CurrentAvMedPolicy N/A

Oxlumo, Rivfloza (Pharmacy Benefit)

Pharmacy prior authorization and step-edit form and clinical criteria for coverage of Oxlumo (lumasiran) and Rivfloza (nedosiran) for treatment of primary hyperoxaluria type 1 (PH1), including recommended dosing, quantity limits, required documentation, prescriber qualifications, initial and reauthorization criteria, and specialty pharmacy dispensing.

Policy Summary

PayerAvMed

PolicyOxlumo, Rivfloza (Pharmacy Benefit)

Policy CodePolicy N/A

Change Typeclarified

Effective Date

Next Review DateJun 13, 2025

Key ActionPrescriber must complete and sign the pharmacy prior authorization/step-edit request form and fax it to 1-305-671-0200 with required documentation including genetic testing, lab values, chart notes, and dosing; incomplete/illegible information may delay authorization.

SourceLink

POLICY UPDATE CHANGES

Document contains a pharmacy prior authorization/step-edit form and clinical criteria for Oxlumo and Rivfloza with initial and reauthorization requirements.

2Drugs covered

6 monthsInitial authorization duration

12 monthsReauthorization duration

SpecialtyDispensing channel

Coverage Summary

This policy is a pharmacy prior authorization and step-edit form containing clinical criteria for coverage of Oxlumo (lumasiran) and Rivfloza (nedosiran) for the treatment of primary hyperoxaluria type 1 (PH1). Drugs are covered with criteria: prescriber qualifications, genetic confirmation, laboratory documentation, required trials (including pyridoxine where applicable), and initial and reauthorization requirements must be met for approval. The form specifies recommended dosing and quantity limits for each agent and requires documentation (genetic testing, labs, chart notes) to support each checked criterion.

Medications must be dispensed via specialty pharmacy (Proprium Rx). The prior authorization request must be completed and signed by the prescriber and faxed with the required documentation; incomplete or illegible information may delay authorization.

Initial Authorization (6 months) — Criteria

Initial Authorization (6 months)

Covered when ALL of the following are met:

ALL of the following

Prescriber qualification
- Must be prescribed by a geneticist, nephrologist, or urologist with expertise in the diagnosis and treatment of primary hyperoxaluria type 1 (PH1)
Genetic confirmation
- Member has a definitive diagnosis of PH1 confirmed by biallelic pathogenic mutation in the alanine:glyoxalate aminotransferase (AGXT) gene as identified on molecular genetic testing
  Documentation must be submitted
Signs and symptoms attributed to PH1
- Recurrent calcium oxalate (CaOx) kidney stones
- Urolithiasis
- Infantile oxalosis
- Failure to thrive and renal failure in an infant <12 months
- Nephrocalcinosis associated with decreased GFR
- Oxalate crystals in any biological fluid or tissue
- Increased serum creatinine with calcium oxalate (CaOx) stones
- CaOx tissue deposits
- Renal failure of unknown causes
Pyridoxine trial or pyridoxine-nonresponsive genotype
- Pyridoxine trial: Failure to achieve normalization of urinary oxalate (UOx) excretion levels after ≥ 3 months of therapy with pyridoxine (vitamin B6) dosed at 5 mg/kg/day, alkalinizing agents (potassium citrate, sodium citrate, neutral phosphate; etc.) and hyperhydration and will continue those therapies while taking the requested medication>= 3 months at 5 mg/kg/day
  must submit lab documentation
- Pyridoxine-nonresponsive genotype: Member's genetic assessment reveals a mutation consistent with pyridoxine (vitamin B6) non-responsive PH1
  must submit lab documentation
Laboratory/documentation findings
- Increased urinary oxalate excretion (i.e. greater than 0.7 mmol/1.73 m2 per day [90 mg/1.73 m2 per day])> 0.7 mmol/1.73 m2 per day (90 mg/1.73 m2 per day)
  must submit lab documentation
- Increased UOx:Cr ratio: Increased urinary oxalate:creatinine ratio relative to normative values for age
  must submit lab documentation
Lab submission requirements
- Current UOx (BSA-corrected): Provider has submitted lab test results documenting member's current 24-hour urinary oxalate excretion (corrected for BSA)
  Provider must supply value
- Baseline plasma oxalate: Provider has submitted lab test results documenting member's baseline plasma oxalate levels
  Provider must supply value
Exclusions and contraindications
- Renal function and transplant/dialysis exclusion: Member does NOT have severe kidney damage (eGFR <30 mL/min/1.73 m2), is NOT receiving hemodialysis and has NOT previously received a liver or kidney transplanteGFR < 30 mL/min/1.73 m2 (exclusion)
- Secondary causes exclusion: Member does NOT have secondary causes of hyperoxaluria (e.g., diet with excessive intake of oxalate, gastric bypass surgery, Irritable Bowel Disease, other intestinal disorders)
- Concomitant agents exclusion: Medication will NOT be used in combination with other urinary oxalate reducing agents (i.e., lumasiran, nedosiran)
- FDA dosing requirement: Requested dosing is in accordance with the United States Food and Drug Administration approved labeling

