CurrentCignaPolicy IP0398

Tavneos (avacopan) — ANCA-associated vasculitis coverage criteria

Defines prior authorization, prescriber requirements, FDA‑approved indications, coverage duration, and clinical criteria for Tavneos (avacopan) use in adults with ANCA-associated vasculitis (GPA or MPA) under Cigna benefit plans.

Policy Summary

PayerCigna

PolicyTavneos (avacopan) — ANCA-associated vasculitis coverage criteria

Policy CodePolicy IP0398

Change TypeClarification and additions (examples and specialist)

Effective DateSep 1, 2025

Next Review Date

Key ActionObtain prior authorization and document patient age, diagnosis (GPA or MPA), active disease status, ANCA positivity, concurrent use of a nonglucocorticoid immunosuppressant, and prescriber specialty or consultation.

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 as an accepted specialist to the specialist requirement.

6 monthsinitial approval duration

1 yearrenewal duration

≥18minimum age

GPA or MPAcovered diagnoses

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Coverage Criteria for Tavneos (avacopan)

Initial Therapy

Covered when ALL of the following are met:

Initial Therapy criteria: i. Patient is ≥ 18 years of age; AND ii. Patient has granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis; AND iii. Patient has active disease (newly diagnosed or relapsing; not in remission); AND iv. Patient is positive for proteinase 3 (PR3) antibodies, myeloperoxidase (MPO) antibodies, or antineutrophil cytoplasmic autoantibody (ANCA); AND v. Patient is using this medication in combination with at least one nonglucocorticoid immunosuppressant for ANCA-associated vasculitis (examples include rituximab, cyclophosphamide, methotrexate, azathioprine, or mycophenolate mofetil); AND vi. Medication is prescribed by or in consultation with a rheumatologist, nephrologist, pulmonologist, or immunologist.6 conditions

Approve for 6 months.

Continuation Therapy (Currently Receiving Tavneos)

Covered when ALL of the following are met:

Established patient criteria: i. Patient is ≥ 18 years of age; AND ii. Patient has been established on Tavneos for at least 6 months; AND iii. Patient meets at least ONE of the following: (a) When assessed by at least one objective measure, the patient experienced a beneficial clinical response from baseline prior to initiating Tavneos (examples of objective measures include improvement in BVAS, eGFR, or decrease in urine albumin-creatinine ratio); OR (b) Compared with baseline prior to receiving Tavneos, the patient experienced improvement in at least one symptom (e.g., joint pain, ulcers, myalgia, persistent cough, skin rash, abdominal pain) or improvement in function/activities of daily living.3 conditions with nested any

Approve for 1 year.

Use of Tavneos (avacopan) for indications other than ANCA-associated vasculitis (granulomatosis with polyangiitis [GPA] or microscopic polyangiitis [MPA]) is considered not medically necessary. Prior authorization and documentation requirements apply for covered indications; therapies prescribed for non‑covered conditions will be denied as not medically necessary under this policy.

Tavneos (avacopan) is specifically considered not medically necessary for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA, also known as Churg‑Strauss syndrome). There are no data evaluating Tavneos in EGPA and patients with EGPA were excluded from the pivotal clinical trial; therefore use in this condition is not covered.

Diagnoses, Age, and Coding Guidance

Covered diagnoses (textual)ICD-10Covered

Granulomatosis with polyangiitis	Granulomatosis with polyangiitis (also known as Wegener's granulomatosis)
Microscopic polyangiitis	Microscopic polyangiitis

Not covered diagnoses (textual)ICD-10Not Covered

Eosinophilic granulomatosis with polyangiitis (EGPA)

Eosinophilic Granulomatosis with Polyangiitis (also known as Churg-Strauss syndrome)

Age — minimum patient age for coverage

Minimum age for coveragePatient must be ≥ 18 years of age for both initial and continuation therapy

Age evidence sourcePolicy references FDA‑approved indication for adults and specifies age threshold in initial and continuation criteria

Applies toApplies to both initial therapy approvals (6 months) and continuation/established patient approvals (1 year)

Authorization, Documentation, and Concomitant Therapy Requirements

Prior Authorization

Prior Authorization Required and Approval Durations

Prior authorization is required for coverage of Tavneos. Initial approvals are provided for 6 months for new starts and 1 year for patients currently receiving Tavneos who meet continuation criteria. Tavneos must be prescribed by or in consultation with a specialist (rheumatologist, nephrologist, pulmonologist, or immunologist).

