Neighborhood Health Plan RI Fabhalta Coverage | OpenPayer
CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A
Fabhalta (iptacopan) — Coverage Criteria for IgAN and C3G
Covers use of Fabhalta (iptacopan) for adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid progression and for adults with complement 3 glomerulopathy (C3G) when specific clinical criteria are met; defines authorization, reauthorization, quantity limits, and exclusions.
Policy Summary
PayerNeighborhood Health Plan of Rhode Island
PolicyFabhalta (iptacopan) — Coverage Criteria for IgAN and C3G
Policy CodePolicy N/A
Change TypeNo material change
Effective DateMar 1, 2025
Next Review DateN/A
Key ActionObtain prior authorization with documentation of biopsy-confirmed diagnosis, recent labs showing proteinuria/UPCR and eGFR, and evidence of prior trials or intolerance to required therapies.
No material clinical or coverage changes in this revision.
6 monthsauthorization period
2 caps/dayquantity limit
≥1.5 g/gIgAN UPCR threshold
≥1.0 g/gC3G UPCR threshold
≥20 / ≥30eGFR minimums
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Coverage Criteria for Fabhalta (iptacopan)
Initial Therapy — Primary IgAN
Authorization of 6 months may be granted when ALL of the following are met:
IgAN initial criteria: 1. Age ≥18 years; 2. Kidney biopsy confirming a diagnosis of primary immunoglobulin A nephropathy (IgAN); 3. Prescribed by or in consultation with a nephrologist; 4. Laboratory report and/or chart note within the previous 3 months showing proteinuria ≥1 g/day or baseline urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g based on a 24-hour urine collection; 5. Documentation that eGFR ≥20 mL/min/1.73 m2; 6. Receiving a stable dose of maximally tolerated renin-angiotensin system (RAS) inhibitor (e.g., ACEI or ARB) for ≥3 months prior to initiation, or has intolerance/contraindication to RAS inhibitors; 7. Receiving a stable dose of maximally tolerated sodium-glucose cotransporter-2 (SGLT2) inhibitor for ≥3 months prior to initiation, or has intolerance/contraindication to SGLT2 inhibitors; 8. Documented inadequate response, intolerance, or contraindication to a 30-day trial of an oral glucocorticoid (e.g., prednisone); 9. Documented inadequate response, intolerance, or contraindication to Filspari or Vanrafia; 10. Not using the requested medication in combination with Filspari, Vanrafia, Voyxact, or Tarpeyo; 11. Not currently receiving dialysis and no prior kidney transplant.all must be met
Authorization of 6 months may be granted when ALL of the following are met:
C3G initial criteria: 1. Kidney biopsy confirming a diagnosis of complement 3 glomerulopathy (C3G); 2. Age ≥18 years; 3. Prescribed by or in consultation with a nephrologist; 4. Laboratory report and/or chart note within the previous 3 months showing proteinuria ≥1 g/day or baseline urine protein-to-creatinine ratio (UPCR) ≥1.0 g/g based on a 24-hour urine collection; 5. Documentation that eGFR ≥30 mL/min/1.73 m2; 6. Baseline reduced serum C3 (defined as <0.85 times the lower limit of normal per reference range); 7. Receiving a stable dose of maximally tolerated renin-angiotensin system (RAS) inhibitor (e.g., ACEI or ARB) for ≥3 months prior to initiation, or has intolerance/contraindication to RAS inhibitors; 8. Receiving a stable dose of maximally tolerated sodium-glucose cotransporter-2 (SGLT2) inhibitor for ≥3 months prior to initiation, or has intolerance/contraindication to SGLT2 inhibitors; 9. Will NOT be using the requested agent in combination with Empaveli.all must be met
From policy C3G initial authorization
Continuation Therapy — IgAN
Authorization of 6 months may be granted for continued treatment when ALL of the following are met:
IgAN reauthorization: 1. No evidence of unacceptable toxicity or disease progression while on the current regimen; 2. Recent laboratory report and/or chart note(s) demonstrating benefit from therapy as evidenced by either: (i) decreased proteinuria from baseline on a 24‑hour urine collection, or (ii) decrease in UPCR from baseline on a 24‑hour urine collection; 3. Documentation that eGFR remains ≥20 mL/min/1.73 m2; 4. Member is not using the requested medication in combination with Filspari, Vanrafia, or Tarpeyo.all must be met
