CurrentColorado Rocky Mountain Health PlansPolicy 2026D0102K

Oxlumo (Lumasiran) and Rivfloza (Nedosiran) Medical Benefit Drug Policy

Medical benefit drug policy governing coverage and medical necessity criteria for lumasiran (Oxlumo) and nedosiran (Rivfloza) for treatment of primary hyperoxaluria type 1 (PH1) under UnitedHealthcare Commercial and Individual Exchange plans.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyOxlumo (Lumasiran) and Rivfloza (Nedosiran) Medical Benefit Drug Policy

Policy CodePolicy 2026D0102K

Change TypeNo material change

Effective DateJun 1, 2026

Next Review Date

Key ActionObtain prior authorization and submit documentation of baseline and on‑treatment urinary or plasma oxalate measurements for continuation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2drugs addressed

12 monthsmax authorization

≥30nedosiran eGFR

≥2 yrsmin age (Rivfloza)

Coverage Criteria for Oxlumo and Rivfloza

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Oxlumo (lumasiran) Coverage Criteria

Oxlumo is covered when ALL of the following are met for initial therapy, and ALL of the following are met for continuation therapy.

Initial therapy: Diagnosis of primary hyperoxaluria type 1 (PH1); patient is not receiving Oxlumo in combination with Rivfloza (nedosiran); dosing is in accordance with the U.S. FDA–approved labeling; initial authorization will be for no more than 12 months

Initial therapy - diagnostic confirmation: Diagnosis of PH1 by, or in consultation with, a specialist (e.g., geneticist, nephrologist, urologist) with expertise in PH1; metabolic testing demonstrating increased urinary oxalate excretion (e.g., >1 mmol/1.73 m2/day or increased urinary oxalate:creatinine ratio) or increased plasma oxalate/glyoxylate; genetic testing confirming a pathogenic AGXT (AGT/AGXT) mutation; patient has not received a liver transplant; prescribed by or in consultation with a specialist

Continuation therapy: Submission of medical records documenting a positive clinical response from pre-treatment baseline (e.g., decreased urinary oxalate concentrations, decreased urinary oxalate:creatinine ratio, decreased plasma oxalate concentrations); patient has not received a liver transplant; patient is not receiving Oxlumo in combination with Rivfloza (nedosiran); prescribed by or in consultation with a specialist with PH1 expertise; dosing is in accordance with the U.S. FDA–approved labeling; reauthorization will be for no more than 12 months

Rivfloza (nedosiran) Coverage Criteria

Rivfloza for provider administration is covered when ALL of the following are met for initial therapy, and ALL of the following are met for continuation therapy.

Initial therapy: Diagnosis of primary hyperoxaluria type 1 (PH1); patient is at least 2 years of age; patient has relatively preserved kidney function (e.g., eGFR ≥ 30 mL/min/1.73 m2); patient is not receiving Rivfloza in combination with Oxlumo (lumasiran); dosing is in accordance with the U.S. FDA–approved labeling; initial authorization will be for no more than 12 months

Continuation therapy: Submission of medical records documenting a positive clinical response from pre-treatment baseline (e.g., decreased urinary oxalate concentrations, decreased urinary oxalate:creatinine ratio, decreased plasma oxalate concentrations); patient has not received a liver transplant; patient has relatively preserved kidney function (e.g., eGFR ≥ 30 mL/min/1.73 m2); patient is not receiving Rivfloza in combination with Oxlumo (lumasiran); prescribed by or in consultation with a specialist with PH1 expertise; dosing is in accordance with the U.S. FDA–approved labeling; reauthorization will be for no more than 12 months

Initial and continuation coverage aligned with FDA labeling

Covered when consistent with FDA indications and member-specific benefit plan:

FDA-indication-alignment: Medication is used for primary hyperoxaluria type 1 (PH1) in the age groups indicated by the FDA labeling: lumasiran for pediatric and adult patients; nedosiran for children 2 years of age and older and adults.

Based on FDA labeling information.

Kidney-function-requirement-for-nedosiran: For nedosiran (Rivfloza), patient has relatively preserved kidney function defined as eGFR ≥ 30 mL/min/1.73 m2.eGFR ≥ 30 mL/min/1.73 m2

Explicit requirement in FDA information.