Initial approval duration: 6 months (see FDA-Approved Indication — Initial Therapy).
Renewal/continuation approval duration: 1 year for patients established on Tavneos ≥ 6 months who meet continuation criteria.

Documentation Required

Concomitant Immunosuppressant Requirement

Tavneos must be used in combination with at least one nonglucocorticoid immunosuppressant for ANCA-associated vasculitis. Examples of acceptable concomitant nonglucocorticoid immunosuppressants include rituximab, cyclophosphamide, methotrexate, azathioprine, and mycophenolate mofetil. The requirement applies to initial therapy per the criteria.

Clinical Background

ANCA‑associated vasculitis (AAV) comprises small‑vessel vasculitides such as granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), conditions often associated with PR3 or MPO ANCA antibodies and that can involve the kidneys, lungs, and other organs. Treatment paradigms generally include an induction phase to achieve remission followed by maintenance to preserve remission. Tavneos (avacopan) is a complement 5a receptor antagonist indicated as an adjunct to standard therapy for ANCA‑associated vasculitis; however, clinical trial data do not support its use in EGPA, and such uses are excluded from coverage.

Definitions and Response Measures

ANCA-associated vasculitis (AAV) — definition/key terms

DefinitionANCA‑associated vasculitis (AAV) is a group of diseases including granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA), and eosinophilic granulomatosis with polyangiitis (EGPA); characterized by antibodies (PR3 or MPO) that cause small‑vessel inflammation

Common antibodiesMany patients are positive for proteinase 3 (PR3) or myeloperoxidase (MPO) antibodies

Typical organ involvementCan affect kidneys, lungs, gastrointestinal tract and other organs due to small‑vessel inflammation

Treatment contextTavneos is indicated as adjunctive treatment for severe active ANCA‑associated vasculitis (GPA and MPA) in adults in combination with standard therapy including glucocorticoids

Objective response measures — examples of response metrics (BVAS, eGFR, UACR, symptomatic improvement)

Policy Summary

PayerCigna

PolicyTavneos (avacopan) — ANCA-associated vasculitis coverage criteria

Policy CodePolicy IP0398

Change TypeClarification and additions (examples and specialist)

Effective DateSep 1, 2025

Next Review Date

SourceLink

On This Page

Concomitant nonglucocorticoid immunosuppressant is required for initial approval (examples: rituximab, cyclophosphamide, methotrexate, azathioprine, mycophenolate mofetil).

Documentation Required

Required Documentation for Authorization

Providers must document patient age (≥ 18 years), diagnosis (granulomatosis with polyangiitis or microscopic polyangiitis), active disease status, positive serology for PR3/MPO/ANCA, use of a nonglucocorticoid immunosuppressant (name of agent), and specialist prescriber or consult. For continuation requests, document that the patient has been established on Tavneos for at least 6 months and provide objective measures of clinical benefit (e.g., BVAS score improvement, improved eGFR, decreased urine albumin-creatinine ratio) or documented symptom/function improvement compared with baseline.

Required documentation for initial approval: age, diagnosis, active disease, positive PR3/MPO/ANCA, name of concomitant nonglucocorticoid immunosuppressant, and prescribing/consulting specialist.
Required documentation for continuation: ≥ 6 months on Tavneos and evidence of benefit by objective measures (e.g., BVAS, eGFR, urine ACR) or symptom/function improvement.

Denial Risk

Denial Triggers and Requirements

Claims or prior authorization requests lacking the required diagnosis codes, documentation of concomitant nonglucocorticoid immunosuppressant use, specialist prescribing/consult note, or objective measures of benefit when required will be denied. Receipt of sample product does not satisfy coverage criteria.

Denial triggers include: missing required diagnostic documentation, no documentation of concomitant nonglucocorticoid immunosuppressant for initial therapy, absence of specialist prescriber/consult, or lack of evidence of clinical benefit for continuation.
Sample medication receipt alone is not acceptable documentation for coverage.

Example objective measures

Improvement in Birmingham Vasculitis Activity Score (BVAS)

Renal function measuresImprovement in estimated glomerular filtration rate (eGFR)

Urinary measureDecrease in urinary albumin‑creatinine ratio (UACR) or urine albumin/creatinine

Symptomatic/functional improvementImprovement in symptoms (e.g., joint pain, ulcers, myalgia, persistent cough, skin rash, abdominal pain) or activities of daily living compared with baseline