

M08.272

M08.279

M08.28

M08.29

M08.2A

M08.3

M08.40

M08.411

M08.412

M08.419

M08.421

M08.422

M08.429

M08.431

M08.432

M08.439

M08.441

M08.442

M08.449

M08.451

M08.452

M08.459

M08.461

M08.462

M08.469

M08.471

M08.472

M08.479

M08.48

M08.4A

M08.80

M08.811

M08.812

M08.819

M08.821

M08.822

M08.829

M08.831

M08.832

M08.839

M08.841

M08.842

M08.849

M08.851

M08.852

M08.859

M08.861

M08.862

M08.869

M08.871

M08.872

M08.879

M08.88

M08.89

M08.90

M08.911

M08.912

M08.919

M08.921

M08.922

M08.929

M08.931

M08.932

M08.939

M08.941

M08.942

M08.949

M08.951

M08.952

M08.959

M08.961

M08.962

M08.969

M08.971

M08.972

M08.979

M08.98

M08.99

M08.9A

M45.0

M45.1

M45.2

M45.3

M45.4

M45.5

M45.6

M45.7

M45.8

M45.9

M60.80

M60.811

M60.812

M60.819

M60.821

M60.822

M60.829

M60.831

M60.832

M60.839

M60.841

M60.842

M60.849

M60.851

M60.852

M60.859

M60.861

M60.862

M60.869

M60.871

M60.872

M60.879

M60.88

M60.89

M60.9

M79.10

M79.11

M79.12

M79.18

N17.8

N17.9

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 3-23-2022 Effective April 01, 2022

Adopted policy
- WasPreviously policy number I-28 (same title). Policy has preferred products [i.e., Remicade (infliximab), Infliximab, Inflectra (infliximab-dyyb), Renflexis (infliximab-abda)] and non-preferred product Avsola (infliximab-axxq)

Internal Medical Policy Committee 9-28-2022 Effective January 01, 2023

Updated preferred products [i.e., Inflectra (infliximab-dyyb), Renflexis (infliximab-abda)] and
Updated non-preferred products [i.e., Remicade (infliximab), Infliximab, Avsola (infliximab-axxq)]
Removed latent tuberculosis criteria from the policy, and
Updated experimental/investigational statement

Internal Medical Policy Committee 1-26-2023 Effective January 26, 2023

Updated reauthorization criteria to removed 'the requested agent' to change to: The individual has been previously approved for 'infliximab or an infliximab biosimilar' through the Blue Cross Blue Shield of North Dakota's precertification process; and The individual has had clinical benefit with 'infliximab or an infliximab biosimilar'.

Internal Medical Policy Committee 1-16-2024 Effective March 01, 2024

Separating Commercial and Medicaid Expansion into separate policies. Commercial will remain I-9028 and Medicaid Expansion will be ME-I-9028-003
Updated diagnosis code list
Updated agents NOT to be used concomitantly list

Internal Medical Policy Committee 7-16-2024 Effective July 01, 2024

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

Internal Medical Policy Committee 11-19-2024 Effective December 08, 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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