CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

TAVNEOS (avacopan) Policy

Policy governs coverage of Tavneos (avacopan) for treatment of adult patients with severe active ANCA-associated vasculitis (GPA and MPA) in combination with standard therapy for members in scope (Medicaid). It defines initial and continuation authorization criteria, a 6-month authorization period, quantity limit, and exclusion of non-FDA indications.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTAVNEOS (avacopan) Policy

Policy CodePolicy N/A

Change TypeReviewed (no clinical changes)

Effective DateApr 1, 2022

Next Review Date

Key ActionSubmit prior authorization documentation showing Tavneos will be used with standard therapy, that the member is anti-PR3 or anti-MPO positive, and pre-treatment BVAS v3 meets the specified thresholds; initial and continuation authorizations are limited to 6 months.

POLICY UPDATE CHANGES

Policy reviewed on 02/2025 with scope Medicaid; no clinical policy statement changes indicated.

1Covered Indications (FDA-approved)

6 moInitial authorization duration

12 moContinuation limit (total therapy)

6 caps/dayQuantity limit

Coverage Summary

Policy governs coverage of Tavneos (avacopan) for treatment of adult patients with severe active ANCA-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy for members in scope (Medicaid). Coverage stance: covered_with_criteria. Non‑FDA uses are considered experimental/investigational and are not covered.

Thresholds and Quick Facts

Authorization duration - initial6 months

Authorization duration - continuation6 months (must not exceed 12 months total therapy)

Quantity limitTavneos 10 mg capsules: 6 capsules per day

Covered Indications (FDA-approved)Adjunctive treatment of severe active ANCA-associated vasculitis (GPA and MPA) in adults, in combination with standard therapy

Initial authorization duration (stats)6 months

Unproven / Not Covered Indications

Use is restricted to the FDA‑approved indication: adjunctive treatment of adult patients with severe active ANCA-associated vasculitis (GPA and MPA) in combination with standard therapy including glucocorticoids. All other indications are considered experimental/investigational and not covered. Claims submitted for Tavneos for non‑FDA indications are not covered and subject to denial risk.

Provider Actions & Operational Requirements

Prior Authorization

Prior authorization required

Authorization for Tavneos is limited to 6 months for initial therapy and 6 months for continuation; provider must submit documentation that Tavneos will be used in combination with standard therapy, that the member is anti-PR3 or anti-MPO positive, and pre-treatment BVAS v3 meets the specified thresholds.

Documentation that Tavneos will be used in combination with standard therapy (e.g., cyclophosphamide, azathioprine, mycophenolate, rituximab)
Documentation that the member is positive for anti-PR3 or anti-MPO antibody
Documentation that pre-treatment BVAS v3 demonstrates at least one major item, or at least three non-major items, or at least two renal items (hematuria and proteinuria)
Authorization durations: 6 months for initial therapy and 6 months for continuation

Documentation Required

BVAS documentation requirement

Provider must document pre-treatment BVAS v3 demonstrating at least one major item or at least three non-major items or at least two renal items (hematuria and proteinuria); for continuation, must document stabilization or improvement in BVAS.

Billing Rule

Quantity limit enforcement

Dispensing must adhere to a maximum of 6 capsules of Tavneos 10 mg per day.

Tavneos 10 mg: 6 capsules/day

Denial Risk

Coverage exclusion for non-FDA indications

Claims for Tavneos for indications other than FDA-approved ANCA-associated vasculitis (GPA/MPA) are considered experimental/investigational and not covered.

Clinical Evidence & References

Key evidence and references: Tavneos [package insert], ChemoCentryx, Inc.; December 2024; 2021 American College of Rheumatology/Vasculitis Foundation guideline for management of ANCA-associated vasculitis; Jayne DRW et al., Avacopan for the treatment of ANCA-associated vasculitis, N Engl J Med. 2021. No numerical trial metrics are provided in this policy beyond these references.

Definitions

BVAS v3 (definition)Birmingham Vasculitis Activity Score, version 3 — used to document disease activity with specified major, non-major, and renal items (major and renal items listed in appendix)

Standard therapy (definition)Concomitant immunosuppressive agents such as cyclophosphamide, azathioprine, mycophenolate, or rituximab plus glucocorticoids

Background

Tavneos (avacopan) is FDA‑approved as adjunctive treatment in adult patients with severe active ANCA‑associated vasculitis (GPA and MPA) in combination with standard therapy including glucocorticoids. The policy limits authorization to the FDA‑approved indication with defined initial and continuation criteria (including BVAS documentation and combination with standard therapy), a 6‑month authorization period for initial and continuation requests, a maximum of 12 months total therapy for continuation, and a quantity limit of 6 capsules per day. Other uses are investigational and not covered.

Revision History

01/2022document_review

Policy reviewed (01/2022).

03/2023document_review

Policy reviewed (03/2023).

02/2024document_review

Policy reviewed (02/2024).

02/2025document_reviewLatest

Policy reviewed on 02/2025 with scope Medicaid; no clinical policy statement changes indicated.

04/01/2022effective_date

Effective date retained at 04/01/2022.