Clinical-trial-response-support: Clinical evidence of urinary oxalate reduction from trials and extension studies (e.g., PHYOX2, PHYOX3) may support coverage and continuation decisions; documentation of response may be required per member-specific plan.

PHYOX3 extension showed maintained urinary oxalate reduction.

Use of nedosiran (Rivfloza) in patients with an estimated glomerular filtration rate below 30 mL/min/1.73 m2 is outside the described FDA indication and therefore excluded from the indicated population in this policy. The policy requires relatively preserved kidney function (e.g., eGFR ≥ 30 mL/min/1.73 m2) for initial and continued use of provider-administered nedosiran.

Providers should not treat patients with nedosiran who fall outside the age or kidney function ranges specified in the FDA labeling. Nedosiran is indicated for individuals aged ≥ 2 years and for those with relatively preserved kidney function; treat only patients meeting these criteria—specifically, age ≥ 2 years and eGFR ≥ 30 mL/min/1.73 m2. Treatment of children < 2 years or of patients with eGFR < 30 mL/min/1.73 m2 does not meet the documented FDA indication in this policy and may be denied unless member-specific coverage permits otherwise.

Procedure and Diagnosis Codes; Key Clinical Thresholds

Procedure/Billing CodesHCPCS

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

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.

Nedosiran eGFR threshold

eGFR threshold for nedosiran>= 30 mL/min/1.73 m2

ContextRequired for initial and continuation Rivfloza (nedosiran) eligibility as ‘relatively preserved kidney function’.

eGFR threshold (reiteration)

eGFR threshold≥ 30 mL/min/1.73 m2

Applies toRivfloza (nedosiran) initial and continuation therapy eligibility

NoteDescribed in FDA labeling as example of ‘relatively preserved kidney function’.

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for initial and continuation therapy. Initial and reauthorization approvals are limited to no more than 12 months.

Initial and reauthorization periods: <= 12 months
Prior authorization required for Oxlumo (lumasiran) and Rivfloza (nedosiran)

Denial Risk

No Combination Therapy

Oxlumo (lumasiran) and Rivfloza (nedosiran) must not be used concurrently. Requests for combination therapy may be denied.

Do not prescribe Oxlumo and Rivfloza together — denial risk for concurrent use

Documentation Required

Nedosiran eGFR Requirement

Nedosiran (Rivfloza) is indicated only for patients with relatively preserved kidney function. Ensure documented eGFR ≥ 30 mL/min/1.73 m2 prior to approval and for reauthorization.

eGFR requirement: >= 30 mL/min/1.73 m2 for initial and continuation therapy
Document kidney function in chart/lab reports for prior auth and reauthorization

Documentation Required

Diagnostic Documentation Required

Document the diagnosis of primary hyperoxaluria type 1 (PH1) by, or in consultation with, a specialist (e.g., geneticist, nephrologist, urologist). Include metabolic testing and genetic testing results that confirm PH1 (metabolic evidence of increased urinary or plasma oxalate and AGXT/AGT mutation). Note whether the patient has received a liver transplant.

Diagnosis must be by/with a specialist experienced in PH1
Metabolic testing: elevated urinary oxalate excretion or increased plasma oxalate/glyoxylate
Genetic testing: confirmed AGXT/AGT mutation
Document absence of prior liver transplant

Documentation Required

Clinical Study and Response Documentation

For continuation/reauthorization, submit medical records demonstrating clinical response compared with pre-treatment baseline (e.g., decreased urinary oxalate concentrations, decreased urinary oxalate:creatinine ratio, decreased plasma oxalate). Prior trial results or enrollment in extension study PHYOX3 and urinary oxalate reduction data may support coverage decisions.

Provide baseline and on‑treatment urinary/plasma oxalate values and urine oxalate:creatinine ratios
If applicable, include documentation of participation/results from PHYOX3 or PHYOX2 trials

Note

Benefit and State Mandate Considerations

Check the member-specific benefit plan document for coverage of experimental/investigational/unproven treatments and for state-mandated off‑label coverage; mandates may supersede policy language. Use the benefit document to make final coverage determinations.

