CurrentCommunity Health ChoicePolicy N/A

Tocilizumab Preferred Product Policy

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This Medical Review Guideline governs medical-necessity review and preferred-product requirements for tocilizumab products, including Actemra, Tofidence, Tyenne, and future tocilizumab biosimilars. It is intended for Community Health Choice clinical staff reviewing requests and does not determine member eligibility or benefit coverage.

Policy Summary

PayerCommunity Health Choice

PolicyTocilizumab Preferred Product Policy

Policy CodePolicy N/A

Change TypeInitial version

Effective DateMay 1, 2025

Next Review DateN/A

Key ActionSubmit tocilizumab requests for medical-necessity review; use preferred Tyenne when applicable, and document additional criteria for non-preferred products.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

TyennePreferred product

7Covered indication categories

800 mgMaximum dosage per administration

12 monthsSSc-ILD pulmonary function test lookback

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CurrentCommunity Health ChoicePolicy N/A

Tocilizumab Preferred Product Policy

Customize your policy alerts

Sign up for all communityhealthchoice policy alerts

Know when communityhealthchoice releases new policies or updates existing guidance.

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Policy Summary

PayerCommunity Health Choice

PolicyTocilizumab Preferred Product Policy

Policy CodePolicy N/A

Change TypeInitial version

Effective DateMay 1, 2025

Next Review DateN/A

Key ActionSubmit tocilizumab requests for medical-necessity review; use preferred Tyenne when applicable, and document additional criteria for non-preferred products.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

TyennePreferred product

7Covered indication categories

800 mgMaximum dosage per administration

12 monthsSSc-ILD pulmonary function test lookback

3Clinical diagnosis categories

Coverage Criteria

Preferred Product and Non-Preferred Product Criteria

Coverage is available when the requested product and the applicable diagnosis-specific criteria are satisfied.

ONE of the following product pathways

Preferred product: Tyenne
- Requested product is Tyenne.
- Member meets the applicable tocilizumab diagnosis-specific criteria for the requested indication.
Non-preferred product: Actemra®, Tofidence, or another non-preferred tocilizumab product
- ONE of the following
  - History of a trial of Tyenne resulting in minimal clinical response, and the physician attests that, in the physician's clinical opinion, the clinical response would be superior with the requested non-preferred tocilizumab product than with Tyenne.
  - History of intolerance, contraindication, or adverse event to Tyenne, and the physician attests that, in the physician's clinical opinion, the same intolerance, contraindication, or adverse event would not be expected to occur with the requested non-preferred tocilizumab product.
  - Diagnosis is Cytokine Release Syndrome (CRS); no trial of Tyenne is required, and the non-preferred product Actemra is requested.
- Member has not had a loss of a favorable response after established maintenance therapy with any tocilizumab product.
- Member meets the applicable tocilizumab diagnosis-specific criteria for the requested indication.

Initial Therapy by Indication

Initial therapy is covered when the member meets the criteria for the applicable indication. The required prescriber specialty, diagnostic confirmation, and treatment history are listed below.

ONE indication-specific initial-therapy pathway

Rheumatoid Arthritis (RA)
- Prescribed by a rheumatology specialist.
- Diagnosis of rheumatoid arthritis (RA) is confirmed by a specialist.
- Trial of an adalimumab product (adalimumab-aaty, adalimumab-adaz, adalimumab-fkjp, Hadlima, Simlandi, or Humira) was ineffective, not tolerated, or contraindicated.
Giant Cell Arteritis (GCA)
- Prescribed by, or in consultation with, a rheumatologist.

Continuation Therapy

Continuing therapy is covered when ALL of the following are met:

ALL of the following

Documentation of the diagnosis for which therapy is being requested.
Documentation of improvement in the condition while on therapy.

Tocilizumab will not be used in combination with other biologics for the same indication.

