CurrentUnitedHealthcarePolicy 1 = 2025 P 2336-4

Rivfloza (nedosiran) prior authorization / medical necessity

Prior authorization and medical necessity criteria for Rivfloza (nedosiran) for treatment of primary hyperoxaluria type 1 (PH1) under UnitedHealthcare medical benefit; affects providers prescribing Rivfloza and patients with PH1.

Policy Summary

PayerUnitedHealthcare

PolicyRivfloza (nedosiran) prior authorization / medical necessity

Policy CodePolicy 1 = 2025 P 2336-4

Change TypeAge indication loweredstep therapy removed

Effective Date8/1/2025

Next Review Date

Key ActionSubmit prior authorization under the UnitedHealthcare medical benefit with medical records documenting diagnosis and clinical response or confirmation testing as required.

SourceLink

POLICY UPDATE CHANGES

Lowered the age limit to 2 years and older to match updated indication.

Removed step-through requirement with Oxlumo (lumasiran).

Specified 'medical benefit' for prior UHC PA bypass and removed footnote limiting program to PFS formulation.

>=2 yrsMinimum patient age for therapy

12 moAuthorization duration

eGFR ≥30Required relative kidney function

ProhibitedConcomitant Oxlumo prohibited

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.

Coverage Criteria for Rivfloza (nedosiran)

Initial Authorization — Established on therapy

Covered when ALL of the following are met

Established therapy criteria: (1) Patient has been established on therapy with Rivfloza under an active UnitedHealthcare medical benefit prior authorization for the treatment of primary hyperoxaluria type 1 (PH1); (2) Submission of medical records (e.g., chart notes, laboratory values) documenting a positive clinical response to therapy from pre-treatment baseline (e.g., decreased urinary oxalate concentrations, decreased urinary oxalate:creatinine ratio, decreased plasma oxalate concentrations); (3) Patient has not received a liver transplant; (4) Patient has relatively preserved kidney function (e.g., eGFR ≥ 30 mL/min/1.73 m2); (5) Patient is not receiving Rivfloza in combination with Oxlumo (lumasiran); (6) Prescribed by, or in consultation with, a specialist (e.g., geneticist, nephrologist, urologist) with expertise in the treatment of PH1

Initial Authorization — New diagnosis with confirmation

Covered when ALL of the following are met

Diagnosis and confirmation: (1) Diagnosis of primary hyperoxaluria type 1 (PH1); (2) Confirmation of diagnosis based on BOTH: (a) Metabolic testing demonstrating either increased urinary oxalate excretion (e.g., greater than 1 mmol/1.73 m2 per day [90 mg/1.73 m2 per day] or increased urinary oxalate:creatinine ratio relative to normative values for age) OR increased plasma oxalate and glyoxylate concentrations; AND (b) Genetic testing confirming a mutation in the alanine:glyoxylate aminotransferase (AGT or AGXT) gene; (3) Patient has not received a liver transplant; (4) Patient is at least 2 years of age or older; (5) Patient has relatively preserved kidney function (e.g., eGFR ≥ 30 mL/min/1.73 m2); (6) Patient is not receiving Rivfloza in combination with Oxlumo (lumasiran); (7) Prescribed by, or in consultation with, a specialist (e.g., geneticist, nephrologist, urologist) with expertise in the treatment of PH1

Reauthorization

Covered when ALL of the following are met

Reauthorization criteria: (1) Submission of medical records (e.g., chart notes, laboratory values) documenting a positive clinical response to therapy from pre-treatment baseline (e.g., decreased urinary oxalate concentrations, decreased urinary oxalate:creatinine ratio, decreased plasma oxalate concentrations); (2) Patient has not received a liver transplant; (3) Patient has relatively preserved kidney function (e.g., eGFR ≥ 30 mL/min/1.73 m2); (4) Patient is not receiving Rivfloza in combination with Oxlumo (lumasiran); (5) Prescribed by, or in consultation with, a specialist (e.g., geneticist, nephrologist, urologist) with expertise in the treatment of PH1

Authorization will be issued for 12 months

Use of Rivfloza (nedosiran) in combination with Oxlumo (lumasiran) is not allowed. Requests for coverage will also be declined for members who have received a liver transplant; prior liver transplant recipients are excluded from coverage under these criteria.

Patients with eGFR < 30 mL/min/1.73 m2 do not meet coverage criteria and are not eligible for Rivfloza under these guidelines. Additionally, patients who have received a liver transplant are excluded from coverage.

Key Coding and Laboratory Thresholds

Increased urinary oxalate excretion threshold — diagnostic criterion

Threshold> 1 mmol/1.73 m2 per day [90 mg/1.73 m2 per day]

ContextMetabolic testing demonstrating increased urinary oxalate excretion qualifies as diagnostic confirmation for PH1 in initial authorization pathway.

Alternate measureIncreased urinary oxalate:creatinine ratio relative to normative values for age may be used instead of absolute excretion.

Prior Authorization, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required under the UnitedHealthcare medical benefit. Initial authorization requires meeting the policy's medical necessity criteria for Rivfloza (see Initial Authorization) and requests must be submitted with supporting clinical documentation as described below.

Applies to Rivfloza (nedosiran) under the UnitedHealthcare medical benefit.
Initial authorization: approval only when the policy's Initial Authorization criteria are met.

Documentation Required

Required Clinical Documentation

Submission of medical records (e.g., chart notes, laboratory values) is required to support both initial and reauthorization requests. Documentation must demonstrate a positive clinical response to therapy compared with pre-treatment baseline (for example: decreased urinary oxalate concentrations, decreased urinary oxalate:creatinine ratio, or decreased plasma oxalate concentrations).

Include relevant laboratory values and chart notes documenting response to therapy.

Background on Rivfloza (nedosiran) and Indication

Rivfloza (nedosiran) is an LDHA-directed small interfering RNA indicated to lower urinary oxalate levels in children 2 years and older and adults with primary hyperoxaluria type 1 (PH1) who have relatively preserved kidney function (eGFR ≥ 30 mL/min/1.73 m2).

Definitions and Clinical Thresholds

PH1 — Primary hyperoxaluria type 1 (PH1)

DefinitionPrimary hyperoxaluria type 1 (PH1).

Indication contextRivfloza (nedosiran) is indicated for treatment of PH1 in children ≥2 years and adults with relatively preserved kidney function.

Diagnostic confirmationConfirmation of PH1 requires metabolic testing (e.g., increased urinary oxalate excretion) and genetic testing (AGXT mutation) per initial authorization criteria.

Relatively preserved kidney function — definition

DefinitionRelatively preserved kidney function defined as eGFR ≥ 30 mL/min/1.73 m2.

Coverage implicationPatients with eGFR < 30 mL/min/1.73 m2 do not meet coverage criteria.