CurrentAvMedPolicy N/A

Fabhalta (iptacopan) — Pharmacy Prior Authorization and Coverage Criteria

Defines pharmacy prior authorization, initial and reauthorization clinical criteria, quantity limits, and documentation requirements for Fabhalta (iptacopan) for AvMed members; applies to prescribers and specialty pharmacy processing requests.

Policy Summary

PayerAvMed

PolicyFabhalta (iptacopan) — Pharmacy Prior Authorization and Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with required supporting documentation (labs, biopsy reports, chart notes, pharmacy paid claims) and prescriber handwritten signature to avoid denial or delay.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 moInitial auth duration

12 moReauth duration

2 caps/dayQuantity limit

≥18Min age

Coverage Criteria for Fabhalta (iptacopan)

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Prescriber and REMS: Medication must be prescribed by or in consultation with a hematologist or nephrologist; prescriber must be enrolled in the Fabhalta REMS program; member must be >=18 years of age.

Indication pathway

Switch therapy details: When converting from eculizumab initiate iptacopan no later than 1 week following the last eculizumab dose; when converting from ravulizumab initiate iptacopan no later than 6 weeks following the last ravulizumab dose; member failed Soliris or Ultomiris and must meet renewal criteria.
Treatment-naive details: PNH confirmed by detection of PNH clones >= 10% by flow cytometry with demonstration of at least two different GPI protein deficiencies in two different cell lines; laboratory evidence of significant hemolysis (LDH > 1.5 x ULN) AND one additional clinical indication such as transfusion dependence within the last 12 months with symptomatic anemia, thrombotic event, organ damage secondary to chronic hemolysis, pregnancy where benefit outweighs risk, or hospitalization for abdominal pain.

Safety and vaccination: Member does NOT have a systemic infection; must be vaccinated against encapsulated bacteria (Streptococcus pneumoniae, Neisseria meningitidis, Haemophilus influenzae type B) at least two weeks prior to initiation and revaccinated per current medical guidelines; Fabhalta will NOT be used concurrently with other complement inhibitor therapies (e.g., Empaveli, Soliris, Ultomiris, Voydeya).

Primary IgA Nephropathy (IgAN) — Initial and Reauthorization

Covered when ALL of the following are met

Prescriber and age: Member >=18 years; provider is a nephrologist.

Diagnosis and prior therapy: Biopsy-proven, primary IgAN at risk of rapid progression; not on dialysis and no prior kidney transplant; established on a stable, maximally tolerated RAAS inhibitor (ACEi or ARB) for >=90 days; has had unsuccessful 3-month trials of Vanrafia or Filspari AND Tarpeyo (documentation required).

Laboratory requirements: Recent labs within 30 days documenting total urine protein >= 1 g/day OR UPCR >= 1.0 g/g, and eGFR >= 30 mL/min/1.73 m2.

Safety and concomitant therapy: Member does NOT have a systemic infection; must be vaccinated against encapsulated bacteria (Streptococcus pneumoniae, Neisseria meningitidis, Haemophilus influenzae type B) at least two weeks prior to initiation and revaccinated per guidelines; member must avoid strong CYP2C8 inhibitors (e.g., gemfibrozil) and inducers (e.g., rifampin); not using concomitant specified agents (Tarpeyo, Filspari, Vanrafia, Voyxact, or other complement inhibitors).

Reauthorization criteria: Member continues to meet initial criteria and demonstrates reduction in proteinuria from baseline after initial approval and reduction or stabilization thereafter; eGFR remains >= 30 mL/min/1.73 m2; no treatment-restricting adverse effects.

Complement 3 Glomerulopathy (C3G) — Initial and Reauthorization

Covered when ALL of the following are met

Prescriber and age: Member >=18 years; provider is a nephrologist.

Diagnosis and prior therapy: Biopsy-proven C3G (biopsy results required); no prior kidney transplant; established on a stable, maximally tolerated RAAS inhibitor for >=90 days; has had an unsuccessful 90-day trial of at least ONE of: corticosteroids with mycophenolate/mycophenolic acid, or rituximab (documentation required).

Laboratory requirements: Recent labs within 30 days documenting UPCR >= 1.0 g/g and eGFR >= 30 mL/min/1.73 m2.

Safety and concomitant therapy: Member does NOT have a systemic infection; must be vaccinated against encapsulated bacteria (Streptococcus pneumoniae, Neisseria meningitidis, Haemophilus influenzae type B) at least two weeks prior to initiation and revaccinated per guidelines; Fabhalta will NOT be used concomitantly with specified complement inhibitors or other listed agents (e.g., Empaveli, Soliris, Tavneos, Ultomiris, Voydeya).

Reauthorization criteria: Member continues to meet initial criteria and demonstrates reduction or stabilization in UPCR or proteinuria from baseline after initial approval and thereafter; no treatment-restricting adverse effects.

