Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
Cerliponase alfa (Brineura) may be considered medically necessary to slow the loss of ambulation in individuals with late infantile CLN2 who meet ALL of the following:
- Individual is three (3) years of age or older; and
- Individual is symptomatic (e.g. motor or language symptoms); and
- Has a confirmed diagnosis of CLN2, defined as:
- Deficient TPP1 activity in leukocytes; and
- Pathogenic variants/mutations in each allele of TPP1/CLN2 gene; and
- Cerliponase alfa (Brineura) is prescribed by or in consultation with a neurologist with experience and expertise in the treatment and ongoing management of individuals with CLN2; and
- Documentation of current rating on the CLN2 Clinical Rating Scale.
Continuation of treatment with cerliponase alfa (Brineura) after initiation of therapy, may be considered medically necessary to slow the loss of ambulation in individuals late infantile CLN2 who meet the following:
- Documentation that individual has slowed the loss of ambulation from initial baseline CLN2 Clinical Rating Scale.
Cerliponase alfa (Brineura) is considered experimental/investigational for any other indication and therefore non-covered. Scientific evidence does not support its use for any other indications.
Procedure Codes