Applicable Codes and Coding Parameters

Applicable HCPCS CodesHCPCSCovered

J3262	Injection, tocilizumab, 1 mg
Q5133	Injection, tocilizumab-bavi (Tofidence), biosimilar, 1 mg
Q5135	Injection, tocilizumab-aazg (Tyenne), biosimilar, 1 mg

Cytokine Release Syndrome Diagnosis CodesICD-10Covered

D89.831	Cytokine release syndrome, grade 1
D89.833	Cytokine release syndrome, grade 3
D89.834	Cytokine release syndrome, grade 4
D89.835	Cytokine release syndrome, grade 5
D89.839	Cytokine release syndrome, grade unspecified

Rheumatoid Arthritis-Related Diagnosis CodesICD-10Covered

M05.20	Rheumatoid vasculitis with rheumatoid arthritis of unspecified site
M05.211	Rheumatoid vasculitis with rheumatoid arthritis of right shoulder
M05.212	Rheumatoid vasculitis with rheumatoid arthritis of left shoulder
M05.219	Rheumatoid vasculitis with rheumatoid arthritis of unspecified shoulder
M05.221	Rheumatoid vasculitis with rheumatoid arthritis of right elbow
M05.222	Rheumatoid vasculitis with rheumatoid arthritis of left elbow
M05.229	Rheumatoid vasculitis with rheumatoid arthritis of unspecified elbow
M05.231	Rheumatoid vasculitis with rheumatoid arthritis of right wrist
M05.232	Rheumatoid vasculitis with rheumatoid arthritis of left wrist
M05.239	Rheumatoid vasculitis with rheumatoid arthritis of unspecified wrist

1–10 of 55

1/6

Rheumatoid arthritis diagnosis codesICD-10

M05.351	Rheumatoid heart disease with rheumatoid arthritis of right hip
M05.352	Rheumatoid heart disease with rheumatoid arthritis of left hip
M05.359	Rheumatoid heart disease with rheumatoid arthritis of unspecified hip
M05.361	Rheumatoid heart disease with rheumatoid arthritis of right knee
M05.362	Rheumatoid heart disease with rheumatoid arthritis of left knee
M05.369	Rheumatoid heart disease with rheumatoid arthritis of unspecified knee
M05.371	Rheumatoid heart disease with rheumatoid arthritis of right ankle and foot
M05.372	Rheumatoid heart disease with rheumatoid arthritis of left ankle and foot
M05.379	Rheumatoid heart disease with rheumatoid arthritis of unspecified ankle and foot
M05.39	Rheumatoid heart disease with rheumatoid arthritis of multiple sites

1–10 of 152

1/16

Rheumatoid arthritis diagnosis codesICD-10Covered

M06.062	Rheumatoid arthritis without rheumatoid factor, left knee
M06.069	Rheumatoid arthritis without rheumatoid factor, unspecified knee
M06.071	Rheumatoid arthritis without rheumatoid factor, right ankle and foot
M06.072	Rheumatoid arthritis without rheumatoid factor, left ankle and foot
M06.079	Rheumatoid arthritis without rheumatoid factor, unspecified ankle and foot
M06.08	Rheumatoid arthritis without rheumatoid factor, vertebrae
M06.09	Rheumatoid arthritis without rheumatoid factor, multiple sites
M06.8A	Other specified rheumatoid arthritis, other specified site
M06.80	Other specified rheumatoid arthritis, unspecified site
M06.811	Other specified rheumatoid arthritis, right shoulder

1–10 of 32

1/4

Juvenile arthritis diagnosis codesICD-10Covered

M08.0A	Unspecified juvenile rheumatoid arthritis, other specified site
M08.00	Unspecified juvenile rheumatoid arthritis of unspecified site
M08.011	Unspecified juvenile rheumatoid arthritis, right shoulder
M08.012	Unspecified juvenile rheumatoid arthritis, left shoulder
M08.019	Unspecified juvenile rheumatoid arthritis, unspecified shoulder
M08.021	Unspecified juvenile rheumatoid arthritis, right elbow
M08.022	Unspecified juvenile rheumatoid arthritis, left elbow
M08.029	Unspecified juvenile rheumatoid arthritis, unspecified elbow
M08.031	Unspecified juvenile rheumatoid arthritis, right wrist
M08.032	Unspecified juvenile rheumatoid arthritis, left wrist

1–10 of 96

1/10

Giant cell arteritis diagnosis codesICD-10Covered

M31.5	Giant cell arteritis with polymyalgia rheumatica
M31.6	Other giant cell arteritis

Maximum Dosage per Administration

J3262 (tocilizumab)Maximum dosage per administration: 800 mg

Q5133 (Tofidence)Maximum dosage per administration: 800 mg

Q5135 (Tyenne)Maximum dosage per administration: 800 mg

SSc-ILD Pulmonary Function Test Lookback

Forced vital capacity (FVC)Must be completed within the past 12 months

Diffusing capacity of the lung for carbon monoxide (DLCO)

Provider Requirements and Review Considerations

Prior Authorization

Prior Authorization Required

Prior authorization is required for tocilizumab therapy. Coverage is available only when the requested treatment is medically necessary and the applicable preferred-product and diagnosis-specific criteria are satisfied.

