CurrentCignaPolicy IP0629

Rivfloza (nedosiran) — Prior Authorization and Coverage Criteria for Primary Hyperoxaluria Type 1

Defines prior authorization, clinical criteria, dosing, and coverage rules for Rivfloza (nedosiran) for treatment of Primary Hyperoxaluria Type 1 for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyRivfloza (nedosiran) — Prior Authorization and Coverage Criteria for Primary Hyperoxaluria Type 1

Policy CodePolicy IP0629

Change TypeNew policy with material revisions (age and threshold updates)

Effective Date

Next Review Date

Key ActionObtain prior authorization and document genetic confirmation of PH1 (biallelic pathogenic variants in AGXT) and relevant labs to support initial 6‑month approval.

SourceLink

POLICY UPDATE CHANGES

New policy created for Rivfloza with initial effective content.

Initial therapy age lowered from ≥9 years to ≥2 years and criteria for urine/plasma oxalate thresholds were restructured by age.

Genetic confirmation language updated to require identification of biallelic pathogenic variants in AGXT.

Urinary oxalate excretion threshold changed from ≥0.7 to ≥0.5 mmol/24 hr/1.73 m2 for approval pathways.

Documentation requirements were added and defined for the policy.

≥ 2 yrsminimum age eligible for initial therapy

eGFR ≥30minimum kidney function required

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initial authorization duration

1 yearrenewal duration

160 mg/moexample dosing (≥50 kg)

Coverage and Medical Necessity Criteria

FDA-Approved Indication - Initial Therapy

Approve Rivfloza for 6 months if ALL of the following are met:

Initial Therapy: Patient is ≥ 2 years of age

Genetic confirmation: Documentation of genetic test confirming diagnosis of Primary Hyperoxaluria Type 1 via identification of biallelic pathogenic variants in the AGXT gene

Kidney function: Documentation provided that the patient has an estimated glomerular filtration rate (eGFR) ≥ 30 ml/min per 1.73 m2

Oxalate burden criteria: Patient meets ONE of the following age-specific oxalate criteria

See nested children

Oxalate criteria for ages 2 to <12: For patients 2 to <12 years: meet ONE of: (1) urinary oxalate excretion ≥ 0.5 mmol/24 hours/1.73 m2 with absence of secondary sources of oxalate; OR (2) urinary oxalate:creatinine ratio above 2 times the 95th percentile for age (per prescriber)

Applies only to 2 to <12 years

Oxalate criteria for ≥12 years: For patients ≥ 12 years: meet ONE of: (1) urinary oxalate excretion ≥ 0.5 mmol/24 hours/1.73 m2 with absence of secondary sources of oxalate; OR (2) urinary oxalate:creatinine ratio above the age-specific upper limit of normal; OR (3) plasma oxalate ≥ 20 µmol/L

Applies only to ≥ 12 years

No prior liver transplant: Patient has not previously received a liver transplant for Primary Hyperoxaluria Type 1

Prescriber specialty: Medication is prescribed by or in consultation with a nephrologist or urologist

Preferred product criteria is met for the product as listed in the policy

Employer/Individual plan criteria may require trial of Oxlumo or prior start of Rivfloza

FDA-Approved Indication - Patient Currently Receiving Rivfloza

Approve for 1 year if BOTH of the following are met:

Continued benefit: Documentation that the patient is continuing to derive benefit from Rivfloza per the prescriber (examples: reduced urinary oxalate excretion, decreased urinary oxalate:creatinine ratio, reduced plasma oxalate, or improved/stabilized clinical signs/symptoms)

No prior liver transplant: Patient has not previously received a liver transplant for Primary Hyperoxaluria Type 1

Employer / Individual and Family Plan Preferred Product Criteria

Coverage for some lines of business requires one of the following:

Step therapy or prior use: Patient has tried and, according to the prescriber, experienced inadequate efficacy or significant intolerance with Oxlumo; OR the patient has already been started on therapy with Rivfloza

Applies to Employer and Individual/Family plans

Not Medically Necessary Uses

Rivfloza is considered not medically necessary for the following uses:

