CurrentAnthemPolicy CC-0256

Rivfloza (nedosiran)

Clinical coverage criteria, coding, and utilization management for Rivfloza (nedosiran) when used to lower urinary oxalate in individuals with primary hyperoxaluria type 1 (PH1); applies to Anthem medical benefit reviews and prior authorization determinations.

Policy Summary

PayerAnthem

PolicyRivfloza (nedosiran)

Policy CodePolicy CC-0256

Change TypeMaterial clinical revision — age threshold updated

Effective Date

Next Review Date

Key ActionObtain prior authorization and documentation verifying PH1 diagnosis (genetic testing or liver biopsy) and use Rivfloza with pyridoxine; initial approvals limited to 6 months.

SourceLink

POLICY UPDATE CHANGES

Updated age in clinical criteria to allow treatment beginning at 2 years of age.

Added HCPCS NOC code C9399 for Rivfloza.

2+minimum age for initiation

eGFR ≥30required renal function

6 moinitial approval

1 yrcontinuation approval

≤2 vials / 1 syringemonthly limits

Clinical Coverage Criteria

Initial Therapy

Covered when ALL of the following are met:

Initial criteria: I. Individual is 2 years of age or older; AND II. Individual has a diagnosis of primary hyperoxaluria type 1 (PH1); AND III. Diagnosis verified by (A) genetic testing demonstrating mutation in the AGXT gene OR (B) liver biopsy demonstrating significantly decreased or absent AGT enzyme activity; AND IV. Documentation of elevated urinary oxalate levels; AND V. Individual is using Rivfloza in combination with pyridoxine (unless the individual is a pyridoxine non-responder).

Based on clinical criteria section for initial requests.

Continuation Therapy

Covered when ALL of the following are met:

Continuation criteria: I. Individual has a diagnosis of primary hyperoxaluria type 1 (PH1); AND II. Diagnosis verified by (A) genetic testing demonstrating mutation in the AGXT gene OR (B) liver biopsy demonstrating significantly decreased or absent AGT enzyme activity; AND III. Documentation of a clinically significant reduction in urinary oxalate excretion with Rivfloza therapy; AND IV. Individual is using Rivfloza in combination with pyridoxine (unless the individual is a pyridoxine non-responder).

Policy Summary

PayerAnthem

PolicyRivfloza (nedosiran)

Policy CodePolicy CC-0256

Change TypeMaterial clinical revision — age threshold updated

Effective Date

Next Review Date

Key ActionObtain prior authorization and documentation verifying PH1 diagnosis (genetic testing or liver biopsy) and use Rivfloza with pyridoxine; initial approvals limited to 6 months.

SourceLink

On This Page

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Prior Authorization, Documentation, and Operational Guidance

Prior Authorization

Prior authorization required; time-limited approvals and quantity limits

Prior authorization is required for Rivfloza (nedosiran). Initial approvals are limited to 6 months; continuation approvals may be granted for up to 1 year. Quantity limits apply per month (see coding/limits).

Initial approval duration: 6 months
Continuation approval duration: 1 year
Monthly quantity limits: up to 2 vials (80 mg) or 1 syringe (128 mg or 160 mg) per month

Step Therapy

Concomitant pyridoxine required (trial recommended for responsive genotypes)

Rivfloza should be used in combination with pyridoxine unless the individual is a documented pyridoxine non-responder. A trial of pyridoxine (5–20 mg/kg per day) is prudent for individuals with pyridoxine-responsive PH1 genotypes.

Concomitant pyridoxine required unless documented non-responder
Recommended pyridoxine trial dose: 5–20 mg/kg per day for pyridoxine-responsive genotypes

Documentation Required

Required supporting documentation: genetic testing, liver biopsy, and oxalate measurements

Submit documentation verifying the PH1 diagnosis and treatment response: genetic testing showing an AGXT mutation OR liver biopsy demonstrating significantly decreased/absent AGT enzyme activity; evidence of elevated urinary oxalate for initial requests; and for continuation requests, documentation of a clinically significant reduction in urinary oxalate with Rivfloza therapy.

Genetic test report demonstrating AGXT mutation OR liver biopsy report showing decreased/absent AGT activity
Baseline documentation of elevated urinary oxalate levels (initial requests)
Documentation of clinically significant reduction in urinary oxalate excretion with therapy (continuation requests)

Denial Risk

Common denial triggers and exclusions

Requests may be denied if exclusion criteria are present, including a diagnosis of PH2 or PH3, history of or planned kidney or liver transplant, eGFR < 30 mL/min/1.73 m2, or concomitant use with Oxlumo (lumasiran).

PH2 or PH3 diagnosis
History of or planned kidney or liver transplant
eGFR < 30 mL/min/1.73 m2
Use in combination with Oxlumo (lumasiran)

Background

Primary hyperoxaluria (PH) is an inherited disorder of glyoxylate metabolism that results in elevated urinary oxalate. PH type 1 (PH1) is caused by mutations in the AGXT gene leading to deficient hepatic alanine–glyoxylate aminotransferase (AGT) activity and represents the predominant form targeted by therapy. Conservative management of PH1 includes high fluid intake, urinary alkalinization, and pyridoxine for responsive genotypes. Rivfloza (nedosiran) is an LDHA-directed small interfering RNA administered subcutaneously and approved to lower urinary oxalate in individuals with PH1 who meet the policy’s diagnostic verification and renal function requirements; ongoing therapy requires documentation of a clinically significant reduction in urinary oxalate excretion.

Key Definitions

PH1 — definition

DefinitionPrimary hyperoxaluria type 1 (PH1) is caused by mutation in the AGXT gene leading to decreased activity of the hepatic alanine-glyoxylate aminotransferase (AGT) enzyme.

Diagnosis confirmationDiagnosis may be confirmed by genetic testing demonstrating an AGXT mutation or by liver biopsy showing significantly decreased or absent AGT enzyme activity.

Epidemiology notePH1 is the most common PH type, accounting for approximately 80% of PH cases.

Rivfloza (nedosiran) — mechanism and administration

Mechanism of actionRivfloza (nedosiran) is an LDHA-directed small interfering RNA (siRNA) that lowers urinary oxalate by targeting lactate dehydrogenase A.

Route and frequencyAdministered subcutaneously once monthly by the individual, caregiver, or healthcare professional.

Indication contextApproved to lower urinary oxalate levels in children (≥2 years) and adults with PH1 and relatively preserved kidney function.

C9399	Unclassified drugs or biologicals [when specified as Rivfloza (nedosiran)]
J3490	Unclassified drugs [when specified as [Rivfloza] (nedosiran)]

OpenPayer

Rivfloza (nedosiran)

Clinical Coverage Criteria

Coding and Diagnosis

Prior Authorization, Documentation, and Operational Guidance

Background

Key Definitions