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Reauthorization (12 months) — Criteria

Reauthorization (12 months)

Covered when ALL of the following are met:

ALL of the following

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

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Provider Actions / Prior Authorization Requirements

Prior Authorization

Submit prior authorization form

Prescriber must complete and sign the pharmacy prior authorization/step-edit request form and fax it to 1-305-671-0200. Include required documentation with the submission: genetic testing results, laboratory values, medical chart notes, and dosing information. Incomplete, incorrect, or illegible information may delay authorization.

Fax completed, signed prior authorization form to 1-305-671-0200
Include genetic testing, lab values, chart notes, and dosing information
Ensure all information is complete, correct, and legible to avoid delays

Documentation Required

Submit genetic testing documentation

Provider must submit genetic testing documentation demonstrating either biallelic pathogenic mutations in the AGXT gene (definitive PH1 diagnosis) or genetic evidence consistent with pyridoxine (vitamin B6) non-responsiveness when required.

Documentation of biallelic pathogenic AGXT mutation (molecular genetic testing)
Or genetic evidence indicating pyridoxine non-responsiveness

Documentation Required

Submit lab test results

Provider must submit laboratory test results including the member's current 24-hour urinary oxalate excretion corrected for body surface area (BSA) and baseline plasma oxalate levels. For reauthorization, submit current medical chart notes and laboratory values demonstrating clinical response to therapy and a clinically significant reduction from pre-treatment baseline in urinary oxalate (corrected for BSA), urinary oxalate:creatinine ratio, or plasma oxalate concentrations.

Current 24-hour urinary oxalate excretion (corrected for BSA) — provide value
Baseline plasma oxalate level — provide value
For reauthorization: labs and chart notes showing clinical response and reduction from baseline in UOx (BSA-corrected), UOx:Cr ratio, or plasma oxalate

Billing Rule

Specialty pharmacy dispensing

Medication must be dispensed via Specialty Pharmacy (Proprium Rx). Use of samples to initiate therapy does not meet preauthorization/step-edit criteria.

Dispense through Proprium Rx specialty pharmacy
Samples do not satisfy preauthorization requirements

Background & Definitions

Background: This is a pharmacy prior authorization/step-edit request form and clinical criteria for two RNAi therapies (Oxlumo and Rivfloza) used to reduce hepatic oxalate production in primary hyperoxaluria type 1 (PH1). The form requires the prescriber’s signature and complete member/prescriber information, and it instructs that incomplete or illegible information can delay the authorization process.

The form requires genetic confirmation (documentation of biallelic pathogenic AGXT mutations or genetic evidence of pyridoxine non-responsiveness when applicable), laboratory documentation (current 24‑hour urinary oxalate corrected for BSA, baseline plasma oxalate levels, and other labs), and that the medication be provided by Specialty Pharmacy - Proprium Rx. Use of samples to initiate therapy does not meet preauthorization criteria.

OpenPayer

Oxlumo, Rivfloza (Pharmacy Benefit)

Coverage Summary

Initial Authorization (6 months) — Criteria

Reauthorization (12 months) — Criteria

Provider Actions / Prior Authorization Requirements

Applicable Codes

Key Thresholds & Duration

Background & Definitions

Revision History