CurrentCignaPolicy IP0095

Primary Hyperoxaluria - Oxlumo

Cigna coverage policy for use of Oxlumo (lumasiran) to treat primary hyperoxaluria type 1 in pediatric and adult patients, specifying medical necessity, dosing, documentation, and exclusions for plans administered by Cigna Companies.

Policy Summary

PayerCigna

PolicyPrimary Hyperoxaluria - Oxlumo

Policy CodePolicy IP0095

Change TypeMaterial clinical and coding updates

Effective DateMar 1, 2025

Next Review Date

Key ActionObtain prior authorization; initial approvals are for 6 months and reauthorizations for 1 year when criteria are met.

SourceLink

POLICY UPDATE CHANGES

Concurrent use of Oxlumo and Rivfloza (nedosiran) is not recommended.

Urinary oxalate excretion threshold for initial therapy was changed from ≥ 0.7 mmol/24 hr/1.73 m2 to ≥ 0.5 mmol/24 hr/1.73 m2 with absence of secondary sources.

Documentation requirements were added/defined for the policy.

HCPCS J0224 (injection, lumasiran, 0.5 mg) was added to coding.

J0224HCPCS code added for lumasiran (0.5 mg)

≥0.5urinary oxalate excretion threshold for coverage

≥20 µmol/Lplasma oxalate criterion (alternative)

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.

initial approval duration

1 yrreauthorization duration

Coverage Criteria for Oxlumo (lumasiran)

FDA-Approved Indication and Coverage Criteria

Approve Oxlumo for Primary Hyperoxaluria Type 1 when the following criteria are met.

Initial Therapy approval (6 months)

Genetic confirmation: Documentation of genetic test confirming biallelic pathogenic variants in AGXT
Laboratory criterion (one required)
- Urinary oxalate excretion ≥ 0.5 mmol/24 hours/1.73 m2 with absence of secondary sources of oxalate≥ 0.5 mmol/24 hours/1.73 m2
  Absence of secondary sources of oxalate must be documented
- Urinary oxalate:creatinine ratio above the age-specific upper limit of normalAbove age-specific upper limit of normal
- Plasma oxalate ≥ 20 µmol/L≥ 20 µmol/L
Transplant status: Patient has not previously received a liver transplant for Primary Hyperoxaluria Type 1
Prescriber specialty: Medication is prescribed by or in consultation with a nephrologist or urologist

Continuation Therapy (Patient is Currently Receiving Oxlumo) approval (1 year)

Continued benefit: Documentation that the patient is continuing to derive benefit from Oxlumo according to the prescriber (examples include reduced urinary oxalate excretion, decreased urinary oxalate:creatinine ratio, reduced plasma oxalate from baseline, or improved/stable clinical signs/symptoms)
Reauthorization applicants need only provide documentation of continued benefit and need not resubmit prior documentation
Transplant status continued: Patient has not previously received a liver transplant for Primary Hyperoxaluria Type 1

Dosing approvals: Approve dosing consistent with weight-based loading and maintenance regimens

Initial: up to 6 mg/kg subcutaneously once monthly for three doses; Maintenance: either 3 mg/kg subcutaneously once monthly OR 6 mg/kg subcutaneously once every 3 months. Administer after hemodialysis on dialysis days if applicable.

Use of Oxlumo (lumasiran) for Primary Hyperoxaluria Type 2 (PH2) and Primary Hyperoxaluria Type 3 (PH3) is not covered. The policy states that Oxlumo is not expected to be effective for PH2 or PH3 because its mechanism of action does not affect the metabolic pathways causing disease in those conditions.

Concurrent administration of Oxlumo with Rivfloza (nedosiran) is not allowed. Rivfloza is another small interfering RNA agent and the policy specifies that it should not be used with Oxlumo; requests for concurrent use will be denied.

Any use of Oxlumo outside the specified coverage criteria for Primary Hyperoxaluria Type 1 (PH1) is considered experimental, investigational, or unproven. Specifically, treatment of PH2 and PH3 with Oxlumo is excluded because Oxlumo has not been studied in those populations and is not expected to be effective.

Concurrent use of Oxlumo with other siRNA agents such as nedosiran (Rivfloza) is explicitly excluded and considered not medically necessary.

Coding and Diagnostic Thresholds

Covered HCPCS CodesHCPCSCovered

J0224

Injection, lumasiran, 0.5 mg

Urinary oxalate excretion — Diagnostic threshold for coverage (inv-05)

Diagnostic thresholdUrinary oxalate excretion ≥ 0.5 mmol/24 hours/1.73 m2 with absence of secondary sources of oxalate

Role in criteriaOne of three laboratory options required for initial therapy approval for PH1 (must meet genetic confirmation and other criteria)

Approval duration when metInitial approval: 6 months

Documentation requirementDocumentation must show urinary oxalate excretion meets threshold and that secondary sources of oxalate have been excluded

Plasma oxalate — Alternative plasma oxalate threshold for coverage (inv-06)

Plasma oxalate thresholdPlasma oxalate ≥ 20 µmol/L

Prior Authorization, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required for Oxlumo. Initial approvals are for 6 months; reauthorizations (continuation therapy) are for 1 year. Refer to HCPCS coding for billing (J0224).

Prior authorization required
Initial approval: 6 months
Reauthorization/continuation approval: 1 year
HCPCS: J0224 (Injection, lumasiran, 0.5 mg)

Step Therapy

Step Therapy / Dosing Regimens

No step‑therapy or sequencing requirement is specified. Dosing regimens include a loading series and maintenance options as follows.

