CurrentMass General Brigham Health PlanPolicy N/A

Rivfloza (nedosiran) prior authorization for PH1

Defines prior authorization requirements for Rivfloza (nedosiran) under the pharmacy benefit for Mass General Brigham Health Plan commercial/exchange members, including initial and continuation criteria and specialty pharmacy dispensing rules.

Policy Summary

PayerMass General Brigham Health Plan

PolicyRivfloza (nedosiran) prior authorization for PH1

Policy CodePolicy N/A

Change TypeMaterial clinical revisions

Effective DateJan 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and submit medical records confirming PH1 (AGXT mutation or absent/reduced AGT activity), baseline eGFR, and 24‑hour urinary oxalate.

SourceLink

POLICY UPDATE CHANGES

Policy updated to indicate it no longer applies to the medical benefit.

Minimum eligible age decreased from 9 years to 2 years to align with labeling.

12 monthsapproval duration

>=2 yrsminimum age

>=30eGFR requirement

>=0.7 mmolurinary oxalate

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Coverage Criteria for Rivfloza (nedosiran)

inv-01: Initial Therapy

Authorization may be granted when the following AND conditions are met:

Initial coverage criteria: Member has documented diagnosis of primary hyperoxaluria type 1 (PH1) confirmed by either (a) AGXT gene mutation OR (b) liver enzyme analysis showing absent or significantly reduced AGT activity; member is >= 2 years of age; pretreatment eGFR >= 30 mL/min/1.73 m2; 24-hour urinary oxalate excretion >= 0.7 mmol normalized to 1.73 m2 BSA; member has no history of renal or liver transplantation; member will not take the requested medication concurrently with lumasiran.see children nodes

All conditions must be met

inv-02: Continuation of Therapy (Reauthorization)

Requests for reauthorization will be approved when ALL of the following are met:

Reauthorization criteria: Member has not had a renal or liver transplant; member has eGFR >= 30 mL/min/1.73 m2; submission of medical records demonstrating a positive response to therapy from baseline (examples: decreased urinary oxalate concentration, decreased plasma oxalate concentration, or decreased spot urinary oxalate:creatinine ratio).clinical or biochemical improvement required

All conditions must be met

The policy prohibits concurrent administration of Rivfloza (nedosiran) with lumasiran. Authorization requires that the member will not take the requested medication concurrently with lumasiran.

Rivfloza is covered under the pharmacy benefit for Commercial/Exchange members and is designated specialty pharmacy–dispensed. An exception is noted for formulation routing: the prefilled syringe is available through both the pharmacy and medical benefits, while the Rivfloza vial is restricted to the medical benefit.

Treatment with Rivfloza is considered not medically necessary when the coverage criteria are not met. Examples include lack of documented confirmation of primary hyperoxaluria type 1 (PH1) by AGXT mutation or absent/reduced AGT activity, pretreatment eGFR < 30 mL/min/1.73 m2, 24‑hour urinary oxalate excretion below 0.7 mmol per 1.73 m2 BSA, or a history of renal or liver transplantation. Concurrent use with lumasiran also renders therapy ineligible per the policy.

Product Codes, Measurements, and Key Clinical Thresholds

Product codes / NDCNDC

NDC (per prescribing info)

Rivfloza (nedosiran) product codes as per manufacturer — specific NDCs referenced in prescribing information

inv-07: eGFR requirement — renal function threshold for eligibility

eGFR thresholdPretreatment estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2

Measurement timingPretreatment (baseline) eGFR required prior to initiation

Reauthorization requirementeGFR ≥ 30 mL/min/1.73 m2 must be documented for continuation

inv-08: 24-hour urinary oxalate excretion threshold

24-hour urinary oxalate threshold24-hour urinary oxalate excretion ≥ 0.7 mmol normalized to 1.73 m2 BSA

NormalizationResult must be normalized to 1.73 m2 body surface area (BSA)

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior authorization required (pharmacy benefit)

Prior authorization is required for Rivfloza (nedosiran) under the pharmacy benefit for Commercial/Exchange members. Members new to the plan within the past 90 days who are currently receiving the medication may be eligible for authorization when documentation supports ongoing treatment.

Step Therapy

Step therapy not required

No step therapy requirement is specified for Rivfloza in this policy.

Documentation Required

Required documentation to support authorization

Submit medical records that confirm the diagnosis and baseline status prior to authorization and for reauthorization as specified.

Background

Rivfloza (nedosiran) is an LDHA‑directed small interfering RNA indicated to reduce urinary oxalate in patients with primary hyperoxaluria type 1 (PH1). The policy applies to children aged 2 years and older and adults and references requirements for diagnostic confirmation, baseline renal function, and urinary oxalate thresholds prior to authorization.

Definitions

inv-15: Primary hyperoxaluria type 1 (PH1) — definition and diagnostic characterization

DefinitionPrimary hyperoxaluria type 1 (PH1) is a genetic disorder characterized by excessive hepatic oxalate production due to AGXT gene mutation or deficient/absent AGT enzyme activity

Diagnostic confirmation methodsConfirmed by AGXT gene mutation OR liver enzyme analysis demonstrating absent or significantly reduced alanine:glyoxylate aminotransferase (AGT) activity

Clinical relevancePH1 with relatively preserved kidney function (eGFR ≥ 30 mL/min/1.73 m2) is the indicated population for nedosiran (Rivfloza)