IL-1 and IL-1b Blockers

Policy ID: I-9210-003

Section: Injections

Effective Date: January 01, 2022

Revised Date: November 14, 2023

Revision Effective Date: January 01, 2024

Last Reviewed: November 15, 2023

Applies To: Commercial Only

Description

Rilonacept (Arcalyst) is a dimeric fusion protein consisting of the ligand-binding domains of the extracellular portions of the human interleukin-1 receptor component (IL-1RI) and IL-1 receptor accessory protein (IL-1RAcP) linked in-line to the Fc portion of human IgG1. Rilonacept (Arcalyst) blocks IL-1b signaling by acting as a soluble decoy receptor that binds IL-1b and prevents its interaction with cell surface receptors. Rilonacept (Arcalyst) also binds IL-1 and IL-1 receptor antagonist (IL-1ra) with reduced affinity.

Canakinumab (Ilaris(R)) is a recombinant, human anti-human-IL-1b monoclonal antibody that belongs to the IgG1/K isotype subclass. Canakinumab (Ilaris) binds to human IL-1b and neutralizes its activity by blocking its interaction with IL-1 receptors, but it does not bind IL-1a or IL-1 receptor antagonist (IL-1ra).

Note: Canakinumab (Ilaris) may be covered under the medical benefit. Rilonacept (Arcalyst) may be covered under the pharmacy benefit.

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.

Canakinumab (Ilaris ) may be considered medically necessary when ALL of the following are met:

ONE of the following:
- Information has been provided that indicates the individual has been treated with canakinumab (Ilaris) (starting on samples is not approvable) within the last 90 days; or
- The prescriber states that the individual has been treated with canakinumab (Ilaris) (starting on samples is not approvable) within the past 90 days and is at risk if therapy is changed; or
- ONE of the following:
  - BOTH of the following:
    1. The individual has one of the following indications:
      1. Cryopyrin Associated Periodic Syndrome (CAPS); or
      2. Familial Cold Auto-Inflammatory Syndrome (FCAS); or
      3. Muckle-Wells Syndrome (MWS); and
    2. BOTH of the following:
      1. The individual has elevated pretreatment serum inflammatory markers (C-reactive protein/serum amyloid A); and
      2. The individual has at least TWO symptoms typical for CAPS (i.e., urticaria-like rash, Cold/stress triggered episodes, Sensorineural hearing loss, Musculoskeletal symptoms of arthralgia/arthritis/myalgia, Chronic aseptic meningitis, Skeletal abnormalities of epiphyseal overgrowth/frontal bossing); or
  - The individual has a diagnosis of Familial Mediterranean Fever (FMF) ANDONE of the following:
    1. The individual has tried and had an inadequate response to colchicine for at least six (6) months; or
    2. The individual has an intolerance or hypersensitivity to colchicine; or
    3. The individual has an FDA labeled contraindication to colchicine; or
  - BOTH of the following:
    - The individual has a diagnosis of Hyperimmunoglobulin D Syndrome (HIDS) or Mevalonate Kinase Deficiency (MKD); and
    - The individual's diagnosis was confirmed via genetic testing for mutations in the mevalonate kinase (MVK) gene; or
  - BOTH of the following:
    - The individual has a diagnosis of Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS); and
    - The individual's diagnosis was confirmed via genetic testing for mutations in the TNFR1 gene; or
  - The individual has a diagnosis of Active systemic juvenile idiopathic arthritis (SJIA) ANDBOTH of the following:
    1. The individual has documented active systemic features (e.g., ongoing fever for at least two (2) weeks, evanescent erythematous rash, generalized lymphadenopathy, greater than or equal to one (1) joint with active arthritis, hepatomegaly, splenomegaly, serositis); and
    2. ONE of the following:
      1. The individual has tried and had an inadequate response to TWO of the following drug classes:
        
        DMARDs (i.e., methotrexate, leflunomide) for at least a three (3)-month trial; or
        Systemic glucocorticoids (oral or IV) for at least a three (3)-month trial; or
        NSAIDs for at least a one (1)-month trial; or
      2. The individual has an intolerance or hypersensitivity to TWO of the prerequisite drug classes; or
      3. The individual has an FDA labeled contraindication to ALL prerequisite agents; or
      4. 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 for the treatment of SJIA; or
  - The individual has a diagnosis of Adult onset Still's disease and BOTH of the following:
    - ONE of the following:
      - The individual has tried and had an inadequate response to at least ONE corticosteroid; or
      - The individual has an intolerance or hypersensitivity to ONE corticosteroid; or
      - The individual has an FDA labeled contraindication to ALL corticosteroids; and
    - ONE of the following:
      1. The individual has tried and had an inadequate response to methotrexate; or
      2. The individual has an intolerance or hypersensitivity to methotrexate; or
      3. The individual has an FDA labeled contraindication to methotrexate; or
  - The individual has another FDA approved indication for c anakinumab (Ilaris); or
  - The individual has another indication that is supported in compendia for c anakinumab (Ilaris) ; and
If the individual has an FDA approved indication, ONE of the following:
- The individual's age is within FDA labeling for the requested indication for c anakinumab (Ilaris); or
- The prescriber has provided information in support of using c anakinumab (Ilaris) for the individual's age for the requested indication; and
The prescriber is a specialist in the area of the individual's diagnosis (e.g., allergist, immunologist, pediatrician, rheumatologist) 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 c anakinumab (Ilaris) in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors); or
- The individual will be using c anakinumab (Ilaris ) in combination with another immunomodulatory agent AND BOTH of the following:
  - The prescribing information for c anakinumab (Ilaris ) 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 canakinumab (Ilaris) f or 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

