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Tavneos (avacopan) Prior Authorization with Quantity Limit Program Summary

Policy Number: PH-91163

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 

07-01-2024            

04-01-2022

FDA LABELED 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.

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 probable 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) jointly with the Vasculitis Foundation (VF) guidelines recommend the following for initial induction therapy and maintenance of remission for GPA/MPA(3,5):

  • Induction:
    • Non-severe disease:
      • Conditional recommendation of initiating treatment with methotrexate with or without glucocorticoids over cyclophosphamide or rituximab
      • Conditional recommendation of initiating treatment with methotrexate with corticosteroids over corticosteroids alone and azathioprine or mycophenolate in combination with corticosteroids
    • Severe disease:
      • Conditional recommendation of initiating treatment with rituximab over cyclophosphamide
      • Either IV pulse corticosteroids or oral high-dose corticosteroids may be prescribed as part of initial therapy
  • Maintenance:
    • Recommend treatment with methotrexate or azathioprine for maintenance of remission
    • Patients with severe disease that entered remission on cyclophosphamide or rituximab, rituximab is conditionally recommended over treatment with methotrexate or azathioprine for maintenance of remission
    • Patients with severe disease that entered remission on cyclophosphamide or rituximab, methotrexate or azathioprine are conditionally recommended over treatment with mycophenolate or leflunomide for maintenance of remission

The ACR/VF guidelines recommend the following treatment options for patients with relapsed disease or refractory disease(3):

  • Relapsed:
    • Patients not on rituximab for maintenance therapy, conditional recommendation to initiate rituximab over cyclophosphamide for re-induction therapy
    • Patients currently treated with rituximab for maintenance therapy, conditionally recommend switching to cyclophosphamide over receiving additional rituximab for re-induction therapy
  • Refractory disease:
    • Patients with severe disease that is refractory to cyclophosphamide or rituximab, conditional recommendation to switch to the other agent over combining the two therapies
    • Patients with refractory to induction therapy, conditional recommendation to add IVIG to current therapy

Treatment with rituximab has emerged as the first line for remission-induction treatment in the ACR/VF guidelines, the European Alliance of Associations for Rheumatology (EULAR), and The Kidney Disease: Improving Global Outcomes (KDIGO) guidelines. All of these guidelines also support adjunct use of avacopan as effective and safe with promising effects on kidney recovery and use of avacopan should be encouraged particularly in patients with severe kidney involvement.(5)

Efficacy

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:(1)

  1. Tavneos group (N of 166): Patients received 30 mg avacopan twice daily for 52 weeks plus prednisone-matching placebo for 20 weeks
  2. Prednisone group (N of 164): Patients received avacopan-matched placebo twice daily for 52 weeks plus prednisone (tapered from 60 mg/day to 0 over 20 weeks)

All patients in both groups received one of the following standard immunosuppressive regimens:(1)

  • IV cyclophosphamide 15 mg/kg IV up to 1.2 g maximum every 2 to 3 weeks for 13 weeks followed by oral azathioprine 1 mg/kg/day with titration up to 2 mg/kg/day (or mycophenolate mofetil at a target dose of 2 g/day if azathioprine was contraindicated) from Week 15 onwards
  • Oral cyclophosphamide 2 mg/kg/day (maximum 200 mg/day) for 14 weeks followed by azathioprine 1 mg/kg/day with titration up to 2 mg/kg/day (or mycophenolate mofetil at a target dose of 2 g/day if azathioprine was contraindicated) from Week 15 onwards
  • IV rituximab 375 mg/m^2 once weekly for 4 weeks without azathioprine or mycophenolate mofetil

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.(1)

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.(1)

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.(1)

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%).(1)

Safety

Tavneos is contraindicated in patients with serious hypersensitivity reaction to avacopan or to any of the excipients.(1)

Before initiating Tavneos, consider performing the following evaluations:(1)

  • Liver function tests: obtain liver test panel (serum alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase, and total bilirubin) before initiating Tavneos. Tavneos is not recommended for use in patients with cirrhosis, especially those with severe hepatic impairment (Child-Pugh C).
  • Hepatitis B (HBV) Serology: Screen patients for HBV infection by measuring HBsAg and anti-HBc. For patients with evidence of prior or current HBV infection, consult with a physician with expertise in managing hepatitis B regarding monitoring and consideration for HBV antiviral therapy before or during treatment with Tavneos.

