CurrentAvMedPolicy N/A

Prior authorization form and coverage criteria for Voyxact (sibeprenlimab-szsi)

Form and clinical criteria required for pharmacy prior authorization and step-edit requests for Voyxact (sibeprenlimab-szsi) for AvMed members; applies to prescribers requesting coverage through the payer's specialty pharmacy process.

Policy Summary

PayerAvMed

PolicyPrior authorization form and coverage criteria for Voyxact (sibeprenlimab-szsi)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed prior authorization form with prescriber signature and supporting documentation including recent labs (UPCR/protein and eGFR) and evidence of prior therapy trials.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

9 monthsinitial authorization duration

12 monthsreauthorization duration

1 inj / 28dquantity limit

400 mgdosage per injection

≥18minimum age

Coverage Criteria for Voyxact (sibeprenlimab-szsi)

inv-01: Initial Therapy

Covered when ALL of the following are met for initial authorization

Initial authorization requirements: Member is 18 years of age or older; Provider is a nephrologist; Diagnosis of biopsy-proven, primary immunoglobulin A nephropathy (IgAN) and is at risk of rapid disease progression; Member is established on a stable and maximally tolerated dose of a RAAS inhibitor (ACE inhibitor or ARB) for at least 90 days (verified by chart notes and/or pharmacy paid claims); Total urine protein ≥ 1 g/day OR urine protein-to-creatinine ratio (UPCR) ≥ 0.75 g/g (laboratory results within 30 days must be submitted); eGFR ≥ 30 mL/min/1.73 m2 (laboratory results within 30 days must be submitted); Member is NOT currently receiving dialysis and has NOT undergone a kidney transplant; Member has had unsuccessful 3-month trials of Vanrafia or Filspari AND Tarpeyo with documentation of therapy failure (chart notes or lab results); Member is NOT using concomitant complement inhibitor therapies including Voyxact, Vanrafia, Tarpeyo, Filspari, Fabhalta, Empaveli, Soliris, Ultomiris, or Voydeya

Initial authorization duration 9 months

inv-02: Continuation Therapy / Reauthorization

Reauthorization requirements (covered when ALL of the following are met)

Policy Summary

PayerAvMed

PolicyPrior authorization form and coverage criteria for Voyxact (sibeprenlimab-szsi)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed prior authorization form with prescriber signature and supporting documentation including recent labs (UPCR/protein and eGFR) and evidence of prior therapy trials.

SourceLink

On This Page

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Reauthorization requirements: Member continues to meet all initial authorization criteria; Member must have reduction in UPCR or proteinuria from baseline after initial approval and reduction or stabilization in UPCR or proteinuria after subsequent approvals (current lab test results must be submitted); eGFR ≥ 30 mL/min/1.73 m2 (laboratory results within 30 days must be submitted); Member has NOT experienced treatment-restricting adverse effects (e.g., hepatotoxicity, acute kidney injury)

Reauthorization duration 12 months

The following conditions preclude approval for Voyxact (sibeprenlimab-szsi): the member is currently receiving dialysis or the member has undergone a kidney transplant. These exclusions must be documented on the prior authorization form and supported by relevant chart notes or lab records; requests that indicate either condition should be denied per the coverage criteria.

Diagnosis, Laboratory and Coding Requirements

Diagnosis codes (to be supplied by prescriber)ICD-10

ICD Code, if applicable (to be provided on form)

Total urine protein or UPCR — Thresholds

RequirementTotal urine protein ≥ 1 g/day OR urine protein-to-creatinine ratio (UPCR) ≥ 0.75 g/g (laboratory results must be from within the last 30 days)

Accepted measuresEither 24-hour total urine protein or UPCR may be used to document proteinuria

DocumentationSubmit supporting lab results with the prior authorization request to verify the value

eGFR — Threshold

RequirementEstimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2 (lab results must be from within the last 30 days)

Reauthorization noteReauthorization requires current labs showing eGFR ≥ 30 mL/min/1.73 m2

DocumentationSubmit recent eGFR result with the prior authorization request

Provider Actions and Submission Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required — Use this form with prescriber signature and supporting documentation; initial approval duration noted.

Prescriber must sign and clearly print name (preprinted stamps not valid).
Fax completed form to 1-305-671-0200.
Initial Authorization: 9 months; Reauthorization: 12 months.

Step Therapy

Step-Edit and Prior Therapy Verification

Step-edit and prior therapy verification — verification will be performed via pharmacy paid claims or submitted chart notes. Use of samples to initiate therapy does not meet step edit/prior authorization criteria.

Previous therapies will be verified through pharmacy paid claims or submitted chart notes.
Member must have had unsuccessful 3-month trials of Vanrafia, Filspari AND Tarpeyo (chart notes or lab results required).
Medication provided by Specialty Pharmacy - Proprium Rx.

