CurrentCignaPolicy IP0629

Rivfloza (nedosiran) coverage

Cigna's coverage policy for Rivfloza (nedosiran subcutaneous injection) for treatment of Primary Hyperoxaluria Type 1 (PH1), detailing prior authorization, clinical criteria, dosing, exclusions, and coding for covered benefit plans administered by Cigna Companies.

Policy Summary

PayerCigna

PolicyRivfloza (nedosiran) coverage

Policy CodePolicy IP0629

Change TypeNew policy and multiple material revisions (age eligibility, biochemical thresholds, genetic confirmation, step therapy added)

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and provide documentation including genetic confirmation of biallelic AGXT pathogenic variants and required biochemical test results.

SourceLink

POLICY UPDATE CHANGES

Policy created as a new coverage policy for Rivfloza.

Initial therapy age eligibility changed from ≥9 years to ≥2 years and age-specific biochemical thresholds were restructured.

Genetic confirmation requirement updated to specify identification of biallelic pathogenic variants in AGXT.

Requirement for continued benefit for patients currently receiving Rivfloza was modified to remove a recent objective measurement qualifier, and a prior liver transplant exclusion was added for continuing patients.

Individual and Family Plan preferred product criteria (trial of Oxlumo required or already on Rivfloza) were added.

≥2 yrsminimum age eligible for initial therapy

≥30

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kidney function requirement (eGFR)

6 moinitial authorization

1 yrrenewal for current patients

160 mgprimary adult/adolescent dose

Coverage Criteria for Rivfloza (nedosiran)

Initial Therapy — Approve for 6 months

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

Initial Therapy criteria: i. Patient is ≥ 2 years of age; ii. Documentation of genetic test confirming PH1 with identification of biallelic pathogenic variants in AGXT; iii. Documentation of estimated glomerular filtration rate (eGFR) ≥ 30 ml/min per 1.73 m2; iv. Patient meets ONE of the age-specific biochemical criteria (see Age-specific biochemical criteria block); v. Patient has not previously received a liver transplant for Primary Hyperoxaluria Type 1; vi. Medication is prescribed by or in consultation with a nephrologist or urologist; vii. Preferred product criteria is met (per plan-specific requirements).as specified

Initial approval duration = 6 months; do not flatten the age-based biochemical branching

Age-specific biochemical criteria

Within Initial Therapy criterion iv: patient must meet ONE of the following depending on age group

If patient is 2 to <12 years: Option 1: Urinary oxalate excretion ≥ 0.5 mmol/24 hours/1.73 m2 with absence of secondary sources of oxalate; OR Option 2: urinary oxalate:creatinine ratio above 2 times the 95th percentile for age.≥ 0.5 mmol/24 hr/1.73 m2 or >2x 95th percentile for age

Applies only to patients 2 to <12 years

If patient is ≥12 years: Option 1: Urinary oxalate excretion ≥ 0.5 mmol/24 hours/1.73 m2 with absence of secondary sources of oxalate; OR Option 2: urinary oxalate:creatinine ratio above the age-specific upper limit of normal; OR Option 3: plasma oxalate ≥ 20 µmol/L.≥ 0.5 mmol/24 hr/1.73 m2 or plasma oxalate ≥ 20 µmol/L or age-specific UOx:Cr elevation

Applies only to patients ≥12 years

The following uses of Rivfloza are considered not medically necessary and are excluded from coverage: Primary Hyperoxaluria Type 2 (PH2), Primary Hyperoxaluria Type 3 (PH3), Primary Hyperoxaluria with end‑stage renal disease (PH with ESRD), and concurrent use with Oxlumo (lumasiran).

Rivfloza is explicitly not covered for treatment of PH2 or PH3 because its efficacy and safety in these populations have not been established and clinical trials are ongoing. Rivfloza is also considered not medically necessary for patients with PH and end‑stage renal disease (ESRD) due to insufficient evidence of benefit in that population. Finally, concurrent administration of Rivfloza with Oxlumo (lumasiran) is not allowed because both are small interfering RNA agents and should not be used together.

Continuation / Patients Currently Receiving Rivfloza

Patient is Currently Receiving Rivfloza — Continuing Therapy

Approve Rivfloza for 1 year when BOTH of the following are met:

Continuing therapy criteria: i. Documentation provided that the patient is continuing to derive benefit from Rivfloza, according to the prescriber (examples include reduced urinary oxalate excretion, decreased urinary oxalate:creatinine ratio, reduced plasma oxalate from baseline, or improved/stabilized clinical signs/symptoms); AND ii. Patient has not previously received a liver transplant for Primary Hyperoxaluria Type 1.as specified

Renewal duration for continuing patients = 1 year; transplant exclusion applies to continuing patients

Dosing

Approve one of the following dosing regimens based on weight:

Weight-based dosing: If weight ≥ 50 kg: 160 mg once monthly; If weight 39 kg to < 50 kg: 128 mg once monthly; If weight < 39 kg: 3.3 mg/kg once monthly (not to exceed 128 mg).weight-based

Use corresponding regimen for patient's body weight

Coding Information

Considered Medically Necessary when criteria metHCPCSCovered

C9399	Unclassified drugs or biologics
J3490	Unclassified drugs

inv-08: Urinary oxalate excretion threshold (used in criteria)

Threshold valueUrinary oxalate excretion ≥ 0.5 mmol/24 hours/1.73 m2

Age group applicabilityApplied as an approval criterion for both pediatric (2 to <12 years) and ≥12 years groups when documented with absence of secondary oxalate sources

Measurement type24-hour urinary oxalate excretion (normalized to 1.73 m2)

Supporting evidenceUsed in pivotal and pediatric studies as a biochemical efficacy measure (study entry criteria and endpoints)

inv-09: Plasma oxalate threshold (criterion for ≥12 years)

Threshold valuePlasma oxalate ≥ 20 µmol/L

Provider Actions, Prior Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization (PA) is required prior to initiation of Rivfloza for medical benefit coverage. Initial approvals are time-limited to 6 months. For patients already receiving Rivfloza who meet reauthorization requirements, renewal approvals are provided for up to 1 year. All reviews will be forwarded to the Medical Director for evaluation. Rivfloza must be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., nephrologist or urologist).

