CurrentAetnaPolicy N/A

Brineura (cerliponase alfa) Precertification Request — Coverage Criteria

Precertification form and required clinical information for Brineura (cerliponase alfa) infusion therapy requests for Aetna members, including initiation and continuation of therapy.

Policy Summary

PayerAetna

PolicyBrineura (cerliponase alfa) Precertification Request — Coverage Criteria

Policy CodePolicy N/A

Change TypeMinor / no material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain precertification and submit documentation confirming CLN2 diagnosis (enzyme assay or genetic testing) and required clinical and infusion information.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1page

S9357,96305,96366CPT codes

Brineuradrug

CLN2indication

Coverage Criteria and Authorization Requirements

Authorization supporting clinical criteria

Coverage-related information requested on the form (used to support authorization decisions):

Initiation request requirements: Diagnosis of CLN2 (TPP1 deficiency) confirmed by enzyme assay demonstrating TPP1 deficiency OR by genetic testing

Form requires affirmative selection for diagnostic confirmation for initiation requests

Administration prerequisites: Medication will be administered by, or under the direction of, a physician knowledgeable in intraventricular administration; assess intraventricular access device complications or presence of a ventriculoperitoneal shunt

Form asks about intraventricular device complications and qualified administrator

Continuation request documentation: Ambulation status must be reported; patient has experienced no loss of ambulation or a slowed loss of ambulation from baseline

Policy Summary

PayerAetna

PolicyBrineura (cerliponase alfa) Precertification Request — Coverage Criteria

Policy CodePolicy N/A

Change TypeMinor / no material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain precertification and submit documentation confirming CLN2 diagnosis (enzyme assay or genetic testing) and required clinical and infusion information.

SourceLink

On This Page

Continuation section requests ambulation outcomes to justify ongoing therapy

The precertification form explicitly queries whether the patient has intraventricular access device-related complications (for example, leakage, device failure, or device-related infection) or a ventriculoperitoneal (VP) shunt. It also asks whether the medication will be administered by or under the direction of a physician knowledgeable in intraventricular administration, prompting the provider to document any device issues that could affect safe intraventricular delivery.

The form does not list explicit “not medically necessary” scenarios. Instead, it requires documentary confirmation of diagnosis and treatment context: for initiation requests an affirmative response is required that the diagnosis of CLN2/TPP1 deficiency was confirmed by either an enzyme assay demonstrating TPP1 deficiency or by genetic testing. Continuation requests must document ambulation outcomes (no loss of ambulation or slowed loss of ambulation) to support ongoing therapy.

Coding and Billing

Outpatient infusion CPT CodesCPT

S9357	Infusion administration code listed on form
96305	Infusion administration code listed on form
96366	Infusion administration code listed on form

Other outpatient infusion CPT (selectable on form)CPT

Other

Other CPT code (option provided on form)

Provider Actions, Documentation, and Precertification

Prior Authorization

Prior Authorization Required for Outpatient Infusion

Precertification is required for outpatient infusion of Brineura (cerliponase alfa). All fields on the medication precertification request must be completed and legible. Submit start of treatment or continuation dates and contact information for the requesting office.

Aetna Precertification Notification: Phone 1-866-752-7021 (TTY:711) or 1-888-267-3277; Fax (use form fax).
Include whether request is start of treatment or continuation and date of last treatment for continuation requests.

Documentation Required

Diagnostic Confirmation Required

Diagnostic confirmation is required before initiation: provide documentation that the diagnosis of late infantile neuronal ceroid lipofuscinosis type 2 (CLN2 / TPP1 deficiency) was confirmed by either an enzyme assay demonstrating deficient TPP1 activity OR by genetic testing showing pathogenic variants.

For initiation requests: check and document confirmation by enzyme assay OR genetic testing.
For continuation requests: document clinical status (ambulation) and that there has been no loss or only slowed loss of ambulation from baseline as applicable.

Documentation Required

Required Documentation for Precertification

Complete required documentation for precertification — include full patient demographics, insurance information, prescriber and dispensing provider details, requested product and dose, administration site and codes, and clinical information specific to diagnosis and treatment status. Incomplete documentation may delay review or result in denial.

