budesonide delayed release cap 4 mg — Blue Cross Blue Shield of Oklahoma

Initial criteria

• ALL of the following:
• 1. Diagnosis of primary immunoglobulin A nephropathy (IgAN) confirmed by kidney biopsy AND
• 2. Requested agent will be used to reduce the loss of kidney function in a patient at risk for disease progression AND
• 3. ONE of the following: (A) urine protein-to-creatinine ratio (UPCR) ≥ 0.44 g/g OR (B) proteinuria ≥ 0.5 g/day AND
• 4. eGFR ≥ 30 mL/min/1.73 m^2 AND
• 5. If the patient has an FDA-labeled indication, ONE of the following: (A) age within FDA labeling for the requested indication OR (B) support for use for patient’s age for the requested indication AND
• 6. ONE of the following: (A) Tried and had inadequate response after ≥ 3 months of maximally tolerated ACE inhibitor (ACEi) or angiotensin II receptor blocker (ARB), or a combination medication containing ACEi or ARB OR (B) Intolerance or hypersensitivity to an ACEi or ARB OR (C) FDA-labeled contraindication to ALL ACEi and ARB AND
• 7. ONE of the following: (A) Patient is currently stable on the requested agent [chart notes required] OR (B) Tried and had an inadequate response to ONE oral generic glucocorticoid [chart notes required] OR (C) ONE oral generic glucocorticoid discontinued for lack of efficacy, diminished effect, or adverse event [chart notes required] OR (D) Intolerance or hypersensitivity to ONE oral generic glucocorticoid not expected with requested agent [chart notes required] OR (E) FDA-labeled contraindication to ALL oral generic glucocorticoids not expected with requested agent [chart notes required] OR (F) ONE oral generic glucocorticoid expected to be ineffective, cause adherence barrier, worsen comorbidity, decrease ability to maintain daily activities, or cause adverse reaction [chart notes required] OR (G) ONE oral generic glucocorticoid not in patient’s best interest based on medical necessity [chart notes required] OR (H) Tried another prescription drug in same pharmacologic class or with same mechanism as ONE oral generic glucocorticoid and discontinued due to lack of efficacy or adverse event [chart notes required] AND
• 8. ONE of the following: (A) Patient has not previously been treated with a 9‑month course of the requested agent OR (B) Patient previously treated with a course of therapy and additional course is supported AND
• 9. Prescriber is a specialist in nephrology or has consulted with a nephrologist AND
• 10. Patient does NOT have any FDA-labeled contraindications to requested agent

Approval duration

10–12 months