PA required prior to initiation.
Initial approval duration: 6 months.
Renewal duration for existing patients: up to 1 year.
Reviews forwarded to Medical Director.
Prescriber requirement: specialist (nephrologist or urologist)

Documentation Required

Required Documentation to Support PA

Submit supporting documentation with the PA request to demonstrate that coverage criteria are met. Documentation may include, but is not limited to, chart notes, laboratory test results, genetic test reports, and prior treatment history. For initial requests include documentation of genetic confirmation of PH1 (biallelic pathogenic AGXT variants), eGFR, urinary or plasma oxalate results per criteria, and documentation that the patient has not had a liver transplant for PH1. For step-therapy criteria include documentation of prior Oxlumo trial and reason for inadequate efficacy or intolerance, or documentation that the patient has already started Rivfloza.

Background

Primary Hyperoxaluria Type 1 (PH1) is a rare autosomal recessive disorder caused by pathogenic variants in the AGXT gene that lead to overproduction of oxalate, resulting in recurrent kidney stones, nephrocalcinosis, and progressive renal impairment. Rivfloza (nedosiran) is an siRNA therapeutic indicated to lower urinary and plasma oxalate in patients with PH1 and is intended for patients aged ≥ 2 years with adequate kidney function when coverage criteria are met.

Definitions

inv-16: PH1 definition — Primary Hyperoxaluria Type 1 (PH1)

DefinitionPrimary Hyperoxaluria Type 1 (PH1) is an autosomal recessive inborn error of glyoxylate metabolism caused by pathogenic variants in the alanine:glyoxylate aminotransferase gene (AGXT), resulting in overproduction of oxalate and formation of calcium oxalate crystals with renal and systemic deposition.

Genetic basisCaused by biallelic pathogenic variants in AGXT; genetic confirmation is required for coverage

Clinical consequencesLeads to nephrolithiasis, nephrocalcinosis, progressive renal impairment, and potential systemic oxalosis

Definitive treatment noteLiver transplantation corrects the underlying enzymatic defect and is the only curative intervention

Policy Summary

PayerCigna

PolicyRivfloza (nedosiran) coverage

Policy CodePolicy IP0629

Change TypeNew policy and multiple material revisions (age eligibility, biochemical thresholds, genetic confirmation, step therapy added)

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and provide documentation including genetic confirmation of biallelic AGXT pathogenic variants and required biochemical test results.

SourceLink

On This Page

Age group applicabilitySpecified as an acceptable biochemical criterion option for patients ≥ 12 years of age

Use in criteriaOne of the alternatives to urinary oxalate measures for meeting age-specific biochemical requirements in adults/adolescents

inv-10: Urinary oxalate:creatinine ratio — age-specific upper limit or >2x 95th percentile for 2 to <12 years option

Pediatric ratio criterion (2 to <12 yrs)Urinary oxalate:creatinine ratio above 2 × the 95th percentile for age (per prescriber documentation)

Adolescent/adult ratio criterion (≥12 yrs)Urinary oxalate:creatinine ratio above the age-specific upper limit of normal

Measurement contextSpot urinary oxalate:creatinine ratio used as a pediatric efficacy endpoint in trials and as an alternative biochemical inclusion criterion

Chart notes documenting diagnosis, clinical history, and prescriber specialty.
Genetic test results confirming biallelic pathogenic variants in AGXT.
Laboratory data: eGFR (≥ 30 mL/min/1.73 m2), urinary oxalate excretion or urinary oxalate:creatinine ratio, or plasma oxalate level as applicable.
Documentation of prior therapy with Oxlumo and evidence of inadequate efficacy or significant intolerance, if applicable.
If already on Rivfloza, documentation of current therapy start date and evidence of clinical benefit for reauthorization.

Denial Risk

Denial Triggers — What May Cause a Denial

Coverage will be denied if required documentation or a covered diagnosis/procedure code is not submitted, if the patient does not meet the specified clinical criteria, or if step-therapy requirements are unmet. Common denial triggers include missing genetic confirmation of PH1, eGFR below required threshold, absent or insufficient urinary/plasma oxalate data, failure to document prior Oxlumo use when required by plan type, evidence of prior liver transplant for PH1, or concurrent use of Oxlumo. Receipt of sample product does not satisfy criteria. Ensure all requested documentation is included with the PA to avoid delays or denials.

Missing or incomplete genetic test confirming PH1 (AGXT biallelic pathogenic variants).
eGFR < 30 mL/min/1.73 m2 at time of request.
No urinary oxalate or plasma oxalate results meeting criteria (or absent values).
No documentation of prior Oxlumo trial or intolerance when required (Employer and Individual/Family plans).
Documentation of prior liver transplant for PH1 (not eligible).
Concurrent use of Rivfloza with Oxlumo (not allowed).
No covered diagnosis/procedure codes submitted with claim or PA request.
Receipt of sample product alone does not meet criteria.