Tocilizumab (Actemra)

Policy ID: I-9005-006

Section: Injections

Effective Date: July 01, 2020

Revised Date: November 13, 2023

Revision Effective Date: January 01, 2024

Last Reviewed: November 15, 2023

Applies To: Commercial Only

Description

Tocilizumab (Actemra®) is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody that works to inhibit IL-6 mediated actions at soluble and membrane bound IL-6 receptors. Inhibiting the signaling pathway can lead to inhibition of activated T- and B-cells, lymphocytes, monocytes, and fibroblasts. Tocilizumab (Actemra) is available as a self-administered subcutaneous injection and as an intravenous infusion.

Tocilizumab (Actemra) and tocilizumab-bavi (Tofidence™) intravenous infusion may be covered under the medical benefit; please refer to pharmacy policies for coverage of tocilizumab (Actemra) self-administered subcutaneous injection.

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.

Tocilizumab (Actemra) intravenous infusion

Tocilizumab (Actemra) intravenous infusion may be considered medically necessary and payable through the medical benefit when an individual meets t he criteria for ANY ONE of the following:

Cytokine Release Syndrome (CRS)

The individual is two (2) years of age and older with severe or life-threatening CRS induced by chimeric antigen receptor T-cell (CAR-T) therapy ; 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 tocilizumab (Actemra) in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors); or
- The individual will be using tocilizumab (Actemra) in combination with another immunomodulatory agent AND BOTH of the following:
  - The prescribing information for tocilizumab (Actemra) 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).

NOTE: If approved, tocilizumab (Actemra) for CRS is approved for a maximum of four (4) doses in one (1) month.

Polyarticular Juvenile Idiopathic Arthritis (PJIA)

The individual has a diagnosis of moderately to severely active PJIA; and
ONE of the following:
- Information has been provided that indicates the individual has been treated with tocilizumab (Actemra) (starting on samples is not approvable) within the past 90 days; or
- The prescriber states the individual has been treated with tocilizumab (Actemra) (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 two (2) years of age or older; or
    - The prescriber has provided information in support of using tocilizumab (Actemra) 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., methotrexate, leflunomide) used in the treatment of PJIA 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 PJIA; or
    - The individual has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of PJIA; 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 PJIA; 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 tocilizumab (Actemra) in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors); or
- The individual will be using tocilizumab (Actemra) in combination with another immunomodulatory agent AND BOTH of the following:
  - The prescribing information for tocilizumab (Actemra) 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).

Rheumatoid Arthritis (RA)

The individual has a diagnosis of moderately to severely active RA; and
ONE of the following:
- Information has been provided that indicates the individual has been treated with tocilizumab (Actemra) (starting on samples is not approvable) within the past 90 days; or
- The prescriber states the individual has been treated with tocilizumab (Actemra) (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 tocilizumab (Actemra) for the individual's age; and
  - ONE of the following:
    - The individual has tried and had an inadequate response to maximally tolerated methotrexate (e.g., titrated to 25 mg weekly) 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 (1) 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 DrugDex with 1 or 2a level of evidence, or NCCN compendium recommended use of 1 or 2a for the treatment of RA; 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 tocilizumab (Actemra) in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors); or
- The individual will be using tocilizumab (Actemra) in combination with another immunomodulatory agent AND BOTH of the following:
  - The prescribing information for tocilizumab (Actemra) 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).