Fabhalta (iptacopan) must not be used concurrently with other complement inhibitors. Examples of agents that are restricted from concurrent use include Empaveli®, Soliris®, Ultomiris®, Voydeya™, Bkemv™, Epysqli™, PiaSky®, Tavneos®, and other FDA‑approved complement inhibitor therapies. For PNH specifically, Fabhalta will not be prescribed concurrently with another FDA‑approved product for PNH (e.g., Bkemv™, Epysqli™, PiaSky®, Ultomiris®, Soliris®, Empaveli®).

Fabhalta is not permitted when the member is receiving specific concomitant therapies. Per policy, members must NOT be using concomitant agents such as Tarpeyo®, Filspari®, Vanrafia™, Voyxact®, or other complement inhibitor therapies (for example, Empaveli®, Soliris®, Ultomiris®, Voydeya™); use in that context is not covered.

Dosing and Initiation Requirements

Dosing and initiation

Dosing and limits

Recommended dosage: 200 mg orally twice daily for PNH, IgAN, and C3G; when converting from eculizumab initiate iptacopan no later than 1 week following the last eculizumab dose and when converting from ravulizumab initiate no later than 6 weeks following the last ravulizumab dose.

Quantity limit: 2 capsules per day for all indications.

Reauthorization Clinical Response and Safety

Reauthorization clinical response and safety

Reauthorization requirements for ongoing coverage

Safety attestation: Provider attests to absence of unacceptable toxicity from the drug (e.g., serious meningococcal infections).

Evidence of benefit: Member has experienced at least ONE of the following: for PNH — decrease in serum LDH, stabilization/increase in hemoglobin, decreased RBC transfusion requirement, or reduction in thromboembolic events; OR for renal indications — reduction or stabilization in proteinuria/UPCR with eGFR >= 30 mL/min/1.73 m2.

Prior Authorization, Step Therapy, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Fabhalta (iptacopan). Initial authorizations are for 6 months for all indicated conditions. Ensure the prescriber is enrolled in the Fabhalta REMS program when required, and that prescriber specialty requirements are met (hematologist for PNH; nephrologist for IgAN and C3G).

Initial Authorization: 6 months
Prescriber specialty required: hematologist (PNH) or nephrologist (IgAN, C3G)
Prescriber must be enrolled in Fabhalta REMS (when applicable)

Step Therapy

Step Therapy / Prior Treatment Requirements

Step therapy / prior treatment requirements vary by indication. For PNH, approval for switch therapy requires prior failure of Soliris (eculizumab) or Ultomiris (ravulizumab) and meeting renewal criteria. For IgAN, member must have had unsuccessful 3-month trials of Vanrafia, Filspari AND Tarpeyo (documentation required). For C3G, member must have an unsuccessful 90-day trial of at least ONE of: corticosteroids combined with mycophenolate (Cellcept/Myfortic) or rituximab (Rituxan/Ruxience/Truxima).

PNH: prior failure of Soliris or Ultomiris required for switch therapy
IgAN: unsuccessful 3-month trials of Vanrafia and Filspari AND Tarpeyo (must submit chart notes/labs)
C3G: unsuccessful 90-day trial of corticosteroids+mycophenolate or rituximab (documentation required)

Documentation Required

Required Supporting Documentation

Provide all required supporting documentation with the authorization request. Missing labs, biopsy reports, flow cytometry, chart notes, and paid pharmacy claims may result in denial or delay. Specific documentation requirements by indication:

PNH: flow cytometry showing ≥10% PNH clones and pathology report demonstrating ≥2 different GPI protein deficiencies in two different cell lines; labs demonstrating hemolysis (e.g., LDH >1.5×ULN) and supporting evidence for transfusion dependence, thrombosis, organ damage, or other clinical indications (submit chart notes and labs)
IgAN: biopsy-proven diagnosis (submit biopsy), recent labs within 30 days showing total urine protein ≥1 g/day or urine protein-to-creatinine ratio ≥1.0 g/g and eGFR ≥30 mL/min/1.73 m2; documentation of stable, maximally tolerated RAAS inhibitor therapy for ≥90 days (chart notes or pharmacy paid claims)
C3G: biopsy results confirming diagnosis (submit biopsy), recent labs within 30 days showing urine protein-to-creatinine ratio ≥1.0 g/g and eGFR ≥30 mL/min/1.73 m2; documentation of stable maximally tolerated RAAS inhibitor therapy for ≥90 days (chart notes or pharmacy paid claims)
Vaccination: evidence of vaccination against encapsulated bacteria (Streptococcus pneumoniae, Neisseria meningitidis, Haemophilus influenzae type B) at least 2 weeks prior to initiation
Conversion from C5 inhibitors: document timing when converting from eculizumab (start iptacopan within 1 week of last dose) or ravulizumab (within 6 weeks)

Documentation Required

Administrative Documentation Required

Administrative information must be complete and legible. The prescriber must sign and print their name (preprinted stamps are not valid). Include member identifiers, AvMed member number, date of birth, prescriber NPI, office contact name, phone and fax. Incomplete or illegible administrative fields may delay the authorization.

