Currentblue cross blue shield - tennesseePolicy N/A

Rivfloza (for primary hyperoxaluria type 1) Coverage Criteria

Policy governs coverage and prior authorization requirements for Rivfloza to lower urinary oxalate in patients with primary hyperoxaluria type 1 (PH1) with preserved kidney function; affects providers prescribing the drug and BlueCross BlueShield of Tennessee members.

Policy Summary

Payerblue cross blue shield - tennessee

PolicyRivfloza (for primary hyperoxaluria type 1) Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJul 31, 202647d

Next Review DateN/A

Key ActionSubmit prior authorization with proof of PH1 diagnosis (AGXT pathogenic variant or absent/reduced AGT activity), baseline oxalate testing, age ≥2 years, and eGFR ≥30 mL/min/1.73 m2.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

>=2 yrsminimum age

eGFR >=30kidney function

No Oxlumocombination restriction

Coverage Criteria for Rivfloza (PH1)

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Initial Therapy

Authorization of 12 months may be granted for PH1 when ALL of the following are met:

PH1 Initial Authorization Criteria: Member is 2 years of age or older; diagnosis of PH1 confirmed by either a molecular genetic test demonstrating a pathogenic AGXT variant OR liver enzyme analysis demonstrating absent or significantly reduced AGT activity; relatively preserved kidney function (e.g., eGFR >= 30 mL/min/1.73 m2); elevated urinary oxalate, urinary oxalate:creatinine ratio, or plasma oxalate levels prior to initiating therapy as reported by the performing laboratory; member has not previously received a liver transplant; requested medication will not be used in combination with Oxlumo (lumasiran).12-month authorization

Prescriber must be a geneticist, nephrologist, or urologist.

Continuation Therapy

Continuation of therapy may be authorized for 12 months when ALL of the following are met:

Continuation Therapy Criteria: Member continues to meet all initial coverage criteria and demonstrates a positive response to therapy (e.g., decrease or normalization in urinary and/or plasma oxalate levels, and/or improvement in kidney function).12-month authorization

Chart notes or medical records documenting response required.

Key Clinical Thresholds and Identifiers

inv-06: eGFR threshold — required preserved kidney function for coverage

eGFR threshold>= 30 mL/min/1.73 m2

ContextApplies to members with relatively preserved kidney function for Rivfloza use in PH1

Source phrasingeGFR of greater than or equal to 30 mL/min/1.73 m2

inv-07: Minimum age — patient age threshold for coverage

Minimum age>= 2 years

Indication scopeApplies to children 2 years and older and adults with PH1

Source phrasingchildren 2 years of age and older and adults

inv-13: Confirmed PH1 — diagnostic confirmation by AGXT pathogenic variant or liver enzyme analysis

Confirmed PH1 - molecular testDiagnosis confirmed by molecular genetic test demonstrating a pathogenic AGXT variant

Confirmed PH1 - enzyme analysisDiagnosis confirmed by liver enzyme analysis demonstrating absent or significantly reduced AGT activity

Policy useRequired for prior authorization of Rivfloza for PH1

Provider Requirements, Documentation, and Denial Risks

Prior Authorization

Prior authorization requirements for PH1 (must provide diagnostic and baseline data)

Prior authorization requires documentation that the member has PH1 confirmed by either molecular genetic test demonstrating a pathogenic AGXT variant or liver enzyme analysis showing absent or significantly reduced AGT activity, baseline elevated urinary or plasma oxalate measures, age ≥ 2 years, preserved kidney function (eGFR ≥ 30 mL/min/1.73 m2), no prior liver transplant, and that the medication will not be used with Oxlumo.

Confirmation of PH1 via AGXT pathogenic variant OR absent/reduced AGT activity.
Baseline elevated urinary oxalate, urinary oxalate:creatinine ratio, or plasma oxalate prior to initiating therapy.
Patient age ≥ 2 years and eGFR ≥ 30 mL/min/1.73 m2.
No prior liver transplant; not to be used with Oxlumo (lumasiran).

Step Therapy

Combination restriction — do not combine with Oxlumo (lumasiran)

The requested medication must not be used in combination with Oxlumo (lumasiran); concurrent use is explicitly prohibited by the policy.

Documentation Required

Required documentation for initial requests — oxalate and genetic/enzyme testing

Initial prior authorization requests must include baseline urinary oxalate (or urinary oxalate:creatinine ratio) or plasma oxalate results and molecular genetic test results demonstrating a pathogenic AGXT variant or liver enzyme analysis showing absent/significantly reduced AGT activity.

Baseline urinary oxalate, urinary oxalate:creatinine ratio, or plasma oxalate testing results.
Molecular genetic test result showing a pathogenic AGXT variant OR liver enzyme analysis demonstrating absent/significantly reduced AGT activity.

Denial Risk

Denial triggers — non‑PH1 indications or inadequate kidney function

Requests for uses other than PH1, for patients with eGFR < 30 mL/min/1.73 m2, or other non–FDA‑approved indications are considered experimental/investigational and not medically necessary and may be denied.

Any indication other than the FDA‑approved PH1 indication with relatively preserved kidney function is not medically necessary.
Patients with eGFR less than 30 mL/min/1.73 m2 do not meet the preserved kidney function requirement.

Clinical Background

Primary hyperoxaluria type 1 (PH1) is an inherited metabolic disorder caused by pathogenic variants in the AGXT gene leading to deficient alanine:glyoxylate aminotransferase (AGT) activity and overproduction of oxalate. Excess oxalate results in markedly elevated urinary and often plasma oxalate levels, promoting calcium oxalate crystal formation, recurrent nephrolithiasis, progressive nephrocalcinosis, and risk of chronic kidney disease and kidney failure. Therapeutic strategies that reduce hepatic oxalate production or lower systemic oxalate burden—such as the FDA‑approved agent indicated to lower urinary oxalate in patients with PH1 who are ≥2 years old and have relatively preserved kidney function—aim to decrease urinary oxalate and thereby reduce kidney injury and complications.

Definitions and Diagnostic Criteria

inv-13: Confirmed PH1 — Diagnosis confirmed by molecular genetic test demonstrating a pathogenic AGXT variant or by liver enzyme analysis demonstrating absent or reduced AGT activity.

Molecular genetic confirmationMolecular genetic test demonstrating a pathogenic variant in the AGXT gene

Liver enzyme confirmationLiver enzyme analysis showing absent or significantly reduced alanine:glyoxylate aminotransferase (AGT) activity

Use in authorizationOne of these confirmations is required to establish diagnosis of PH1 for coverage consideration