Giant Cell Arteritis (GCA)

The individual has a diagnosis of GCA; and
ONE of the following:
- Information has been provided that indicates the individual has been treated with tocilizumab (Actemra) (starting on samples is not approvable) within the past 90 days; or
- The prescriber states the individual has been treated with tocilizumab (Actemra) (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 tocilizumab (Actemra) for the individual's age; and
  - ONE of the following:
    - The individual has tried and had an inadequate response to systemic corticosteroids (e.g., prednisone, methylprednisolone) used in the treatment of GCA for at least 7-10 days; or
    - The individual has an intolerance or hypersensitivity to systemic corticosteroids used in the treatment of GCA; or
    - The individual has an FDA labeled contraindication to ALL systemic corticosteroids used in the treatment of GCA; 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 GCA; or
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 tocilizumab (Actemra) in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors); or
- The individual will be using tocilizumab (Actemra) in combination with another immunomodulatory agent AND BOTH of the following:
  - The prescribing information for tocilizumab (Actemra) 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 tocilizumab (Actemra); 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 tocilizumab (Actemra); or
- The prescriber has provided information in support of using tocilizumab (Actemra) 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 tocilizumab (Actemra) 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 prescribing information for tocilizumab (Actemra) 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 tocilizumab (Actemra) in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors; or
- The individual will be using tocilizumab (Actemra) in combination with another immunomodulatory agent AND BOTH of the following:

The use of tocilizumab (Actemra) 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

J3262

Reauthorization Criteria

Continuation of therapy with tocilizumab (Actemra) intravenous infusion may be considered medically necessary when the following criteria are met:

The individual has been previously approved for tocilizumab (Actemra) through the Blue Cross Blue Shield of North Dakota's precertification process; and
The individual has had clinical benefit with tocilizumab (Actemra); 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 tocilizumab (Actemra) in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors); or
- The individual will be using tocilizumab (Actemra) in combination with another immunomodulatory agent AND BOTH of the following:
  - The prescribing information for tocilizumab (Actemra) 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).
    
    Note: Tocilizumab (Actemra) intravenous infusion for CRS should always be reviewed under the initial criteria

Procedure Code

J3262

Tocilizumab-bavi (Tofidence™) intravenous infusion

Tocilizumab-bavi (Tofidence) intravenous infusion may be considered medically necessary and payable through the medical benefit when an individual meets t he criteria for ANY ONE of the following:

Rheumatoid Arthritis (RA)

The individual has a diagnosis of moderately to severely active RA; and
ONE of the following:
- Information has been provided that indicates the individual has been treated with tocilizumab-bavi (Tofidence) (starting on samples is not approvable) within the past 90 days; or
- The prescriber states the individual has been treated with tocilizumab-bavi (Tofidence) (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 tocilizumab-bavi (Tofidence) for the individual's age; and
  - ONE of the following:
    - The individual has tried and had an inadequate response to maximally tolerated methotrexate (e.g., titrated to 25 mg weekly) 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 (1) 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 DrugDex with 1 or 2a level of evidence, or NCCN compendium recommended use of 1 or 2a for the treatment of RA; 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 tocilizumab-bavi (Tofidence) in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors); or
- The individual will be using tocilizumab-bavi (Tofidence) in combination with another immunomodulatory agent AND BOTH of the following:
  - The prescribing information for tocilizumab-bavi (Tofidence) 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).

Polyarticular Juvenile Idiopathic Arthritis (PJIA)

The individual has a diagnosis of moderately to severely active PJIA; and
ONE of the following:
- Information has been provided that indicates the individual has been treated with tocilizumab-bavi (Tofidence) (starting on samples is not approvable) within the past 90 days; or
- The prescriber states the individual has been treated with tocilizumab-bavi (Tofidence) (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 two (2) years of age or older; or
    - The prescriber has provided information in support of using tocilizumab-bavi (Tofidence) 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., methotrexate, leflunomide) used in the treatment of PJIA 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 PJIA; or
    - The individual has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of PJIA; 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 PJIA; 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 tocilizumab-bavi (Tofidence) in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors); or
- The individual will be using tocilizumab-bavi (Tofidence) in combination with another immunomodulatory agent AND BOTH of the following:
  - The prescribing information for tocilizumab-bavi (Tofidence) 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 tocilizumab-bavi (Tofidence); 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 tocilizumab-bavi (Tofidence); or
- The prescriber has provided information in support of using tocilizumab-bavi (Tofidence) 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 tocilizumab-bavi (Tofidence) 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 tocilizumab-bavi (Tofidence) in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors; or
- The individual will be using tocilizumab-bavi (Tofidence) in combination with another immunomodulatory agent AND BOTH of the following:
  - The prescribing information for tocilizumab-bavi (Tofidence) 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 tocilizumab-bavi (Tofidence) 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

