CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Tocilizumab (Tyenne) subcutaneous — coverage criteria

Defines medical necessity criteria, dosing, quantity limits, and continuation requirements for Tyenne (tocilizumab) subcutaneous for multiple indications (RA, JIA, NMOSD, GCA, SSc-ILD) for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTocilizumab (Tyenne) subcutaneous — coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization with documentation of indication-specific criteria, dosing, and quantity limits (use HCPCS Q5133 or Q5135 where applicable).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial coverage duration

6 monthsRenewal coverage duration

18 monthsMax renewal for GCA

162 mgAvailable strength

4/28 daysQuantity limit

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Medical Necessity and Coverage Criteria

inv-01: Initial Therapy

Covered when ALL of the following are met for initial therapy:

General initial criteria

RA specific: Patient is ≥18 years; baseline disease severity documented with an objective measure; documented moderate to severe active disease; at least a 3-month trial and failure of one csDMARD (e.g., methotrexate, azathioprine, hydroxychloroquine, sulfasalazine, leflunomide) AND inadequate response/intolerance/contraindication to at least a 3-month trial of adalimumab at maximum tolerated doses OR documentation patient is already established on biologic or targeted synthetic therapy; may be used as single agent or in combination with csDMARD
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JIA (sJIA/pJIA) specific: Patient is ≥2 years; baseline disease severity documented with an objective measure; active sJIA or pJIA; at least a 1-month trial and failure (unless contraindicated/intolerant) of NSAID OR csDMARD (e.g., methotrexate, hydroxychloroquine, leflunomide, sulfasalazine) AND inadequate response/intolerance/contraindication to at least a 3-month trial of adalimumab at maximum tolerated doses OR documentation patient is already established on biologic or targeted synthetic therapy; may be used alone or with methotrexate
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NMOSD specific: Confirmed diagnosis: either AQP4-IgG seropositive with ≥1 core clinical characteristic and exclusion of alternative diagnoses OR seronegative/unknown AQP4-IgG with ≥2 core clinical characteristics from one or more attacks (with at least one being acute optic neuritis, acute myelitis, or area postrema syndrome) plus fulfillment of typical MRI findings; alternative diagnoses excluded; may be used alone or with other immunosuppressive therapy (e.g., azathioprine, methotrexate, mycophenolate)
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GCA specific: Large-vessel arteritis verified by biopsy or imaging (CDUS, MRI, PET-CT, or CT angiography); active disease with elevated CRP and/or ESR; inadequate response/contraindication/intolerance to glucocorticoid therapy alone; used in combination with a tapering course of glucocorticoids (tocilizumab may be used alone after discontinuation of glucocorticoids)
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SSc-ILD specific: Confirmed systemic sclerosis with ACR/EULAR classification score ≥9; disease onset (first non-Raynaud symptom) ≤5 years; baseline percent predicted FVC (%FVC) >55%; tocilizumab will not be used in combination with other SSc-ILD treatment modalities (e.g., nintedanib, pirfenidone, rituximab, cyclophosphamide, mycophenolate mofetil)
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Administration/dosing: Dosing varies by indication and weight; Tyenne 162 mg subcutaneous formulation available with indication-specific schedules (see dosing/administration table)

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inv-02: Continuation Therapy

Continuation/renewal covered when ALL of the following are met:

General continuation criteria: Patient continues to meet all initial therapy criteria; AND absence of unacceptable toxicity from the drug (examples: serious infection, severe neutropenia, severe thrombocytopenia, severe hepatotoxicity, gastrointestinal perforation, immunosuppression, severe hypersensitivity, demyelinating disorders)

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RA response criteria: Documentation of disease response compared to baseline such as improvement in tender/swollen joint counts, reduction in C-reactive protein, improvement in patient global assessment, and/or improvement on a disease activity scoring tool (e.g., DAS28 improvement ≥1.2 points, ≥20% ACR20, or improvement on RAPID3)

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JIA response criteria: Documentation of disease response compared to baseline such as improvement in tender/swollen joint counts, reduction in C-reactive protein, improvement in patient global assessment, and/or improvement on a disease activity scoring tool (e.g., JADAS or ACR‑Pedi30 with ≥30% improvement in 3 of 6 variables)

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For the indication of systemic sclerosis-associated interstitial lung disease (SSc-ILD), therapy with Tyenne (tocilizumab) must not be combined with certain other SSc-ILD treatment modalities. The policy explicitly restricts concurrent use with agents such as nintedanib (Ofev), pirfenidone (Esbriet), rituximab, cyclophosphamide, and mycophenolate mofetil. In addition to this combination exclusion, members must meet the SSc-ILD–specific entry requirements including a confirmed systemic sclerosis diagnosis with an ACR/EULAR score ≥ 9, disease onset ≤ 5 years from first non‑Raynaud symptom, and a documented baseline %FVC > 55%.