Patient information: name, DOB, weight, height, contact information, allergies.
Insurance information: Aetna Member ID, group number, other coverage details (carrier, ID#), Medicare/Medicaid identifiers if applicable.
Prescriber information: name, specialty, NPI, state license number, phone, fax, signature and date on request.
Dispensing/provider administration: place of administration (physician's office, outpatient infusion center, home infusion), center/provider name, address, phone, TIN, PIN, and administration CPT code(s).
Product information: Brineura (cerliponase alfa), requested dose and frequency.
Diagnosis information: primary and secondary ICD codes.
Clinical information: confirmation of CLN2 diagnosis, intraventricular access device status, physician experienced in intraventricular administration, and for continuation requests documentation of ambulation status.

Denial Risk

Incomplete or Fraudulent Requests — Denial Risk

Fraudulent or intentionally incomplete requests may be denied and are subject to criminal and civil penalties. The plan may request additional information or clarification as needed to evaluate requests.

Request must be signed and dated by the requestor. Providing materially false information or concealing material information is a fraudulent insurance act.
Incomplete requests lacking required clinical confirmation (enzyme assay or genetic testing), demographics, insurance, prescriber signature, or product/dose details may be returned or denied.

Initiation Criteria for Brineura

Initiation criteria — initiation requests must confirm diagnosis

Initiation requests are covered when ALL of the following are met:

Diagnostic confirmation: Diagnosis of late infantile neuronal ceroid lipofuscinosis type 2 (CLN2 / TPP1 deficiency) is confirmed by either an enzyme assay demonstrating deficiency of TPP1 enzyme activity OR by genetic testing

Form requires selection of confirmation for initiation requests

Qualified administrator: Requested medication will be administered by, or under the direction of, a physician knowledgeable in intraventricular administration

Affirmative selection required on form

Device assessment: No unresolved intraventricular access device–related complications (e.g., leakage, device failure, device-related infection) or presence of a ventriculoperitoneal shunt that would preclude administration

Form queries device complications and VP shunt status

Continuation Criteria and Clinical Benefit

Continuation criteria — continuation requires documentation of clinical benefit (e.g., ambulation)

Continuation requests are covered when ALL of the following are met:

Documented clinical benefit (ambulation): Patient has experienced no loss of ambulation or has a slowed loss of ambulation from baseline; ambulation status selected (No loss of ambulation or Slowed loss of ambulation)

Used to assess ongoing benefit for continuation authorization

Ongoing qualified administration: Medication continues to be administered by or under the direction of a physician knowledgeable in intraventricular administration

Continuation requests require confirmation of appropriate administration setting

Step Therapy / Prior Requirements

Step	Requirement
1	Diagnosis must be confirmed prior to initiation by either an enzyme assay demonstrating deficiency of tripeptidyl peptidase 1 (TPP1) enzyme activity OR by genetic testing

Place of Administration

Note

Specify place of administration on the form

Indicate the place of administration on the form by selecting the appropriate option: Physician's office, Outpatient Infusion Center, or Home Infusion (the form also allows Self‑administered and Home options).

If requesting outpatient infusion, provide the CPT administration code selection (e.g., S9357, 96305, 96366) and facility contact details.
Provide dispensing provider/center name, phone, address as requested.

Definitions and Condition Naming

CLN2 / TPP1 deficiency — definition and related form queries

Condition (term)Late infantile neuronal ceroid lipofuscinosis type 2 (CLN2) — also known as tripeptidyl peptidase 1 (TPP1) deficiency

Form queryForm asks whether the patient is diagnosed with CLN2/TPP1 deficiency (Yes/No)

Diagnostic confirmation (initiation)For initiation requests, diagnosis must be confirmed by either an enzyme assay demonstrating TPP1 deficiency OR by genetic testing

Administration considerationForm asks whether medication will be administered by or under the direction of a physician knowledgeable in intraventricular administration

Intraventricular device statusForm queries presence of intraventricular access device–related complications (e.g., leakage, device failure, device-related infection) or presence of a ventriculoperitoneal shunt

Background

Late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), also described as tripeptidyl peptidase 1 (TPP1) deficiency, is the indication queried by the Brineura precertification form. The form requires documentation that the patient has this diagnosis and—for initiation—confirmation by either an enzyme assay demonstrating TPP1 enzyme deficiency or genetic testing. Ambulation status is collected for continuation requests to assess clinical benefit.