J3590

Reauthorization Criteria

Continuation of therapy with tocilizumab-bavi (Tofidence) intravenous infusion may be considered medically necessary when the following criteria are met:

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

J3590

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

D89.831

D89.832

D89.833

D89.834

D89.835

D89.839

G92.01

G92.02

G92.03

G92.04

G92.05

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

M05.111

M05.112

M05.121

M05.122

M05.131

M05.132

M05.141

M05.142

M05.151

M05.152

M05.161

M05.162

M05.171

M05.172

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

M05.7A

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

M05.8A

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

M05.9

M06.0A

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

M06.1

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

M06.8A

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

M06.9

M08.0A

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

M08.2A

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

M08.3

M08.4A

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

M08.80

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

M08.9A

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

M31.5

M31.6

R65.10

R65.11

T45.1X5A

T45.1X5D

T45.1X5S

T80.90XA

T80.90XD

T80.90XS

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

Original Effective Date of tocilizumab (Actemra) policy: July 1, 2018

Internal Medical Policy Committee 3-16-2020 - Effective January 01, 2020

Updated preferred products, and
Removed tuberculosis (TB) criteria and made a Note
Added additional Diagnosis codes

Internal Medical Policy Committee 7-22-2020

Updated policy number from I-31 to I-9005, and
Separated out criteria for self-administered subcutaneous injections and intravenous infusion, and
Updated preferred products in subcutaneous injections, and
Removed preferred products from intravenous infusion

Internal Medical Policy Committee 9-21-2020

Added language that self-administered tocilizumab (Actemra) subcutaneous injection will be reviewed under pharmacy policies, and
Removed subcutaneous injection criteria from the policy, and
Updated Diagnosis codes

Internal Medical Policy Committee 3-17-2021

Updated criteria for CRS, PJIA, RA, and SJIA and
Updated reauthorization criteria

Internal Medical Policy Committee 9-21-2021

Added additional diagnosis codes G92.01, G92.02, G92.03, G92.04 and G92.05

Internal Medical Policy Committee 9-28-2022 Annual review, no clinical content change

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

Added criteria for giant cell arteritis (GCA), and
Updated combination therapy criteria, and
Removed latent tuberculosis criteria from the policy, and
Removed FDA labeled contraindications criteria from the policy; and
Added Agents NOT to be used Concomitantly list, and
Updated experimental/investigational statement

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

Added biosimilar tocilizumab-bavi (Tofidence)
Removed Systemic Juvenile Idiopathic Arthritis (SJIA) specific criteria
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-9005-005

Section: Injections

Effective Date: July 01, 2020

Revised Date: November 16, 2022

Revision Effective Date: January 01, 2023

Last Reviewed: November 29, 2022

Archived Date: December 31, 2023

Applies To: Commercial Only

Description

Tocilizumab (Actemra) intravenous infusion may be covered under the medical benefit; please refer to pharmacy policies for coverage of tocilizumab (Actemra) self-administered subcutaneous injection.

Criteria

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

Tocilizumab (Actemra) intravenous infusion

Tocilizumab (Actemra) intravenous infusion may be considered medically necessary and payable through the medical benefit when an individual meets the criteria for ANY ONE of the following:

Cytokine Release Syndrome (CRS)

The individual is two (2) years of age and older with severe or life-threatening CRS induced by chimeric antigen receptor T-cell (CAR-T) therapy; 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 tocilizumab (Actemra) in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors); or
- The individual will be using tocilizumab (Actemra) in combination with another immunomodulatory agent AND BOTH of the following:
  - The prescribing information for tocilizumab (Actemra) 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).