J0638

Reauthorization Criteria

Canakinumab (Ilaris) may be considered medically necessary when ALL of the following are met:

The individual has been previously approved for c anakinumab (Ilaris) through Blue Cross Blue Shield of North Dakota's precertification process; and
The individual has had clinical benefit with c anakinumab (Ilaris ); and
The prescriber is a specialist in area of the individual's diagnosis (e.g., allergist, immunologist, pediatrician, rheumatologist) 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 c anakinumab (Ilaris) in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors); or
- The individual will be using c anakinumab (Ilaris ) in combination with another immunomodulatory agent AND BOTH of the following:
  - The prescribing information for c anakinumab (Ilaris ) 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 canakinumab (Ilaris)f or 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

J0638

Rilonacept (Arcalyst) may be covered under the pharmacy benefit.

Procedure Code

J2793

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.

Diagnosis Codes

Covered Diagnosis Codes for Procedure Code J0638

L50.2

M04.1

M04.2

M06.1

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

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)

Sotyktu (deucravacitinib)

Stelara (ustekinumab)

Taltz (ixekizumab)

Tezspire (tezepelumab-ekko)

Tremfya (guselkumab)

Truxima (rituximab-abbs)

Tysabri (natalizumab)

Xeljanz (tofacitinib)

Xeljanz XR (tofacitinib extended release)

Xolair (omalizumab)

Zeposia (ozanimod)

ND Committee Review

Internal Medical Policy Committee 11-23-2021 Effective 1-1-2022

Adopted new medical precertification policy for canakinumab (Ilaris) which was previously reviewed through the pharmacy benefit.

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

Updated combination therapy criteria, and
Updated FDA approved and compendia supported criteria, 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

Updated HIDS, MKD and TRAPS 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-9210-002

Section: Injections

Effective Date: January 01, 2022

Revised Date: November 23, 2022

Revision Effective Date: January 01, 2023

Last Reviewed: November 29, 2022

Archived Date: December 31, 2023

Applies To: Commercial Only

Description

Note: Canakinumab (Ilaris) may be covered under the medical benefit. Rilonacept (Arcalyst) may be covered under the pharmacy benefit.

Criteria

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

Canakinumab (Ilaris) may be considered medically necessary when ALL of the following are met:

ONE of the following:
- Information has been provided that indicates the individual has been treated with canakinumab (Ilaris) (starting on samples is not approvable) within the last 90 days; or
- The prescriber states that the individual has been treated with canakinumab (Ilaris) (starting on samples is not approvable) within the past 90 days and is at risk if therapy is changed; or
- ONE of the following:
  - BOTH of the following:
    - The individual has one of the following indications:
      - Cryopyrin Associated Periodic Syndrome (CAPS); or
      - Familial Cold Auto-Inflammatory Syndrome (FCAS); or
      - Muckle-Wells Syndrome (MWS); and
    - BOTH of the following:
      - The individual has elevated pretreatment serum inflammatory markers (C-reactive protein/serum amyloid A); and
      - The individual has at least TWO symptoms typical for CAPS (i.e., urticaria-like rash, Cold/stress triggered episodes, Sensorineural hearing loss, Musculoskeletal symptoms of arthralgia/arthritis/myalgia, Chronic aseptic meningitis, Skeletal abnormalities of epiphyseal overgrowth/frontal bossing); or
  - The individual has a diagnosis of Familial Mediterranean Fever (FMF) AND ONE of the following:
    - The individual has tried and had an inadequate response to colchicine for at least six (6) months; or
    - The individual has an intolerance or hypersensitivity to colchicine; or
    - The individual has an FDA labeled contraindication to colchicine; or
  - The individual has a diagnosis of Hyperimmunoglobulin D Syndrome (HIDS) or Mevalonate Kinase Deficiency (MKD); or
  - The individual has a diagnosis of Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS); or
  - The individual has a diagnosis of Active systemic juvenile idiopathic arthritis (SJIA) AND BOTH of the following:
    - The individual has documented active systemic features (e.g., ongoing fever for at least two (2) weeks, evanescent erythematous rash, generalized lymphadenopathy, greater than or equal to one (1) joint with active arthritis, hepatomegaly, splenomegaly, serositis); and
    - ONE of the following:
      - The individual has tried and had an inadequate response to TWO of the following drug classes:
        