From policy IgAN reauthorization
Continuation Therapy — C3G
Authorization of 6 months may be granted for continued treatment when ALL of the following are met:
C3G reauthorization: 1. No evidence of unacceptable toxicity or disease progression while on the current regimen; 2. Recent laboratory report and/or chart note(s) demonstrating benefit from therapy as evidenced by either: (a) decreased proteinuria from baseline on a 24‑hour urine collection, or (b) decrease in UPCR from baseline on a 24‑hour urine collection; 3. Documentation that eGFR remains ≥30 mL/min/1.73 m2; 4. Member will NOT be using the requested agent in combination with Empaveli.all must be met
From policy C3G reauthorization
All indications for Fabhalta (iptacopan) that are not the FDA‑approved indications for primary immunoglobulin A nephropathy (IgAN) or complement 3 glomerulopathy (C3G) are considered experimental/investigational and not medically necessary. The FDA‑approved uses covered by policy are limited to: reducing proteinuria in adults with primary IgAN at risk of rapid progression and reducing proteinuria in adults with C3G; requests for other diagnoses do not meet coverage criteria and should be denied as not medically necessary.
Use of Fabhalta for any indication other than the FDA‑approved indications for adults with primary IgAN (to reduce proteinuria in patients at risk of rapid progression) and adults with C3G (to reduce proteinuria) is considered experimental/investigational and not medically necessary. Continued approval for the IgAN indication is under accelerated approval and requires confirmatory data to establish clinical benefit on kidney function.
Clinical Thresholds and Coding-related Values
UPCR / 24-hour proteinuria
IgAN UPCR / 24‑hr proteinuriaUPCR ≥1.5 g/g or ≥1 g/day (based on 24‑hour urine collection)
C3G UPCR / 24‑hr proteinuriaUPCR ≥1.0 g/g or ≥1 g/day (based on 24‑hour urine collection)
Documentation timingLaboratory report and/or chart notes must be within the previous 3 months
eGFR minimums
IgAN minimum eGFReGFR ≥20 mL/min/1.73 m2
C3G minimum eGFReGFR ≥30 mL/min/1.73 m2
Documentation timing
Provider Requirements, Documentation, and Denials
Prior Authorization
Prior Authorization Required
Prior authorization is required for initial therapy. For IgAN, authorization of up to 6 months may be granted when all initial criteria are met, including biopsy-proven diagnosis, age ≥18, nephrologist involvement, recent labs documenting proteinuria/UPCR and eGFR ≥20 mL/min/1.73 m2, and stable maximally tolerated RAS inhibitor and SGLT2 inhibitor therapy for ≥3 months unless contraindicated or intolerant. For C3G, authorization of up to 6 months may be granted when all initial criteria are met, including biopsy-proven diagnosis, age ≥18, nephrologist involvement, recent labs documenting proteinuria/UPCR and eGFR ≥30 mL/min/1.73 m2, reduced baseline serum C3, and stable maximally tolerated RAS inhibitor and SGLT2 inhibitor therapy for ≥3 months unless contraindicated or intolerant.
IgAN: documentation of kidney biopsy confirming diagnosis (required)
IgAN: documentation that eGFR ≥ 20 mL/min/1.73 m2 (required)
IgAN: member receiving stable, maximally tolerated RAS inhibitor (ACEI or ARB) for ≥3 months prior to initiation, or documentation of intolerance/contraindication
IgAN: member receiving stable, maximally tolerated SGLT2 inhibitor for ≥3 months prior to initiation, or documentation of intolerance/contraindication
Background on Fabhalta (iptacopan)
Fabhalta (iptacopan) is an oral complement pathway inhibitor indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression (generally defined as UPCR ≥ 1.5 g/g) and to reduce proteinuria in adults with complement 3 glomerulopathy (C3G). The IgAN approval was granted under accelerated approval based on proteinuria reduction; it has not been established whether Fabhalta slows kidney function decline and continued approval may depend on confirmatory trial results.
