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Coverage criteria policies

Cerliponase alfa (Brineura®)

These services may or may not be covered by your HealthPartners plan. Please see your plan documents for your specific coverage information. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage.

Administrative Process

Cerliponase alfa (Brineura) requires prior authorization from HealthPartners Pharmacy Administration.


Brineura is generally covered subject to the indications and criteria listed below and per your plan documents.

Brineura is generally covered for late infantile neuronal ceroid lipofuscinosis type 2 (CLN2) (or tripeptidyl peptidase (TPP1) deficiency) when all of the following criteria are met:

  1. Patient is 3 years of age or older; and,
  2. Patient must have a definitive diagnosis of late infantile neuronal ceroid lipofuscinosis type 2 (CLN2) confirmed by deficiency of the lysosomal enzyme tripeptidyl peptidase-1 (TPP1); and,
  3. Patient has symptomatic disease (ex. Seizures, motor decline, or cognitive decline); and,
  4. Patient is ambulatory; and,
  5. Patient does not have ventriculoperitoneal shunts; and,
  6. Patient does not have acute intraventricular device related complications (ex. Leakage, device failure or device-related infection); and,
  7. Baseline documentation of pre-treatment motor function has been provided to HealthPartners (ex. Motor Domain of a Hamburg CLN2 clinical rating scale); and.
  8. Prescribed within an FDA approved dosing regimen; and,
  9. The guardian has attested that they will adhere to the treatment plan.

Initial approvals will be for six months.

Renewal approval criteria:
  1. Patient continues to meet the criteria above; and,
  2. Absence of toxicity from the drug or complications from the device (ex. intraventricular access device leakage or infection, severe hypersensitivity reaction etc.); and,
  3. Treatment has efficacy demonstrated by improvement/lack of decline in motor function/milestones on validated scale such as the Motor domain of a Hamburg CLN2 Clinical Rating Scale. Decline is defined as having a sustained 2-category decline or an unreversed score of 0 in the Motor domain of the CLN2 Clinical Rating Scale.

Reauthorizations will be approved for 12 months

Indications that are not covered

Brineura is not covered for any additional indication.


Brineura is a hydrolytic lysosomal N-terminal tripeptidyl peptidase indicated to slow the loss of ambulation in symptomatic pediatric patients 3 years of age and older with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase 1 (TPP1) deficiency.

If available, codes are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all-inclusive.

The services associated with these codes require prior authorization:




Injection, cerliponase alfa, 1 mg (Hospital outpatient use ONLY – use before 1/1/2019)


Injection, cerliponase alfa, 1 mg (effective 1/1/2019)


Unclassified biologics (use before 1/1/2019)





Brineura 2 X 150 MG/5ML KIT

CPT Copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.


This information is for most, but not all, HealthPartners plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. These coverage criteria may not apply to Medicare Products if Medicare requires different coverage. For more information regarding Medicare coverage criteria or for a copy of a Medicare coverage policy, contact Member Services at 952-883-7979 or 1-800-233-9645.


  1. Brineura [Prescribing Information]. Novato, CA: BioMarin Pharmaceutical Inc.; July 2018

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Policy activity

  • 11/06/2017 - Date of origin
  • 01/01/2018 - Effective date
Review date
  • 11/2018

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