CurrentUnitedHealthcarePolicy CSIND0102.09

Rivfloza (Nedosiran) — Medical Benefit Drug Policy (Indiana)

Defines medical benefit coverage criteria for provider-administered Rivfloza (nedosiran) for treatment of primary hyperoxaluria type 1 (PH1) for UnitedHealthcare Community Plan members in Indiana.

Policy Summary

PayerUnitedHealthcare

PolicyRivfloza (Nedosiran) — Medical Benefit Drug Policy (Indiana)

Policy CodePolicy CSIND0102.09

Change TypeICD-10 diagnosis code additions (administrative)

Effective DateOct 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with diagnostic documentation (specialist diagnosis, metabolic and genetic testing) for initial and reauthorization requests up to 12 months.

SourceLink

POLICY UPDATE CHANGES

Added multiple specific ICD-10 diagnosis codes (E72.530, E72.538, E72.539, E72.540, E72.541, E72.548, and E72.549) to the applicable codes list.

eGFR ≥30min kidney function

≥2 yrsmin age

≤12 moinitial auth max

≤12 moreauth max

J3490billing code

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Coverage Criteria for Rivfloza (nedosiran)

Coverage excludes use of Rivfloza in combination with Oxlumo (lumasiran). Patients who have received a liver transplant are not eligible for coverage under these criteria. These exclusions apply to both initial and continuation therapy and are grounds for denial if present.

Rivfloza is not supported for use in patients who do not have a confirmed diagnosis of primary hyperoxaluria type 1 (PH1) by BOTH metabolic testing (e.g., increased urinary oxalate excretion, increased urinary oxalate:creatinine ratio, or increased plasma oxalate/glyoxylate) and genetic testing confirming an AGXT mutation. Treatment is restricted to patients who are at least 2 years of age or older and who have relatively preserved kidney function, defined as eGFR ≥ 30 mL/min/1.73 m2. Use in patients younger than 2 years or with eGFR < 30 mL/min/1.73 m2 is not supported by the policy.

Procedure, Billing, and Diagnosis Codes

Procedure / Billing CodesHCPCS

J3490

Unclassified drugs.

Applicable Diagnosis Codes (ICD-10)ICD-10

E72.530	Primary hyperoxaluria, type 1.
E72.538	Other specified primary hyperoxaluria.
E72.539	Primary hyperoxaluria, unspecified.
E72.540	Dietary hyperoxaluria.
E72.541	Enteric hyperoxaluria.
E72.548	Other secondary hyperoxaluria.
E72.549	Secondary hyperoxaluria, unspecified.

Minimum kidney function required for eligibility

eGFR thresholdeGFR ≥ 30 mL/min/1.73 m2

Context in criteriaRequired for both initial therapy and continuation/reauthorization (relatively preserved kidney function)

Age relationshipPolicy indicates nedosiran is indicated in patients 2 years and older with eGFR ≥ 30 mL/min/1.73 m2

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required for Rivfloza (initial and reauthorization). Initial authorization will be for no more than 12 months; reauthorization will be for no more than 12 months. Prescriptions must be by, or in consultation with, a specialist (e.g., geneticist, nephrologist, urologist) with expertise in PH1.

Initial authorization duration: ≤ 12 months
Reauthorization duration: ≤ 12 months
Prescriber requirement: specialist or in consultation with specialist

Step Therapy

Step therapy is not specified in this policy. No prerequisite agents or trial-and-failure sequences are required prior to authorization.

Background

Primary hyperoxaluria (PH) is a rare inherited disorder of glyoxylate metabolism characterized by hepatic overproduction of oxalate that leads to kidney deposition, recurrent nephrolithiasis, and progressive kidney injury. Primary hyperoxaluria type 1 (PH1) is caused by pathogenic variants in the AGXT gene and carries a high risk of end‑stage renal disease. Nedosiran (Rivfloza) is an RNA interference agent that targets hepatic LDHA to reduce hepatic oxalate production; liver transplantation remains the only curative treatment for PH1.

Definitions

Primary hyperoxaluria type 1 (PH1) — definition and cause

DefinitionPrimary hyperoxaluria type 1 (PH1) is a rare inborn error of glyoxylate metabolism caused by autosomal recessive mutations in the AGXT (alanine: glyoxylate aminotransferase) gene, leading to increased hepatic oxalate production and risk of kidney deposition and end‑stage renal disease.

Genetic causeMutations in the AGXT gene (encoding AGT) result in enzymatic defect in hepatic peroxisomal enzyme alanine: glyoxylate aminotransferase.

Inheritance patternAutosomal recessive disorder — PH1 accounts for ~80% of PH cases.

Clinical consequenceExcess oxalate is deposited as calcium oxalate, particularly in the kidney, which may lead to end‑stage renal disease; liver transplantation corrects the underlying enzymatic defect.

Nedosiran (Rivfloza) — mechanism and intent

Mechanism of action

Documentation Required

Required Documentation

Required documentation must be submitted with the prior authorization request and for reauthorization. Documentation should include diagnostic confirmation, specialist consultation notes, relevant laboratory and testing results, and evidence of clinical response for continuation requests.

Diagnosis documented by or in consultation with a specialist (e.g., geneticist, nephrologist, urologist)
Confirmation of PH1 diagnosis including both: metabolic testing (e.g., increased urinary oxalate excretion >1 mmol/1.73 m2/day or increased urinary oxalate:creatinine ratio for age, or increased plasma oxalate and glyoxylate concentrations) AND genetic testing confirming a pathogenic mutation in AGXT (alanine:glyoxylate aminotransferase) gene
Documentation that patient has not received a liver transplant
Evidence patient is ≥ 2 years of age (for initial therapy)
Evidence of relatively preserved kidney function (e.g., eGFR ≥ 30 mL/min/1.73 m2)
Statement that patient is not receiving Rivfloza in combination with Oxlumo (lumasiran)
Prescription details showing dosing consistent with FDA-approved labeling
For continuation: medical records demonstrating positive clinical response from pre-treatment baseline (e.g., decreased urinary oxalate concentrations, decreased urinary oxalate:creatinine ratio, decreased plasma oxalate concentrations)