Prescriber signature and printed name required (stamps not valid)
Member name, AvMed ID, date of birth
Prescriber NPI, office contact, phone and fax

Denial Risk

Incomplete or Missing Documentation May Result in Denial

Requests missing required supporting or administrative documentation (e.g., labs, flow cytometry reports, biopsy results, chart notes, proof of prior therapy, vaccination records, signed prescriber signature, or pharmacy paid claims) are at risk for delay or denial.

Missing signature or illegible information may result in delay/denial
Absent diagnostic labs, biopsy, or flow cytometry reports may result in denial
Lack of documentation of prior therapy trials or vaccine records may result in denial

Diagnostic and Laboratory Thresholds

inv-07: PNH clone size (flow cytometry) — threshold value

PNH clone size (flow cytometry)>= 10% PNH clones by flow cytometry

Required cell-line confirmationFlow cytometry must demonstrate at least two different GPI protein deficiencies (e.g., CD55, CD59) in two different cell lines

DocumentationSubmit flow cytometry pathology report with laboratory values to support clone percentage

inv-08: Urine protein / UPCR threshold

Urine protein thresholdTotal urine protein >= 1 g/day

UPCR thresholdUrine protein-to-creatinine ratio (UPCR) >= 1.0 g/g

Timing of labsSubmit urine protein/UPCR results taken within the last 30 days

inv-09: eGFR threshold

eGFR threshold>= 30 mL/min/1.73 m2

Timing of measurementeGFR must be from labs obtained within the last 30 days

Applies to indicationsRequired for both IgAN and C3G initial eligibility and reauthorization

inv-10: LDH for hemolysis threshold

LDH threshold for hemolysis> 1.5 x ULN (lactate dehydrogenase)

ContextRequired laboratory evidence of significant hemolysis for PNH treatment-naive eligibility

DocumentationSubmit LDH lab result demonstrating >1.5 x ULN

Step Therapy Requirements

Requirement	Documentation to submit
Verification of prior RAAS optimization or prior specific agent trial (e.g., 90-day trial of RAAS optimization for IgAN/C3G; 3-month trials of Vanrafia or Filspari AND Tarpeyo for IgAN; 90-day trial of corticosteroids + mycophenolate or rituximab for C3G)
Chart notes documenting treatment course and clinical response or pharmacy paid claims confirming fills and durations of the prior therapy
Laboratory or test results where indicated to confirm failure (e.g., urine protein/UPCR and eGFR for IgAN/C3G) submitted within last 30 days per indication requirements
Biopsy report when required to confirm diagnosis (biopsy-proven IgAN or C3G)
Signed prior authorization form with prescriber information and supporting documentation attached (chart notes, lab reports, pharmacy paid claims)

Key Definitions and Thresholds

inv-18: PNH diagnostic criteria (PNH clones >=10% by flow cytometry, at least two different cell lineages)

PNH diagnostic clone thresholdPNH clones >= 10% by flow cytometry

GPI deficiency requirementDemonstration of at least two different GPI protein deficiencies in two different cell lines (e.g., CD55, CD59)

Required evidenceSubmit flow cytometry pathology report to confirm diagnosis

inv-19: Proteinuria thresholds for IgAN and C3G (urine protein >=1 g/day or UPCR >=1.0 g/g; eGFR >=30 mL/min/1.73 m2)

Proteinuria thresholdUrine protein >= 1 g/day OR UPCR >= 1.0 g/g

eGFR requirementeGFR >= 30 mL/min/1.73 m2

Lab timingResults must be from tests performed within the last 30 days

Background

Iptacopan (Fabhalta) is an oral complement pathway inhibitor indicated in this policy for paroxysmal nocturnal hemoglobinuria (PNH), primary IgA nephropathy (IgAN), and complement 3 glomerulopathy (C3G). The document requires prescriber oversight (hematologist or nephrologist), enrollment in the Fabhalta REMS program for PNH use, and appropriate vaccination against encapsulated organisms prior to initiation. For PNH, diagnostic confirmation requires flow cytometry demonstrating PNH clones ≥10% with at least two different GPI protein deficiencies and laboratory evidence of hemolysis (e.g., LDH >1.5 x ULN); for renal indications the policy requires proteinuria thresholds (e.g., urine protein ≥1 g/day or UPCR ≥1.0 g/g) and eGFR ≥30 mL/min/1.73 m2. Initial authorizations are typically for 6 months with reauthorization contingent on clinical response and safety.