BRINEURA (cerliponase alfa IV)
OFFICE ADMINISTRATION
Indications for Prior Authorization:
- 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
Patients must meet the following criteria for the indication(s) above:
- Prescribed by a specialist in CLN2 treatment, AND
- 3 years of age or older, AND
- Documented diagnosis of symptomatic late infantile neuronal ceroid lipofusinosis type 2 (CLN2) confirmed by TPP1 deficiency or the detection of pathogenic mutations in each allele of the TPP1 gene (also known as the CLN2 gene), AND
- Patient does not have acute intraventricular access device-related complications (e.g., leakage, device failure, or device-related infection) or a ventriculoperitoneal shunt
Authorization renewal:
- The member has demonstrated that ambulation loss has slowed from baseline
Dosing:
- 300 mg once every other week given by intracerebroventricular (ICV) infusion
- Following administration, the patient must also receive intraventricular electrolyte infusion
Approval:
- 1 year