CurrentUnitedHealthcarePolicy N/A

Tavneos (avacopan) prior authorization — Clinical/Medical Policy

Defines prior authorization and medical necessity criteria for Tavneos (avacopan) for treating adults with severe active ANCA-associated vasculitis (GPA or MPA) when used as adjunctive therapy in combination with standard therapy; applies to UnitedHealthcare coverage decisions.

Policy Summary

PayerUnitedHealthcare

PolicyTavneos (avacopan) prior authorization — Clinical/Medical Policy

Policy CodePolicy N/A

Change TypeAdded language

Effective DateApr 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with medical records documenting severe active ANCA-associated vasculitis (GPA or MPA) and evidence of induction immunosuppressive therapy; prescriber must be or consult with an appropriate specialist.

SourceLink

POLICY UPDATE CHANGES

Added 'or in consultation with' for prescriber requirement in the initial criteria.

6 monthsinitial authorization duration

12 monthsreauthorization duration

GPA, MPAcovered diagnoses

Requiredspecialist prescriber

Yes

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Coverage Criteria for Tavneos (avacopan)

Initial Therapy — Initial Authorization

Initial Authorization: Covered when ALL of the following are met

Initial authorization criteria: (1) Diagnosis of severe active ANCA-associated vasculitis; (2) Submission of medical records (e.g., chart notes, laboratory values) documenting the disease type as granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA); (3) Patient is being treated with an initial immunosuppressive regimen to induce remission (e.g., rituximab, cyclophosphamide); (4) Tavneos (avacopan) is prescribed as adjunctive treatment in combination with standard therapy (e.g., prednisone, azathioprine, mycophenolate, methotrexate, rituximab, cyclophosphamide); (5) Prescribed by or in consultation with a Rheumatologist, Nephrologist, Pulmonologist, or Vascular Medicine Specialist.

Authorization will be issued for 6 months.

Continuation / Reauthorization — Reauthorization

Reauthorization: Covered when ALL of the following are met

Reauthorization criteria: (1) No evidence of progressive disease while on Tavneos therapy; (2) Tavneos continues to be prescribed as adjunctive treatment in combination with standard therapy (e.g., prednisone, azathioprine, mycophenolate, methotrexate, rituximab, cyclophosphamide); (3) Prescribed by or in consultation with a Rheumatologist, Nephrologist, Pulmonologist, or Vascular Medicine Specialist.

Authorization will be issued for 12 months.

Supply limits may be in place. Coverage decisions for Tavneos (avacopan) can also be affected by state mandates, federal regulatory requirements, and the member’s specific benefit plan; these factors may modify or limit coverage even when clinical criteria are met.

Provider Requirements and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Tavneos (avacopan) for treatment of severe active ANCA‑associated vasculitis. Requests must include sufficient clinical information to support the diagnosis and treatment plan; authorization will be issued for up to 6 months for initial approvals.

Prior authorization required for Tavneos (avacopan).
Authorization duration: up to 6 months for initial approval.

Note

Induction Therapy Requirement

Induction therapy requirement — patient must be receiving an initial immunosuppressive regimen to induce remission (e.g., rituximab or cyclophosphamide) prior to or concurrent with avacopan as part of adjunctive therapy.

Patient must be treated with an initial immunosuppressive regimen to induce remission (rituximab or cyclophosphamide).
Avacopan must be prescribed as adjunctive treatment in combination with standard therapy (e.g., prednisone, azathioprine, mycophenolate, methotrexate, rituximab, cyclophosphamide).

Background on Avacopan (Tavneos)

Avacopan (Tavneos) is a complement C5a receptor (C5aR) antagonist approved as an adjunctive treatment for adults with severe active ANCA‑associated vasculitis, including granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA). Use of Tavneos is intended to be adjunctive to standard immunosuppressive therapy (for induction and maintenance) and does not replace the need for concomitant agents such as glucocorticoids or other conventional immunosuppressants.

Key Definitions

ANCA-associated vasculitis (definitions)

ConditionSevere active ANCA-associated vasculitis (includes granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]).

GPA (Granulomatosis with polyangiitis)Listed as an accepted disease type for coverage when severe and active; medical records must document GPA.

