TAVNEOS (avacopan)

TAVNEOS (avacopan)

Self-Administration – oral

Diagnosis considered for coverage:

Indicated as an 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.

Coverage Criteria:

For diagnosis of severe active ANCA-associated vasculitis:

• Dose does not exceed 30 mg (three 10 mg capsules) twice daily; AND
• Patient is 18 years of age or older; AND
• Prescribed by or in consultation with one of the following:
  • Nephrologist 
  • Pulmonologist 
  • Rheumatologist; AND
• Patient has a diagnosis of one of the following types of severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis:
  • Granulomatosis with polyangiitis (GPA) 
  • Microscopic polyangiitis (MPA); AND
• Diagnosis is confirmed by one of the following:
  • ANCA test positive for proteinase 3 (PR3) antigen 
  • ANCA test positive for myeloperoxidase (MPO) antigen 
  • Tissue biopsy; AND
• Patient is concurrently on glucocorticoids (e.g., prednisone) or has a contraindication or intolerance to glucocorticoids (e.g., prednisone); AND
• Patient is receiving concurrent immunosuppressant therapy with cyclophosphamide or rituximab

Reauthorization Criteria:

For diagnosis of severe active ANCA-associated vasculitis:

• Dose does not exceed 30 mg (three 10 mg capsules) twice daily; AND
• Prescribed by or in consultation with a nephrologist, pulmonologist, or rheumatologist; AND
• Patient does not show evidence of progressive disease while on therapy; AND
• Patient is receiving concurrent immunosuppressant therapy (e.g., azathioprine, cyclophosphamide, methotrexate, rituximab)

Coverage Duration: 

• Initial: 1 year
• Reauthorization: 1 year

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 

• Recommended dose: 30 mg (three 10 mg capsules) twice daily
• Reduce the dosage of Tavneos to 30 mg once daily when used concomitantly with strong CYP3A4 inhibitors
• Avoid use with strong and moderate CYP3A4 enzyme inducers
• Before initiating Tavneos, consider performing liver function tests and Hepatitis B (HBV) serology
• Advise patients that Tavneos capsules should not be crushed, chewed or opened
• Warnings: hepatotoxicity, hypersensitivity reactions, Hepatitis B virus (HBV) reactivation, serious infections 

Policy Updates:

• 5/17/2022 – New policy approved by P&T

References:

Tavneos Prescribing Information. ChemoCentryx, Inc. Cincinnati, OH. October 2021.