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.
Cerliponase alfa (Brineura) requires prior authorization from HealthPartners Pharmacy Administration.
Initial approval criteria:
- Patient is 3 years of age or older; and,
- Patient must have a definitive diagnosis of late infantile CLN2 confirmed by deficiency of the lysosomal enzyme tripeptidyl peptidase-1 (TPP1); and,
- Patient has symptomatic disease (e.g., seizures, motor decline, cognitive decline, decreased visual acuity, etc.); and,
- Patient is ambulatory; and,
- Patient must not have ventriculoperitoneal shunts; and,
- Patient must not have acute intraventricular access device-related complications (e.g., leakage, device failure, or device-related infection); and,
- Patients with a history of bradycardia, conduction disorder, or with structural heart disease must have electrocardiogram (ECG) monitoring performed during the infusion; and,
- Baseline documentation of pretreatment motor function/milestones, including but not limited to, the following validated scale: the Motor domain of a Hamburg CLN2 Clinical Rating Scale, etc.
Initial approval is for 6 months.
Renewal approval criteria:
- Patient continues to meet the criteria above; and,
- Absence of unacceptable toxicity from the drug or complications from the device. Examples include the following: intraventricular access device leakage or infection, severe hypersensitivity reaction, severe hypotension; etc.; and,
- Patient had a 12-lead ECG evaluation performed within the last 6 months (those with cardiac abnormalities require ECG during each infusion); and,
- Patient has responded to therapy compared to pretreatment baseline with stability/lack of decline in motor function/milestones on validated scale such as the Motor domain of a Hamburg CLN2 Clinical Rating Scale, etc. (Note: decline is defined as having an unreversed (sustained) 2-category decline or an unreversed score of 0 in the Motor domain of the CLN2 Clinical Rating Scale).
Renewal approval is for 12 months.
Limited to 2 kits per 28 days.
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
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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.