        DMARDs (i.e., methotrexate, leflunomide) for at least a three (3)-month trial; or
        Systemic glucocorticoids (oral or IV) for at least a three (3)-month trial; or
        NSAIDs for at least a 1-month trial; or
      - The individual has an intolerance or hypersensitivity to TWO of the prerequisite drug classes; or
      - The individual has an FDA labeled contraindication to ALL prerequisite agents; 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 for the treatment of SJIA; or
  - The individual has a diagnosis of Adult onset Still’s disease and BOTH of the following:
    - ONE of the following:
      - The individual has tried and had an inadequate response to at least ONE corticosteroid; or
      - The individual has an intolerance or hypersensitivity to ONE corticosteroid; or
      - The individual has an FDA labeled contraindication to ALL corticosteroids; and
    - ONE of the following:
      - The individual has tried and had an inadequate response to methotrexate; or
      - The individual has an intolerance or hypersensitivity to methotrexate; or
      - The individual has an FDA labeled contraindication to methotrexate; or
  - The individual has another FDA approved indication for canakinumab (Ilaris); or
  - The individual has another indication that is supported in compendia for canakinumab (Ilaris); and
ONE of the following:
- The individual's age is within FDA labeling for the requested indication for canakinumab (Ilaris); or
- The prescriber has provided information in support of using canakinumab (Ilaris) for the individual’s age for the requested indication; and
The prescriber is a specialist in the area of the individual’s diagnosis (e.g., allergist, immunologist, pediatrician, rheumatologist) 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 canakinumab (Ilaris) in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors); or
- The individual will be using canakinumab (Ilaris) in combination with another immunomodulatory agent AND BOTH of the following:
  - The prescribing information for canakinumab (Ilaris) 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 canakinumab (Ilaris) 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

J0638

Reauthorization Criteria

Canakinumab (Ilaris) may be considered medically necessary when ALL of the following are met:

The individual has been previously approved for canakinumab (Ilaris) through Blue Cross Blue Shield of North Dakota's precertification process; and
The individual has had clinical benefit with canakinumab (Ilaris); and
The prescriber is a specialist in area of the individual’s diagnosis (e.g., allergist, immunologist, pediatrician, rheumatologist) 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 canakinumab (Ilaris) in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors); or
- The individual will be using canakinumab (Ilaris) in combination with another immunomodulatory agent AND BOTH of the following:
  - The prescribing information for canakinumab (Ilaris) 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 canakinumab (Ilaris) 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

J0638

Rilonacept (Arcalyst) may be covered under the pharmacy benefit.

Procedure Codes

J2793

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.

NOTE: Compendia allowed are DrugDex 1 or 2a level of evidence.

Diagnosis Codes

Covered Diagnosis Codes for Procedure Code J0638

L50.2

M04.1

M04.2

M06.1

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

Professional Statements and Societal Positions Guidelines

Agents NOT to be used Concomitantly (subject to change)

Adbry (tralokinumab-ldrm)

Actemra (tocilizumab)

Arcalyst (rilonacept)

Avsola (infliximab-axxq)

Benlysta (belimumab)

Cibinqo (abrocitinib)

Cimzia (certolizumab)

Cinqair (reslizumab)

Cosentyx (secukinumab)

Dupixent (dupilumab)

Enbrel (etanercept)

Entyvio (vedolizumab)

Fasenra (benralizumab)

Humira (adalimumab)

Ilaris (canakinumab)

Ilumya (tildrakizumab-asmn)

Inflectra (infliximab-dyyb)

Infliximab

Kevzara (sarilumab)

Kineret (anakinra)

Nucala (mepolizumab)

Olumiant (baricitinib)

Opzelura (ruxolitinib)

Orencia (abatacept)

Otezla (apremilast)

Remicade (infliximab)

Renflexis (infliximab-abda)

Riabni (rituximab-arrx)

Rinvoq (upadacitinib)

Rituxan (rituximab)

Rituxan Hycela (rituximab/hyaluronidase human)

Ruxience (rituximab-pvvr)

Siliq (brodalumab)

Simponi (golimumab)

Simponi ARIA (golimumab)

Skyrizi (risankizumab-rzaa)

Stelara (ustekinumab)

Taltz (ixekizumab)

Tezspire (tezepelumab-ekko)

Tremfya (guselkumab)

Truxima (rituximab-abbs)

Tysabri (natalizumab)

Xeljanz (tofacitinib)

Xeljanz XR (tofacitinib extended release)

Xolair (omalizumab)

Zeposia (ozanimod)

ND Committee Review

Internal Medical Policy Committee 11-23-2021 Effective 1-1-2022

Adopted new medical precertification policy for canakinumab (Ilaris) which was previously reviewed through the pharmacy benefit.

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

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

Links

References (PDF)

Disclaimer

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Medical Policies Quick Search

IL-1 and IL-1b Blockers

Description

Criteria

Procedure Code

Procedure Code

Procedure Code

Diagnosis Codes

Covered Diagnosis Codes for Procedure Code J0638

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer

Description

Criteria

Procedure Codes

Procedure Codes

Procedure Codes

Diagnosis Codes

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer