FDA LABELED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
Voyxact® (sibeprenlimab-szsi) Subcutaneous injection |
To reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression |
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1 |
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.
PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL
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Module |
Clinical Criteria for Approval |
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*Preferred Agents may be targeted in another Utilization Management program and require Prior Authorization Initial Evaluation Target Agent(s) will be approved when ALL of the following are met: 1. ONE of the following: A. The patient has a diagnosis of primary immunoglobulin A nephropathy (IgAN) confirmed by kidney biopsy AND all of the following: 1. ONE of the following: A. The patient has a urine protein-to-creatinine ratio (UPCR) greater than or equal to 0.44 g/g OR B. The patient has proteinuria greater than or equal to 0.5 g/day AND 2. The patient’s eGFR is greater than or equal to 30 mL/min/1.73 m^2 AND 3. The patient has ONE of the following: A. Tried and had an inadequate response after at least a 3-month duration of therapy with a maximally tolerated angiotensin-converting-enzyme inhibitor (ACEi, e.g., benazepril, lisinopril) or angiotensin II blocker (ARB, e.g., losartan), or a combination medication containing an ACEi or ARB OR B. An intolerance or hypersensitivity to an ACEi or ARB, or a combination medication containing an ACEi or ARB OR C. An FDA labeled contraindication to ALL ACEi and ARB OR B. The patient has another FDA labeled indication for the requested agent and route of administration AND 2. If the client has preferred agents, then ONE of the following: A. The requested agent is a preferred agent OR B. The requested agent is a non-preferred agent AND the patient has ONE of the following: 1. Tried and had an inadequate response to ONE preferred agent OR 2. An intolerance or hypersensitivity to ONE preferred agent OR 3. An FDA labeled contraindication to ALL preferred agents AND 3. If the patient has an FDA labeled indication, then ONE of the following: A. The patient’s age is within FDA labeling for the requested indication for the requested agent OR B. There is support for using the requested agent for the patient’s age for the requested indication AND 4. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., nephrologist), or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND 5. The patient does NOT have any FDA labeled contraindications to the requested agent Length of Approval: 12 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.
Renewal Evaluation Target Agent(s) will be approved when ALL of the following are met: 1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process (Note: patients not previously approved for the requested agent will require initial evaluation review) AND 2. ONE of the following: A. The patient has a diagnosis of primary immunoglobulin A nephropathy (IgAN) AND the patient has had improvements or stabilization with the requested agent as indicated by ONE of the following: 1. Decrease from baseline (prior to treatment with the requested agent) of urine protein-to-creatinine (UPCR) ratio OR 2. Decrease from baseline (prior to treatment with the requested agent) in proteinuria OR B. The patient has a diagnosis other than IgAN AND has had clinical benefit with the requested agent AND 3. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., nephrologist), or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND 4. The patient does NOT have any FDA labeled contraindications to the requested agent Length of Approval: 12 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria. |
PRIOR AUTHORIZATION CLINICAL CRITERIA OPERATIONAL LEVEL OF EVIDENCE REQUIREMENTS
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Module |
Ops Set Up |
Validation Options |
Other Explanation |
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Validation: Apply Baseline and go to Validation Options |
Age Verification;Contraindication, intolerance, hypersensitivity;Lab Values;Renewal Clinical Benefit - check for specific efficacy/improvement |
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QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL
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Module |
Clinical Criteria for Approval |
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Universal QL |
Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met: 1. The requested quantity (dose) does NOT exceed the program quantity limit OR 2. The requested quantity (dose) exceeds the program quantity limit AND ONE of the following: A. BOTH of the following: 1. The requested agent does NOT have a maximum FDA labeled dose for the requested indication AND 2. There is support for therapy with a higher dose for the requested indication OR B. BOTH of the following: 1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND 2. There is support for why the requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does NOT exceed the program quantity limit OR C. BOTH of the following: 1. The requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND 2. There is support for therapy with a higher dose for the requested indication Length of Approval: up to 12 months |
QUANTITY LIMIT CLINICAL CRITERIA OPERATIONAL LEVEL OF EVIDENCE REQUIREMENTS
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Module |
Ops Set Up |
Validation Options |
Other Explanation |
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Universal QL |
Validation: Apply Baseline and go to Validation Options |
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Immunoglobulin A Nephropathy |
