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    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsGeorgia DCH Oxlumo Rivfloza Prior Auth Coverage | …
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    CurrentGeorgia Department of Community HealthPolicy N/A

    Hyperoxaluria agents (Oxlumo, Rivfloza) prior authorization

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    Outpatient pharmacy prior authorization summary for Oxlumo (lumasiran) and Rivfloza (nedosiran) for Georgia Medicaid Fee-for-Service members; describes authorization length, clinical criteria, and exceptions for coverage.

    Policy Summary
    PayerGeorgia Department of Community Health
    PolicyHyperoxaluria agents (Oxlumo, Rivfloza) prior authorization
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionInitiate prior authorization via OptumRx (1-866-525-5827) for Oxlumo (preferred) or Rivfloza (non-preferred).
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    6 moInitial authorization
    1 yrReauthorization
    Oxlumo preferredPreferred status

    Coverage Criteria — Oxlumo and Rivfloza

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    Initial therapy (Oxlumo and Rivfloza)

    Approvals are available when ALL of the following are met:

    Hyperoxaluria agent coverage criteria: Member has diagnosis of primary hyperoxaluria type 1 (PH1) with signs or symptoms or family history and secondary causes of PH1 have been ruled out
    Prior supportive therapy: Member has been on potassium citrate, neutral phosphate or magnesium oxide as well as pyridoxine therapy
    Genetic or biopsy confirmation: Genetic testing confirmed a mutation in the alanine:glyoxylate aminotransferase (AGT/AGXT) gene OR liver biopsy confirmed AGT enzyme deficiency
    Oxalate excretion: Urinary oxalate excretion corrected for body surface area (BSA) > 1 mmol/1.73 m2 per day AND urinary oxalate to creatinine ratio greater than normal for age> 1 mmol/1.73 m2 per day

    BSA-corrected and age-normalized ratios required

    Glycolate excretion: Urinary glycolate excretion corrected for body surface area (BSA) > 0.5 mmol/1.73 m2 per day AND urinary glycolate to creatinine ratio greater than normal for age> 0.5 mmol/1.73 m2 per day

    BSA-corrected and age-normalized ratios required

    Prescriber requirement: Medication must be prescribed by or in consultation with a specialist in treating primary hyperoxaluria type 1 (PH1)

    Rivfloza additional requirement

    For Rivfloza only, approval also requires ONE of the following:

    Rivfloza prerequisite: Member experienced inadequate response, allergy, contraindication, drug-drug interaction, or intolerable side effect to Oxlumo

    Must document reason for switching to Rivfloza

    If the hyperoxaluria medication is administered in a physician’s office or clinic, it must be billed through the DCH physician services program rather than the outpatient pharmacy program. The outpatient pharmacy prior authorization criteria in this policy apply only when the drug is dispensed through the outpatient pharmacy benefit; services billed through the physician services program follow the billing rules and referral pathways on the DCH MMIS physician services site. For questions or to initiate an exceptions review via prior authorization, providers may contact OptumRx at 1-866-525-5827.

    Laboratory Thresholds and Coding

    inv-04: Urinary oxalate excretion (BSA corrected)
    Threshold> 1 mmol/1.73 m2 per day
    MeasurementUrinary oxalate excretion corrected for body surface area (BSA)
    ContextRequired as part of initial approval for Oxlumo and Rivfloza when combined with genetic/biopsy confirmation and other criteria
    inv-05: Urinary glycolate excretion (BSA corrected)
    Threshold> 0.5 mmol/1.73 m2 per day
    MeasurementUrinary glycolate excretion corrected for body surface area (BSA)
    ContextRequired as part of initial approval for Oxlumo and Rivfloza when combined with genetic/biopsy confirmation and other criteria

    Provider Actions, Documentation & Denial Risks

    Prior Authorization

    Prior authorization required

    Prior authorization is required for both Oxlumo (preferred) and Rivfloza (non‑preferred). Initiate the prior authorization through OptumRx at 1‑866‑525‑5827; initial authorization is for 6 months with reauthorization for 1 year.

    • Oxlumo is preferred but requires prior authorization.
    • Initial authorization: 6 months; reauthorization: 1 year.
    Step Therapy

    Step requirement before Rivfloza

    Before Rivfloza will be approved, document that the member experienced an inadequate response, allergy, contraindication, drug‑drug interaction, or intolerable side effect to Oxlumo.

    • Must document the reason for switching to Rivfloza (inadequate response, allergy, contraindication, drug interaction, or intolerable side effect).
    Documentation Required

    Required documentation to support PA

    Provide documentation of genetic testing confirming a mutation in the AGXT (AGT) gene or liver biopsy confirming AGT enzyme deficiency; include urinary oxalate and glycolate excretion values corrected for BSA and age‑normalized urine ratios, prior/concurrent use of potassium citrate, neutral phosphate or magnesium oxide and pyridoxine, and specialist involvement.