Tyenne is the preferred tocilizumab product.
Actemra®, Tofidence, and other non-preferred biosimilar products are subject to both preferred-product and diagnosis-specific criteria.

Step Therapy

Rheumatoid Arthritis Adalimumab Step

For initial rheumatoid arthritis therapy, the member must have an appropriate adalimumab product trial that was ineffective, not tolerated, or contraindicated before tocilizumab is covered.

Eligible adalimumab products include adalimumab-aaty, adalimumab-adaz, adalimumab-fkjp, Hadlima, Simlandi, and Humira.
The prescription must be from a rheumatology specialist, and the RA diagnosis must be confirmed by the specialist.

Clinical Background

Tocilizumab is an interleukin-6 receptor antagonist used for inflammatory rheumatologic diseases, systemic sclerosis-associated interstitial lung disease, and cytokine release syndrome. The policy establishes a preferred-product hierarchy and requires indication-specific evidence of diagnosis, specialist involvement, prior therapy, diagnostic testing, or clinical improvement, depending on the requested indication.

Definitions

Products Included as Tocilizumab

ActemraIncluded in the term tocilizumab

Tocilizumab biosimilarsAll tocilizumab biosimilar products are included

Policy applicationThe definition applies to the diagnosis-specific criteria

Preferred and Non-preferred Products

Preferred productTyenne

Non-preferred productsActemra and Tofidence

Other biosimilarsOther biosimilar tocilizumab products are non-preferred

Initial Therapy by Diagnosis

Rheumatoid Arthritis

Initial therapy for rheumatoid arthritis requires ALL of the following.

Rheumatoid arthritis initial therapy

Prescribed by a rheumatology specialist.
Rheumatoid arthritis is confirmed by the specialist.
A trial of an adalimumab product was ineffective, not tolerated, or contraindicated.
Qualifying products include adalimumab-aaty, adalimumab-adaz, adalimumab-fkjp, Hadlima, Simlandi, and Humira.

Giant Cell Arteritis

Initial therapy for giant cell arteritis requires ALL of the following.

Giant cell arteritis initial therapy

Continuation Therapy

Tocilizumab Continuation Therapy

Continuing therapy requires ALL of the following.

Tocilizumab continuation therapy

Documentation of the diagnosis being requested.
Documentation of improvement in the condition while on therapy.

Required Treatment Sequencing

Step	Indication	Required prior therapy	Requirement is satisfied when
1	Rheumatoid arthritis or polyarticular juvenile idiopathic arthritis (PJIA)	Trial of an adalimumab product, including adalimumab-aaty, adalimumab-adaz, adalimumab-fkjp, Hadlima, Simlandi, or Humira	The adalimumab product was ineffective, not tolerated, or contraindicated.

Step	Indication	Required prior therapy	Requirement is satisfied when
1	Systemic sclerosis-associated interstitial lung disease (SSc-ILD)	Mycophenolate	Mycophenolate was ineffective, contraindicated, or not tolerated.

Step	Requested product	Required prior therapy	Exception
1	Non-preferred tocilizumab product, including Actemra, Tofidence, or another non-preferred biosimilar	Trial of preferred Tyenne (tocilizumab-aazg)	The Tyenne trial resulted in minimal clinical response with physician attestation that the response would be superior with the non-preferred product; or Tyenne caused an intolerance, contraindication, or adverse event with physician attestation that the same event would not be expected with the requested product. For cytokine release syndrome, no Tyenne trial is required and non-preferred Actemra is allowed.

Quantity Limits

Covered productsTocilizumab, Actemra, Tofidence, and Tyenne

Maximum dosage per administration800 mg

Future productsThe limit also applies to future biosimilar tocilizumab products

Biosimilar Product Policy

Billing Rule

Use preferred Tyenne when appropriate

Use Tyenne (tocilizumab-aazg) as the preferred tocilizumab product when the member meets the diagnosis-specific criteria.

Tyenne is billed under HCPCS Q5135.