Initial dosing: up to 6 mg/kg subcutaneously once monthly for three doses
Maintenance dosing (choose one): 3 mg/kg SC monthly OR 6 mg/kg SC every 3 months

Background on Primary Hyperoxaluria and Oxlumo

Primary hyperoxaluria type 1 (PH1) is a genetic disorder caused by pathogenic variants that result in overproduction of oxalate, leading to recurrent kidney stones, nephrocalcinosis, and progressive renal impairment. Oxlumo (lumasiran) is an HAO1-directed small interfering RNA indicated to lower urinary and plasma oxalate in patients with PH1; it is not a cure, and liver transplantation remains the only curative option for PH1.

Because Oxlumo’s mechanism targets the metabolic pathway relevant to PH1 but not the distinct pathways of PH2 or PH3, the agent is not expected to be effective for those other forms of primary hyperoxaluria.

Definitions

Primary hyperoxaluria type 1 (PH1) — Definition and genetic basis (inv-13)

DefinitionPrimary hyperoxaluria type 1 (PH1) is a rare autosomal recessive inborn error of glyoxylate metabolism leading to overproduction of oxalate and deposition in kidneys and other organs

Genetic basisCaused by pathogenic (biallelic) variants in the alanine:glyoxylate aminotransferase gene (AGXT)

Clinical consequencesResults in nephrocalcinosis, recurrent renal stones, and can lead to renal impairment

Curative optionLiver transplantation is the only curative intervention as it corrects the underlying enzymatic defect

Oxlumo (lumasiran) — Drug description and indication (inv-14)

Drug class and targetOxlumo (lumasiran) is a hydroxyacid oxidase 1 (HAO1)-directed small interfering RNA (siRNA)

Policy Revision History

2025-03-01material_revisionLatest

Diagnostic threshold for urinary oxalate excretion lowered from ≥ 0.7 to ≥ 0.5 mmol/24 hr/1.73 m2 and liver biopsy removed as a diagnostic option; requirement added that patient has not previously received a liver transplant; documentation requirements added/defined.

2024-09-10coding_update

HCPCS code J0224 was added to the policy coding list.

2024-05-01

Policy Summary

PayerCigna

PolicyPrimary Hyperoxaluria - Oxlumo

Policy CodePolicy IP0095

Change TypeMaterial clinical and coding updates

Effective DateMar 1, 2025

Next Review Date

Key ActionObtain prior authorization; initial approvals are for 6 months and reauthorizations for 1 year when criteria are met.

SourceLink

On This Page

Use in criteriaAcceptable as one alternative laboratory criterion for initial approval of Oxlumo for PH1

Clinical trial basisSupported by pivotal trial that included patients with genetically-confirmed PH1 and plasma oxalate ≥ 20 µmol/L

Approval duration when metInitial approval: 6 months

Urinary oxalate:creatinine ratio — Alternative age-specific criterion (inv-07)

Urinary oxalate:creatinine criterionUrinary oxalate:creatinine ratio above the age-specific upper limit of normal

Use in criteriaServes as an alternative laboratory option for initial Oxlumo approval when genetic confirmation is present

Pediatric relevanceUsed in trials for patients <6 years as an elevated spot urinary oxalate:creatinine ratio

Approval duration when metInitial approval: 6 months

Receipt of sample product does not satisfy coverage requirements

Documentation Required

Required Documentation for Initial and Reauthorization Requests

Documentation is required for both initial and reauthorization requests. Acceptable documentation includes, but is not limited to, chart notes, laboratory tests, claims records, and other medical records. For reauthorization, documentation must show continued benefit from Oxlumo therapy.

Initial request: genetic testing confirming biallelic pathogenic variants in AGXT; relevant urinary or plasma oxalate laboratory results; evidence patient has not had a prior liver transplant; documentation that a nephrologist or urologist prescribed or consulted
Reauthorization: documentation the patient is continuing to derive benefit (examples: decreased urinary oxalate excretion, decreased urinary oxalate:creatinine ratio, reduced plasma oxalate, or improved/stable clinical signs such as nephrocalcinosis, stone formation, or renal function)
Acceptable sources: chart notes, lab reports, imaging reports, claims records, and other clinical documentation

Denial Risk

Triggers for Denial

Coverage will be denied when the conditions below are present or documentation/criteria are not met.

Diagnosis is not Primary Hyperoxaluria Type 1 (PH2 or PH3 are not covered)
Concurrent use with Rivfloza (nedosiran) — concurrent therapy with another siRNA agent is not permitted
Failure to provide required documentation (genetic confirmation, specified laboratory values, proof of prescriber specialty, or evidence of benefit on reauthorization)
History of prior liver transplant for Primary Hyperoxaluria Type 1
Use for indications outside the FDA‑approved indication

IndicationIndicated to lower urinary and plasma oxalate levels in pediatric and adult patients with Primary Hyperoxaluria Type 1

Regulatory contextApproved for treatment of PH1 and included in policy coverage criteria when genetic and laboratory requirements are met

Dosing referenceDosing regimens (weight-based loading and maintenance) are specified in the policy for initial and continuation therapy

Concurrent use of Oxlumo and Rivfloza (nedosiran) was added to the Conditions Not Recommended for approval (concurrent use should not be used).

2024-02-15coding_note

Annual revision noted addition of J0224 (no clinical criteria changes at that time).