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    v1.0.28
    OpenPayerPolicy UpdatesGenetic & Molecular TestingCommunity-Care cipaglucosidase alfa Coverage | Ope…
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    CurrentCommunity-CarePolicy N/A

    Cipaglucosidase alfa (Pombiliti) for late-onset Pompe disease — Coverage Criteria

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    Defines medical benefit coverage criteria for initiation and continuation of cipaglucosidase alfa (Pombiliti) for members with late-onset Pompe disease, and applies to providers seeking authorization under the payer's medical benefit medication policy.

    Policy Summary
    PayerCommunity-Care
    PolicyCipaglucosidase alfa (Pombiliti) for late-onset Pompe disease — Coverage Criteria
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Last ReviewMar 1, 2024
    Next Review DateN/A
    Key ActionObtain prior authorization demonstrating diagnosis confirmation, specialist prescriber, miglustat co-prescription, and symptomatic disease.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    1 yearauthorization period if approved
    Nonequantity limits
    J1202HCPCS code

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    Mar 2024
    last reviewed

    Coverage Criteria for Cipaglucosidase alfa (Pombiliti)

    Initial Therapy

    Covered when ALL of the following are met for initial approval:

    Initial Approval - Late-onset Pompe disease: Clinical diagnosis of late-onset Pompe disease confirmed by genetic sequencing OR acid alpha-glucosidase enzyme assay.

    Weight is required for approval.

    Prescriber Requirement: Prescribed by a medical geneticist or neuromuscular specialist.
    Concomitant Therapy: Miglustat is prescribed with cipaglucosidase alfa (Pombiliti).
    Clinical Status: Patient is experiencing symptoms or objective signs of Pompe disease.

    Continuation Therapy

    Covered when ALL of the following are met for continuation of therapy:

    Ongoing Diagnosis: Ongoing diagnosis of late-onset Pompe disease.
    Clinical Benefit: Member is benefiting from therapy, is being monitored, and is appropriate to continue therapy.

    Authorization period up to one year if approved.

    This policy defines coverage criteria for cipaglucosidase alfa (Pombiliti) in members with late-onset Pompe disease. For initial approval, coverage requires confirmation of the clinical diagnosis by genetic sequencing OR acid alpha-glucosidase enzyme assay, prescription by a medical geneticist or neuromuscular specialist, co-prescription of miglustat with cipaglucosidase alfa, and that the patient is experiencing symptoms or objective signs of Pompe disease. Documentation of weight is also required for approval.

    For continuation of therapy, coverage is allowed when the member has an ongoing diagnosis of late-onset Pompe disease and is benefiting from therapy, is being monitored, and is clinically appropriate to continue treatment. If approved, authorization is allowed for up to one year. There are no quantity limits specified for treatment of late-onset Pompe disease.

    Confirmation of late-onset Pompe disease

    Diagnostic genetic testing or biochemical assay required to confirm diagnosis prior to coverage of therapy:

    Confirmation of late-onset Pompe disease: Diagnostic confirmation by ONE of the following: genetic sequencing OR acid alpha-glucosidase enzyme assay.

    Required for coverage of therapy.

    Coding and Billing

    Applicable HCPCS CodesHCPCS
    J1202HCPCS Code listed (HCPCS Code Description not provided in document)
    Weight
    RequirementA weight measurement is required for approval.
    ContextListed under Quantity Limits for late-onset Pompe disease in the policy.
    UseProvide current patient weight with prior authorization request to support dosing and coverage decision.

    Provider Actions and Authorization Requirements

    Prior Authorization

    Prior Authorization Required

    Prior authorization is required. Requests must demonstrate that initial approval criteria are met for late-onset Pompe disease before services or medication are provided.

    • Prior authorization required for initial and continuation therapy
    • Authorization period: up to 1 year if approved
    • Weight required for approval
    Documentation Required

    Required Documentation

    Clinical documentation must be submitted with the prior authorization request to support the diagnosis and medical necessity.

    • Confirmation of diagnosis via genetic sequencing OR acid alpha-glucosidase enzyme assay (lab report or genetic test result)
    • Prescriber specialty documented: medical geneticist or neuromuscular specialist

    Covered Indications

    Confirmation of late-onset Pompe disease

    Diagnostic genetic testing or biochemical assay required to confirm diagnosis prior to coverage of therapy:

    Confirmation of late-onset Pompe disease: Diagnostic confirmation by ONE of the following: genetic sequencing OR acid alpha-glucosidase enzyme assay.

    Required for coverage of therapy.

    Clinical Definitions

    Clinical diagnosis
    DefinitionClinical diagnosis of late-onset Pompe disease must be confirmed by genetic sequencing OR acid alpha-glucosidase enzyme assay.
    Prescriber requirementMust be prescribed by a medical geneticist or neuromuscular specialist.
    Treatment requirementMiglustat must be prescribed with cipaglucosidase alfa (Pombiliti).
    Clinical statusPatient must be experiencing symptoms or objective signs of Pompe disease at initiation.

    Eligibility Requirements

    There are no additional top-level eligibility requirement nodes specified in this policy beyond the coverage criteria for initial and continuation therapy. Eligibility for coverage is determined by meeting the listed diagnostic, prescriber, concomitant medication, and clinical benefit requirements.

    Background

    Late-onset Pompe disease is a lysosomal storage disorder for which diagnosis can be established by either genetic sequencing or by measurement of acid alpha-glucosidase enzyme activity. This policy requires a confirmed diagnosis by one of these methods and that treatment with cipaglucosidase alfa be prescribed by a medical geneticist or neuromuscular specialist. The policy also requires that miglustat be prescribed concomitantly and that the patient have symptoms or objective findings consistent with Pompe disease before initiating therapy.

    Policy Summary
    PayerCommunity-Care
    PolicyCipaglucosidase alfa (Pombiliti) for late-onset Pompe disease — Coverage Criteria
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Last ReviewMar 1, 2024
    Next Review DateN/A
    Key ActionObtain prior authorization demonstrating diagnosis confirmation, specialist prescriber, miglustat co-prescription, and symptomatic disease.
    SourceLink
    On This Page
    Coverage Criteria for Cipaglucosidase alfa (Pombiliti)Coding and BillingProvider Actions and Authorization RequirementsCovered IndicationsClinical DefinitionsEligibility RequirementsBackground
  1. Documentation of symptoms or objective signs of Pompe disease and clinical rationale for therapy
  2. For continuation requests, documentation the member is benefiting from therapy and is being monitored
  3. Weight (current) for the patient
    4. Denial Risk

    Triggers for Denial

    Requests may be denied if required diagnostic confirmation, specialist prescriber, or other required documentation is not provided.

    • No documented genetic sequencing or acid alpha-glucosidase enzyme assay confirming late-onset Pompe disease
    • Prescriber is not a medical geneticist or neuromuscular specialist
    • Lack of documentation showing the patient is symptomatic or demonstrating objective signs of Pompe disease
    • For continuation, absence of documentation showing clinical benefit or monitoring
    Note

    Provider Action Checklist

    Provider actions — ensure criteria and documentation are submitted with the authorization request and consult payer requirements for any additional form(s) or supporting records.

    • Submit prior authorization request with required documentation listed above
    • Ensure prescriber specialty is clearly indicated (medical geneticist or neuromuscular specialist)
    • Include recent patient weight and clinical monitoring notes for continuation requests
    • Confirm miglustat is prescribed with cipaglucosidase alfa (Pombiliti) when applicable