| Paroxysmal nocturnal hemoglobinuria

Empaveli vs Fabhalta

Side-by-side clinical, coverage, and cost comparison for paroxysmal nocturnal hemoglobinuria.
Deep comparison between: Empaveli vs Fabhalta with Prescriber.AI
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Safety signalsFabhalta has a higher rate of injection site reactions vs Empaveli based on FDA-approved prescribing information
Coverage gaps3 major payers require step therapy for Fabhalta but not Empaveli, including UnitedHealthcare
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Empaveli
Fabhalta
At A Glance
SC injection
Twice weekly
C3 complement inhibitor
Oral
Twice daily
Factor B inhibitor
Indications
  • Paroxysmal nocturnal hemoglobinuria
  • C3 glomerulopathy
  • Immune-complex membranoproliferative glomerulonephritis
  • Paroxysmal nocturnal hemoglobinuria
  • IGA Glomerulonephritis
  • Complement 3 Glomerulopathies
Dosing
Paroxysmal nocturnal hemoglobinuria 1,080 mg SC twice weekly; adjust to 1,080 mg every three days if LDH >2x ULN.
C3 glomerulopathy, Immune-complex membranoproliferative glomerulonephritis Adults: 1,080 mg SC twice weekly; pediatric patients (12 to <18 years): weight-based dosing from 648 mg to 1,080 mg SC twice weekly based on body weight.
Paroxysmal nocturnal hemoglobinuria, IGA Glomerulonephritis, Complement 3 Glomerulopathies 200 mg orally twice daily without regard to food; swallow capsules whole.
PNH Patients Switching From Anti-C5 Initiate FABHALTA no later than 1 week after last eculizumab dose or no later than 6 weeks after last ravulizumab dose.
Contraindications
  • Hypersensitivity to pegcetacoplan or any excipient
  • Unresolved serious infection caused by encapsulated bacteria including Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B
  • Serious hypersensitivity to iptacopan or any of the excipients
  • Unresolved serious infection caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, or Haemophilus influenzae type b (contraindicated for initiation)
Adverse Reactions
Most common (>=10%) Injection-site reactions, infections, diarrhea, abdominal pain, respiratory tract infection, viral infection, fatigue
Serious Infections, intestinal ischemia, biliary sepsis, hypersensitivity pneumonitis
Postmarketing Anaphylaxis, urticaria
Most common (>=10%) headache, nasopharyngitis, diarrhea, abdominal pain, bacterial infection, viral infection, nausea, rash
Serious serious infections caused by encapsulated bacteria, hyperlipidemia
Pharmacology
C3 complement inhibitor; pegcetacoplan binds complement protein C3 and its activation fragment C3b, regulating downstream complement activation to control both C3b-mediated extravascular hemolysis and terminal complement-mediated intravascular hemolysis in PNH, and to inhibit C3 glomerular fragment deposition and C5b-9 assembly in C3G and primary IC-MPGN.
Factor B inhibitor; iptacopan binds to Factor B of the alternative complement pathway, regulating C3 cleavage and inhibiting downstream effectors to control both C3b-mediated extravascular hemolysis and terminal complement-mediated intravascular hemolysis in PNH, and to inhibit complement-driven glomerular injury in IgAN and C3G.
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Most Common Insurance
Anthem BCBS
Empaveli
  • Covered on 5 commercial plans
  • PA (9/12) · Step Therapy (9/12) · Qty limit (9/12)
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Fabhalta
  • Covered on 5 commercial plans
  • PA (9/12) · Step Therapy (9/12) · Qty limit (9/12)
View full coverage details ›
UnitedHealthcare
Empaveli
  • Covered on 4 commercial plans
  • PA (4/8) · Step Therapy (4/8) · Qty limit (4/8)
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Fabhalta
  • Covered on 4 commercial plans
  • PA (5/8) · Step Therapy (4/8) · Qty limit (5/8)
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Humana
Empaveli
  • Covered on 0 commercial plans
  • PA (2/3) · Step Therapy (2/3) · Qty limit (2/3)
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Fabhalta
  • Covered on 0 commercial plans
  • PA (3/3) · Step Therapy (2/3) · Qty limit (3/3)
View full coverage details ›
Coverage data sourced from MMIT. Updated monthly.
Savings
Cost estimate not availableApellis Bridge Program: Empaveli
Commercial or private insurance
Medicare, Medicaid, VA, TRICARE
Cost estimate not availableAssistance Fund: Immunoglobulin A Nephropathy (IgAN)
Commercial or private insurance
Medicare, Medicaid, VA, TRICARE
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Clinical data sourced from FDA-approved labeling. Coverage data via MMIT. Updated monthly.