CurrentColorado Rocky Mountain Health PlansPolicy 2025 P 2390-1

Voyxact (sibeprenlimab-szsl) prior authorization for IgA nephropathy

Prior authorization and medical necessity criteria for Voyxact (sibeprenlimab-szsl) to reduce proteinuria in adults with primary IgA nephropathy (IgAN); applies to prescribers and pharmacy/medical benefits review for covered members.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyVoyxact (sibeprenlimab-szsl) prior authorization for IgA nephropathy

Policy CodePolicy 2025 P 2390-1

Change TypeNew prior authorization program

Effective DateApr 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization with documentation of biopsy‑confirmed primary IgAN, eGFR ≥30, stabilized ACEi/ARB and SGLT2 therapy (or documented contraindications), nephrologist involvement, and evidence of proteinuria reduction for reauthorization.

SourceLink

POLICY UPDATE CHANGES

New prior authorization program established for Voyxact (sibeprenlimab-szsl) for IgAN.

2026-04-01policy effective date

01/2026P&T approval

≥30eGFR threshold

12 monthsapproval duration

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Initial Therapy

Initial Authorization — Voyxact will be approved when ALL of the following are met:

Initial Authorization Criteria

Diagnosis of primary immunoglobulin A nephropathy (IgAN) confirmed by renal biopsy.
Risk status: Patient is at risk of rapid disease progression.
Indication: Used to reduce proteinuria.
Renal function: Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2.eGFR ≥ 30 mL/min/1.73 m2
Concomitant ACEi/ARB requirement: Either patient is on a stabilized dose and receiving concomitant therapy with a maximally tolerated ACE inhibitor or ARB, OR patient has a contraindication or intolerance to ACE inhibitors and ARBs.
Concomitant SGLT2 requirement: Either patient is on a stabilized dose and receiving concomitant therapy with a maximally tolerated SGLT2 inhibitor, OR patient has a contraindication or intolerance to SGLT2 inhibitors.
Glucocorticoid history: History of failure to a 30-day trial of a glucocorticoid, or documented contraindication or intolerance to glucocorticoids.
Prescriber: Prescribed by or in consultation with a nephrologist.

ref

title

ref_verbose

Continuation Therapy

Reauthorization — Voyxact will be approved when the following are met:

Reauthorization Criteria

Clinical response: Documentation of positive clinical response demonstrated by a reduction in proteinuria.

ref

title

ref_verbose

The policy notes that Voyxact received its IgAN indication under an accelerated approval pathway. As stated in the product background, approval was granted based on a reduction in proteinuria, and long‑term benefit on kidney function has not been established. Continued approval for this indication may therefore be contingent on confirmatory trial data verifying clinical benefit.

This policy covers use of Voyxact only for the documented indication: to reduce proteinuria in adults with biopsy‑confirmed primary IgA nephropathy (IgAN) who are at risk of rapid disease progression. Use for other indications is not supported by this policy. In addition, automated or claims‑based approvals and program supply limits may apply per the payer’s administrative rules.

Initial Therapy

Initial Authorization — Voyxact will be approved when ALL of the following are met:

Initial Authorization Criteria

Diagnosis of primary immunoglobulin A nephropathy (IgAN) confirmed by renal biopsy.
Risk status: Patient is at risk of rapid disease progression.
Indication: Used to reduce proteinuria.
Renal function: Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2.eGFR ≥ 30 mL/min/1.73 m2
Concomitant ACEi/ARB requirement: Either patient is on a stabilized dose and receiving concomitant therapy with a maximally tolerated ACE inhibitor or ARB, OR patient has a contraindication or intolerance to ACE inhibitors and ARBs.
Concomitant SGLT2 requirement: Either patient is on a stabilized dose and receiving concomitant therapy with a maximally tolerated SGLT2 inhibitor, OR patient has a contraindication or intolerance to SGLT2 inhibitors.
Glucocorticoid history: History of failure to a 30-day trial of a glucocorticoid, or documented contraindication or intolerance to glucocorticoids.
Prescriber: Prescribed by or in consultation with a nephrologist.

