CurrentCignaPolicy N/A

Brineura (cerliponase alfa) patient information and prior authorization form

This document is a Cigna patient information and prior authorization form for Brineura (cerliponase alfa) used to treat CLN2 disease; it governs information collection and submission requirements for providers requesting coverage and administration of this drug.

Policy Summary

PayerCigna

PolicyBrineura (cerliponase alfa) patient information and prior authorization form

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionComplete and fax the Brineura prior authorization form with confirmation of CLN2 diagnosis and supporting documentation (genetic/enzyme tests, chart notes, prior therapies) to (855) 840-1678 or submit via CoverMyMeds/SureScripts.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5 business daysstandard response time

urgent optionexpedited review

requiredsupporting docs

Coverage Criteria

Initial coverage criteria

Coverage evaluation requires ALL of the following to be documented on the form and attached:

Confirm diagnosis: Document diagnosis of Neuronal Ceroid Lipofuscinosis Type 2 (CLN2)

Form asks 'Does the patient have a diagnosis of Neuronal Ceroid Lipofuscinosis Type 2 (CLN2)?'

Genetic or enzyme confirmation: Provide genetic testing confirming biallelic pathogenic or likely pathogenic variants in TPP1 OR a test confirming reduced TPP1 activity

Form asks whether genetic testing confirming biallelic TPP1 variants or a test confirming reduced TPP1 activity is present

Specialist involvement: Medication prescribed by or in consultation with a metabolic specialist, geneticist, pediatric neurologist, or physician specializing in NCLs

Form queries whether prescriber is a listed specialist

Policy Summary

PayerCigna

PolicyBrineura (cerliponase alfa) patient information and prior authorization form

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

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Initial Therapy Requirements

Initial therapy requirements

Initial therapy authorization requires documentation of diagnosis and confirmation testing plus specialist involvement and administration plan.

Diagnosis documented: Form checkbox confirming CLN2 diagnosis is checked and diagnosis is provided

See clinical information section asking 'Does the patient have a diagnosis of Neuronal Ceroid Lipofuscinosis Type 2 (CLN2)?'

Confirmatory testing attached: Genetic testing showing biallelic pathogenic or likely pathogenic TPP1 variants OR a test confirming reduced TPP1 activity must be attached

Form asks if genetic testing confirming TPP1 variants or reduced TPP1 activity testing has been done; supportive documentation must be attached

Specialist prescriber: Prescribed by or in consultation with a metabolic specialist, geneticist, pediatric neurologist, or NCL specialist

Form asks whether the medication is being prescribed by or in consultation with the listed specialists

Administration protocol documented: Each dose is followed by intraventricular electrolyte infusion as supplied in the Brineura package; administration CPT codes and facility/provider dispensing information must be provided

Form requests CPT codes for administration and facility/doctor dispensing and administering medication (including Tax ID and address)

Prior therapies and rationale: List any alternatives tried with drug name, dates taken, duration, and documented results or reasons for discontinuation/intolerance

Form requests documentation of alternatives tried, with dates and outcomes

Provider Actions & Submission Requirements

Prior Authorization

Prior Authorization Submission

Complete and submit a prior authorization request for Brineura using the Cigna Brineura PA form (or online via CoverMyMeds/SureScripts). Include clinical confirmation of CLN2 diagnosis and attach all required supporting documentation listed below. Incomplete submissions may delay review.

Medication requested: Brineura (or other, specify)
ICD-10 diagnosis code for CLN2 or related diagnosis
Dose, frequency, duration, and administration CPT codes
Submit via CoverMyMeds or SureScripts in EHR when available

Documentation Required

Required Supportive Documentation

Supportive documentation is required for this drug request. Requests submitted without required items (see list) may be deemed incomplete and not approvable until documentation is provided.

Genetic testing report confirming biallelic pathogenic or likely pathogenic variants in TPP1
Laboratory report confirming reduced TPP1 enzyme activity, if performed
Relevant chart notes documenting diagnosis, clinical findings, and specialist consultation
Administration plans including infusion details and facility/provider information

Denial Risk

Missing Supporting Documentation — Denial Risk

If the request lacks genetic testing, enzyme testing, or pertinent chart notes (including prior therapy history and outcomes), the request may not be approvable. The plan may request additional records or deny/pend the request until documentation is provided.

Missing genetic test report confirming CLN2 (TPP1)
Missing TPP1 enzyme activity results when available
Missing chart notes documenting neurologic findings, specialist evaluation, or treatment rationale
Missing documentation of prior therapies, dates, durations, and outcomes

Note

Patient and Provider Information

Provide complete patient and prescriber identifiers and facility details on the PA form. Ensure all asterisked (*) items are completed to allow the plan to respond. Include prior therapy details and an attestation signature.

Patient: name, Cigna ID, date of birth, address, phone
Prescriber: name, specialty, DEA/NPI/TIN, office contact, phone, fax, address
Medication details: requested drug, dose, frequency, duration, ICD-10 code
Facility: dispensing/administration facility name, state, tax ID, address
Prior therapies: list drug names, dates taken, duration, and documented outcomes/intolerances
Prescriber attestation and signature

Prior therapy (drug or intervention)	Dates taken	Duration	Outcome / Reason for discontinuation (include intolerance or adverse reaction)
Provide the name of any alternative medication(s) or intervention(s) previously tried	List start and end dates or approximate dates the prior therapy was taken	Specify duration of therapy (e.g., weeks, months)	Document the clinical outcome and reason for stopping (lack of efficacy, intolerance, adverse reaction, other). Include details of intolerance or adverse reactions.

Definitions

CLN2 — definition of Neuronal Ceroid Lipofuscinosis Type 2

TermNeuronal Ceroid Lipofuscinosis Type 2 (CLN2)

DefinitionA specific form of late infantile neuronal ceroid lipofuscinosis (Batten disease).

Clinical contextDiagnosis is queried on the prior authorization form and must be documented and supported with testing and chart notes.

TPP1 testing — genetic testing confirming biallelic pathogenic/likely pathogenic variants or reduced TPP1 activity

Test types acceptedGenetic testing showing biallelic pathogenic or likely pathogenic variants in the TPP1 gene OR a test confirming reduced TPP1 (tripeptidyl peptidase 1) enzyme activity.

Genetic result requiredDocumentation must confirm biallelic pathogenic or likely pathogenic variants in TPP1.

Enzyme assay optionAlternatively, provide a test demonstrating reduced TPP1 enzyme activity if genetic confirmation is not available.

Submission noteSupportive documentation (genetic testing or enzyme results) must be attached to the Brineura prior authorization form.

Related form fieldsForm includes checkboxes querying whether genetic test confirming TPP1 variants and whether a test confirming reduced TPP1 activity have been performed.

OpenPayer

Brineura (cerliponase alfa) patient information and prior authorization form

Coverage Criteria

Diagnosis and Procedure Codes

Initial Therapy Requirements

Provider Actions & Submission Requirements

Dispensing and Administration Site

Step Therapy / Prior Treatments

Definitions

Background