NOTE: If approved, tocilizumab (Actemra) for CRS is approved for a maximum of 4 doses in one month.

Polyarticular Juvenile Idiopathic Arthritis (PJIA)

The individual has a diagnosis of moderately to severely active PJIA; and
ONE of the following:
- Information has been provided that indicates the individual has been treated with tocilizumab (Actemra) (starting on samples is not approvable) within the past 90 days; or
- The prescriber states the individual has been treated with tocilizumab (Actemra) (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 two (2) years of age or older; or
    - The prescriber has provided information in support of using tocilizumab (Actemra) 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., methotrexate, leflunomide) used in the treatment of PJIA 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 PJIA; or
    - The individual has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of PJIA; 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 PJIA; 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 tocilizumab (Actemra) in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors); or
- The individual will be using tocilizumab (Actemra) in combination with another immunomodulatory agent AND BOTH of the following:
  - The prescribing information for tocilizumab (Actemra) 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).

Rheumatoid Arthritis (RA)

The individual has a diagnosis of moderately to severely active RA; and
ONE of the following:
- Information has been provided that indicates the individual has been treated with tocilizumab (Actemra) (starting on samples is not approvable) within the past 90 days; or
- The prescriber states the individual has been treated with tocilizumab (Actemra) (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 tocilizumab (Actemra) for the individual’s age; and
  - ONE of the following:
    - The individual has tried and had an inadequate response to maximally tolerated methotrexate (e.g., titrated to 25 mg weekly) 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 DrugDex with 1 or 2a level of evidence, or NCCN compendium recommended use of 1 or 2a for the treatment of RA; 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 tocilizumab (Actemra) in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors); or
- The individual will be using tocilizumab (Actemra) in combination with another immunomodulatory agent AND BOTH of the following:
  - The prescribing information for tocilizumab (Actemra) 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).

Systemic Juvenile Idiopathic Arthritis (SJIA)

The individual has a diagnosis of active SJIA; and
ONE of the following:
- Information has been provided that indicates the individual has been treated with tocilizumab (Actemra) (starting on samples is not approvable) within the past 90 days; or
- The prescriber states the individual has been treated with tocilizumab (Actemra) (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 two (2) years of age or older; or
    - The prescriber has provided information in support of using tocilizumab (Actemra) for the individual’s age; and
  - ONE of the following:
    - The individual has tried and had an inadequate response to at least ONE NSAID (e.g., ibuprofen, celecoxib) used in the treatment of SJIA for at least one (1)-month; or
    - The individual has an intolerance or hypersensitivity to NSAIDs used in the treatment of SJIA; or
    - The individual has an FDA labeled contraindication to NSAIDs used in the treatment of SJIA; or
    - The individual has tried and had an inadequate response to another conventional agent (i.e., methotrexate, leflunomide, systemic corticosteroids) used in the treatment of SJIA 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 SJIA; or
    - The individual has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of SJIA; 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 SJIA; 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 tocilizumab (Actemra) in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors); or
- The individual will be using tocilizumab (Actemra) in combination with another immunomodulatory agent AND BOTH of the following:
  - The prescribing information for tocilizumab (Actemra) 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).

Giant Cell Arteritis (GCA)

The individual has a diagnosis of GCA; and
ONE of the following:
- Information has been provided that indicates the individual has been treated with tocilizumab (Actemra) (starting on samples is not approvable) within the past 90 days; or
- The prescriber states the individual has been treated with tocilizumab (Actemra) (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 tocilizumab (Actemra) for the individual’s age; and
  - ONE of the following:
    - The individual has tried and had an inadequate response to systemic corticosteroids (e.g., prednisone, methylprednisolone) used in the treatment of GCA for at least 7-10 days; or
    - The individual has an intolerance or hypersensitivity to systemic corticosteroids used in the treatment of GCA; or
    - The individual has an FDA labeled contraindication to ALL systemic corticosteroids used in the treatment of GCA; 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 GCA; or
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 tocilizumab (Actemra) in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors); or
- The individual will be using tocilizumab (Actemra) in combination with another immunomodulatory agent AND BOTH of the following:
  - The prescribing information for tocilizumab (Actemra) 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

Tocilizumab (Actemra) intravenous infusion may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.

