CurrentAvMedPolicy N/A

Brineura IV (Medical)

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Prior authorization form and medical policy criteria for Brineura (cerliponase alfa) administered intraventricularly (ICV) for symptomatic late infantile neuronal ceroid lipofuscinosis type 2 (CLN2). Defines initial and reauthorization clinical criteria, dosing recommendation, administration site options, and duration of approvals.

Policy Summary

PayerAvMed

PolicyBrineura IV (Medical)

Policy CodePolicy N/A

Change TypeClarified dosing and approval durations

Effective Date

Last ReviewJul 6, 2019

Next Review Date

Key ActionPrescribing physician must complete and sign the prior authorization form and provide required documentation (labs, diagnostics, chart notes); incomplete/illegible information may delay authorization.

SourceLink

POLICY UPDATE CHANGES

Initial and reauthorization durations specified as 12 months.

Recommended dosage listed as 300 mg once every other week by intraventricular (ICV) infusion with post-administration intraventricular electrolyte infusion.

12 moInitial Approval Duration

12 moReauthorization Duration

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CurrentAvMedPolicy N/A

Brineura IV (Medical)

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Policy Summary

PayerAvMed

PolicyBrineura IV (Medical)

Policy CodePolicy N/A

Change TypeClarified dosing and approval durations

Effective Date

Last ReviewJul 6, 2019

Next Review Date

SourceLink

POLICY UPDATE CHANGES

Initial and reauthorization durations specified as 12 months.

Recommended dosage listed as 300 mg once every other week by intraventricular (ICV) infusion with post-administration intraventricular electrolyte infusion.

12 moInitial Approval Duration

12 moReauthorization Duration

Coverage Summary

Coverage stance: covered_with_criteria. Scope: prior authorization and medical policy criteria for Brineura (cerliponase alfa) administered intraventricularly (ICV) for symptomatic late infantile neuronal ceroid lipofuscinosis type 2 (CLN2). Dosing recommendation: 300 mg once every other week by intraventricular (ICV) infusion. Administration route: intraventricular (ICV). Minimum age threshold: >= 3 years. Approval durations: Initial Approval - 12 months and Reauthorization/Continued Approval - 12 months.

Initial Therapy Criteria

Initial Approval - 12 months

All criteria must be met for approval. To support each line checked, all documentation, including lab results, diagnostics, and/or chart notes, must be provided or request may be denied.

Age: Member must be 3 years of age or older>= 3 years
Diagnosis - CLN2 (symptomatic): Member must have a documented diagnosis of symptomatic late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase 1 (TPP1) deficiency and Jansky-Bielschowski disease
Diagnostic confirmation: Diagnosis of CLN2 must have been confirmed by TPP1 deficiency or the detection of pathogenic mutations in each allele of the TPP1 gene (also known as the CLN2 gene)
Provide laboratory or genetic testing results
Symptomatic status: Member is symptomatic
Device status: Member does not have acute intraventricular access device-related complications (i.e. leakage, device failure, or device-related infection) or a ventriculoperitoneal shunt

Reauthorization / Continued Approval Criteria

Reauthorization/Continued Approval - 12 months

To qualify, documentation must be submitted.

Clinical benefit: Member must demonstrate that ambulation loss has slowed from baseline
Documentation demonstrating slowed rate of ambulation loss compared to baseline is required

Provider Actions & Prior Authorization Requirements

Prior Authorization

Prior authorization required

Prescribing physician must complete and sign the prior authorization form and provide required documentation (labs, diagnostics, chart notes); incomplete/illegible information may delay authorization.

Affected codes: J3590, C9399
Incomplete, incorrect, or illegible information may delay authorization

Documentation Required

Diagnostic confirmation required

Provide documentation confirming CLN2 diagnosis via TPP1 deficiency or pathogenic mutations in each allele of the TPP1 gene.

Submit laboratory evidence of TPP1 deficiency or genetic testing showing pathogenic mutations in each allele of the TPP1 (CLN2) gene

Applicable Codes

Relevant HCPCS/CPT codes listed on formmixed

J3590	Unclassified drugs (listed on form)
C9399	Unclassified drugs or biologicals, not otherwise classified (listed on form)

Background

Brineura (cerliponase alfa) is administered intraventricularly for symptomatic CLN2 disease (tripeptidyl peptidase 1 [TPP1] deficiency). The form documents dosing and administration logistics. Recommended dosing: 300 mg once every other week given by intraventricular (ICV) infusion. Following administration, the member must also receive an intraventricular electrolyte infusion.

CLN2: Late infantile neuronal ceroid lipofuscinosis type 2, also known as tripeptidyl peptidase 1 (TPP1) deficiency and Jansky-Bielschowski disease.

Clinical Evidence

The brief does not include structured clinical trial evidence entries. Clinical criteria and required documentation (lab results, diagnostics, and chart notes) are specified in the policy for initial approval and reauthorization, and no additional trial metrics were provided in the brief.

Revision History

change_clarified

Initial and reauthorization durations specified as 12 months.

change_clarified

Recommended dosage listed as 300 mg once every other week by intraventricular (ICV) infusion with post-administration intraventricular electrolyte infusion.

2019-07-06last_reviewLatest