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    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsCommunity-Care Brineura Coverage Prior Auth | Open…
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    CurrentCommunity-CarePolicy N/A

    Brineura (cerliponase alfa) — Medical Benefit Coverage Criteria

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    Defines clinical and administrative criteria for initial and continued medical-benefit coverage of Brineura (cerliponase alfa) for treatment of CLN2/TPP1 deficiency for Community-Care members.

    Policy Summary
    PayerCommunity-Care
    PolicyBrineura (cerliponase alfa) — Medical Benefit Coverage Criteria
    Policy CodePolicy N/A
    Change TypeNo material changes
    Effective DateN/A
    Last ReviewSep 1, 2024
    Next Review DateSep 1, 2025
    Key ActionObtain prior authorization with documentation of genetic or enzymatic confirmation and baseline Hamburg Scale combined motor/language score.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    ≥2Hamburg score for initial
    ≥1Hamburg score for continuation
    4 kits/28dMax quantity

    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.

    1 year
    Auth period
    J0567HCPCS

    Coverage Criteria for Brineura (cerliponase alfa)

    Initial Therapy

    Covered when ALL of the following are met

    Initial Approval for Brineura: Diagnosis of neuronal ceroid lipofuscinosis type 2 (CLN2) or tripeptidyl peptidase 1 (TPP1) deficiency; prescribed by, or in consultation with, a neurologist, ophthalmologist, geneticist, or a provider who specializes in the treatment of CLN2; diagnosis confirmed with gene or enzymatic testing (documentation required); baseline assessment of aggregate motor/language score on the Hamburg Scale with a combined score of ≥ 2.>= 2 (Hamburg Scale combined motor/language)

    Documentation of diagnostic confirmation and baseline Hamburg Scale score required

    Continuation Therapy

    Covered when ALL of the following are met

    Continuation of Brineura: Diagnosis of CLN2/TPP1 deficiency; member is being monitored, has had a positive response to treatment, and it is appropriate to continue therapy with cerliponase alfa (Brineura); prescriber attests that current Hamburg Scale combined aggregate motor/language score is ≥ 1.>= 1 (Hamburg Scale combined motor/language)

    Prescriber attestation of current Hamburg score and clinical benefit required; coverage authorized up to 1 year per approval

    Exclusions

    Excluded population: Patients with CLN2 who have lost significant motor and language function are not allowed initial coverage.

    Applies to initial approval determinations

    Patients who have experienced an advanced loss of motor and language function from CLN2/TPP1 deficiency are excluded from initial coverage. The policy explicitly states that patients with CLN2 who have lost significant motor and language function would not be allowed initial coverage, meaning such patients do not meet the initial-approval criteria and are not eligible for starting Brineura under this medical-benefit policy.

    Coding and Clinical Thresholds

    Applicable HCPCS CodesHCPCSCovered
    J0567Injection, cerliponase alfa, 1 mg
    inv-06: Hamburg Scale combined motor/language score for initial approval
    Hamburg Scale combined motor/language score (initial)>= 2
    UseRequired baseline aggregate motor/language score on the Hamburg Scale must be documented for initial approval
    ContextApplies to patients with confirmed CLN2/TPP1 deficiency prescribed by or in consultation with an appropriate specialist
    inv-07: Hamburg Scale combined motor/language score for continuation — numeric threshold
    Hamburg Scale combined motor/language score (continuation)>= 1
    UsePrescriber must attest current aggregate motor/language score on the Hamburg Scale for continuation

    Provider Actions and Requirements

    Prior Authorization

    Prior authorization: prescriber specialty, diagnostic confirmation, and Hamburg Scale data required

    Prior authorization must be obtained. The prescriber must be the ordering clinician or have consulted a neurologist, ophthalmologist, geneticist, or a provider who specializes in treatment of CLN2, and the request must include documentation confirming diagnosis by genetic or enzymatic testing and a baseline Hamburg Scale combined motor/language score (≥ 2). For continuation, the prescriber must attest the current Hamburg Scale combined motor/language score (≥ 1) and document clinical benefit.

