Rivfloza (nedosiran) prior authorization for PH1
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Defines UnitedHealthcare prior authorization and medical necessity requirements for Rivfloza (nedosiran) for treatment of primary hyperoxaluria type 1 (PH1) in patients aged 2 years and older with relatively preserved kidney function; applies to providers submitting for coverage under UHC medical benefit.
No material clinical or coverage changes in this revision.
Coverage Criteria for Rivfloza (nedosiran)
Initial Authorization — continuation
Covered when ALL of the following are met
Initial Authorization — diagnostic confirmation
Covered when ALL of the following are met
Reauthorization
Covered when ALL of the following are met
Requests for Rivfloza (nedosiran) will be denied when the patient has received a prior liver transplant or when the medication is being used in combination with Oxlumo (lumasiran). The policy explicitly excludes patients with a history of liver transplantation and does not permit concomitant administration of Rivfloza with Oxlumo as a covered indication.
Providers should confirm transplant history and current concurrent therapies when submitting prior authorization requests; absence of documentation demonstrating no liver transplant or evidence of combination therapy with Oxlumo is a common reason for denial.
Coverage requires that patients have preserved renal function and are not receiving combination therapy with Oxlumo. Specifically, the policy requires an estimated glomerular filtration rate of ≥ 30 mL/min/1.73 m2 for initial approval and reauthorization, and use of Rivfloza in combination with Oxlumo (lumasiran) is not approved under these criteria.
Before approving therapy, the payer will verify current medications and recent renal function testing. Requests for members with an eGFR below 30 mL/min/1.73 m2 or for those intended to be treated concurrently with Oxlumo will not meet medical necessity per the policy.
Laboratory and Diagnostic Thresholds
Prior Authorization and Documentation Requirements
Prior authorization required — two initial approval pathways
Prior authorization is required. Initial approvals follow one of two pathways: (1) Continuation-on-therapy — patient is already established on Rivfloza under an active UnitedHealthcare medical benefit prior authorization and the request includes medical records documenting a positive clinical response from pre‑treatment baseline; patient has not received a liver transplant; eGFR ≥ 30 mL/min/1.73 m2; patient is not receiving Rivfloza in combination with Oxlumo (lumasiran); and the drug is prescribed by or in consultation with a PH1 specialist. (2) Diagnostic-confirmation — diagnosis of PH1 with both metabolic testing and AGXT genetic confirmation; patient is ≥ 2 years of age; eGFR ≥ 30 mL/min/1.73 m2; patient has not received a liver transplant; not receiving Rivfloza with Oxlumo; and prescribed by or in consultation with a PH1 specialist. Authorization is issued for 12 months.
- Continuation-on-therapy pathway requires active UHC prior authorization and documentation of clinical response (e.g., decreased urinary oxalate, urine oxalate:creatinine ratio, or plasma oxalate).
- Diagnostic-confirmation pathway requires metabolic testing and genetic confirmation of AGXT mutation, age ≥ 2 years, and the other exclusions/requirements above.
- Authorization period: 12 months.
No step-through Oxlumo required
No step-therapy requirement through Oxlumo (lumasiran) is present in the current criteria; prior program updates removed the step-through Oxlumo requirement.
- Provider does not need to trial or fail Oxlumo before requesting Rivfloza under current criteria.
Required clinical documentation — baseline and response data
Submit medical records (e.g., chart notes, laboratory values) demonstrating baseline and response data: examples include decreased urinary oxalate concentrations, decreased urinary oxalate:creatinine ratio, or decreased plasma oxalate concentrations for continuation or reauthorization.
- For continuation/reauthorization include documentation of positive clinical response compared to pre‑treatment baseline.
- For diagnostic-confirmation pathway include metabolic testing results and AGXT genetic test report (see coverage criteria).
Key denial triggers — transplant and combination therapy
Requests may be denied if the patient has received a liver transplant or if Rivfloza is being used in combination with Oxlumo (lumasiran); both are explicit exclusions in the criteria.
- Do not submit requests for patients who have received a liver transplant.
- Do not request coverage for concurrent use of Rivfloza with Oxlumo (lumasiran).
Diagnostic Definitions and Criteria
Background
Rivfloza (nedosiran) is an LDHA-directed small interfering RNA indicated to lower urinary oxalate in patients with primary hyperoxaluria type 1 (PH1). The policy applies to children aged 2 years and older and adults with relatively preserved kidney function and evaluates clinical benefit using measures such as urinary oxalate concentration, urinary oxalate:creatinine ratio, and plasma oxalate concentration.
For initial authorization the policy recognizes two pathways: continuation-on-therapy for patients already established on Rivfloza with documented clinical response, and a diagnostic-confirmation pathway requiring both metabolic evidence of increased oxalate (or plasma oxalate/glyoxylate) and genetic confirmation of an AGXT mutation. All pathways require that the patient has not received a liver transplant, has an eGFR of at least 30 mL/min/1.73 m2, is not receiving Rivfloza in combination with Oxlumo, and that prescribing involves a specialist with expertise in PH1.
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