Definitions and Regulatory Notes
Proteinuria/UPCR thresholds — detailed
IgAN detailed thresholdUPCR ≥1.5 g/g or ≥1 g/day (24‑hour urine); must be documented within previous 3 months
C3G detailed thresholdUPCR ≥1.0 g/g or ≥1 g/day (24‑hour urine); must be documented within previous 3 months
Measurement standardThresholds are based on 24‑hour urine collection or equivalent UPCR result
Accelerated approval — note
Accelerated approval — statementThe IgAN indication is approved under accelerated approval based on reduction of proteinuria
Implication for clinical benefitClinical benefit on slowing kidney function decline has not been established
Policy Summary
PayerNeighborhood Health Plan of Rhode Island
PolicyFabhalta (iptacopan) — Coverage Criteria for IgAN and C3G
Policy CodePolicy N/A
Change TypeNo material change
Effective DateMar 1, 2025
Next Review DateN/A
Key ActionObtain prior authorization with documentation of biopsy-confirmed diagnosis, recent labs showing proteinuria/UPCR and eGFR, and evidence of prior trials or intolerance to required therapies.
C3G: documentation that eGFR ≥ 30 mL/min/1.73 m2 (required)
C3G: documentation of reduced serum C3 at baseline (defined as <0.85 × lower limit of normal per lab reference)
C3G: member receiving stable, maximally tolerated RAS inhibitor (ACEI or ARB) for ≥3 months prior to initiation, or documentation of intolerance/contraindication
C3G: member receiving stable, maximally tolerated SGLT2 inhibitor for ≥3 months prior to initiation, or documentation of intolerance/contraindication
C3G: not using the requested agent in combination with Empaveli
Documentation Required
Required documentation
Provide documentation to support the initial request and any reauthorization. Required documentation must be submitted with the prior authorization request.
Kidney biopsy report confirming diagnosis (IgAN or C3G)
Recent laboratory reports or clinic chart notes within the previous 3 months documenting proteinuria and/or UPCR (24-hour urine collection preferred)
For C3G: baseline serum C3 demonstrating reduced level (<0.85 × lower limit of normal per reference)
Documentation of prior therapies: trials, inadequate response, intolerance, or contraindications (see required prior therapies)
Documentation of stable dosing of maximally tolerated RAS inhibitor (ACEI or ARB) and SGLT2 inhibitor for ≥3 months prior to initiation, or documentation of intolerance/contraindication to these classes
For reauthorization: recent labs/chart notes demonstrating clinical benefit (decreased proteinuria or decreased UPCR from baseline) and no evidence of unacceptable toxicity or disease progression
Step Therapy
Required prior therapies
Members must have trialed and had inadequate response or have intolerance/contraindication to specified alternative therapies prior to approval.
For IgAN: documented inadequate response, intolerance, or contraindication to a 30-day trial of an oral glucocorticoid (e.g., prednisone)
For IgAN: documented inadequate response, intolerance, or contraindication to Filspari or Vanrafia
For C3G: do not use requested agent in combination with Empaveli (combination prohibited)
For IgAN: do not use requested agent in combination with Filspari, Vanrafia, Voyxact, or Tarpeyo (combination prohibited)
Denial Risk
Denial triggers
Requests that lack the required biopsy, age, laboratory (UPCR/proteinuria), eGFR, concomitant therapy, or prior treatment trial documentation may be denied.
Missing kidney biopsy confirming diagnosis
Age <18 years without appropriate exception
No recent (within 3 months) lab documentation of proteinuria or UPCR at disease-specific thresholds
eGFR below required threshold for the condition (IgAN <20 mL/min/1.73 m2; C3G <30 mL/min/1.73 m2)
No documentation of trial of maximally tolerated RAS inhibitor and SGLT2 inhibitor for ≥3 months or documentation of intolerance/contraindication
No documentation of prior trial and inadequate response/intolerance/contraindication to required alternative therapies
Requirement for continued approvalContinued approval may depend on confirmatory trial verification of clinical benefit