    • Prescriber is the ordering clinician or consultation with a neurologist, ophthalmologist, geneticist, or CLN2 specialist is required.
    • Include documentation of diagnosis confirmation via gene or enzymatic testing.
    • Include baseline Hamburg Scale combined motor/language score ≥ 2 for initial requests.
    • For continuation requests, prescriber attestation of current Hamburg Scale combined motor/language score ≥ 1 and evidence of clinical benefit/monitoring is required.
    Note

    Provider responsibilities for submission, monitoring, and renewals

    Initial Therapy — Specific Criteria

    Initial therapy

    Covered when ALL of the following are met

    Initial: Prescribed by, or in consultation with, an appropriate specialist (neurologist, ophthalmologist, geneticist, or CLN2 specialist); diagnosis of CLN2/TPP1 deficiency confirmed by gene or enzymatic testing (documentation required); baseline Hamburg Scale combined motor/language score ≥ 2; patients who have lost significant motor and language function are excluded from initial coverage.>= 2

    Authorization period up to 1 year; documentation required for diagnosis confirmation and baseline Hamburg score

    Continuation Therapy — Specific Criteria

    Continuation therapy

    Criteria required for continued coverage of Brineura

    Continuation: Ongoing diagnosis of CLN2/TPP1 deficiency; documented clinical benefit and monitoring demonstrating it is appropriate to continue therapy; prescriber attests current Hamburg Scale combined motor/language score ≥ 1.>= 1

    Coverage renewed for up to 1 year per authorization period; prescriber attestation required

    Quantity Limits and Authorization Period

    inv-16: cerliponase alfa (Brineura) — maximum authorized quantity and related limits
    Maximum authorized quantityUp to 4 kits per 28 days (1 kit = 300 mg)
    Authorization periodIf approved, coverage is allowed for 1 year (subject to benefit changes)
    ApplicabilityQuantity limit applies when cerliponase alfa (Brineura) is approved for CLN2/TPP1 deficiency

    Site of Care

    Note

    Site of care: not specified

    The policy does not specify a required site-of-care for administration of cerliponase alfa.

    • No site-of-care requirement or restriction is stated in the policy

    Background

    Neuronal ceroid lipofuscinosis type 2 (CLN2), caused by deficiency of the enzyme tripeptidyl peptidase 1 (TPP1), is a progressive lysosomal storage disorder that leads to decline in motor and language abilities. Brineura (cerliponase alfa) is an enzyme replacement therapy administered for CLN2; coverage requires specialist involvement and objective confirmation of diagnosis by genetic or enzymatic testing. Baseline and follow-up assessments use the Hamburg Scale aggregate motor/language score to determine eligibility and continued benefit.

    Definitions

    inv-13: Hamburg Scale (aggregate motor/language score) definition and use
    DefinitionHamburg Scale (aggregate motor/language score): an assessment that combines motor and language function to quantify disease status in CLN2 patients
    Role in coverage decisionsBaseline combined score >= 2 is required for initial approval; prescriber attestation of combined score >= 1 is required for continuation
    DocumentationBaseline assessment must be provided and recorded as part of prior authorization; prescriber must attest current score for renewal
    Exclusion tie-inPatients who have lost significant motor and language function are not allowed initial coverage
    Policy Summary
    PayerCommunity-Care
    PolicyBrineura (cerliponase alfa) — Medical Benefit Coverage Criteria
    Policy CodePolicy N/A
    Change TypeNo material changes
    Effective DateN/A
    Last ReviewSep 1, 2024
    Next Review DateSep 1, 2025
    Key ActionObtain prior authorization with documentation of genetic or enzymatic confirmation and baseline Hamburg Scale combined motor/language score.
    SourceLink
    On This Page
    Coverage Criteria for Brineura (cerliponase alfa)Coding and Clinical ThresholdsProvider Actions and RequirementsInitial Therapy — Specific CriteriaContinuation Therapy — Specific CriteriaQuantity Limits and Authorization PeriodSite of CareBackgroundDefinitions
    ContextContinuation requires documented positive response to treatment and ongoing monitoring

    Providers must ensure documentation is submitted with the authorization request and must monitor and attest to clinical response for renewals. If approved, authorize quantities up to the policy limit and request reassessment at renewal (authorization period up to 1 year).

    • Submit diagnostic confirmation and baseline Hamburg Scale score with initial authorization.
    • For continuation, document monitoring, positive response to treatment, and prescriber attestation of current Hamburg Scale score ≥ 1.
    • Authorization, if approved, is for up to 1 year and quantity limits apply (see policy).
    Documentation Required

    Documentation required: genetic/enzymatic confirmation and baseline Hamburg Scale score

    Required documentation for initial authorization includes confirmation of CLN2/TPP1 deficiency by gene or enzymatic testing and a baseline Hamburg Scale combined motor/language score of ≥ 2; these must be provided with the request.

    • Diagnosis confirmation via gene or enzymatic testing (documentation required).
    • Baseline Hamburg Scale combined motor/language score (aggregate motor/language) of ≥ 2.
    Denial Risk

    Initial coverage exclusion: significant motor and language loss

    Initial coverage will not be allowed for patients with CLN2 who have lost significant motor and language function; such patients are ineligible for initial approval.

    • Patients who have lost significant motor and language function would not be allowed initial coverage.