CurrentViva HealthPolicy IC-0579

Oxlumo (lumasiran) subcutaneous coverage

Medical policy governing coverage, dosing, authorization length, renewal criteria, and applicable billing codes for Oxlumo (lumasiran) for treatment of Primary Hyperoxaluria Type 1 (PH1). Applies to Viva Health members for non‑Medicare determinations (Medicare guidance noted separately).

Policy Summary

PayerViva Health

PolicyOxlumo (lumasiran) subcutaneous coverage

Policy CodePolicy IC-0579

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrescriptions must be by, or in consultation with, a specialist in genetics, nephrology, or urology and include definitive diagnostic evidence of PH1 plus required baseline oxalate and renal function measurements.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial authorization length

756Max billable HCPCS units (initial loading period)

J0224Primary HCPCS code

E72.53Covered diagnosis (PH1)

Coverage Criteria for Oxlumo (lumasiran)

Initial Approval Criteria

Policy Summary

PayerViva Health

PolicyOxlumo (lumasiran) subcutaneous coverage

Policy CodePolicy IC-0579

Change TypeNo material change

Effective Date

Next Review Date

SourceLink

On This Page

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ALL of the following

Patient has not had a liver transplant
Prescribed by, or in consultation with, a specialist in genetics, nephrology, or urology
Will not be used in combination with other urinary oxalate reducing agents (e.g., nedosiran)
Primary Hyperoxaluria Type 1 (PH1) specific
- Definitive diagnosis of PH1 established by ONE of
  - Biallelic pathogenic mutation in the AGXT gene identified on molecular genetic testing
  - Identification of alanine:glyoxylate aminotransferase (AGT) enzyme deficiency on liver biopsy
- Patient has a baseline for one or more of the following: urinary oxalate excretion (corrected for BSA), spot urinary oxalate:creatinine ratio, estimated glomerular filtration rate (eGFR), or plasma oxalate level

Renewal Criteria

Coverage may be renewed when ALL of the following are met:

ALL of the following

Patient continues to meet the universal and the relevant indication‑specific criteria from initial approval
Absence of unacceptable toxicity from the drug (examples: severe injection site reactions)
Disease response demonstrated by at least one of
- Decrease in urinary oxalate excretion level (corrected for BSA) from baseline
- Reduction in spot urinary oxalate:creatinine ratio from baseline
- Stabilization of estimated glomerular filtration rate (eGFR)
- Decrease in plasma oxalate level from baseline

Relevant Codes and Billing Identifiers

Covered HCPCSHCPCSCovered

J0224

Injection, lumasiran, 0.5 mg; 1 billable unit = 0.5 mg

Covered ICD-10 Diagnosis CodesICD-10Covered

E72.53

Primary hyperoxaluria

NDCNDC

71336-1002-xx

Oxlumo 94.5 mg/0.5 mL single-dose vial solution for injection

Documentation Required

Timing relative to hemodialysis

For patients on hemodialysis, lumasiran must be given after hemodialysis when administered on dialysis days; document the timing of administration in the medical record. Billing uses HCPCS code J0224 for lumasiran (1 unit = 0.5 mg).

J0224

What Providers Must Do

Prior Authorization

Specialist prescribing requirement

Prescription must be written by, or in consultation with, a specialist in genetics, nephrology, or urology; this specialist involvement is required for coverage authorization.

Prior Authorization

Concomitant therapy exclusion

Lumasiran must not be used in combination with other urinary oxalate–reducing agents (for example, nedosiran); concomitant use is a condition that will lead to denial of coverage.

Documentation Required

Diagnostic evidence for PH1

Document definitive diagnostic evidence of PH1 and baseline biomarker measurements: either a biallelic pathogenic AGXT mutation on molecular genetic testing or AGT enzyme deficiency on liver biopsy, plus a baseline for one or more of urinary oxalate excretion (corrected for BSA), spot urinary oxalate:creatinine ratio, eGFR, or plasma oxalate. Include ICD-10 code E72.53 as applicable.

E72.53

Documentation Required

Renewal response documentation

For renewal requests, provide documentation of disease response (at least one of the listed biomarker improvements) and absence of unacceptable toxicity.

Decrease in urinary oxalate excretion (corrected for BSA) from baseline
Reduction in spot urinary oxalate:creatinine ratio from baseline
Stabilization of eGFR
Decrease in plasma oxalate level from baseline
Documentation showing absence of unacceptable toxicity (e.g., no severe injection site reactions)

Clinical and Administrative Background

Oxlumo (lumasiran) is an RNAi therapeutic approved for Primary Hyperoxaluria Type 1 (PH1) and coverage is allowed under Viva Health with criteria-based authorization. The policy requires a definitive diagnostic confirmation of PH1 prior to initiation—either documentation of a biallelic pathogenic mutation in the AGXT gene on molecular genetic testing or identification of AGT enzyme deficiency on liver biopsy (these represent the accepted definitive diagnostic findings). [[5]]

Initial authorization length6 months

Maximum billable HCPCS units per month (initial loading period)756 units/month

Primary HCPCS code for lumasiranJ0224

Covered diagnosis code (PH1)E72.53

OpenPayer

Oxlumo (lumasiran) subcutaneous coverage

Coverage Criteria for Oxlumo (lumasiran)

Relevant Codes and Billing Identifiers

What Providers Must Do

Clinical and Administrative Background

Defined Terms