CurrentUnitedHealthcarePolicy CSOH2026D0102.E

Oxlumo (lumasiran) and Rivfloza (nedosiran) — Ohio medical benefit drug policy (coverage criteria)

Defines UnitedHealthcare Ohio-specific medical benefit drug coverage criteria for lumasiran (Oxlumo) and nedosiran (Rivfloza) for treatment of primary hyperoxaluria type 1 (PH1), including initial and continuation authorization requirements for provider-administered therapy.

Policy Summary

PayerUnitedHealthcare

PolicyOxlumo (lumasiran) and Rivfloza (nedosiran) — Ohio medical benefit drug policy

Policy CodePolicy CSOH2026D0102.E

Change TypeCodes updated (ICD-10 additions/removal)

Effective DateJan 1, 2026

Next Review Date

Key ActionSubmit prior authorization with documentation of PH1 diagnosis and metabolic or genetic confirmation; initial and reauthorization limited to 12 months.

SourceLink

POLICY UPDATE CHANGES

Added ICD-10 diagnosis codes E72.530, E72.538, E72.539, E72.540, E72.541, E72.548, and E72.549

Removed ICD-10 diagnosis code E72.53

Archived previous policy version CSOH2025D0102.D

12 monthsmax auth period

≥30eGFR threshold

≥2 yrsmin age (Rivfloza)

C9399,J0224,J3490HCPCS/CPT listed

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Coverage Criteria for Oxlumo (lumasiran) and Rivfloza (nedosiran)

Coverage excludes concurrent administration of the two siRNA therapies: Oxlumo (lumasiran) and Rivfloza (nedosiran) may not be used in combination. Additionally, patients who have received a liver transplant are excluded from coverage under these criteria; both the Oxlumo and Rivfloza criteria specify that the patient has not received a liver transplant as a condition for initial and continuation authorization.

Therapy is limited to patients with documented PH1 and appropriate specialist involvement. Use without diagnostic confirmation—either metabolic evidence (e.g., urinary oxalate excretion > 1 mmol/1.73 m2/day or an elevated urinary oxalate:creatinine ratio, or increased plasma oxalate/glyoxylate) or genetic confirmation (AGXT mutation for nedosiran)—does not meet medical necessity. Prescribing must be by, or in consultation with, a specialist experienced in PH1 (for example, a geneticist, nephrologist, or urologist). Concurrent administration of the alternative siRNA product is not permitted and will render the request not medically necessary.

Billing and Diagnostic Codes

Procedure/HCPCS CodesHCPCS

C9399	Unclassified drugs or biologicals.
J0224	Injection, lumasiran, 0.5 mg.
J3490	Unclassified drugs

ICD-10 Diagnosis CodesICD-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

inv-08: Urinary oxalate excretion

Urinary oxalate excretion thresholdGreater than 1 mmol/1.73 m2 per day (≈90 mg/1.73 m2 per day)

Alternative metabolic evidenceIncreased urinary oxalate:creatinine ratio relative to normative values for age

Supporting plasma measuresIncreased plasma oxalate and/or glyoxylate concentrations may also confirm diagnosis

inv-09: Kidney function (eGFR)

eGFR requirement for nedosiraneGFR ≥ 30 mL/min/1.73 m2 (required for Rivfloza/nedosiran)

Continuation requirementFor continuation, patient must continue to have relatively preserved kidney function (e.g., eGFR ≥ 30 mL/min/1.73 m2)

FDA indication noteRivfloza indicated for patients with relatively preserved kidney function, e.g., eGFR ≥ 30 mL/min/1.73 m2

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required before initiation of therapy. Requests must include the clinical documentation elements listed below and will be reviewed when submitted by, or in consultation with, a specialist experienced in PH1 management.

Submit prior authorization request to UnitedHealthcare prior to starting therapy
Include treating specialist name and specialty (e.g., geneticist, nephrologist, urologist)
Include proposed drug (Oxlumo/lumasiran or Rivfloza/nedosiran) and planned dosing per FDA labeling
Initial authorization limited to up to 12 months; reauthorization limited to up to 12 months

Step Therapy

Step Therapy / Sequencing

There is no policy-specified step therapy sequence that requires trials of one agent before another. However, Oxlumo (lumasiran) and Rivfloza (nedosiran) are mutually exclusive per coverage rules and are not to be used in combination.