Excluded indications: Primary Hyperoxaluria Type 2 (PH2); Primary Hyperoxaluria Type 3 (PH3); Primary Hyperoxaluria with end stage renal disease (ESRD); concurrent use of Rivfloza with Oxlumo (lumasiran); other non-PH1 uses not supported by evidence

List may not be all inclusive

Dosing Options (coverage-approved dosing)

Approve one of the following weight-based dosing regimens:

Weight ≥ 50 kg: 160 mg once monthly

Weight 39 kg to < 50 kg: 128 mg once monthly

Weight < 39 kg: 3.3 mg/kg once monthly, not to exceed 128 mg

Concurrent use of Rivfloza with Oxlumo (lumasiran) is prohibited. When Rivfloza is being considered or prescribed, it must not be used together with Oxlumo, as concurrent administration of these two small interfering RNA agents is not allowed.

Use of Rivfloza for indications other than Primary Hyperoxaluria Type 1 (PH1) is considered not medically necessary. This includes treatment of PH2, PH3, primary hyperoxaluria with end-stage renal disease (ESRD), and other non-PH1 uses not supported by available evidence.

Billing, Codes, and Clinical Thresholds

Considered Medically Necessary when criteria metmixedCovered

C9399	Unclassified drugs or biologics.
J3490	Unclassified drugs

Urinary oxalate excretion — Numeric threshold used as approval criterion

Urinary oxalate excretion (approval threshold)≥ 0.5 mmol/24 hours/1.73 m2 (required documentation of absence of secondary sources of oxalate for this measure)

Previous study threshold (context)Pivotal study enrolled patients with urinary oxalate ≥ 0.7 mmol/24 hr/1.73 m2

Pediatric spot ratio alternative (ages 2 to <12)Urinary oxalate:creatinine ratio > 2 × 95th percentile for age may be used instead of 24‑hr collection

Plasma oxalate — Numeric threshold

Plasma oxalate (approval threshold)≥ 20 µmol/L

Age applicabilityPlasma oxalate ≥ 20 µmol/L is an option for patients ≥ 12 years of age

Prior Authorization, Documentation, and Billing Guidance

Prior Authorization

Prior Authorization Required

Prior authorization is required for Rivfloza. Initial approvals are granted for 6 months; reauthorizations for patients currently receiving Rivfloza are approved for 1 year when documentation shows continued benefit. Initial prescribing must be by or in consultation with a specialist (nephrologist or urologist). All reviews will be forwarded to the Medical Director for evaluation.

Initial approvals: 6 months
Reauthorization (current users): 1 year
Prescriber requirement: nephrologist or urologist
Reviews forwarded to Medical Director

Step Therapy

Preferred Product / Step Therapy

Employer and Individual/Family plans require documentation of a trial of Oxlumo with inadequate efficacy or significant intolerance, OR documentation that the patient has already been started on Rivfloza. These criteria apply in addition to the clinical eligibility criteria (age, genetic confirmation, eGFR, urine/plasma oxalate thresholds, transplant history, and dosing). Receipt of sample product does not satisfy criteria.

Clinical Background

Primary hyperoxaluria type 1 (PH1) is a rare autosomal recessive metabolic disorder caused by pathogenic variants in the AGXT gene, resulting in overproduction of oxalate. Excess oxalate combines with calcium to form calcium oxalate crystals that deposit in the kidneys and other organs, leading to progressive nephrolithiasis, nephrocalcinosis, renal impairment, and systemic complications. Liver transplantation is the only curative treatment. Rivfloza (nedosiran) is an LDHA-directed small interfering RNA therapy indicated to lower urinary and plasma oxalate levels in patients with PH1 with relatively preserved kidney function.

