CurrentCignaPolicy N/A

prior_authorization_policy_metabolic_disorders_rivfloza

Defines Cigna prior authorization requirements, coverage criteria, documentation, durations, and exclusions for Rivfloza (nedosiran) for treatment of Primary Hyperoxaluria Type 1 (PH1) in eligible patients.

Policy Summary

PayerCigna

Policyprior_authorization_policy_metabolic_disorders_rivfloza

Policy CodePolicy N/A

Change TypeNew Policy

Effective Date

Next Review Date

Key ActionPrior authorization is recommended; obtain required documentation (genetic confirmation, eGFR, urinary/plasma oxalate measures) and ensure Rivfloza is prescribed by or in consultation with a nephrologist or urologist.

SourceLink

POLICY UPDATE CHANGES

New Policy created; Review Date = 11/22/2023.

1Covered Indications (PH1)

4Not Covered Uses Listed

2Approval Durations

Coverage Summary & Scope

Defines Cigna prior authorization requirements and coverage criteria for Rivfloza (nedosiran) for treatment of Primary Hyperoxaluria Type 1 (PH1). Coverage is covered_with_criteria with requirements including genetic confirmation, renal function and oxalate thresholds, specialist prescribing or consultation, and specified approval durations. Status = CURRENT.

Excluded or Experimental Indications

Conditions Not Covered (Experimental/Investigational/Unproven)

Rivfloza is considered experimental, investigational or unproven for ANY other use(s) including but not limited to:

ALL of the following

Primary Hyperoxaluria Type 2 (PH2)
Primary Hyperoxaluria Type 3 (PH3)
Primary Hyperoxaluria with end stage renal disease (ESRD)
Concurrent use of Rivfloza with Oxlumo (lumasiran subcutaneous injection)

Denial Risk

Exclusion for concurrent siRNA therapy

Claims may be denied or considered not medically necessary for concurrent use of Rivfloza with Oxlumo (lumasiran).

Prior Authorization, Documentation & Prescriber Requirements

Prior Authorization

Prior authorization required

Prior authorization is recommended/required for prescription benefit coverage of Rivfloza; initial approvals are for 6 months and continuation approvals are for 1 year.

Documentation Required

Documentation requirements

Documentation (chart notes, laboratory tests, claims, etc.) is required to confirm AGXT genetic mutation, current eGFR, urinary and/or plasma oxalate measures, and evidence of continued benefit for reauthorization; reauthorization does not require resubmission of prior documentation except for documentation of continued benefit (most recent within the past 6 months).

Documentation Required

Prescriber specialty requirement

Rivfloza must be prescribed by or in consultation with a nephrologist or urologist.

Background and Indication

Rivfloza (nedosiran) is an LDHA-directed small interfering RNA indicated to lower urinary and plasma oxalate levels in PH1 patients aged ≥ 9 years with relatively preserved kidney function.

Primary Hyperoxaluria Type 1 is a rare autosomal recessive disorder caused by mutations in the AGXT gene leading to oxalate overproduction; accumulation of calcium oxalate causes nephrocalcinosis, renal stones, and renal impairment. Liver transplantation is the only curative intervention as it corrects the underlying enzymatic defect.

Policy Summary

PayerCigna

Policyprior_authorization_policy_metabolic_disorders_rivfloza

Policy CodePolicy N/A

Change TypeNew Policy

Effective Date

Next Review Date

SourceLink

On This Page

OpenPayer

prior_authorization_policy_metabolic_disorders_rivfloza

Coverage Summary & Scope

Coverage Criteria (Medical Necessity)

Excluded or Experimental Indications

Prior Authorization, Documentation & Prescriber Requirements

Coding

Background and Indication

Revision History

Definitions