CurrentMass General Brigham Health PlanPolicy N/A

Oxlumo (lumasiran) coverage for primary hyperoxaluria type 1 (PH1)

Defines prior authorization, quantity limits, and clinical criteria for pharmacy coverage of Oxlumo (lumasiran) for members with primary hyperoxaluria type 1 (PH1) under Mass General Brigham Health Plan.

Policy Summary

PayerMass General Brigham Health Plan

PolicyOxlumo (lumasiran) coverage for PH1

Policy CodePolicy N/A

Change TypeCriteria revision

Effective DateMar 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and provide diagnostic confirmation of PH1 (molecular genetic testing showing AGXT mutation or liver enzyme analysis) and documentation of decreased or normalized urinary or plasma oxalate for reauthorization.

SourceLink

POLICY UPDATE CHANGES

Updated initial criteria to remove minimum eGFR requirement.

Updated reauthorization criteria to allow for approval if the member's plasma oxalate levels have decreased.

12 monthsApproval duration

4 vials/90dQuantity limit

90 daysNew-to-plan grace

Coverage Criteria for Oxlumo (lumasiran)

Initial Therapy

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Initial Authorization for Oxlumo: Member has a documented diagnosis of primary hyperoxaluria type 1 (PH1) confirmed by a molecular genetic test showing a mutation in the alanine:glyoxylate aminotransferase (AGXT) gene OR by liver enzyme analysis demonstrating absent or significantly reduced alanine:glyoxylate aminotransferase (AGT) activity.

Also: members new to the plan within the past 90 days who are currently receiving treatment with the requested medication may be authorized per the new-to-plan continuity clause (excludes product obtained as samples or via manufacturer's patient assistance programs).

Continuation of Therapy

Requests for reauthorization will be approved when ONE of the following is met:

Reauthorization criteria: a) Member's urinary oxalate excretion has decreased or normalized since initiating therapy OR b) Member's plasma oxalate excretion has decreased or normalized since initiating therapy.

Approvals for reauthorization will be granted for 12 months with quantity limits applied (Oxlumo 94.5 mg/0.5 mL: 4 vials per 90 days).

Authorization for members who are new to the plan within the past 90 days may be granted to permit continuity of care when the member is already receiving Oxlumo at the time of plan enrollment. However, this new-to-plan continuity exception does not apply if the medication was obtained as samples or through a manufacturer's patient assistance program; requests in those situations are excluded from the continuity clause and may be denied.

Quantity Limits and Coding

Quantity limit (NDC/medication-specific)NDC | medication

Oxlumo 94.5mg/0.5mL

Quantity Limit = 4 vials per 90 days

Quantity limit (medication-specific)

Quantity limitOxlumo (94.5 mg/0.5 mL) — 4 vials per 90 days

Limit duration windowMeasured over a 90-day period

Applicable formulationOxlumo 94.5 mg/0.5 mL subcutaneous injection

New-to-plan continuity

New-to-plan continuity windowMember has been new to the plan within the past 90 days

Condition for continuity exceptionMember must be currently receiving treatment with the requested medication

Exclusion to continuity exceptionDoes not apply if product was obtained as samples or via manufacturer’s patient assistance programs

Provider Actions, Documentation, and Operational Rules

Prior Authorization

Prior Authorization Required

Prior authorization required. Initial and reauthorization approvals are granted for up to 12 months. Members new to the plan within the past 90 days who are currently receiving the medication may be granted authorization to continue therapy (continuity exception), excluding situations where the product was obtained as samples or through the manufacturer's patient assistance program.

Initial and reauthorization duration = 12 months
Continuity exception: member new to plan ≤ 90 days and currently receiving medication (samples or patient assistance program excluded)

Step Therapy

No step therapy requirements specified for this medication.

Documentation Required

Diagnostic Confirmation Required

Documentation of diagnosis is required. Authorization is contingent on confirmation of primary hyperoxaluria type 1 (PH1) by either genetic testing or liver enzyme analysis demonstrating absent or significantly reduced alanine:glyoxylate aminotransferase (AGT) activity.

Acceptable diagnostic confirmation: molecular genetic test showing a pathogenic mutation in the AGXT gene
Or liver enzyme analysis demonstrating absent or significantly reduced AGT activity

Documentation Required

Response Monitoring for Reauthorization

Reauthorization requires objective evidence of response to therapy. Requests for continuation will be approved when there is documentation that urinary or plasma oxalate levels have decreased or normalized since initiation of therapy.

Reauthorization criteria: decreased or normalized urinary oxalate since therapy initiation
Or decreased or normalized plasma oxalate since therapy initiation

Billing Rule

Limitations and Quantity Limits

Quantity limits apply to the pharmacy benefit.

Oxlumo (lumasiran) 94.5 mg/0.5 mL subcutaneous injection: Quantity limit = 4 vials per 90 days

Background

Oxlumo (lumasiran) is a HAO1-directed small interfering RNA (siRNA) therapy that targets hydroxyacid oxidase 1 to reduce oxalate production. It is indicated to treat primary hyperoxaluria type 1 (PH1) by lowering urinary and plasma oxalate levels in pediatric and adult patients. Diagnosis of PH1 should be confirmed by molecular genetic testing demonstrating an AGXT mutation or by liver enzyme analysis showing absent or markedly reduced alanine:glyoxylate aminotransferase (AGT) activity.

Definitions

Primary hyperoxaluria type 1 (PH1)

DefinitionPrimary hyperoxaluria type 1 (PH1) is a genetic disorder caused by mutations in the AGXT gene resulting in deficient alanine:glyoxylate aminotransferase (AGT) activity and elevated oxalate production.

Diagnostic basis — molecular testingDiagnosis confirmed by a molecular genetic test showing a mutation in the AGXT gene.

Diagnostic basis — enzyme analysisAlternatively, diagnosis may be confirmed by liver enzyme analysis demonstrating absent or significantly reduced AGT activity.

Oxlumo (lumasiran)

Therapy classHAO1-directed small interfering ribonucleic acid (siRNA)

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

Formulation referencedOxlumo (lumasiran) 94.5 mg/0.5 mL subcutaneous injection

Revision History and Policy Changes

2025-03-01material_revisionLatest

Initial criteria revised to remove minimum eGFR requirement; reauthorization criteria updated to allow approval if plasma oxalate levels have decreased.

2021-07-01policy_effective

Policy created following May 19, 2021 review and made effective on 2021-07-01.