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    v1.0.28
    OpenPayerPolicy UpdatesEndocrinologyNeighborhood Health Plan RI Redemplo Coverage | Op…
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    CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

    Redemplo (plozasiran) — Coverage Criteria for Familial Chylomicronemia Syndrome

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    Defines coverage and medical necessity criteria for Redemplo (plozasiran) as adjunct therapy to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS); applies to requests for initial and continued authorization.

    Policy Summary
    PayerNeighborhood Health Plan of Rhode Island
    PolicyRedemplo (plozasiran) — Coverage Criteria for Familial Chylomicronemia Syndrome
    Policy CodePolicy N/A
    Change TypeNo material changes
    Effective DateMay 1, 2026
    Last ReviewFeb 1, 2026
    Next Review DateN/A
    Key ActionSubmit prior authorization with documentation of confirmed FCS, fasting TG ≥ 880 mg/dL, and evidence of refractoriness to standard therapies.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    25 mgrecommended dose
    1/90dquantity limit
    ≥880

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    TG threshold
    12 moauth duration
    ≥18min age

    Coverage and Medical Necessity Criteria

    Initial Therapy

    Covered when ALL of the following are met for initial authorization (12 months).

    Initial Authorization for FCS: 1. Member is 18 years of age or older; 2. Medication is prescribed by or in consultation with a lipidologist or specialist familiar with FCS; 3. Confirmed diagnosis of FCS by one of: (a) genetic testing demonstrating biallelic pathogenic variants in FCS-causing genes (e.g., LPL, GPIHBP1, APOA5, APOC2, LMF1, GPD1), (b) NAFCS Score ≥ 60, or (c) recurrent acute pancreatitis; 4. Fasting triglyceride ≥ 880 mg/dL (10 mmol/L); 5. Refractory to standard triglyceride-lowering therapies (e.g., statins, fibrates, other lipid-lowering medications); 6. Secondary factors that increase triglycerides have been excluded (e.g., high alcohol intake, uncontrolled diabetes, medications, medical conditions); 7. Member is adherent to and will continue a low-fat diet (≤ 20–30 g total fat/day, ~10–15% of calories); 8. Member is not using the medication in combination with Tryngolza (olezarsen); 9. Prescriber attests to monitoring fasting glucose/HbA1c before and during treatment; 10. Coverage will not be provided for a diagnosis of multifactorial chylomicronemia (MCS).

    Continuation Therapy

    Covered when ALL of the following are met for continued treatment (12 months).

    Reauthorization for FCS: 1. Documentation of positive clinical response to the medication (e.g., reduction in fasting triglyceride from baseline or reduction in episodes of acute pancreatitis); 2. Continued adherence to a low-fat diet (≤ 20–30 g total fat/day, ~10–15% of calories); 3. Member continues to be managed by or in consultation with a lipidologist or specialist familiar with FCS; 4. Member is not using the medication in combination with Tryngolza (olezarsen).

    Coverage will not be provided for a diagnosis of multifactorial chylomicronemia (MCS). This exclusion applies when the member’s hypertriglyceridemia is attributed to multiple secondary factors rather than the defined criteria for familial chylomicronemia syndrome (FCS), and requests for Redemplo in that clinical context should be denied.

    Use of Redemplo (plozasiran) for conditions other than familial chylomicronemia syndrome (FCS), including multifactorial chylomicronemia (MCS), is not eligible for coverage per this policy. Coverage is limited to adults meeting the specific FCS indications and documentation requirements outlined in the criteria.

    Key Clinical Thresholds and Coding-related Items

    Fasting triglyceride
    Fasting triglyceride threshold≥ 880 mg/dL (10 mmol/L)
    Context in criteriaRequired baseline fasting TG for initial authorization (listed as criterion #4).
    Consequence of missing documentationFailure to document fasting triglyceride ≥ 880 mg/dL may result in denial of coverage.

    Prior Authorization, Documentation, and Provider Requirements

    Prior Authorization

    Prior Authorization Required

    Prior authorization is required. Initial and reauthorization requests may be granted for up to 12 months when all criteria are met.

    • Authorization duration: up to 12 months for initial and reauthorization requests when criteria are met
    Denial Risk

    Prohibited Combination

    Do not prescribe or authorize the requested medication in combination with Tryngolza (olezarsen). Use of the requested drug in combination with Tryngolza is prohibited and will result in denial.

