Cerliponase Alfa IV (Brineura)

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