Immunoglobulin A nephropathy (IgAN) is the most common primary glomerular disease in the world, and it is the leading cause of chronic kidney disease (CKD) and kidney failure. The disease occurs when IgA deposits build up in the kidneys, causing inflammation that damages the glomeruli, in turn causing the kidneys to leak blood and protein into the urine. The damage may lead to scarring of the nephrons that progresses slowly over many years. Eventually, IgAN can lead to end-stage renal disease (ESRD).(3,4) Kidney biopsy is required to confirm the diagnosis of IgAN as there are no validated diagnostic serum or urine biomarkers for IgAN. Biopsy is indicated when a patient has signs of severe or progressive disease. After a diagnosis has been established, guidelines recommend that all patients with IgAN be assessed for secondary causes (e.g., liver cirrhosis, HIV, hepatitis, inflammatory bowel disease).(2) One primary focus of IgAN management is optimized supportive care (e.g., blood pressure management, maximally tolerated angiotensin-converting-enzyme inhibitor [ACEi] or angiotensin II blocker [ARB], lifestyle modification, cardiovascular risk reduction) which can preserve kidney function and reduce cardiovascular complications. KDIGO guidelines recommend that all patients with proteinuria greater than 0.5 g/d be treated with an ACEi or ARB irrespective of whether they have hypertension.(2) Guidelines also support the use of Filspari (sparsentan) with or without the use of a sodium-glucose cotransporter-2 inhibitors (SGLT2i) as a component of maximal supportive care.(2,3) Disease-modifying therapies and therapies that manage the consequences of IgAN-induced nephron loss are recommended to be simultaneously commenced.(2) KDIGO guidelines define a patient with IgAN at risk of progressive loss of kidney function if they have a proteinuria greater than or equal to 0.5 g/d (or equivalent).(2) Proteinuria of 0.5 g/d is approximately equivalent to a urine protein to creatinine ratio (UPCR) of 0.44 g/g.(4) Systemic glucocorticoids have no proven impact on levels of pathogenic forms of IgA or IgA immune complexes and are used to manage glomerular inflammation. However, a 9-month course of Tarpeyo (Nefecon) is recommended as efficacy data supports a reduction in pathogenic IgA and IgA immune complexes.(2) The American Journal of Kidney Disease (AJKD) recommends corticosteroids (targeted release budesonide, Nefecon, or reduced dose corticosteroids) for high-risk patients with inflammatory lesions seen on kidney biopsy.(3) Most literature supports some use of corticosteroids as part of a treatment regimen; however, the dose and duration is questionable.(2,3) Furthermore, long-term outcomes-based comparative studies for corticosteroids in the IgAN setting is lacking and future studies are needed to determine any clinical significance. It is further noted that the following patient characteristics are likely to increase the risks of systemic glucocorticoid toxicity:(2) · eGFR less than 30 mL/min/1.73 m^2 · Diabetes and prediabetes · Obesity · Latent infections (e.g., viral hepatitis, tuberculosis) · Active peptic ulceration · Uncontrolled psychiatric illness · Osteoporosis · Cataracts The goal of treatment in patients with IgAN at risk of progressive loss of kidney function is to reduce the rate of loss of kidney function to less than 1 mL/min per year for the rest of the patient's life. An additional treatment goal is the reduction of proteinuria to less than 0.5 g/d (or equivalent).(2) |
Efficacy |
The efficacy of Voyxact in reducing proteinuria was demonstrated in a randomized, double-blind, placebo-controlled, multicenter, global study in 510 patients with biopsy confirmed disease (VISIONARY, NCT05248646). The study enrolled adult patients who had a UPCR greater than or equal to 0.75 g/g (or urine protein greater than or equal to 1 g/day) and eGFR greater than or equal to 30 mL/min/1.73 m^2. Patients were required to be on a stable and maximally tolerated RAS inhibitor with or without an SGLT2 for at least 3 months prior to screening. Patients with other glomerulopathies or those who had been treated with systemic immunosuppressants in the 16 weeks prior to screening were excluded. Patients were randomized (1:1) to receive either Voyxact or placebo injected subcutaneously once every 4 weeks. An interim analysis for efficacy was conducted on the first 320 (63%) randomized patients who had the opportunity to reach the Month 9 visit, 152 of whom were randomized to receive Voyxact while 168 were randomized to receive placebo. The primary efficacy endpoint was the relative change from baseline in UPCR at 9 months. At 9 months, the Voyxact treated population showed a 50% reduction in UPCR while the placebo treated population showed a 2% increase compared to baseline (p-value <0.0001).(1) |
Safety |
Voyxact is contraindicated in patients with serious hypersensitivity to sibeprenlimab-szsi or any excipients in Voyxact.(1) |
Number |
Reference |
1 |
Voyxact prescribing information. Otsuka America Pharmaceutical, Inc. November 2025. |
2 |
Floege J, Barratt J, Cook HT, et al. Executive summary of the KDIGO 2025 Clinical Practice Guideline for the Management of Immunoglobulin A Nephropathy (IgAN) and Immunoglobulin A Vasculitis (IgAV). Kidney Int. 2025;108(4):548-554. doi:10.1016/j.kint.2025.04.003 |
3 |
Caster DJ, Lafayette RA. The treatment of primary IGA nephropathy: Change, change, change. American Journal of Kidney Diseases. 2023;83(2):229-240. doi:10.1053/j.ajkd.2023.08.007 |
4 |
Pitcher D, Braddon F, Hendry B, et al. Long-Term outcomes in IGA nephropathy. Clinical Journal of the American Society of Nephrology. 2023;18(6):727-738. doi:10.2215/cjn.0000000000000135 |
POLICY AGENT SUMMARY PRIOR AUTHORIZATION
Final Module |
Target Agent GPI |
Target Brand Agent(s) |
Target Generic Agent(s) |
Strength |
Targeted MSC |
Targeted NDCs When Exclusions Exist |
Final Age Limit |
Preferred Status |
Effective Date |
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5648055000 |
Voyxact |
sibeprenlimab-szsi subcutaneous soln pref syringe |
400 MG/2ML |
M ; N ; O ; Y |
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02-12-2026 |
POLICY AGENT SUMMARY QUANTITY LIMIT
Target Agent GPI |
Target Brand Name(s) |
Target Generic Name(s) |
Strength |
QL Amount |
Dose Form |
Days Supply |
Duration |
Targeted NDCs When Exclusions Exist |
Age Limit |
Effective Date |
Term Date |
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5648055000E520 |
Voyxact |
sibeprenlimab-szsi subcutaneous soln pref syringe |
400 MG/2ML |
1 |
Syringe |
28 |
Days |
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02-12-2026 |
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