CurrentCignaPolicy N/A

Vasculitis - Tavneos Prior Authorization Policy

Defines Cigna's prior authorization requirements for coverage of Tavneos (avacopan) for adults with ANCA-associated vasculitis and who may prescribe it, including initial and continuation approvals and noncovered uses.

Policy Summary

PayerCigna

PolicyVasculitis - Tavneos Prior Authorization Policy

Policy CodePolicy N/A

Change TypeClarified / Added examples

Effective DateN/A

Next Review DateJul 9, 2025

Key ActionSubmit prior authorization requests showing patient is ≥18 with GPA or MPA, active disease, ANCA positivity, and concomitant nonglucocorticoid immunosuppressant use.

SourceLink

POLICY UPDATE CHANGES

The requirement for use of Tavneos in combination with an immunosuppressant was clarified to 'nonglucocorticoid' immunosuppressant for ANCA-associated vasculitis.

Cyclophosphamide was added as an example of a nonglucocorticoid immunosuppressant.

Pulmonologist was added to the list of accepted specialists who may prescribe Tavneos.

≥18minimum patient age for coverage

6 monthsinitial approval duration

1 yearcontinuation approval

EGPAexplicit noncovered condition

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Coverage Criteria for Tavneos (avacopan)

Initial Therapy

Covered when ALL of the following are met for initial therapy (approve for 6 months):

Initial Therapy (A)

Patient is ≥ 18 years of age;
Patient has granulomatosis with polyangiitis or microscopic polyangiitis;
Patient has active disease (newly diagnosed or relapsed; not in remission);
Patient is positive for proteinase 3 antibodies, myeloperoxidase antibodies, or anti-neutrophil cytoplasmic autoantibody (ANCA);
Patient is using this medication in combination with at least one nonglucocorticoid immunosuppressant for ANCA-associated vasculitis.
Examples of nonglucocorticoid immunosuppressants include rituximab, cyclophosphamide, methotrexate, azathioprine, and mycophenolate mofetil.
Medication is prescribed by or in consultation with a rheumatologist, nephrologist, pulmonologist, or immunologist.

Tavneos (avacopan) is not medically necessary for any use outside of the specified indications in this policy. Specifically, treatment of eosinophilic granulomatosis with polyangiitis (EGPA) is excluded and requests for Tavneos for EGPA will be denied.

Use of Tavneos for EGPA (Churg–Strauss syndrome) is not supported by available evidence. The policy notes there are no data evaluating Tavneos for EGPA, and patients with EGPA were excluded from the pivotal clinical trial; therefore Tavneos is considered not medically necessary for this condition.

Coding and Approval Durations

Coding guidancemixed

affected codes

Document references that providers must use the most appropriate codes; specific CPT/HCPCS/NDC codes for Tavneos are not listed in this policy text.

inv-06: Initial therapy approval duration — 6 months

Approval durationInitial therapy approvals are for 6 months when the patient meets all initial therapy criteria (see policy).

Applicable populationAdults (≥ 18 years) meeting all Initial Therapy criteria for ANCA-associated vasculitis (GPA or MPA).

Condition for approvalPatient must have active (newly diagnosed or relapsed) disease, not in remission.

Concomitant therapy requirementMedication must be used in combination with at least one nonglucocorticoid immunosuppressant for ANCA-associated vasculitis.

inv-07: Continuation therapy approval duration — 1 year

Approval durationContinuation therapy approvals for patients currently receiving Tavneos are for 1 year when continuation criteria are met.

Prior Authorization, Documentation, and Provider Guidance

Prior Authorization

Prior Authorization Required

Prior authorization is required for Tavneos. Initial approvals are granted for 6 months when all initial therapy criteria are met. Continuation (current therapy) approvals are granted for 1 year when continuation criteria are met. Tavneos must be prescribed by or in consultation with a specialist (rheumatologist, nephrologist, pulmonologist, or immunologist).

Initial approval duration: 6 months when ALL initial therapy criteria met.
Continuation approval duration: 1 year when ALL continuation criteria met and patient established on Tavneos ≥ 6 months.
Specialist prescriber requirement: rheumatologist, nephrologist, pulmonologist, or immunologist.

