Fabhalta — Medical Mutual
Complement 3 Glomerulopathy
Initial criteria
- Patient is age ≥ 18 years; AND
- Patient has not received a kidney transplant in the past; AND
- Diagnosis has been confirmed by biopsy; AND
- Patient has a urine protein-to-creatinine ratio ≥ 1.0 g/g; AND
- Patient has an estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2; AND
- Patient has received the maximum or maximally tolerated dose of ONE of the following for ≥ 90 days prior to starting Fabhalta: Angiotensin converting enzyme inhibitor OR Angiotensin receptor blocker; AND
- Medication is prescribed by or in consultation with a nephrologist
Reauthorization criteria
- Patient is age ≥ 18 years; AND
- Patient has not received a kidney transplant in the past; AND
- Diagnosis has been confirmed by biopsy; AND
- According to the prescriber, patient has had a response to Fabhalta (examples: reduction in urine protein-to-creatinine ratio from baseline, reduction in proteinuria from baseline); AND
- Patient has an estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2; AND
- Medication is prescribed by or in consultation with a nephrologist
Approval duration
initial 6 months; reauth 1 year