The Company reserves the right to modify the Dosing and Frequency Requirements listed in this policy to ensure consistency with the most recently published recommendations for the use of Cerliponase alfa (Brineura®). Changes to these guidelines are based on a consensus of information obtained from resources such as, but not limited to: the US Food and Drug Administration (FDA); Company-recognized authoritative pharmacology compendia; or published peer-reviewed clinical research. The professional provider must supply supporting documentation (i.e., published peer-reviewed literature) in order to request coverage for an amount of Cerliponase alfa (Brineura®) outside of the Dosing and Frequency Requirements listed in this policy. For a list of Company-recognized pharmacology compendia, view our policy on off-label coverage for prescription drugs and biologics.
Accurate member information is necessary for the Company to approve the requested dose and frequency of this drug. If the member's dose, frequency, or regimen changes (based on factors such as changes in member weight or incomplete therapeutic response), the provider must submit those changes to the Company for a new approval based on those changes as part of the utilization management activities. The Company reserves the right to conduct post-payment review and audit procedures for any claims submitted for cerliponase alfa (Brineura®).
| Age Groups | BRINEURA Dose (Every Other Week)
| Volume of BRINEURA Solution
| Infusion Rate |
Birth to < 6 months
| 100 mg
| 3.3 mL | 1.25 mL/hr |
6 months to < 1 year
| 150 mg
| 5 mL
| 2.5 mL/hr
|
1 year to < 2 years
| 200 mg (first 4 doses)
300 mg (subsequent doses)
| 6.7 mL (first 4 doses)
10 mL (subsequent doses)
| 2.5 mL/hr
|
2 years and older
| 300 mg
| 10 mL
| 2.5 mL/hr |
The FDA does not recommend dosing in pediatric individuals less than 37 weeks post-menstrual age (gestational age plus post-natal age) or those weighing less than 2.5kg.
