CurrentAvMedPolicy N/A

Oxlumo | Rivfloza (Medical)

Prior authorization form and clinical coverage criteria for Oxlumo (lumasiran) J0224 and Rivfloza (nedosiran) J3490 for treatment of primary hyperoxaluria type 1 (PH1), including initial and reauthorization requirements, dosing/unit limits, provider qualifications, required documentation, and exclusions/contraindications for use.

Policy Summary

PayerAvMed

PolicyOxlumo | Rivfloza (Medical)

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrescribing physician must sign and clearly print name on the request and submit required documentation (genetic testing, lab results, chart notes) via fax to 1-877-535-1391; incomplete or illegible information may delay authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes noted in this brief.

2Drugs covered

6Initial auth (months)

12Reauth (months)

>=3 moPyridoxine trial

Coverage Summary

Prior authorization and clinical coverage criteria for Oxlumo (lumasiran) J0224 and Rivfloza (nedosiran) J3490 for treatment of primary hyperoxaluria type 1 (PH1). Coverage stance: covered_with_criteria. Initial authorization duration: 6 months; reauthorization duration: 12 months. Key thresholds: Increased urinary oxalate excretion > 0.7 mmol/1.73 m2 per day (90 mg/1.73 m2 per day), eGFR severe kidney damage cutoff < 30 mL/min/1.73 m2, and requirement for a pyridoxine trial ≥ 3 months at 5 mg/kg/day where specified. Provider qualifications required: prescribed by a geneticist, nephrologist, or urologist with expertise in PH1 and submission of required documentation (genetic testing, lab results, and chart notes).

Clinical Criteria for Approval

Reauthorization (12 months)

All criteria must be met for approval. Documentation including chart notes and labs must be provided.

ALL of the following

Member continues to meet all initial authorization criteria
Provider has submitted current medical chart notes and laboratory values documenting a positive clinical response to therapy (e.g., improvement in nephrocalcinosis, decreased formation of renal stones)
Provider has submitted documentation of a clinically significant reduction from pre-treatment baseline of urinary oxalate concentration (corrected for BSA), urinary oxalate:creatinine ratio, or plasma oxalate concentrations

Actions Required from Providers

Prior Authorization

Submit completed prior authorization form

Have the prescribing physician sign and clearly print their name on the completed prior authorization form; fax the form and required documentation (genetic testing, lab results, chart notes) to 1-877-535-1391. Incomplete, incorrect, or illegible information may delay authorization.

Affected codes: J0224, J3490

Documentation Required

Genetic confirmation required

Submit documentation demonstrating a definitive PH1 diagnosis with biallelic pathogenic mutation(s) in the AGXT gene as identified on molecular genetic testing.

Documentation Required

Laboratory documentation required

Submit laboratory documentation including current 24‑hour urinary oxalate excretion corrected for body surface area (BSA) and baseline plasma oxalate levels; for reauthorization, submit current labs showing response (e.g., reductions in urinary oxalate concentration, urinary oxalate:creatinine ratio, or plasma oxalate).

Denial Risk

Exclusion for severe kidney damage, dialysis, or transplant

Requests do not meet criteria if the member has severe kidney damage (eGFR <30 mL/min/1.73 m2), is receiving hemodialysis, or has previously received a liver or kidney transplant.

Threshold: eGFR severe kidney damage cutoff: < 30 mL/min/1.73 m2

Billing Rule

Maximum units per dosing period

Bill according to the stated vial/syringe limits and monthly dosing units; follow the per‑dose and per‑period maximums for each product.

Oxlumo_units
Rivfloza_80mg
Rivfloza_128mg
Rivfloza_160mg

Documentation Required

Prior therapies verification

Document prior use of pyridoxine (vitamin B6), alkalinizing agents, and hyperhydration and show failure to normalize urinary oxalate after ≥3 months at the specified pyridoxine dose; prior therapies may be verified via pharmacy paid claims or submitted chart notes.

Prior Authorization

Initial and reauthorization durations

Initial approvals are for 6 months. Reauthorization approvals are for 12 months and require that the member continues to meet all initial criteria and that the provider submits chart notes and labs documenting clinical benefit.

Background

This prior authorization form outlines clinical criteria for use of lumasiran and nedosiran in PH1. A definitive diagnosis requires documentation of biallelic pathogenic AGXT mutations on molecular genetic testing. Laboratory evidence must include elevated urinary and/or plasma oxalate (for example, 24-hour urinary oxalate excretion corrected for BSA or plasma oxalate values) and exclusion of secondary hyperoxaluria (such as excessive dietary oxalate, gastric bypass, or intestinal disease). The form specifies that these agents must not be used in combination with other urinary oxalate–reducing agents and that requested dosing must follow FDA labeling. Prescriptions must be written by a geneticist, nephrologist, or urologist and the prescribing physician must sign and print their name on the request.

Clinical thresholds

Increased urinary oxalate excretion> 0.7 mmol/1.73 m2 per day (90 mg/1.73 m2 per day)

eGFR severe kidney damage cutoff< 30 mL/min/1.73 m2

Pyridoxine trial duration>= 3 months at 5 mg/kg/day

Definitions

PH1: Primary hyperoxaluria type 1, a genetic disorder requiring biallelic pathogenic AGXT mutations for definitive diagnosis.

UOx: Urinary oxalate, typically measured as 24-hour urinary oxalate excretion corrected for body surface area or as a urinary oxalate:creatinine ratio; threshold example for increased excretion is > 0.7 mmol/1.73 m2 per day (90 mg/1.73 m2 per day).

eGFR: Estimated glomerular filtration rate; severe kidney damage exclusion threshold is < 30 mL/min/1.73 m2 (members with eGFR below this, on hemodialysis, or with prior liver/kidney transplant are excluded).

OpenPayer

Oxlumo | Rivfloza (Medical)

Coverage Summary

Clinical Criteria for Approval

Billing and Codes

Actions Required from Providers

Background

Definitions

Revision History

J0224	Oxlumo (lumasiran)
J3490	Rivfloza (nedosiran) - unclassified J-code

Oxlumo_units	Oxlumo: 345 mg every month for 3 doses then every 3 months thereafter; 1 vial (94.5 mg/0.5 mL) = 189 billable units (vial-to-unit conversion as stated)
Rivfloza_80mg	Rivfloza 80 mg vial: 2 vials per month
Rivfloza_128mg	Rivfloza 128 mg prefilled syringe: 1 syringe per month
Rivfloza_160mg	Rivfloza 160 mg prefilled syringe: 1 syringe per month