Billing Rule

Apply non-preferred requirements to Tofidence

Tofidence (tocilizumab-bavi) is non-preferred and requires both the preferred-product criteria and the diagnosis-specific criteria.

Tofidence is billed under HCPCS Q5133.
Document the applicable Tyenne exception unless the request is for cytokine release syndrome.

Policy Summary

PayerCommunity Health Choice

PolicyTocilizumab Preferred Product Policy

Policy CodePolicy N/A

Change TypeInitial version

Effective DateMay 1, 2025

Next Review DateN/A

Key ActionSubmit tocilizumab requests for medical-necessity review; use preferred Tyenne when applicable, and document additional criteria for non-preferred products.

SourceLink

On This Page

Diagnosis of GCA is confirmed by ONE of the following

Temporal artery biopsy.
Doppler ultrasound.
Magnetic resonance angiography (MRA).
Positron emission tomography (PET).

Polyarticular Juvenile Idiopathic Arthritis (PJIA)

Prescribed by a rheumatologist.
Diagnosis of PJIA.
Trial of an adalimumab product (adalimumab-aaty, adalimumab-adaz, adalimumab-fkjp, Hadlima, Simlandi, or Humira) was ineffective, not tolerated, or contraindicated.

Systemic Juvenile Idiopathic Arthritis (SJIA) or Adult-Onset Still's Disease (AOSD)

Prescribed by a rheumatologist.
Diagnosis of SJIA or AOSD.

Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD)

Prescribed by a pulmonologist or rheumatologist.
Member has SSc-ILD defined by BOTH of the following
- Systemic sclerosis.
- Interstitial lung disease.
High-resolution computed tomography (HRCT) scan indicates at least ONE of the following
- Reticulation.
- Traction bronchiectasis.
- Traction bronchiolectasis.
- Honeycomb cysts.
- Ground-glass opacities or air-space consolidation.
- Other interstitial lung abnormalities.
- Any recognized pattern of interstitial pneumonias.
BOTH pulmonary function tests have been completed within the past 12 months
- Forced vital capacity (FVC).
- Diffusing capacity of the lung for carbon monoxide (DLCO).
Member is 18 years of age or older.
A trial of mycophenolate was ineffective, contraindicated, or not tolerated.

Cytokine Release Syndrome (CRS)

Diagnosis of cytokine release syndrome.
Member has received ONE of the following
- Chimeric antigen receptor (CAR) T-cell therapy, such as Kymriah, Yescarta, or Breyanzi.
- CD3-directed therapy, such as Blincyto, Tecvayli, or Elrexfio.

Must be completed within the past 12 months

SSc-ILD requirementBoth FVC and DLCO must be completed within the past 12 months

SSc-ILD Minimum Age

Minimum age18 years of age or older

Applicable conditionSystemic sclerosis-associated interstitial lung disease (SSc-ILD)

Therapy stageInitial therapy

Step Therapy

Disease-Specific Prerequisite Therapy

Disease-specific prerequisite therapy must be documented for the applicable indication before initial treatment is authorized.

For PJIA, the member must have a diagnosis of PJIA, treatment prescribed by a rheumatologist, and a trial of an eligible adalimumab product that was ineffective, not tolerated, or contraindicated.
For SSc-ILD, the member must be at least 18 years old, be prescribed therapy by a pulmonologist or rheumatologist, and have an ineffective, contraindicated, or not-tolerated trial of mycophenolate.
SSc-ILD must be documented as systemic sclerosis with interstitial lung disease, with qualifying HRCT findings and both FVC and DLCO completed within the prior 12 months.

Documentation Required

Preferred-Product Exception Documentation

Requests for a non-preferred tocilizumab product must include documentation supporting the Tyenne exception and the prescriber’s clinical rationale.

Document a Tyenne trial resulting in minimal clinical response and the physician’s attestation that the member would have a superior response to the requested non-preferred product; or
Document intolerance, contraindication, or an adverse event with Tyenne and the physician’s attestation that the same problem would not be expected with the requested product.
For cytokine release syndrome, a Tyenne trial is not required; non-preferred Actemra may be allowed.

Documentation Required

Continuation Documentation

Continued therapy requires documentation that the requested diagnosis remains present and that the member has improved on tocilizumab therapy.

Document the diagnosis for which continued treatment is requested.
Document clinical improvement or favorable response on therapy.

