CurrentEmblemHealthPolicy MG.MM.PH.327

Oxlumo (lumasiran) Subcutaneous Injection — Clinical coverage criteria

Clinical coverage criteria for Oxlumo (lumasiran) subcutaneous injection to treat primary hyperoxaluria type 1 in pediatric and adult patients; governs preauthorization, dosing limits, and renewal for EmblemHealth/ConnectiCare members.

Policy Summary

PayerEmblemHealth

PolicyOxlumo (lumasiran) Subcutaneous Injection — Clinical coverage criteria

Policy CodePolicy MG.MM.PH.327

Change TypeMaterial revisions to thresholds, renewal criteria, and exclusions

Effective Date

Next Review Date

Key ActionSubmit prior authorization with genetic confirmation of AGXT mutation and baseline oxalate measurements to support initial 6‑month approval.

SourceLink

POLICY UPDATE CHANGES

Urinary oxalate threshold for coverage was changed from ≥ 0.7 mmol/24 hours/1.73 m2 to ≥ 0.5 mmol/24 hours/1.73 m2 (absence of secondary sources required).

Renewal criteria simplified to 'patient is continuing to derive benefit' with examples of responses listed; prior language about stabilization and unacceptable toxicity removed.

Explicit limitations added: Oxlumo not expected to be effective for PH2 or PH3 and should not be used concurrently with Rivfloza (nedosiran).

6 monthsinitial authorization length

1 yearrenewal authorization length

756max billable units

Coverage Criteria for Oxlumo (lumasiran)

Initial Therapy — Primary Hyperoxaluria Type 1

Covered when ALL of the following are met

Initial Criteria for PH1: A. Oxlumo is being prescribed by, or in consultation with, a nephrologist or urologist; AND B. Documentation of a genetic test confirming Primary Hyperoxaluria Type 1 via identification of an AGXT mutation; AND C. Patient has elevated urine or plasma oxalate as demonstrated by ONE of the following: (i) urinary oxalate excretion >= 0.5 mmol/24 hours/1.73 m2 with absence of secondary sources of oxalate; OR (ii) urinary oxalate:creatinine ratio above the age-specific upper limit of normal; OR (iii) elevated plasma oxalate concentration (POx > ULN); AND D. Patient has not previously received a liver transplant for Primary Hyperoxaluria.see text

Operators nested: AND with an OR block for oxalate measures

Continuation Therapy — Renewal Criteria

Renewal criteria — Coverage can be renewed when ALL are met

Renewal Criteria: 1. The patient is continuing to derive benefit from Oxlumo as documented by the prescriber; AND 2. Patient has not previously received a liver transplant for Primary Hyperoxaluria Type 1.see text

Examples of benefit (prescriber-documented): reduced urinary oxalate excretion, decreased urinary oxalate:creatinine ratio, reduced plasma oxalate from baseline, or improved/stabilized clinical signs/symptoms (e.g., nephrocalcinosis, renal stones, renal impairment)

Oxlumo (lumasiran) is not expected to be effective for Primary Hyperoxaluria Type 2 (PH2) or Type 3 (PH3) because its mechanism of action does not affect the metabolic pathways that cause hyperoxaluria in PH2 or PH3. These conditions are therefore excluded from coverage for Oxlumo.

Concurrent therapy with another small interfering RNA agent for primary hyperoxaluria is prohibited. Specifically, concurrent use of Oxlumo with Rivfloza (nedosiran) is not permitted.

The policy language has been revised to remove a prior blanket statement that Oxlumo was “not medically necessary” for indications other than those listed. In place of that general statement, the policy now specifies particular exclusions: Oxlumo is excluded for PH2 and PH3 because its mechanism does not address those metabolic pathways, and the policy explicitly prohibits concurrent use with Rivfloza (nedosiran).

Coding and Clinical Thresholds

Applicable HCPCS/CPT CodesHCPCSCovered

J0224

Oxlumo, Injection, lumasiran, 0.5 mg

Applicable NDCsNDC

71336-1002-01

Oxlumo 94.5mg/0.5mL Solution

Relevant ICD-10 DiagnosesICD-10

E72.53

Primary hyperoxaluria

Urinary oxalate excretion

ThresholdUrinary oxalate excretion ≥ 0.5 mmol/24 hours/1.73 m2

ContextApplies when secondary sources of oxalate have been excluded

Alternative measuresCoverage may also be based on urinary oxalate:creatinine ratio above age-specific ULN or elevated plasma oxalate (> ULN)

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial approval will be granted for 6 months. The prescriber must submit documentation that the patient meets the initial coverage criteria at the time of request.

Initial authorization length: 6 months; renewals may be for one year when renewal criteria are met.
Prior authorization must include evidence meeting the Initial Therapy criteria (nephrologist/urologist involvement, genetic confirmation of AGXT mutation, and baseline elevated urine or plasma oxalate).

Denial Risk

Concurrent Therapy Restriction

Concurrent therapy with another siRNA for primary hyperoxaluria is not permitted. Oxlumo must not be used concomitantly with Rivfloza (nedosiran).

Background

Oxlumo (lumasiran) is a small interfering RNA (siRNA) that targets HAO1 mRNA to reduce expression of glycolate oxidase, thereby decreasing conversion of glycolate to glyoxylate and ultimately lowering oxalate production. It is indicated to lower urinary oxalate in patients with Primary Hyperoxaluria Type 1 (PH1); dosing uses weight‑based loading and maintenance schedules.

Definitions

Oxlumo (lumasiran)

DrugOxlumo (lumasiran)

Mechanism of actionHAO1-directed small interfering RNA (siRNA) that targets HAO1 mRNA in hepatocytes to reduce glycolate oxidase (GO) levels via RNA interference

IndicationIndicated for treatment of Primary Hyperoxaluria Type 1 to lower urinary oxalate levels in pediatric and adult patients

Documentation Required

Required Clinical Documentation

Required clinical documentation for initial and renewal review. Include specialty involvement, genetic testing results, baseline laboratory data, and treatment response documentation for renewals.

Documentation that Oxlumo is being prescribed by, or in consultation with, a nephrologist or urologist.
Genetic testing confirming diagnosis of Primary Hyperoxaluria Type 1 via identification of an AGXT mutation.
Baseline evidence of elevated urine or plasma oxalate demonstrated by ONE of: urinary oxalate excretion ≥ 0.5 mmol/24 hours/1.73 m2 (with absence of secondary sources), urinary oxalate:creatinine ratio above the age-specific upper limit of normal, or elevated plasma oxalate concentration (> ULN).
Documentation that the patient has not previously received a liver transplant for Primary Hyperoxaluria Type 1.
For renewals, clinical documentation that the patient is continuing to derive benefit from Oxlumo (e.g., reduced urinary oxalate excretion, decreased urinary oxalate:creatinine ratio, reduced plasma oxalate levels from baseline, or improved/stabilized clinical signs/symptoms such as nephrocalcinosis, decreased stone formation, or stabilized renal function).