Consult the member specific Certificate of Coverage or benefit plan document
Confirm any applicable state mandates for off-label or investigational coverage

Note

Plan‑Specific Requirements

This policy is interpretive guidance. Verify member plan terms and any applicable federal or state mandates before making coverage decisions. In case of conflict, the member-specific benefit plan document governs.

Policy is guidance — member-specific plan document controls
Confirm Medicare/MA rules (NCD/LCD) and applicable state/federal mandates when relevant

Definitions and Drug Descriptions

Primary Hyperoxaluria Type 1 (PH1)

DefinitionPrimary hyperoxaluria type 1 (PH1) is a rare autosomal recessive inborn error of glyoxylate metabolism caused by mutations in the AGXT gene leading to overproduction of oxalate with deposition (especially in the kidney) and risk of end‑stage renal disease.

EtiologyDue to hepatic peroxisomal enzyme alanine:glyoxylate aminotransferase (AGT) deficiency from AGXT mutations.

Clinical consequenceExcessive urinary oxalate excretion can lead to calcium oxalate deposition and ESRD; liver transplant is the only curative intervention.

Lumasiran (Oxlumo) — mechanism & indication

MechanismLumasiran (Oxlumo) is an HAO1‑directed small interfering RNA (siRNA) that reduces glycolate oxidase (GO) by targeting HAO1 mRNA in hepatocytes via RNA interference, decreasing glyoxylate substrate for oxalate production.

IndicationIndicated to lower urinary and plasma oxalate levels in pediatric and adult patients with primary hyperoxaluria type 1 (PH1).

Clinical roleUsed to reduce oxalate burden in PH1 as part of medical management; dosing per FDA label and specialist oversight recommended.

Nedosiran (Rivfloza) — mechanism, indication, age & kidney note

MechanismNedosiran (Rivfloza) is an LDHA‑directed small interfering RNA (siRNA) that degrades LDHA mRNA in hepatocytes via RNA interference, reducing hepatic lactate dehydrogenase (LDH) and thereby lowering hepatic oxalate production.

IndicationIndicated to lower urinary oxalate levels in children 2 years of age and older and adults with primary hyperoxaluria type 1 (PH1).

Kidney function noteApproval and policy specify use in patients with relatively preserved kidney function (e.g., eGFR ≥ 30 mL/min/1.73 m2).

‘Relatively preserved kidney function’ definition

DefinitioneGFR ≥ 30 mL/min/1.73 m2 is defined in this policy as ‘relatively preserved kidney function’.

Use in policyRequired for nedosiran (Rivfloza) eligibility for initial and continuation therapy per FDA‑aligned criteria.

Coverage consequencePatients with eGFR below this threshold are not within the described FDA indication and may be excluded from coverage absent plan‑specific exceptions.

Background on Primary Hyperoxaluria Type 1

Primary hyperoxaluria type 1 (PH1) is an autosomal recessive inborn error of glyoxylate metabolism caused by mutations in the AGXT gene that result in hepatic overproduction of oxalate. Excess oxalate is excreted by the kidney where it can crystallize and deposit, causing nephrolithiasis, nephrocalcinosis, progressive renal injury and ultimately end-stage renal disease. Liver transplant remains the only curative therapy because it corrects the underlying hepatic enzyme deficiency. Targeted small interfering RNA (siRNA) therapies reduce hepatic production of oxalate precursors: lumasiran (Oxlumo) targets HAO1 to lower urinary and plasma oxalate in pediatric and adult patients with PH1, while nedosiran (Rivfloza) targets LDHA and is indicated for children ≥ 2 years and adults with PH1 who have relatively preserved kidney function (e.g., eGFR ≥ 30 mL/min/1.73 m2).

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyOxlumo (Lumasiran) and Rivfloza (Nedosiran) Medical Benefit Drug Policy

Policy CodePolicy 2026D0102K

Change TypeNo material change

Effective DateJun 1, 2026

Next Review Date

Key ActionObtain prior authorization and submit documentation of baseline and on‑treatment urinary or plasma oxalate measurements for continuation.

SourceLink

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