Documentation Required

Required Documentation

Required documentation — Prescriber signature, member identifiers, dosing, weight, diagnosis/ICD, recent labs, and supporting notes must be provided. Incomplete information may delay or deny the authorization.

Member name, AvMed ID number, and date of birth.
Prescriber name, NPI, office contact, phone and fax number, and prescriber signature with date.
Drug name/form/strength, dosing schedule, length of therapy, recommended dosage, and quantity requested.
Diagnosis and ICD code (if applicable); chart notes supporting biopsy-proven primary IgA nephropathy.
Weight and date weight obtained (if applicable).
Recent lab results (within last 30 days) documenting: total urine protein ≥ 1 g/day OR UPCR ≥ 0.75 g/g, and eGFR ≥ 30 mL/min/1.73 m2.
Documentation confirming member is not on dialysis and has not had a kidney transplant.
Documentation of prior therapy failures (3-month trials) and any pharmacy claims/chart notes verifying prior treatments.

Denial Risk

Triggers for Delay or Denial

Triggers for delay or denial — Incomplete, incorrect, or illegible forms or missing supporting documentation (labs, diagnostics, chart notes, prescriber signature) may delay or result in denial of the authorization request.

Missing or illegible prescriber signature (preprinted stamps not valid).
Incomplete member or prescriber information (missing AvMed number, DOB, NPI, contact info).
Missing dosing, weight (if applicable), recommendation, or quantity details.
Absent or outdated labs (required labs must be within 30 days).
No evidence of required prior therapies or verification via pharmacy claims/chart notes.
Use of samples to initiate therapy — samples do not meet step edit/authorization criteria.

Background

Voyxact (sibeprenlimab-szsi) is indicated for adults with biopsy-proven primary immunoglobulin A nephropathy (IgAN) who are at risk of rapid disease progression. Prior authorization requires submission of recent laboratory results demonstrating baseline proteinuria and renal function, specifically Total urine protein ≥ 1 g/day OR UPCR ≥ 0.75 g/g and eGFR ≥ 30 mL/min/1.73 m2. Initial approval is contingent on meeting all criteria including prior therapy trials and absence of dialysis or kidney transplant; the initial authorization period is 9 months with reauthorization available for 12 months when response and safety criteria are met.

Definitions and Measurement Criteria

IgAN — Definition

DefinitionBiopsy-proven, primary immunoglobulin A nephropathy (IgAN)

Intended populationAdults with biopsy-proven primary IgAN at risk of rapid disease progression

DocumentationChart notes confirming biopsy-proven diagnosis must be submitted with the request

Proteinuria measures — UPCR and 24-hour protein

UPCRUrine protein-to-creatinine ratio (UPCR); threshold for approval: ≥ 0.75 g/g

24-hour proteinTotal 24-hour urine protein; threshold for approval: ≥ 1 g/day

TimingLaboratory test results must be taken within the last 30 days and submitted with the request

Initial Therapy Dosing and Criteria

inv-14: Initial dosing and criteria

Initial authorization criteria and dosing

Dosing and administration: Recommended dosage: 400 mg / 2 mL injected subcutaneously once every 4 weeks; Quantity limit: 2 mL (1 injection = 400 mg) per 28 days; Medication provided by specialty pharmacy - Proprium Rx

Initial authorization duration 9 months

Reauthorization / Continuation Criteria

inv-15: Reauthorization

Reauthorization criteria require clinical response and safety

Reauthorization: Documented reduction in UPCR or proteinuria from baseline after initial approval and reduction or stabilization thereafter (current lab results must be submitted); eGFR ≥ 30 mL/min/1.73 m2 (labs within 30 days); No treatment-restricting adverse effects (e.g., hepatotoxicity, acute kidney injury); Member continues to meet all initial authorization criteria

Reauthorization for 12 months

Step Therapy Requirements

Step	Prior therapy requirement	Verification method	Duration of required trial
1	Unsuccessful 3-month trials of Vanrafia (sparsentan) or Filspari AND Tarpeyo (budesonide)	Pharmacy paid claims documentation or submitted chart notes confirming therapy and clinical failure	3 months

Quantity Limits and Dosage

Voyxact (sibeprenlimab-szsi) — Product and dosing

ProductVoyxact (sibeprenlimab-szsi)

Presentation2 mL per vial (1 injection = 400 mg)

Recommended dosage400 mg (2 mL) injected subcutaneously once every 4 weeks

Quantity limit2 mL (1 injection = 400 mg) per 28 days

Site of Care and Dispensing

Note

Specialty pharmacy dispensing — Proprium Rx

This medication is dispensed through the specialty pharmacy service (Proprium Rx); coordinate dispensing and site‑of‑care arrangements with Proprium Rx.

Medication being provided by Specialty Pharmacy - Proprium Rx