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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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:

Module

Clinical Criteria for Approval

A.          The patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days OR

B.          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

C.          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

D.          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:

A.          The patient’s age is within FDA labeling for the requested indication for the requested

agent OR

B.          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:

A.          The patient is currently treated with standard therapy (e.g., cyclophosphamide, rituximab, azathioprine, mycophenolate mofetil) for the requested indication AND

B.          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:

A.          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

B.          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

Module

Clinical Criteria for Approval

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.

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Ops Set Up

Validation Options

Other Explanation

Validation: Apply Baseline and go to Validation Options

Age Verification;Continuation of Therapy;Diagnosis

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:

A.          The requested quantity (dose) exceeds the program quantity limit AND

B.          The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND

C.          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:

A.          The requested quantity (dose) exceeds the program quantity limit AND

B.          The requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND

C.          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

Module

Ops Set Up

Validation Options

Other Explanation

Validation: Apply Baseline and go to Validation Options