    • Prohibited combination: Tryngolza (olezarsen)

    Clinical Background

    Familial chylomicronemia syndrome (FCS) is an inherited disorder characterized by very high fasting triglyceride levels and a risk of recurrent acute pancreatitis. Redemplo is indicated as an adjunct to a low-fat diet to reduce triglycerides in adults with FCS. Prior authorization may be granted for up to 12 months when all coverage criteria are met, including age ≥ 18, specialist involvement, confirmed FCS (by genetic testing demonstrating biallelic pathogenic variants, NAFCS Score ≥ 60, or recurrent acute pancreatitis), fasting triglycerides ≥ 880 mg/dL (10 mmol/L), refractoriness to standard triglyceride-lowering therapies, exclusion of secondary causes, adherence to a low-fat diet (≤ 20–30 g total fat/day), and other monitoring and combination-use restrictions.

    Definitions and Patient Requirements

    Confirmed FCS
    DefinitionConfirmed diagnosis of FCS by genetic testing demonstrating biallelic pathogenic variants in FCS-causing genes (e.g., LPL, GPIHBP1, APOA5, APOC2, LMF1, GPD1).
    Alternative diagnostic evidenceNAFCS Score ≥ 60 or recurrent acute pancreatitis are accepted alternatives to genetic confirmation.
    Prescriber requirementDiagnosis must be documented as part of initial authorization requirements (criterion #3).
    Low-fat diet
    Recommended intakeAdherence to a low-fat diet of ≤ 20–30 grams total fat per day (approximately 10%–15% of calories from fat).
    Role in authorizationMember must be adherent to and will continue a low-fat diet per initial and reauthorization criteria (criterion #7).
    Policy Summary
    PayerNeighborhood Health Plan of Rhode Island
    PolicyRedemplo (plozasiran) — Coverage Criteria for Familial Chylomicronemia Syndrome
    Policy CodePolicy N/A
    Change TypeNo material changes
    Effective DateMay 1, 2026
    Last ReviewFeb 1, 2026
    Next Review DateN/A
    Key ActionSubmit prior authorization with documentation of confirmed FCS, fasting TG ≥ 880 mg/dL, and evidence of refractoriness to standard therapies.
    SourceLink
    On This Page
    Coverage and Medical Necessity CriteriaKey Clinical Thresholds and Coding-related ItemsPrior Authorization, Documentation, and Provider RequirementsClinical BackgroundDefinitions and Patient Requirements
    Documentation Required

    Initial Authorization — Documentation Required

    Required documentation for initial authorization: provide evidence that all of the following are met.

    • Member age ≥ 18 years
    • Medication prescribed by or in consultation with a lipidologist or specialist familiar with FCS
    • Confirmed diagnosis of Familial Chylomicronemia Syndrome (one of): genetic testing showing biallelic pathogenic variants in FCS-causing genes (e.g., LPL, GPIHBP1, APOA5, APOC2, LMF1, GPD1); OR NAFCS Score ≥ 60; OR history of recurrent acute pancreatitis
    • Fasting triglyceride ≥ 880 mg/dL (10 mmol/L)
    • Documentation that member is refractory to standard triglyceride-lowering therapies (e.g., statins, fibrates, or other lipid-lowering medications)
    • Exclusion of secondary causes that raise triglycerides (e.g., high alcohol intake, uncontrolled diabetes, medications or medical conditions known to increase TG)
    • Documentation of adherence to a low-fat diet (e.g., ≤ 20–30 g total fat/day; ~10–15% of calories from fat)
    • Prescriber attestation to monitoring fasting glucose/HbA1c before and during treatment
    • Statement that the member does not have a diagnosis of multifactorial chylomicronemia (MCS)
    Documentation Required

    Reauthorization — Documentation Required

    Required documentation for reauthorization: provide evidence that treatment is producing clinical benefit and that baseline management requirements continue to be met.

    • Documentation of positive clinical response (e.g., reduction in fasting triglyceride from baseline and/or fewer episodes of acute pancreatitis)
    • Member remains adherent to a low-fat diet (e.g., ≤ 20–30 g total fat/day)
    • Member continues management by or in consultation with a lipidologist or specialist familiar with FCS
    • Confirmation that member is not using the medication in combination with Tryngolza (olezarsen)
    MonitoringDocumentation of continued adherence to a low-fat diet is required for reauthorization (part of continued treatment criteria).