Use of Tyenne (tocilizumab) for SSc-ILD is prohibited in combination with specified therapies listed in the exclusions. Examples called out in the policy include anti-fibrotic agents and other immunomodulators such as Ofev (nintedanib), Esbriet (pirfenidone), rituximab, cyclophosphamide, and mycophenolate mofetil. Concurrent administration with these agents is considered outside the stated coverage.

Billing and Code Information

HCPCS/CPT CodesHCPCS

Q5133	Injection, tocilizumab-bavi (tofidence), biosimilar, 1 mg
Q5135	Injection, tocilizumab-aazg (tyenne), biosimilar, 1 mg

%FVC baseline

Baseline %FVC requirement> 55%

Assessment timingDocument baseline percent predicted FVC prior to initiation

Disease contextApplies to systemic sclerosis-associated interstitial lung disease (SSc-ILD)

Related exclusionNot to be used in combination with select other SSc-ILD therapies (e.g., nintedanib, pirfenidone, rituximab, cyclophosphamide, mycophenolate)

Disease duration constraintOnset of disease (first non‑Raynaud symptom) ≤ 5 years is required

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for tocilizumab and biosimilars. Include indication-specific criteria, dosing, quantity limits, and HCPCS codes in the request.

Prior authorization required; submit indication, dosing, and requested quantity
Include HCPCS codes: Q5133, Q5135

Step Therapy

Step Therapy Requirements for Arthritis Indications

For arthritis indications (RA, polyarticular JIA, systemic JIA), step therapy requires documentation of prior trials and failures as specified below.

Rheumatoid arthritis: ≥ 3-month trial and inadequate response, intolerance, or contraindication to ONE csDMARD (e.g., methotrexate, azathioprine, hydroxychloroquine, sulfasalazine, leflunomide) AND inadequate response, intolerance, or contraindication to a ≥3-month trial of adalimumab at maximum tolerated doses; OR patient already established on biologic/targeted synthetic therapy
Juvenile idiopathic arthritis (pJIA/sJIA): ≥1-month trial and failure of NSAIDs OR csDMARDs (unless contraindicated/intolerant) AND inadequate response, intolerance, or contraindication to a ≥3-month trial of adalimumab at maximum tolerated doses

Clinical Background

Tocilizumab is a monoclonal antibody that targets the interleukin-6 (IL-6) receptor, inhibiting IL-6 mediated proinflammatory signaling. It is indicated in multiple inflammatory conditions addressed by this policy and is available as the subcutaneous formulation Tyenne (162 mg pen/syringe). Prior to initiation, patients must be screened for latent tuberculosis and have no active clinically important infection; the drug must not be given concurrently with live vaccines or other biologic or targeted synthetic therapies. Dosing and administration vary by indication and weight, and are detailed in the dosing table and quantity‑limit sections of the policy.

Definitions and Key Clinical Concepts

Core clinical characteristics of NMOSD

Optic neuritisAcute optic neuritis

MyelitisAcute myelitis

Area postrema syndrome (APS)Episode of unexplained hiccups and/or nausea and vomiting lasting ≥48 hours or with MRI dorsal brainstem lesion

Brainstem syndromesAcute brainstem syndrome other than APS

Diencephalic and cerebral syndromesSymptomatic narcolepsy/acute diencephalic syndrome with typical MRI lesions, or acute cerebral syndrome with NMOSD‑typical brain lesions on MRI

References (policy sources)

Policy Revision History

2024-11section_reviewLatest

Policy references section reviewed in November 2024; reference list updated to include Tyenne (March 2024) and other sources.

2022-12reference_added

Actemra (tocilizumab) package insert (Genentech) dated December 2022 cited in references.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTocilizumab (Tyenne) subcutaneous — coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization with documentation of indication-specific criteria, dosing, and quantity limits (use HCPCS Q5133 or Q5135 where applicable).

