CurrentColorado Rocky Mountain Health PlansPolicy CS2026D0102Q

Oxlumo (lumasiran) and Rivfloza (nedosiran) for primary hyperoxaluria type 1

Medical benefit drug policy governing coverage criteria for lumasiran and nedosiran for treatment of primary hyperoxaluria type 1 (PH1); applies to provider-administered and specialty pharmacy settings for the listed states and plans.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyOxlumo (lumasiran) and Rivfloza (nedosiran) for primary hyperoxaluria type 1

Policy CodePolicy CS2026D0102Q

Change TypeNo material changes

Effective DateJun 1, 2026

Next Review Date

Key ActionObtain prior authorization and submit documentation of specialist diagnosis and required metabolic or genetic testing per the criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period

eGFR ≥30nedosiran eGFR threshold

Age ≥2nedosiran min age

PH1required diagnosis

J0224, C9399example codes

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Coverage Criteria for Oxlumo and Rivfloza

Oxlumo (lumasiran) — Initial therapy

Covered when ALL of the following are met

Oxlumo initial: Diagnosis of PH1 by, or in consultation with, a specialist (e.g., geneticist, nephrologist, urologist) with expertise in the diagnosis of PH1; and confirmation of the PH1 diagnosis based on metabolic testing demonstrating either increased urinary oxalate excretion (e.g., >1 mmol/1.73 m2 per day or increased urinary oxalate:creatinine ratio for age) or increased plasma oxalate and glyoxylate concentrations; and patient is not receiving Oxlumo in combination with Rivfloza (nedosiran); and dosing is in accordance with the United States FDA approved labeling; and initial authorization will be for no more than 12 months.see metabolic testing thresholds

Exact lab thresholds and testing types specified in policy

Oxlumo (lumasiran) — Continuation therapy

Covered when ALL of the following are met

Oxlumo continuation: Submission of medical records (e.g., chart notes, laboratory values) documenting a positive clinical response from pre-treatment baseline (e.g., decreased urinary oxalate concentrations, decreased urinary oxalate:creatinine ratio, decreased plasma oxalate concentrations); and patient has not received a liver transplant; and patient is not receiving Oxlumo in combination with Rivfloza (nedosiran); and prescribed by, or in consultation with, a specialist (e.g., geneticist, nephrologist, urologist) with expertise in the treatment of PH1; and dosing is in accordance with the United States FDA approved labeling; and reauthorization will be for no more than 12 months.documented improvement from baseline

Clinical response examples listed in policy

Rivfloza (nedosiran) — Initial therapy

Covered when ALL of the following are met

Rivfloza initial: Diagnosis of PH1 by, or in consultation with, a specialist (e.g., geneticist, nephrologist, urologist) with expertise in the diagnosis of PH1; and confirmation of the PH1 diagnosis based on metabolic testing demonstrating either increased urinary oxalate excretion (e.g., >1 mmol/1.73 m2 per day or increased urinary oxalate:creatinine ratio for age) or increased plasma oxalate and glyoxylate concentrations; and genetic testing confirming a mutation in the AGXT (alanine:glyoxylate aminotransferase) gene; and patient has not received a liver transplant; and patient is at least 2 years of age; and patient has relatively preserved kidney function (e.g., eGFR ≥ 30 mL/min/1.73 m2); and patient is not receiving Rivfloza in combination with Oxlumo (lumasiran); and prescribed by, or in consultation with, a specialist with expertise in PH1; and dosing is in accordance with the United States FDA approved labeling; and initial authorization will be for no more than 12 months.age and eGFR thresholds

Genetic confirmation required for rivfloza

Rivfloza (nedosiran) — Continuation therapy

Covered when ALL of the following are met

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

Continuation requires evidence of benefit

Coverage is excluded for concurrent administration of Oxlumo (lumasiran) and Rivfloza (nedosiran). The policy explicitly requires that patients receiving one agent must not be treated with the other agent concurrently for either initial or continuation authorization (no combination therapy). Additionally, individuals who have received a prior liver transplant are excluded from coverage under these criteria, and transplantation status must be documented in the medical record for both initial and reauthorization requests.

