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Tavneos (avacopan) Prior Authorization with Quantity Limit Program Summary
Policy Number: PH-1163
This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace formularies.
POLICY REVIEW CYCLE
Effective Date |
Date of Origin |
7/1/2023 |
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FDA APPROVED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
Tavneos® (avacopan) Capsule |
Adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy including glucocorticoids. Tavneos does not eliminate glucocorticoid use. |
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1 |
See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm
CLINICAL RATIONALE
ANCA-Associated Vasculitides |
Vasculitis is inflammation of blood vessel walls and can be broken down into multiple categories (i.e., large vessel, medium vessel, small vessel, variable vessel, single organ, associated with systemic disease, associated with probably etiology). Anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis falls into the small vessel vasculitis category consisting of granulomatosis with polyangiitis (also known as Wegener's [GPA]), microscopic polyangiitis (MPA), and eosinophilic granulomatosis with polyangiitis (also known as Churg-Strauss [EGPA]).(2)
There are no universally accepted diagnostic criteria for GPA or MPA and the diagnosis is based on a combination of clinical findings, laboratory tests, and imaging studies. A positive ANCA test strongly supports the diagnosis but does not confirm the diagnosis.(4)
The American College of Rheumatology (ACR) guidelines recommend the following for initial induction therapy and maintenance of remission for GPA/MPA(3):
The ACR guidelines recommend the following treatment options for patients with relapsed disease or refractory disease(3):
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Efficacy(1) |
The efficacy and safety of Tavneos was evaluated in a double-blind, active-controlled, phase 3 clinical trial (NCT02994927) in 330 patients with newly diagnosed or relapsed ANCA-associated vasculitis who were randomized 1:1 to one of the following treatment groups:
All patients in both groups received one of the following standard immunosuppressive regimens:
Glucocorticoids were allowed as pre-medication for rituximab to reduce hypersensitivity reactions, taper after glucocorticoids given during the screening period, treatment of persistent vasculitis, worsening of vasculitis, or relapses, as well as for non-vasculitis reasons such as adrenal insufficiency.
Randomization was stratified based on 3 factors: newly diagnosed or relapsing ANCA-associated vasculitis, proteinase 3 positive or myeloperoxidase positive ANCA-associated vasculitis, and standard immunosuppressive regimen. The primary endpoints of the study were disease remission at Week 26 and sustained disease remission at Week 52. Disease remission was defined as achieving a Birmingham Vasculitis Activity Score (BVAS) of 0 and no use of glucocorticoids for treatment of ANCA-associated vasculitis from Week 22 to Week 26. Sustained remission was defined as remission at Week 26 and remission at Week 52, without relapse between Week 26 and Week 52. Remission at Week 52 was defined as BVAS of 0 and no use of glucocorticoids for treatment of ANCA-associated vasculitis from Week 48 to Week 52. Relapse was defined as occurrence of one major item, at least 3 non-major items, or 1 or 2 non-major items for at least 2 consecutive visits on the BVAS after remission (BVAS of 0) had been achieved.
Patients had either GPA (54.8%) or MPA (45.2%) and had presence of anti-PR3 (43.0%) or anti-MPO (57.0%) antibodies. Approximately 65% of patients received rituximab, 31% received IV cyclophosphamide, and 4% received oral cyclophosphamide.
Remission was achieved by 72.3% of patients in the Tavneos group and 70.1% of patients in the prednisone group at Week 26 (treatment difference: 3.4%, 95% CI [-6.0%, 12.8%]). At Week 52, a significantly higher percentage of patients had sustained remission in Tavneos group (65.7%) compared to the prednisone group (54.9%). |
Safety(1) |
Tavneos is contraindicated in patients with serious hypersensitivity reaction to avacopan or to any of the excipients.
Before initiating Tavneos, consider performing the following evaluations:
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REFERENCES
Number |
Reference |
1 |
Tavneos prescribing information. ChemoCentryx, Inc. October 2021. |
2 |
Jennette JC, Falk RJ, Bacon PA, et al. 2012 revised International Chapel Hill Consensus Conference Nomenclature of Vasculitides. Arthritis Rheum 2013; 65:1. |
3 |
Chung, S. A., Langford, C. A., Maz, M., Abril, A., Gorelik, M., Guyatt, G., Archer, A. M., Conn, D. L., Full, K. A., Grayson, P. C., Ibarra, M. F., Imundo, L. F., Kim, S., Merkel, P. A., Rhee, R. L., Seo, P., Stone, J. H., Sule, S., Sundel, R. P., … Mustafa, R. A. (2021). 2021 American College of Rheumatology/vasculitis FOUNDATION guideline for the management of Antineutrophil CYTOPLASMIC ANTIBODY–ASSOCIATED VASCULITIS. Arthritis & Rheumatology. https://doi.org/10.1002/art.41773. |
4 |
Bossuyt X, Cohen Tervaert JW, Arimura Y, et al. Position paper: Revised 2017 international consensus on testing of ANCAs in granulomatosis with polyangiitis and microscopic polyangiitis. Nat Rev Rheumatol 2017; 13:683. |
POLICY AGENT SUMMARY PRIOR AUTHORIZATION
Target Brand Agent(s) |
Target Generic Agent(s) |
Strength |
Targeted MSC |
Available MSC |
Preferred Status |
Effective Date |
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Tavneos |
avacopan cap |
10 MG |
M ; N ; O ; Y |
N |
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POLICY AGENT SUMMARY QUANTITY LIMIT
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
QL Amount |
Dose Form |
Day Supply |
Duration |
Addtl QL Info |
Allowed Exceptions |
Targeted NDCs When Exclusions Exist |
Effective Date |
|
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Tavneos |
Avacopan Cap |
10 MG |
180 |
CAPS |
30 |
DAYS |
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CLIENT SUMMARY – PRIOR AUTHORIZATION
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
Tavneos |
avacopan cap |
10 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
CLIENT SUMMARY – QUANTITY LIMITS
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
Tavneos |
Avacopan Cap |
10 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
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Initial Evaluation Target Agent(s) will be approved when ALL of the following are met:
Length of Approval: 6 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.
Renewal Evaluation Target Agent(s) will be approved when ALL of the following are met:
Length of Approval: 12 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria. |
QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
|
Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met:
Length of approval: Initial approval - 6 months; Renewal approval - 12 months |
This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.
Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.
Commercial _ PS _ Tavneos (avacopan) Prior Authorization with Quantity Limit _ProgSum_ 7/1/2023