CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Tavneos (avacopan) coverage for ANCA-associated vasculitis

Defines coverage criteria and authorization requirements for Tavneos (avacopan) as adjunctive treatment of severe active ANCA-associated vasculitis (GPA and MPA) for Medicaid members when approval criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTavneos (avacopan) coverage for ANCA-associated vasculitis

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateApr 1, 2022

Next Review DateN/A

Key ActionObtain prior authorization; initial approval may be granted for 6 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 moinitial authorization duration

6 mocontinuation authorization duration

12 momaximum total duration

6 caps/dayquantity limit

FDA-onlycoverage stance

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Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Initial authorization criteria for Tavneos: Indication: severe active ANCA-associated vasculitis (granulomatosis with polyangiitis [GPA] or microscopic polyangiitis [MPA]) as adjunctive therapy in combination with standard therapy (including glucocorticoids).

Tavneos will be used in combination with standard therapy (e.g., cyclophosphamide, azathioprine, mycophenolate, rituximab).

Member is positive for anti-PR3 or anti-MPO antibody.

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).BVAS criteria: presence of ≥1 major OR ≥3 non-major OR ≥2 renal items

Authorization duration: initial approval may be granted for 6 months.

Continuation Therapy — Covered for continuation when ALL of the following are met

Covered for continuation when ALL of the following are met

Continuation criteria for Tavneos: Member has achieved or maintained a positive clinical response as evidenced by stabilization or improvement in the Birmingham Vasculitis Activity Score (BVAS).

Member has not received more than 12 months of therapy with Tavneos.Maximum total therapy referenced as 12 months

Authorization duration: continuation may be granted for an additional 6 months when the above are met.

The medication is covered only for the FDA‑approved indication: adjunctive treatment of adult patients with severe active ANCA‑associated vasculitis (GPA or MPA) when given in combination with standard therapy including glucocorticoids. The policy recognizes that Tavneos does not eliminate glucocorticoid use and coverage is limited to the population and treatment context specified by the FDA.

Use of Tavneos for any indication other than the FDA‑approved adjunctive treatment of severe active ANCA‑associated vasculitis (GPA and MPA) is considered not medically necessary / experimental and not a covered benefit under this policy.

Scoring and Diagnostic Criteria (BVAS)

BVAS criteria

BVAS threshold — major/non-major/renalPresence of at least one major item, or at least three non-major items, or at least two renal items (hematuria and proteinuria)

Source instrumentBirmingham Vasculitis Activity Score (BVAS) version 3

Renal item specificsRenal items counted include hematuria (≥10 RBCs/hpf) and proteinuria (>1+ or >0.2 g/g creatinine)

Use for pre-treatment assessmentPre-treatment BVAS v3 must demonstrate qualifying items to meet initial authorization criteria

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. Initial authorization may be granted for up to 6 months when specified criteria are met.

Authorization of 6 months may be granted for treatment of severe active ANCA-associated vasculitis (GPA and MPA) when all required documentation is provided.
Required documentation for initial authorization: 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 of the pre‑treatment Birmingham Vasculitis Activity Score (BVAS) version 3 demonstrating at least one major item, or at least three non‑major items, or at least two renal items of hematuria and proteinuria.

Prior Authorization

Continuation Authorization

Prior authorization for continuation may be granted for an additional 6 months if clinical response is documented and total therapy does not exceed 12 months.

Required documentation for continuation authorization: documentation that the member has achieved or maintained a positive clinical response as evidenced by stabilization or improvement in the BVAS.
Total cumulative therapy with Tavneos must be ≤ 12 months to qualify for continuation authorization.

Documentation Required

Documentation and Coverage Limits

Tavneos must be used in combination with standard therapy; requests for use as monotherapy or for non‑FDA indications are not covered.

Combination therapy requirement: documentation that Tavneos will be used with standard agents (e.g., cyclophosphamide, azathioprine, mycophenolate, rituximab).
Non‑FDA indications: requests for indications other than the FDA‑approved indication (adjunctive treatment of severe active ANCA‑associated vasculitis in adults, in combination with standard therapy) are not covered.

Background

ANCA‑associated vasculitis refers to systemic small‑vessel vasculitides including granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA). Tavneos (avacopan) received FDA approval as an adjunctive treatment for adults with severe active disease in combination with standard therapy (including glucocorticoids). Clinical assessment of disease severity and eligibility for therapy should follow the FDA‑approved context: therapy is intended to be added to, not to replace, background standard therapy.

Definitions and Scoring Details

Severe active ANCA-associated vasculitis — definition

Condition definedGranulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA)

Activity requirementSevere active disease demonstrated by BVAS v3 meeting threshold (≥1 major OR ≥3 non-major OR ≥2 renal items)

Approval contextFDA-approved as adjunctive treatment in adults in combination with standard therapy including glucocorticoids

Antibody requirementMember must be positive for anti-PR3 or anti-MPO antibody per authorization criteria

BVAS major and non-major items (examples)

Major BVAS itemsMajor items are organ- or life‑threatening features (examples in appendix: respiratory major items such as pleural effusion/pleurisy, infiltrate, endobronchial involvement, massive hemoptysis/alveolar hemorrhage, respiratory failure)

Non-major BVAS itemsNon-major items include less severe clinical signs and organ‑specific findings across systems (general, cutaneous, mucous membranes/eyes, ENT, nervous system, chest, other) as listed in BVAS v3 appendix)

Organ‑specific examplesRenal findings: hypertension; proteinuria >1+ or >0.2 g/g creatinine; hematuria ≥10 RBCs/hpf; serum creatinine elevations and rises in creatinine or falls in clearance are listed as renal items

Scoring noteMajor items are indicated in BVAS v3 appendix formatting (bold/italics) to distinguish them from non-major items