Therapy is not medically necessary when provided without diagnostic confirmation of PH1. For Oxlumo and Rivfloza this includes the absence of metabolic testing demonstrating increased urinary oxalate excretion (for example, >1 mmol/1.73 m2/day or an elevated urinary oxalate:creatinine ratio) or elevated plasma oxalate/glyoxylate. For Rivfloza (nedosiran) the policy also requires genetic confirmation of an AGXT mutation; lack of this genetic testing is a basis for denial. Use that conflicts with age or renal function limits for nedosiran (e.g., <2 years of age or eGFR below the policy threshold) is prohibited, as is use that fails to show the required clinical response on continuation (documented reductions in urinary or plasma oxalate).

Procedure and Diagnosis Codes; Lab Criteria

Procedure/HCPCS 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

inv-09: Urinary oxalate — example thresholds and measurement conventions

Example absolute thresholdUrinary oxalate > 1 mmol/1.73 m2 per day (≈90 mg/1.73 m2 per day)

BSA-normalized 24‑hr threshold used in trials24‑hour urinary oxalate corrected for BSA: normal ≤ 0.514 mmol/24 hr/1.73 m2 (ILLUMINATE‑A reported normalization endpoint)

Spot ratio conventionSpot urinary oxalate:creatinine ratio compared with age‑normative values (used in ILLUMINATE‑B and policy for young children)

Alternate metabolic markersIncreased plasma oxalate and glyoxylate concentrations may also confirm metabolic abnormality

inv-10: eGFR threshold — kidney function requirement for nedosiran

eGFR numeric threshold

Prior Authorization, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required for initiation and continuation of therapy. Initial and reauthorization approvals are limited to a maximum of 12 months.

Initial and reauthorization approvals limited to <= 12 months

Denial Risk

Concurrent Therapy Restriction

Therapy with Oxlumo (lumasiran) and Rivfloza (nedosiran) must not be used concurrently. Requests that document concurrent use of both products will be denied.

Concurrent use of Oxlumo and Rivfloza (nedosiran) is prohibited

Background on Primary Hyperoxaluria Type 1

Primary hyperoxaluria type 1 (PH1) is an autosomal recessive metabolic disorder caused by pathogenic variants in the AGXT gene leading to deficiency of alanine:glyoxylate aminotransferase and resulting in hepatic overproduction of oxalate. Excess oxalate is excreted by the kidneys where it can precipitate as calcium oxalate, causing nephrolithiasis, nephrocalcinosis, progressive renal injury and potentially end-stage renal disease. Liver transplantation corrects the underlying enzymatic defect and is therefore a key consideration in treatment planning. RNA interference therapies referenced in this policy (HAO1-directed lumasiran and LDHA-directed nedosiran) target hepatic enzymes to reduce oxalate production and lower urinary and/or plasma oxalate concentrations.

Key Definitions

inv-16: PH1 — definition and genetic basis

DefinitionPrimary hyperoxaluria type 1 (PH1) is an autosomal recessive disorder caused by mutations in the AGXT gene encoding alanine:glyoxylate aminotransferase, leading to excess hepatic oxalate production and renal deposition.

Genetic basisPH1 is due to mutations of the AGXT (AGT) gene; liver transplantation corrects the underlying enzymatic defect.

Clinical consequenceExcess oxalate production leads to calcium oxalate deposition, high urinary oxalate excretion, and risk of end‑stage renal disease (ESRD).

inv-17: Lumasiran (Oxlumo) — drug definition and indication summary

Drug class and targetLumasiran (Oxlumo) is an HAO1‑directed small interfering RNA (siRNA) that reduces glycolate oxidase (GO) to lower glyoxylate and oxalate production.

Indication summary