Documentation Required

Diagnosis-Specific Clinical Documentation

Submit diagnosis-specific clinical documentation, including the required specialist involvement, confirmed diagnosis, objective findings, and relevant treatment history for the requested indication.

Giant cell arteritis requires prescribing by or consultation with a rheumatologist and confirmation by temporal artery biopsy, Doppler ultrasound, MRA, or PET.
SJIA or AOSD requires rheumatologist prescribing and documentation of the diagnosis.
SSc-ILD requires qualifying HRCT findings, including one or more recognized interstitial lung abnormalities such as reticulation, traction bronchiectasis or bronchiolectasis, honeycomb cysts, ground-glass opacities or consolidation, or a recognized interstitial pneumonia pattern.
Cytokine release syndrome requires documentation of the diagnosis and prior treatment with CAR T-cell therapy or CD3-directed therapy, such as Kymriah, Yescarta, Breyanzi, Blincyto, Tecvayli, or Elrexfio.

Denial Risk

General Denial Risks

Authorization may be denied when the clinical requirements are not met or when continued treatment is not supported by the member’s response and treatment circumstances.

The member must not have lost a favorable response after established maintenance therapy with any tocilizumab product.
Tocilizumab must not be used in combination with another biologic for the same indication.
Requests may be denied when the requested indication-specific criteria, prerequisite therapy, or continuation documentation are not satisfied.

Prior Authorization

Non-Preferred Product Requirements

Non-preferred products require satisfaction of both the preferred-product requirements and the diagnosis-specific criteria. The request must establish why the preferred product is not appropriate or would not provide the expected clinical benefit.

Non-preferred products include Actemra®, Tofidence, and other tocilizumab biosimilars.
Unless the cytokine release syndrome exception applies, document the required Tyenne trial or Tyenne intolerance, contraindication, or adverse event, along with the physician’s clinical attestation.
The requested product must still meet all applicable indication-specific requirements.

Prescribed by, or in consultation with, a rheumatologist.
ONE of
- Giant cell arteritis is confirmed by temporal artery biopsy.
- Giant cell arteritis is confirmed by Doppler ultrasound.
- Giant cell arteritis is confirmed by magnetic resonance angiography (MRA).
- Giant cell arteritis is confirmed by positron emission tomography (PET).

Polyarticular Juvenile Idiopathic Arthritis

Initial therapy for polyarticular juvenile idiopathic arthritis requires ALL of the following.

PJIA initial therapy

Prescribed by a rheumatologist.
The member has a diagnosis of polyarticular juvenile idiopathic arthritis.
A trial of an adalimumab product was ineffective, not tolerated, or contraindicated.
Qualifying products include adalimumab-aaty, adalimumab-adaz, adalimumab-fkjp, Hadlima, Simlandi, and Humira.

Systemic Juvenile Idiopathic Arthritis and Adult-Onset Still's Disease

Initial therapy for systemic juvenile idiopathic arthritis and adult-onset Still's disease requires ALL of the following.

SJIA or AOSD initial therapy

Prescribed by a rheumatologist.
The member has a diagnosis of systemic juvenile idiopathic arthritis or adult-onset Still's disease.

Systemic Sclerosis-Associated Interstitial Lung Disease

Initial therapy for systemic sclerosis-associated interstitial lung disease requires ALL of the following.

SSc-ILD initial therapy

Prescribed by a pulmonologist or rheumatologist.
Both diagnoses are present
- The member has systemic sclerosis.
- The member has interstitial lung disease.
At least ONE HRCT finding
- Reticulation.
- Traction bronchiectasis.
- Traction bronchiolectasis.
- Honeycomb cysts.
- Ground-glass opacities or air-space consolidation.
- Other interstitial lung abnormalities.
- A recognized pattern of interstitial pneumonias.
Both pulmonary function tests completed within the past 12 months
- Forced vital capacity (FVC) has been completed within the past 12 months.Within the past 12 months
- Diffusing capacity of the lung for carbon monoxide (DLCO) has been completed within the past 12 months.Within the past 12 months
The member is 18 years of age or older.>= 18 years
A trial of mycophenolate was ineffective, contraindicated, or not tolerated.

Billing Rule

Include future tocilizumab biosimilars

Apply this policy to future biosimilar tocilizumab products in addition to the products currently named in the policy.

The listed products include tocilizumab, Actemra, Tofidence, and Tyenne.
The maximum dosage per administration for the listed HCPCS products is 800 mg.