Avacopan (Tavneos) Form

Avacopan (Tavneos) is a complement 5α receptor (c5αR) antagonist. FDA Approved Indication(s)
Tavneos is indicated as an adjunctive treatment of adult patients with severe active neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangitis [MPA]) in combination with standard therapy including glucocorticoids. Tavneos does not eliminate glucocorticoid use.
Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Tavneos is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. ANCA-Associated Vasculitis (must meet all):

1. Diagnosis of GPA (formerly known as Wegener's) or MPA;
   2. Prescribed by or in consultation with a rheumatologist;
   3. Age ≥ 18 years;
   4. Must meet one of the following (a, b, or c): a. Positive indirect immunofluorescence test for P-ANCA or C-ANCA; b. Positive ELISA test for anti-proteinase-3; c. Positive ELISA test for anti-myeloperoxidase;
2. Documentation of baseline Birmingham vasculitis activity score (BVAS, see Appendix D), with at least one of the following (a, b, or c): a. At least 1 major item; b. At least 3 non-major items; c. At least the 2 renal items of proteinuria and hematuria;
3. Tavneos is prescribed in combination with at least one of the following standard therapies, unless clinically significant adverse effects are experienced or all are contraindicated: rituximab, cyclophosphamide, azathioprine or mycophenolate mofetil (if member is unable to use azathioprine);Prior authorization may be required

4. Dose does not exceed 60 mg (6 capsules) per day. Approval duration: 6 months Page 1 of 6

   CLINICAL POLICY Avacopan B. Other diagnoses/indications (must meet 1 or 2):

5. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
6. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. ANCA-Associated Vasculitis (must meet all):
   
   1. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
7. Member is responding positively to therapy as evidenced by both of the following (a and b): a. Disease remission (BVAS of zero); b. No use of glucocorticoids;
8. If request is for a dose increase, new dose does not exceed 60 mg (6 capsules) per day. Approval duration: 6 months B. Other diagnoses/indications (must meet 1 or 2):

9. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: Page 2 of 6

   CLINICAL POLICY Avacopan CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

10. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
    III. Diagnoses/Indications for which coverage is NOT authorized:
    A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key ANCA: antineutrophil cytoplasmic antibody
    BVAS: Birmingham vasculitis activity score
    c5αR: complement 5α receptor
    ELISA: enzyme-linked immunosorbent assay GPA: granulomatosis with polyangiitis FDA: Food and Drug Administration MPA: microscopic polyangiitis Appendix B: Therapeutic Alternatives
    Not applicable Appendix C: Contraindications/Boxed Warnings
    • Contraindication(s): Serious hypersensitivity to avacopan or to any of the excipients • Boxed warning(s): None Appendix D: Birmingham Vasculitis Activity Score (BVAS)
    • BVAS is a composite score made up of 59 items organized into 9 different groups, expressing possible organ involvement: general, cutaneous, mucous/membranes/eyes, ear/nose/throat, chest, cardiovascular, abdominal, renal, nervous system, and other
    • The maximum scores vary for each section, and differ based on whether the symptoms are classified as new/worse or persistent. The higher the global score achieved, the more severe the disease; the maximum attainable scores are 33 and 63 for BVAS persistent and BVAS new/worse respectively.
    • Major items include the following:
    o Cutaneous: gangrene o Mucous/membrane/eyes: scleritis, retinal exudates/hemorrhage o Ear/nose/throat: sensorineural deafness o Abdominal: mesenteric ischemia o Pulmonary: alveolar hemorrhage, respiratory failure o Renal: RBC casts, rise in creatinine > 30% or fall in creatinine > 25% o Nervous system: meningitis, cord lesion, stroke, cranial nerve palsy, sensory peripheral neuropathy, motor mononeuritis multiplex Page 3 of 6

    CLINICAL POLICY Avacopan V. Dosage and Administration Indication ANCA-associated vasculitis Dosing Regimen 30 mg PO BID Maximum Dose 60 mg/day VI. Product Availability
    Oral capsule: 10 mg VII.