    • Genetic test showing AGXT mutation OR liver biopsy showing AGT deficiency.
    • Urinary oxalate excretion (BSA corrected) and oxalate:creatinine ratio (age‑normalized).
    • Urinary glycolate excretion (BSA corrected) and glycolate:creatinine ratio (age‑normalized).
    • Documentation of prior supportive therapies (potassium citrate, neutral phosphate or magnesium oxide, and pyridoxine).
    • Prescriber is a specialist or consult with a specialist in PH1.
    Denial Risk

    Conditions that may trigger denial

    Coverage will be denied if there is no genetic confirmation of an AGXT mutation or liver biopsy‑confirmed AGT deficiency, if urinary oxalate or glycolate excretion thresholds are not met, or if required documentation of prior supportive therapy or specialist prescribing is not provided.

    • Missing genetic testing or liver biopsy confirmation of AGT/AGXT.
    • Urinary oxalate (BSA corrected) ≤ 1 mmol/1.73 m2 per day or oxalate:creatinine ratio not greater than expected for age.
    • Urinary glycolate (BSA corrected) ≤ 0.5 mmol/1.73 m2 per day or glycolate:creatinine ratio not greater than expected for age.
    • Lack of documentation of prior supportive therapies or absence of specialist prescribing/consultation.

    Key Definitions and Diagnostic Criteria

    inv-11: PH1 with AGXT/AGT confirmation
    DefinitionPrimary hyperoxaluria type 1 (PH1) with genetic confirmation by mutation in the AGXT (AGT) gene or liver biopsy–confirmed AGT enzyme deficiency
    Diagnostic requirementGenetic testing demonstrating an AGXT (AGT) mutation OR liver biopsy showing AGT deficiency
    Associated criteriaDiagnosis must be accompanied by supportive therapies (potassium citrate, neutral phosphate or magnesium oxide, and pyridoxine) and specialist prescribing
    inv-12: Accelerated excretion criteria
    Oxalate threshold> 1 mmol/1.73 m2 per day (BSA-corrected urinary oxalate excretion)
    Glycolate threshold> 0.5 mmol/1.73 m2 per day (BSA-corrected urinary glycolate excretion)
    Ratio requirementUrinary oxalate-to-creatinine and glycolate-to-creatinine ratios must be greater than normal for age
    ApplicationThese BSA-corrected values are required as part of initial approval criteria for Oxlumo and Rivfloza

    Initial Therapy — Authorization Logic

    Initial therapy

    Initial approval criteria for Oxlumo and Rivfloza (see coverage criteria).

    Initial therapy nodes: See coverage criteria: diagnosis of PH1 with signs/symptoms or family history, prior supportive therapy with potassium citrate/neutral phosphate/magnesium oxide and pyridoxine, genetic testing or liver biopsy confirmation of AGXT/AGT deficiency, BSA-corrected urinary oxalate >1 mmol/1.73 m2/day with age-normalized oxalate:creatinine ratio, BSA-corrected urinary glycolate >0.5 mmol/1.73 m2/day with age-normalized glycolate:creatinine ratio, and specialist prescribing

    Initial authorization length: 6 months

    Reauthorization / Continuation Criteria

    Reauthorization

    Reauthorization conditions follow initial approval criteria and length.

    Reauthorization: Authorization renews for 1 year; continued specialist oversight and documentation that initial criteria remain met are required

    Reauthorization requires meeting continuing clinical criteria as per PA guidelines

    Step Therapy Requirements

    StepRequirement
    1Required prior trial of Oxlumo (lumasiran) or documented intolerance (inadequate response, allergy, contraindication, drug–drug interaction, or intolerable side effect) to Oxlumo before approval of Rivfloza (nedosiran).

    Site of Care Billing Rules

    Billing Rule

    Office/clinic billing — use DCH physician services program

    If the medication is administered in a physician’s office or clinic, bill it through the DCH physician services program rather than the outpatient pharmacy program; the outpatient pharmacy PA criteria apply only to outpatient pharmacy claims.

    • Information and billing instructions for the physician services program are available at www.mmis.georgia.gov.
    • Exceptions to outpatient pharmacy coverage are considered through the prior authorization process.

    Background

    Primary hyperoxaluria type 1 (PH1) is a genetic disorder of glyoxylate metabolism caused by pathogenic variants in the AGXT gene resulting in deficiency of the alanine:glyoxylate aminotransferase (AGT) enzyme. AGT deficiency leads to elevated urinary oxalate and glycolate excretion with a high risk of recurrent kidney stones, nephrocalcinosis, and progressive renal damage. This policy sets the coverage prerequisites for RNA interference therapies (lumasiran/Oxlumo and nedosiran/Rivfloza), including the requirement for genetic confirmation of an AGXT mutation or liver biopsy–confirmed AGT deficiency, specified laboratory thresholds for BSA‑corrected urinary excretion, prior use of supportive therapies, and specialist prescribing.

    Policy Summary
    PayerGeorgia Department of Community Health
    PolicyHyperoxaluria agents (Oxlumo, Rivfloza) prior authorization
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionInitiate prior authorization via OptumRx (1-866-525-5827) for Oxlumo (preferred) or Rivfloza (non-preferred).
    SourceLink
    On This Page
    Coverage Criteria — Oxlumo and RivflozaLaboratory Thresholds and CodingProvider Actions, Documentation & Denial RisksKey Definitions and Diagnostic CriteriaInitial Therapy — Authorization LogicReauthorization / Continuation CriteriaStep Therapy RequirementsSite of Care Billing RulesBackground