SourceLink

On This Page

NMOSD response criteria: Documentation of stabilization or improvement such as decreased acute relapses, reduced hospitalizations, reduction/discontinuation of plasma exchange treatments, and/or reduction/discontinuation of corticosteroids without relapse

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GCA response criteria: Documentation of improvement in signs and symptoms compared to baseline (e.g., headache, temporal artery tenderness, visual symptoms), improvement in inflammatory markers (ESR, CRP), and improvement on periodic imaging studies (CDUS, MRI, PET‑CT, or CT angiography)

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SSc-ILD response criteria: Documentation of reduction in the rate of decline or stabilization in %FVC or percent-predicted FVC compared to pre-treatment baseline; AND no evidence of progression defined as an absolute decline >10% in percent‑predicted FVC within any 12‑month period

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Documentation Required

Required Documentation

Documentation must confirm diagnosis, baseline disease severity, prior treatment history, and other supporting information as applicable to the indication.

Diagnosis confirmation and objective baseline disease severity measure/tool
Documentation of prior therapies, duration of trials, and reasons for failure/intolerance/contraindication
For NMOSD, documentation of AQP4-IgG status and core clinical characteristics; for GCA, biopsy or large-vessel imaging and elevated CRP/ESR; for SSc-ILD, ACR/EULAR score and baseline %FVC

Denial Risk

Triggers for Denial

Therapy must not be initiated if the patient has an active infection, has not been screened for latent TB, is receiving concurrent biologic or targeted synthetic therapy, or is scheduled to receive live vaccines concurrently.

Active infection or clinically important localized infection — denial risk
No documented latent TB screening prior to initiation — denial risk
Concurrent use with another biologic (e.g., IL-inhibitor, TNF inhibitor, integrin antagonist, T cell costimulation modulator) or targeted synthetic therapy (e.g., apremilast, abrocitinib, tofacitinib, upadacitinib, ruxolitinib, etrasimod) — denial risk
Concurrent administration with live vaccines — denial risk

Note

Prior Authorization — References Only

No separate prior authorization process details are specified in the references-only section; this section is informational and does not replace the formal PA submission requirements.

References section provides bibliographic sources but does not list submission requirements or operational PA instructions

Billing Rule

Prior Authorization and Coding

Quantity limits and coding must be documented with the PA request to support dispensing limits and billing.

Quantity limit: Tyenne 162 mg — 4 syringes/pens per 28 days
Include HCPCS codes with request: Q5133 (tocilizumab-bavi), Q5135 (tocilizumab-aazg)

Note

References (Informational)

This section contains bibliographic citations for guidance and background; these references do not themselves establish authorization or denial criteria.

Bibliographic references are provided for clinical context only
References do not replace required clinical documentation or PA criteria

Note

Step Therapy — References Only

No separate step therapy program requirements beyond the indication-specific trials/failures described for arthritis indications are specified in the references-only portion of the policy.

If step therapy applies, it is detailed under the specific arthritis indication criteria above
References section does not describe additional step therapy requirements

Documentation Required

Operational Submission Checklist

Ensure PA requests include: indication, relevant objective baseline severity measures, prior treatment history (including durations and reasons for discontinuation), latent TB screening results, vaccination status regarding live vaccines, requested dosing schedule, and HCPCS code(s).

Required for PA: indication, baseline severity tool, prior therapy trials and outcomes, TB screen, live vaccine status, dosing and quantity, HCPCS code(s) (Q5133/Q5135)
Coverage durations: Initial 6 months; renewals 6 months (GCA up to 18 months)
Dosing and quantity limits per indication as specified in dosing/administration and quantity limit sections

Tyenne (tocilizumab) package insert

Tyenne [package insert]. Lake Zurich, IL; Fresenius Kabi USA, LLC; March 2024

Actemra (tocilizumab) package insertActemra [package insert]. Genentech, Inc; December 2022

ACR RA guidelineSingh JA et al., 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis

TANGO trial (NMOSD)Zhang C et al., TANGO study: tocilizumab vs azathioprine in relapsing NMOSD (Lancet Neurol. 2020)

focuSSced and SSc evidenceKhanna D et al., focuSSced (tocilizumab in systemic sclerosis); Khanna et al. 2020 Lancet Respir Med