ref

title

ref_verbose

Coding & Thresholds

eGFR threshold — requirement

eGFR requirementEstimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2

Purpose of thresholdMinimum renal function required for initial authorization of Voyxact

Related criteriaMust be met in conjunction with biopsy-confirmed primary IgAN and at-risk status

eGFR ≥ 30 mL/min/1.73 m2 — definition/threshold

Defined thresholdeGFR ≥ 30 mL/min/1.73 m2

Where appliedPart of initial authorization criteria for Voyxact (must be met AND other criteria)

Measurement contextEstimated glomerular filtration rate reported in mL/min/1.73 m2

Provider Actions & Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Voyxact requires prior authorization before initiation. Approval duration: 12 months. State mandates, federal requirements, and member benefit plan coverage may also affect authorization.

Prior authorization required for initial and reauthorization requests.
Authorization period: 12 months.

Prior Authorization

Concomitant Therapy Required

Concomitant therapy requirement: Member must be receiving concomitant therapy with maximally tolerated doses of an ACE inhibitor or ARB, and a maximally tolerated SGLT2 inhibitor, unless there is documented intolerance or contraindication.

Patient must be on a stabilized dose of a maximally tolerated ACE inhibitor (e.g., captopril, enalapril) or maximally tolerated ARB (e.g., candesartan, valsartan).
Patient must be on a stabilized dose of a maximally tolerated SGLT2 inhibitor (e.g., empagliflozin) or have documented intolerance/contraindication to SGLT2 inhibitors.

Documentation Required

Medical Record Documentation Must Include

Documentation Required: Medical records must support the diagnosis and clinical need for therapy.

Diagnosis of primary immunoglobulin A nephropathy (IgAN) confirmed by renal biopsy (denial likely if not biopsy-confirmed).
Evidence that therapy is being used to reduce proteinuria and documentation of risk of rapid disease progression.
Baseline and follow-up documentation including eGFR (must be ≥ 30 mL/min/1.73 m2 at initiation), proteinuria measurements, and clinical notes.
Documentation of failure of a 30-day trial of a glucocorticoid, or documented contraindication/intolerance to glucocorticoids, when applicable.
Prescription by or in consultation with a nephrologist.

Denial Risk

Denial Likely If

Denial Risk Conditions: Requests are at high risk of denial when key criteria are missing or not met.

Diagnosis not confirmed by renal biopsy.
eGFR persistently < 30 mL/min/1.73 m2.
No evidence the patient is at risk of rapid disease progression.
Lack of documentation that patient is on maximally tolerated ACEi/ARB and SGLT2 inhibitor or lacks documented intolerance/contraindication.
No documentation of trial/failure or contraindication to glucocorticoids when required.
Prescriber is not a nephrologist and no nephrology consultation is documented.

Step Therapy Requirements

Requirement	Details
ACE inhibitor or ARB	Patient is on a stabilized dose and receiving concomitant therapy with a maximally tolerated angiotensin‑converting enzyme (ACE) inhibitor (e.g., captopril, enalapril) or a maximally tolerated angiotensin II receptor blocker (ARB) (e.g., candesartan, valsartan), or has a documented intolerance/contraindication to ACEi/ARB.
SGLT2 inhibitor	Patient is on a stabilized dose and receiving concomitant therapy with a maximally tolerated sodium‑glucose cotransporter‑2 (SGLT2) inhibitor (e.g., empagliflozin/Jardiance), or has a documented intolerance/contraindication to SGLT2 inhibitors.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyVoyxact (sibeprenlimab-szsl) prior authorization for IgA nephropathy

Policy CodePolicy 2025 P 2390-1

Change TypeNew prior authorization program

Effective DateApr 1, 2026

Next Review DateN/A

SourceLink

On This Page

OpenPayer

Voyxact (sibeprenlimab-szsl) prior authorization for IgA nephropathy

Coverage Criteria

Initial Therapy

Continuation / Reauthorization Criteria

Coding & Thresholds

Provider Actions & Documentation Requirements

Step Therapy Requirements

Key Definitions

Background