CurrentMass General Brigham Health PlanPolicy N/A

Hyperoxaluria Agents Oxlumo (lumasiran) Effective 09/01/2025_

Policy governs prior authorization, quantity limit, and coverage criteria for Oxlumo (lumasiran) under the pharmacy benefit for Commercial/Exchange members, including initial and continuation (reauthorization) criteria and authorization duration.

Policy Summary

PayerMass General Brigham Health Plan

PolicyHyperoxaluria Agents Oxlumo (lumasiran) Effective 09/01/2025_

Policy CodePolicy N/A

Change TypeFormatting updates; classing revised; authorization duration changed (historical)

Effective DateSep 1, 2025

Next Review Date

Key ActionObtain prior authorization and include genetic testing results showing AGXT mutations, specialist prescriber/consult notes, and current member weight to verify FDA-based dosing.

SourceLink

POLICY UPDATE CHANGES

Formatting updates made to policy; no clinical changes.

Oxlumo has been combined under Hyperoxaluria Agents class.

Approval duration changed to 12 months.

1Covered Indication (PH1)

12 moAuthorization Duration

AGXTGenetic Test Requirement

Coverage Summary

Oxlumo (lumasiran) is an siRNA therapy indicated to lower urinary oxalate levels in pediatric and adult patients with primary hyperoxaluria type 1 (PH1). This policy covers Oxlumo under the pharmacy benefit for Commercial/Exchange members with a coverage stance of covered_with_criteria, and governs prior authorization, quantity limits, and coverage criteria for both initial and continuation (reauthorization) requests. Authorization duration is 12 months.

Initial Therapy Criteria

Initial Authorization

Authorization will be granted when all the following criteria has been met:

ALL of the following

Diagnosis of primary hyperoxaluria type 1 (PH1)
Genetic testing: Results from genetic testing showing mutations in the AGXT gene
Prescriber is a specialist (e.g., nephrologist) or consult notes from a specialist's office are provided
Weight: Member's current weight (use to verify correct dosing)
Dosing is appropriate per FDA labeling
Verify dose using weight

Continuation Therapy Criteria (Reauthorization)

Continuation of Therapy / Reauthorization

Reauthorization by physician will need to meet the following criteria:

ALL of the following

Response: Documentation of positive response to therapy
Updated weight: Updated member weight (use to verify correct dosing)
Dosing is appropriate per FDA labeling

Provider Actions & Documentation Requirements

Prior Authorization

Prior authorization required

Prior authorization is required under the pharmacy benefit for Commercial/Exchange members. Authorizations for members who are new to the plan and currently receiving Oxlumo may be reviewed on a case-by-case basis.

Documentation Required

Genetic testing documentation

Provide genetic testing results demonstrating mutations in the AGXT gene as part of the initial authorization documentation.

Documentation Required

Specialist prescriber or consult notes

The prescriber must be a specialist (for example, a nephrologist) or specialist consult notes must be supplied with the authorization request.

Documentation Required

Weight documentation for dosing

Provide the member's current weight at treatment initiation and provide updated weight at reauthorization to verify dosing is appropriate per FDA labeling.

Documentation Required

Response documentation for reauthorization

For continuation/reauthorization, provide documentation showing a positive response to therapy.

Clinical Evidence

Manufacturer prescribing information cited: Oxlumo (lumasiran) package insert, Alnylam, Nov 2020.

FDA dosing is followed per the product labeling and is weight‑based as referenced in the prescribing information and policy dosing requirements.

Background

Oxlumo (lumasiran) is a hydroxyacid oxidase 1 (HAO1)-directed small interfering RNA (siRNA) therapy indicated to lower urinary oxalate levels in pediatric and adult patients with primary hyperoxaluria type 1 (PH1). The policy aligns coverage with required genetic confirmation of AGXT gene mutations and requires that the prescriber be a specialist (for example, a nephrologist) or that specialist consult notes be provided. The policy also requires documentation of the member’s current weight (and updated weight at reauthorization) to verify dosing is appropriate per FDA labeling.

This policy governs prior authorization, quantity limits, and coverage criteria for Oxlumo under the pharmacy benefit for Commercial/Exchange members; prior authorization is required and authorizations may be reviewed case-by-case for members new to the plan who are currently receiving treatment. Initial authorizations and reauthorizations are limited to 12 months.

Authorization duration12 months

Genetic test requirementAGXT mutation required

Coverage stancecovered_with_criteria

Revision History

05/10/23material

05/10/23 review: Approval duration changed to 12 months (effective 6/5/23).

10/9/24administrative

10/9/24 review: Oxlumo has been combined under Hyperoxaluria Agents class (administrative grouping change).

2025-09-01non-materialLatest

08/13/25 review noted minor formatting updates; formatting updates made to policy with no clinical changes (effective 9/1/25).

Policy Summary

PayerMass General Brigham Health Plan

PolicyHyperoxaluria Agents Oxlumo (lumasiran) Effective 09/01/2025_

Policy CodePolicy N/A

Change TypeFormatting updates; classing revised; authorization duration changed (historical)

Effective DateSep 1, 2025

Next Review Date

Key ActionObtain prior authorization and include genetic testing results showing AGXT mutations, specialist prescriber/consult notes, and current member weight to verify FDA-based dosing.

SourceLink

On This Page

OpenPayer

Hyperoxaluria Agents Oxlumo (lumasiran) Effective 09/01/2025_

Coverage Summary

Initial Therapy Criteria

Continuation Therapy Criteria (Reauthorization)

Provider Actions & Documentation Requirements

Applicable Codes

Clinical Evidence

Background

Revision History