Procedure Codes

J3262

Reauthorization Criteria

Continuation of therapy with tocilizumab (Actemra) intravenous infusion may be considered medically necessary when the following criteria are met:

The individual has been previously approved for tocilizumab (Actemra) through the Blue Cross Blue Shield of North Dakota’s precertification process; and
The individual has had clinical benefit with tocilizumab (Actemra); 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 tocilizumab (Actemra) in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors); or
- The individual will be using tocilizumab (Actemra) in combination with another immunomodulatory agent AND BOTH of the following:
  - The prescribing information for tocilizumab (Actemra) 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).
    
    Note: Tocilizumab (Actemra) intravenous infusion for CRS should always be reviewed under the initial criteria

Procedure Codes

J3262

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

D89.831

D89.832

D89.833

D89.834

D89.835

D89.839

G92.01

G92.02

G92.03

G92.04

G92.05

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

M05.111

M05.112

M05.121

M05.122

M05.131

M05.132

M05.141

M05.142

M05.151

M05.152

M05.161

M05.162

M05.171

M05.172

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

M05.7A

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

M05.8A

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

M05.9

M06.0A

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

M06.1

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

M06.8A

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

M06.9

M08.0A

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

M08.2A

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

M08.3

M08.4A

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

M08.80

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

M08.9A

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

M31.5

M31.6

R65.10

R65.11

T45.1X5A

T45.1X5D

T45.1X5S

T80.90XA

T80.90XD

T80.90XS

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

Original Effective Date of tocilizumab (Actemra) policy: July 1, 2018

Internal Medical Policy Committee 3-16-2020 - Effective January 01, 2020

Updated preferred products, and
Removed tuberculosis (TB) criteria and made a Note
Added additional Diagnosis codes

Internal Medical Policy Committee 7-22-2020

Updated policy number from I-31 to I-9005, and
Separated out criteria for self-administered subcutaneous injections and intravenous infusion, and
Updated preferred products in subcutaneous injections, and
Removed preferred products from intravenous infusion

Internal Medical Policy Committee 9-21-2020

Added language that self-administered tocilizumab (Actemra) subcutaneous injection will be reviewed under pharmacy policies, and
Removed subcutaneous injection criteria from the policy, and
Updated Diagnosis codes

Internal Medical Policy Committee 3-17-2021

Updated criteria for CRS, PJIA, RA, and SJIA and
Updated reauthorization criteria

Internal Medical Policy Committee 9-21-2021

Added additional diagnosis codes G92.01, G92.02, G92.03, G92.04 and G92.05

Internal Medical Policy Committee 9-28-2022 Annual review, no clinical content change

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

Added criteria for giant cell arteritis (GCA), and
Updated combination therapy criteria, and
Removed latent tuberculosis criteria from the policy, and
Removed FDA labeled contraindications criteria from the policy; and
Added Agents NOT to be used Concomitantly list, and
Updated experimental/investigational statement

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Tocilizumab (Actemra)

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Tocilizumab (Actemra) intravenous infusion

Giant Cell Arteritis (GCA)

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Professional Statements and Societal Positions Guidelines

ND Committee Review

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Description

Criteria

Systemic Juvenile Idiopathic Arthritis (SJIA)

Giant Cell Arteritis (GCA)

Procedure Codes

Procedure Codes

Diagnosis Codes

Professional Statements and Societal Positions Guidelines

ND Committee Review

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