CurrentAvMedPolicy N/A

Tocilizumab (Actemra) subcutaneous for Systemic Sclerosis-associated Interstitial Lung Disease

Prior authorization and clinical criteria for coverage of self-administered subcutaneous tocilizumab (Actemra SQ) for systemic sclerosis-associated interstitial lung disease (SSc-ILD) for AvMed members; affects prescribing clinicians and specialty pharmacy.

Policy Summary

PayerAvMed

PolicyTocilizumab (Actemra) subcutaneous for SSc-ILD coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed prior authorization with required documentation including prescriber signature, diagnosis, dosing, baseline FVC and DLCO, prior therapy history, and supporting labs/chart notes.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 moinitial authorization duration

12 moreauthorization duration

162 mg wklyrequested dosing

≥55%FVC requirement

>45%DLCO requirement

Coverage Criteria for Actemra (tocilizumab) subcutaneous

Initial Therapy

Covered when ALL of the following are met

Initial therapy criteria: Medication is prescribed by or in consultation with a pulmonology specialist; diagnosis of systemic sclerosis confirmed with ACR/EULAR classification criteria score ≥ 9; onset of disease (first non‑Raynaud symptom) occurred ≤ 5 years ago; member has worsening disease despite concomitant use of low‑dose corticosteroids (eg, prednisone ≤ 10 mg/day) and stable doses of immunosuppressant therapy (eg, mycophenolate, methotrexate, cyclophosphamide); member's baseline percent forced vital capacity (%FVC) is ≥ 55%; member's baseline percent predicted DLCO (corrected for hemoglobin) is > 45%; no concomitant use of nintedanib (OFEV) and pirfenidone (Esbriet).

Initial authorization duration: 12 months

Reauthorization / Continuation Therapy

Reauthorization covered when ALL of the following are met

Reauthorization criteria: Member has experienced disease response as indicated by a reduction in the rate of decline or stabilization in forced vital capacity (%FVC) or percent predicted FVC (ppFVC) compared to pre‑treatment baseline; member does not have evidence of disease progression defined as an absolute decline of more than 10% in percent predicted FVC within any 12‑month period.

Policy Summary

PayerAvMed

PolicyTocilizumab (Actemra) subcutaneous for SSc-ILD coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

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Provider Requirements and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Actemra SQ (tocilizumab) for Systemic Sclerosis-associated Interstitial Lung Disease. Incomplete, incorrect, or illegible information on the prior authorization form can delay or result in denial of the authorization.

Drug Requested: Actemra® SQ (tocilizumab) — Systemic Sclerosis-associated Interstitial Lung Disease
Fax prior authorization form to 1-305-671-0200

Note

Previous Therapy Verification

Use of samples to initiate therapy does not meet step edit/preauthorization criteria. Previous therapies will be verified through pharmacy paid claims or submitted chart notes; documentation of prior treatments should be provided when applicable.

Previous therapy verification may include pharmacy paid claims or submitted chart notes
If drug is non-formulary, documentation of medical necessity will be required

Documentation Required

Required Clinical Documentation

To avoid delays or denial, provide all required supporting documentation for each clinical criterion checked. This includes recent lab results, pulmonary function test results (%FVC, %DLCO), diagnostics, and chart notes demonstrating disease history, specialist consultation, baseline measures, and response to therapy.

Required supporting documents: labs, diagnostics, chart notes, PFT results (%FVC, %DLCO)
Documentation must support specialist involvement, ACR/EULAR classification, disease onset timing, prior/immunosuppressant therapy, and lack of concomitant OFEV/Esbriet use

Denial Risk

Form Completeness and Identifying Information

Prescriber signature and complete member and prescriber identifying information are required. The prescribing physician must sign and clearly print name (preprinted stamps not valid). Missing or incomplete fields (member name, AvMed ID, DOB, prescriber name, prescriber signature, contact phone/fax, DEA or NPI) can delay authorization.

Prescriber signature (hand-signed; stamps not valid) and date
Member name, AvMed number, date of birth
Prescriber name, DEA or NPI, office contact name, phone and fax numbers

Requirement	How verified
Previous therapies must be documented
Verification through pharmacy paid claims or submitted chart notes; samples do not satisfy the requirement

Definitions and Clinical Thresholds

inv-13: ACR/EULAR classification criteria score ≥ 9 — Reference to classification threshold used to confirm systemic sclerosis diagnosis.

DefinitionACR/EULAR classification criteria score ≥ 9 is the threshold used to confirm systemic sclerosis diagnosis for eligibility

Where documentedPrescriber must document ACR/EULAR score in chart notes supplied with prior authorization

Role in criteriaOne of the required elements that must be met for initial coverage approval

inv-14: Percent predicted FVC (%FVC) — Baseline percent forced vital capacity; policy requires %FVC ≥ 55% for initiation.

ThresholdPercent predicted FVC (%FVC) — baseline must be ≥ 55%

UseRequired for initiation of Actemra SQ (tocilizumab) for SSc-ILD

EvidenceSubmit pulmonary function test showing %FVC at baseline with prior authorization request

inv-15: Percent predicted DLCO (%DLCO) — Baseline percent predicted diffusing capacity for carbon monoxide, corrected for hemoglobin; policy requires >45%.

ThresholdPercent predicted DLCO (%DLCO, corrected for hemoglobin) — baseline must be > 45%

UseRequired for initiation of Actemra SQ (tocilizumab) for SSc-ILD

EvidenceSubmit hemoglobin-corrected DLCO value from pulmonary function testing with the PA request

OpenPayer

Tocilizumab (Actemra) subcutaneous for Systemic Sclerosis-associated Interstitial Lung Disease

Coverage Criteria for Actemra (tocilizumab) subcutaneous

Initial Therapy Requirements

Reauthorization / Continuation Criteria

Key Clinical Thresholds and Coding

Provider Requirements and Documentation

Step Therapy and Prior Treatment Requirements

Definitions and Clinical Thresholds

Background

Site of Care and Dispensing