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 SA, Langford CA, Maz M, Abril A, Gorelik M, Guyatt G, Archer AM, Conn DL, Full KA, Grayson PC, Ibarra MF, Imundo LF, Kim S, Merkel PA, Rhee RL, Seo P, Stone JH, Sule S, Sundel RP, Vitobaldi OI, Warner A, Byram K, Dua AB, Husainat N, James KE, Kalot MA, Lin YC, Springer JM, Turgunbaev M, Villa-Forte A, Turner AS, Mustafa RA. 2021 American College of Rheumatology/Vasculitis Foundation Guideline for the Management of Antineutrophil Cytoplasmic Antibody-Associated Vasculitis. Arthritis Rheumatol. 2021 Aug;73(8):1366-1383. doi: 10.1002/art.41773. Epub 2021 Jul 8. PMID: 34235894.

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.

5

Marta Casal Moura, Philipp Gauckler, Hans-Joachim Anders, Annette Bruchfeld, Gema M Fernandez-Juarez, Jürgen Floege, Eleni Frangou, Dimitrios Goumenos, Marten Segelmark, Kultigin Turkmen, Cees van Kooten, Vladimir Tesar, Duvuru Geetha, Fernando C Fervenza, David R W Jayne, Kate I Stevens, Andreas Kronbichler, on behalf of the ERA Immunonephrology Working Group (IWG), Management of antineutrophil cytoplasmic antibody–associated vasculitis with glomerulonephritis as proposed by the ACR 2021, EULAR 2022 and KDIGO 2021 guidelines/recommendations, Nephrology Dialysis Transplantation, Volume 38, Issue 11, November 2023, Pages 2637–2651.

POLICY AGENT SUMMARY PRIOR AUTHORIZATION

Target Brand Agent(s)

Target Generic Agent(s)

Strength

Targeted MSC

Available MSC

Final Age Limit

Preferred Status

Tavneos

avacopan cap

10 MG

M ; N ; O ; Y

N

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

Tavneos

Avacopan Cap

10 MG

180

Capsules

30

DAYS

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

Initial Evaluation

Target Agent(s) will be approved when ALL of the following are met:

  1. ONE of the following:
    1. The patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days OR
    2. The prescriber states the patient has been treated with the requested agent within the past 90 days (starting on samples is not approvable) AND is at risk if therapy is changed OR
    3. ALL of the following:
      1. The patient has a diagnosis of severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and/or microscopic polyangiitis [MPA]) AND
      2. The patient has a positive ANCA-test AND 
      3. The patient has been screened for prior or current hepatitis B infection AND if positive a prescriber specializing in hepatitis B treatment has been consulted OR
    4. BOTH of the following:
      1. The patient has another FDA approved indication for the requested agent AND
      2. The patient has been screened for prior or current hepatitis B infection AND if positive a prescriber specializing in hepatitis B treatment has been consulted AND
  2. If the patient has an FDA approved indication, then ONE of the following:
    1. The patient’s age is within FDA labeling for the requested indication for the requested agent OR
    2. There is support for using the requested agent for the patient’s age for the requested indication AND
  3. The patient does NOT have severe hepatic impairment (Child-Pugh C) AND
  4. If the patient has a diagnosis of ANCA-associated vasculitis, then BOTH of the following:
    1. The patient is currently treated with standard therapy (e.g., cyclophosphamide, rituximab, azathioprine, mycophenolate mofetil) for the requested indication AND
    2. The patient will continue standard therapy (e.g., cyclophosphamide, rituximab, azathioprine, mycophenolate mofetil) in combination with the requested agent for the requested indication AND
  5. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., rheumatologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND
  6. The patient does NOT have any FDA labeled contraindications to the requested agent

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:

  1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process [Note: patients not previously approved for the requested agent will require initial evaluation review] AND
  2. The patient has had clinical benefit with the requested agent AND
  3. The patient does NOT have severe hepatic impairment (Child-Pugh C) AND
  4. ONE of the following:
    1. The patient has a diagnosis of ANCA associated vasculitis AND BOTH of the following:
      1. The patient is currently treated with standard therapy (e.g., azathioprine, mycophenolate mofetil) for the requested indication AND
      2. The patient will continue standard therapy (e.g., azathioprine, mycophenolate mofetil) in combination with the requested agent for the requested indication OR
    2. The patient has another FDA approved indication for the requested agent AND
  5. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., rheumatologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND
  6. The patient does NOT have any FDA labeled contraindications to the requested agent

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:

  1. The requested quantity (dose) does NOT exceed the program quantity limit OR
  2. ALL of the following:
    1. The requested quantity (dose) exceeds the program quantity limit AND
    2. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND
    3. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit OR
  3. ALL of the following:
    1. The requested quantity (dose) exceeds the program quantity limit AND
    2. The requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND
    3. There is support for therapy with a higher dose for the requested indication

Length of approval: Initial approval - up to 6 months; Renewal approval - up to 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_PAQL _ProgSum_ 07-01-2024