MPA (Microscopic polyangiitis)Listed as an accepted disease type for coverage when severe and active; medical records must document MPA.

Drug indication contextAvacopan (Tavneos) is indicated as adjunctive treatment for adults with severe active ANCA-associated vasculitis in combination with standard therapy including glucocorticoids.

Standard therapy / adjunctive (concomitant treatment requirements)

Definition

Initial Therapy Requirements

Initial therapy — initial authorization requirements

Initial authorization requirements

Initial nodes: Diagnosis of severe active ANCA-associated vasculitis (GPA or MPA); submission of medical records documenting the disease type; patient treated with an initial immunosuppressive induction regimen (e.g., rituximab or cyclophosphamide); Tavneos prescribed as adjunctive to standard therapy (e.g., prednisone, azathioprine, mycophenolate, methotrexate, rituximab, cyclophosphamide); prescriber is or consults with an appropriate specialist (Rheumatologist, Nephrologist, Pulmonologist, or Vascular Medicine Specialist).

Authorization will be issued for 6 months.

Continuation / Reauthorization Requirements

Reauthorization — reauthorization conditions

Reauthorization conditions

Reauthorization nodes: Patient must show no evidence of progressive disease while on Tavneos; Tavneos must remain prescribed as adjunctive treatment in combination with standard therapy (e.g., prednisone, azathioprine, mycophenolate, methotrexate, rituximab, cyclophosphamide); prescriber must be or consult with an appropriate specialist (Rheumatologist, Nephrologist, Pulmonologist, or Vascular Medicine Specialist).

Authorization will be issued for 12 months.

Step Therapy / Prior Treatment Requirements

Step	Requirement
1	Patient must be treated with an initial immunosuppressive regimen to induce remission (e.g., rituximab, cyclophosphamide) prior to or concurrent with Tavneos initiation.

Policy Summary

PayerUnitedHealthcare

PolicyTavneos (avacopan) prior authorization — Clinical/Medical Policy

Policy CodePolicy N/A

Change TypeAdded language

Effective DateApr 1, 2026

Next Review DateN/A

SourceLink

On This Page

Documentation Required

Required Documentation

Documentation required: submit medical records (chart notes, laboratory values, diagnostic findings) demonstrating severe active ANCA‑associated vasculitis and specifying disease type (GPA or MPA). Include treatment history showing induction immunosuppressive regimen and documentation of prescribing clinician specialty (rheumatologist, nephrologist, pulmonologist, or vascular medicine specialist).

Required documentation: chart notes, labs, diagnostic test results indicating GPA or MPA.
Include evidence of initial immunosuppressive therapy and clinician specialty or consultation.

Denial Risk

Triggers for Denial

Triggers for denial include lack of documentation of severe active ANCA‑associated vasculitis, absence of records confirming GPA or MPA, missing evidence of initial induction immunosuppressive therapy, avacopan not prescribed as adjunctive to standard therapy, or prescribing clinician not in the required specialties.

Denial triggers: no documentation of diagnosis as severe active ANCA‑associated vasculitis (GPA or MPA).
Denial triggers: missing documentation of initial immunosuppressive induction therapy (e.g., rituximab or cyclophosphamide).
Denial triggers: avacopan not used as adjunctive therapy with standard regimen.
Denial triggers: prescribing clinician not a rheumatologist, nephrologist, pulmonologist, or vascular medicine specialist, and no documented consultation.

Concomitant use of glucocorticoids and/or conventional immunosuppressive agents (examples: prednisone, azathioprine, mycophenolate, methotrexate, rituximab, cyclophosphamide) when prescribing Tavneos.

Adjunctive use requirementTavneos must be prescribed as adjunctive treatment in combination with standard therapy (glucocorticoids and/or conventional immunosuppressants).

Induction therapy necessityPatient must be treated with an initial immunosuppressive regimen to induce remission (e.g., rituximab or cyclophosphamide) prior to or concurrent with Tavneos initiation.

Glucocorticoid noteTavneos does not eliminate the need for glucocorticoids; standard therapy includes glucocorticoids alongside other immunosuppressive agents.