Rivfloza (for primary hyperoxaluria type 1) Coverage Criteria
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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.
No material clinical or coverage changes in this revision.
Coverage Criteria for Rivfloza (PH1)
Initial Therapy
Authorization of 12 months may be granted for PH1 when ALL of the following are met:
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:
Chart notes or medical records documenting response required.
Not Medically Necessary
Use of the requested medication in combination with Oxlumo (lumasiran) is not permitted. Prior liver transplant recipients are excluded from coverage for this therapy.
Any indication other than the FDA‑approved indication for primary hyperoxaluria type 1 (PH1) in patients with relatively preserved kidney function (e.g., eGFR ≥ 30 mL/min/1.73 m2) is considered experimental/investigational and not medically necessary.
Key Clinical Thresholds and Identifiers
Provider Requirements, Documentation, and Denial Risks
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).
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.
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 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
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