budesonide delayed release capsule — Blue Cross Blue Shield of New Mexico

Initial criteria

• Diagnosis of primary immunoglobulin A nephropathy (IgAN) confirmed by kidney biopsy AND
• Requested agent will be used to reduce the loss of kidney function in a patient at risk for disease progression AND
• ONE of the following: (A) Urine protein-to-creatinine ratio (UPCR) ≥ 0.44 g/g OR (B) Proteinuria ≥ 0.5 g/day AND
• eGFR ≥ 30 mL/min/1.73 m^2 AND
• If the patient has an FDA labeled indication, then ONE of the following: (A) Age is within FDA labeling for requested indication OR (B) There is support for using the requested agent for the patient's age AND
• ONE of the following: (A) Tried and had inadequate response after ≥ 3 months therapy with a maximally tolerated ACE inhibitor (e.g., benazepril, lisinopril) or ARB (e.g., losartan), or combination containing an ACEi or ARB OR (B) Intolerance or hypersensitivity to an ACEi or ARB OR (C) FDA labeled contraindication to ALL ACEi and ARB AND
• ONE of the following: (A) Currently treated with and stable on the requested agent [chart notes required] OR (B) Tried and had inadequate response to ONE oral generic glucocorticoid [chart notes required] OR (C) ONE oral generic glucocorticoid discontinued due to lack of efficacy, diminished effect, or adverse event [chart notes required] OR (D) Intolerance or hypersensitivity to ONE oral generic glucocorticoid not expected to occur with requested agent [chart notes required] OR (E) FDA labeled contraindication to ALL oral generic glucocorticoids not expected to occur with requested agent [chart notes required] OR (F) ONE oral generic glucocorticoid expected to be ineffective, cause adherence barrier, worsen comorbidity, reduce function, or cause adverse reaction/harm [chart notes required] OR (G) ONE oral generic glucocorticoid not in best interest based on medical necessity [chart notes required] OR (H) Tried another drug in same pharmacologic class/mechanism as ONE oral generic glucocorticoid and discontinued due to inadequate response or adverse event [chart notes required] AND
• ONE of the following: (A) Patient has not previously been treated with a 9-month course of therapy with the requested agent OR (B) Previously treated and there is support for an additional course of therapy AND
• Prescriber is a specialist in the area of the patient’s diagnosis (e.g., nephrologist) or has consulted with one AND
• Patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

10–12 months