Note

Guideline Context (Informational)

Guideline recommendations are informational and not a required step in the approval process. The ACR/Vasculitis Foundation (2021) and EULAR/ERA-EDTA (2022) guidelines discuss use of Tavneos in GPA and MPA; EULAR notes Tavneos may be considered with rituximab or cyclophosphamide to reduce glucocorticoid exposure and recommends stopping Tavneos after 6–12 months due to limited longer-term data. These guideline points may inform clinical judgment but are not prerequisites for coverage.

Definitions

inv-14: ANCA-associated vasculitis (GPA/MPA) — definition and disease group characteristics

DefinitionANCA-associated vasculitis is a group of diseases including granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) characterized by ANCAs that cause small-vessel inflammation affecting organs such as kidneys and lungs.

Typical antibodiesMany patients are positive for proteinase 3 (PR3) or myeloperoxidase (MPO) antibodies (ANCA).

Clinical courseTreatment involves induction to achieve remission and maintenance to prevent relapse; active disease includes newly diagnosed or relapsed cases (not remission).

Measures of responseClinical response may be assessed by BVAS, improvement in eGFR, or decrease in urinary albumin-creatinine ratio.

inv-15: Tavneos (avacopan) — drug description and indication as adjunctive treatment for severe active ANCA-associated vasculitis

Background

ANCA-associated vasculitis (which includes granulomatosis with polyangiitis and microscopic polyangiitis) is a small-vessel vasculitis driven by anti-neutrophil cytoplasmic antibodies (ANCAs) directed against proteinase 3 or myeloperoxidase, causing multi-organ inflammation that commonly affects the kidneys and lungs. Management of these diseases requires induction therapy to achieve remission and maintenance therapy to prevent relapse. Tavneos (avacopan) is a C5a receptor antagonist indicated as adjunctive treatment for severe active ANCA-associated vasculitis in adults, to be used in combination with standard therapy (including glucocorticoids and a nonglucocorticoid immunosuppressant). Clinical response can be assessed with objective measures such as BVAS, estimated glomerular filtration rate (eGFR), or urine albumin-creatinine ratio, and these measures inform continuation decisions.

Policy Summary

PayerCigna

PolicyVasculitis - Tavneos Prior Authorization Policy

Policy CodePolicy N/A

Change TypeClarified / Added examples

Effective DateN/A

Next Review DateJul 9, 2025

Key ActionSubmit prior authorization requests showing patient is ≥18 with GPA or MPA, active disease, ANCA positivity, and concomitant nonglucocorticoid immunosuppressant use.

SourceLink

On This Page

Prior use requirementPatient must have been established on Tavneos for at least 6 months prior to the continuation request.

Documentation of benefitApproval requires evidence of benefit: either objective improvement (e.g., eGFR, urinary albumin-creatinine ratio, BVAS) or symptom improvement versus baseline.

ACR/VF (2021): Rituximab with reduced-dose glucocorticoids recommended for remission induction; cyclophosphamide in select scenarios. Tavneos trial data noted but guideline does not mandate its use.
EULAR/ERA-EDTA (2022): Tavneos may be considered for induction in GPA/MPA as part of steroid-sparing strategy; recommend stopping at 6–12 months.

Billing Rule

Benefit Plan / Coding Conflicts

Requests that do not include a covered diagnosis or that conflict with the member's benefit plan may be denied. Coverage determinations are ultimately governed by the applicable benefit plan document and claims billed with non-covered diagnosis or procedure codes will be denied. Ensure submitted documentation and coding align with covered diagnosis codes (e.g., GPA or MPA) and the member's specific benefit coverage before submission.

Coverage is determined by the applicable benefit plan document in effect on date of service.
Claims submitted with diagnoses or procedure codes not covered under the applicable policy will be denied.
Verify member benefits and submit covered diagnosis codes (GPA/MPA) to avoid denial.

Tavneos (avacopan) — a complement 5a (C5a) receptor antagonist.

IndicationIndicated as adjunctive treatment for severe active ANCA-associated vasculitis (GPA and MPA) in combination with standard therapy including glucocorticoids in adults.

Role in therapyUsed with standard therapy but does not eliminate glucocorticoid use; intended to support induction/management of active disease.

Prescribing contextPolicy requires use in combination with at least one nonglucocorticoid immunosuppressant for coverage when initiating therapy.