CurrentAvMedPolicy N/A

Brineura IV (Medical)

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

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

>=3Minimum Age

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):

Policy Summary

PayerAvMed

PolicyBrineura IV (Medical)

Policy CodePolicy N/A

Change TypeClarified dosing and approval durations

Effective Date

Next Review Date

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

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

Documentation Required

Symptomatic status and device status

Document that the member is symptomatic and does not have acute intraventricular access device complications or a ventriculoperitoneal shunt.

Documentation Required

Reauthorization evidence

For reauthorization, submit documentation that ambulation loss has slowed from baseline.

Billing Rule

Administration site reporting

Indicate location/site of drug administration and provide NPI or DEA number of administering location, or indicate Specialty Pharmacy - PropriumRx.

Provide NPI or DEA of the administering location, or indicate Specialty Pharmacy - PropriumRx

Documentation Required

Prescriber signature requirement

Prescribing physician must sign and clearly print name on the request (preprinted stamps not valid).

OpenPayer

Brineura IV (Medical)

Coverage Summary

Initial Therapy Criteria

Reauthorization / Continued Approval Criteria

Provider Actions & Prior Authorization Requirements

Applicable Codes

Background

Clinical Evidence

Revision History

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