Definitions and Mechanisms

inv-15: PH1 (Primary hyperoxaluria type 1)

DefinitionPrimary hyperoxaluria type 1 (PH1) — a rare autosomal recessive inborn error of glyoxylate metabolism caused by mutations in the AGXT (AGT) gene leading to overproduction of oxalate and deposition of calcium oxalate in the kidneys, potentially resulting in end‑stage renal disease

Clinical consequenceExcessive urinary oxalate excretion may lead to kidney deposition and progression to ESRD

Curative therapy noteLiver transplantation corrects the underlying enzymatic defect and is the only curative intervention for PH1

inv-16: Mechanism of action — lumasiran

Target and actionLumasiran is an HAO1-directed small interfering RNA (siRNA) that targets HAO1 mRNA to reduce glycolate oxidase (GO) levels in hepatocytes

Downstream effect

Background

Primary hyperoxaluria type 1 (PH1) is an inherited disorder in which defective hepatic metabolism leads to overproduction of oxalate, resulting in elevated urinary and often plasma oxalate concentrations with progressive kidney deposition and risk of end-stage renal disease. Effective management requires confirmation of the diagnosis by metabolic testing (increased urinary oxalate excretion or plasma oxalate/glyoxylate) or genetic testing for AGXT mutations. Small interfering RNA therapies—Oxlumo (lumasiran) and Rivfloza (nedosiran)—target hepatic enzymes in the oxalate production pathway to reduce oxalate generation and are indicated only when prescribed or managed by clinicians experienced in PH1 care; liver transplant is a curative option and patients with prior liver transplant are excluded from these coverage criteria.

Policy History and Revisions

2026-01-01codes_addedLatest

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

2026-01-01codes_removed

Removed ICD-10 diagnosis code E72.53 from the applicable codes list.

2026-01-01archived

Policy Summary

PayerUnitedHealthcare

PolicyOxlumo (lumasiran) and Rivfloza (nedosiran) — Ohio medical benefit drug policy

Policy CodePolicy CSOH2026D0102.E

Change TypeCodes updated (ICD-10 additions/removal)

Effective DateJan 1, 2026

Next Review Date

Key ActionSubmit prior authorization with documentation of PH1 diagnosis and metabolic or genetic confirmation; initial and reauthorization limited to 12 months.

SourceLink

On This Page

No required prior trial of an alternative RNAi or other agent is specified in this policy
Concurrent use of Oxlumo and Rivfloza is not permitted (coverage excludes combination therapy)

Documentation Required

Required Documentation

Documentary support must accompany prior authorization and reauthorization requests to demonstrate diagnosis and clinical response.

Medical records or chart notes documenting diagnosis and specialist consultation
Genetic testing results (e.g., AGXT/AGT mutation confirmation required for Rivfloza) when applicable
Metabolic testing results demonstrating PH1 (e.g., increased urinary oxalate excretion >1 mmol/1.73 m2/day or increased plasma oxalate/glyoxylate)
Laboratory values showing baseline and on-treatment responses (e.g., urinary oxalate concentration or urinary oxalate:creatinine ratio, plasma oxalate)
Documentation of eGFR when relevant (Rivfloza requires relatively preserved kidney function, eGFR ≥30 mL/min/1.73 m2)
If continuation request, submission must show positive clinical response compared to pre-treatment baseline

Denial Risk

Triggers for Denial / Denial Risks

Coverage may be denied if required information is missing or exclusion criteria are present. Verify all documentation and contraindications prior to submission.

Missing confirmation of PH1 by appropriate metabolic or genetic testing
Absence of specialist involvement or consultation from a provider with PH1 expertise
Concurrent receipt of both Oxlumo and Rivfloza (combination therapy)
History of liver transplant (patients who have received a liver transplant are excluded)
For Rivfloza: inadequate kidney function (eGFR < 30 mL/min/1.73 m2) when required by criteria
Lack of documentation showing a positive clinical response for continuation requests

Decreased GO reduces available glyoxylate substrate for oxalate production, lowering urinary and plasma oxalate

Indication contextIndicated to lower urinary and plasma oxalate levels in pediatric and adult patients with PH1

inv-17: Mechanism of action — nedosiran

Target and actionNedosiran is an LDHA-directed small interfering RNA (siRNA) that degrades LDHA mRNA to reduce hepatic lactate dehydrogenase (LDH) levels

Downstream effectReduction of hepatic LDH decreases hepatic oxalate production, lowering urinary oxalate burden

Indication contextIndicated to lower urinary oxalate levels in children ≥2 years and adults with PH1 and relatively preserved kidney function

Archived previous policy version CSOH2025D0102.D.