Drug and Disease Definitions

Rivfloza (nedosiran) — Drug description and indication summary

Generic name and classNedosiran — an LDHA‑directing small interfering RNA (siRNA)

Indication (FDA‑approved)Indicated for treatment of Primary Hyperoxaluria Type 1 (PH1) to lower urinary and plasma oxalate levels

Age and kidney functionApproved for adults and children ≥ 2 years of age with relatively preserved kidney function

Prescriber guidancePolicy requires prescription by or in consultation with a nephrologist or urologist for coverage

Primary Hyperoxaluria Type 1 (PH1) — Definition and genetic cause

DefinitionPrimary Hyperoxaluria Type 1 (PH1) is a rare autosomal recessive inborn error of glyoxylate metabolism that results in overproduction of oxalate and calcium oxalate deposition in kidneys and other organs.

Policy Summary

PayerCigna

PolicyRivfloza (nedosiran) — Prior Authorization and Coverage Criteria for Primary Hyperoxaluria Type 1

Policy CodePolicy IP0629

Change TypeNew policy with material revisions (age and threshold updates)

Effective Date

Next Review Date

Key ActionObtain prior authorization and document genetic confirmation of PH1 (biallelic pathogenic variants in AGXT) and relevant labs to support initial 6‑month approval.

SourceLink

On This Page

Use in continued-therapy decisionsReduction in plasma oxalate cited as an example of clinical benefit for reauthorization

eGFR — Renal function threshold for eligibility

eGFR (renal function threshold)≥ 30 ml/min per 1.73 m2

ApplicabilityRequired for initial approval (patient must have relatively preserved kidney function)

Policy wordingDocumentation provided that the patient has an estimated glomerular filtration rate (eGFR) ≥ 30 ml/min per 1.73 m2

Employer plans: trial/failure/intolerance to Oxlumo or already on Rivfloza
Individual & Family plans: trial/failure/intolerance to Oxlumo or already on Rivfloza
Sample product does not satisfy criteria
Clinical eligibility criteria (age, genetic test, eGFR, oxalate measures, no prior liver transplant) must also be met

Documentation Required

Required Documentation

Documentation is required to support use of Rivfloza and should be included with initial and (when applicable) continuation requests. Acceptable documentation may include chart notes, laboratory tests (e.g., urinary oxalate excretion, urinary oxalate:creatinine ratio, plasma oxalate), genetic test results confirming biallelic pathogenic AGXT variants, claims records, and prescriber statements of clinical benefit. For reauthorization of ongoing therapy, documentation that the patient is continuing to derive benefit from Rivfloza is required (examples: reduced urinary oxalate excretion or plasma oxalate from baseline, decreased urinary oxalate:creatinine ratio, or improved/stabilized clinical signs/symptoms such as nephrocalcinosis, stone formation, or renal function).

Acceptable documents: chart notes, labs (urine/plasma oxalate), genetic test reports, claims records, prescriber clinical assessment
Reauthorization requirement: evidence of continued benefit (quantitative lab improvements or clinical stabilization)
Do not need to re-submit full prior documentation for reauthorization except evidence of continued benefit if prior criteria were met

Denial Risk

Billing and Coding Denial Risks

Claims submitted without appropriate covered diagnosis or procedure codes, or without documentation supporting medical necessity per this policy, will be denied. Use the most appropriate and current codes for the services and diagnoses. Billing without meeting the clinical criteria (including required genetic confirmation, age/eGFR thresholds, oxalate measurements, or applicable step-therapy requirements) or without required documentation (e.g., genetic test, labs, prescriber documentation of benefit) risks denial. Concurrent use of Rivfloza with Oxlumo is not medically necessary and claims for such concurrent therapy will be denied.

Claims lacking covered diagnosis/procedure codes will be denied
Ensure coding reflects Primary Hyperoxaluria Type 1 and relevant services/tests
Failure to document required genetic testing, eGFR, oxalate measures, specialist prescribing/consultation, or step-therapy trial will result in denial
Concurrent use with Oxlumo is not covered

Genetic causeCaused by biallelic pathogenic variants in the alanine:glyoxylate aminotransferase gene (AGXT)

Clinical consequencesLeads to nephrocalcinosis, recurrent renal stones, and progressive renal impairment; liver transplant is the only curative intervention