Brineura
Prior Authorization Form
855-207-0250
For questions regarding this
Prior authorization, call
ND Medicaid requires that patients receiving Brineura to meet prior authorization criteria. The prior authorization criteria can
be found at http://hidesigns.com/assets/files/ndmedicaid/2019/Criteria/PA_Criteria.pdf
Part I: TO BE COMPLETED BY PRESCRIBER
Recipient Medicaid ID Number
Specialist involved in therapy (if not treating physician)
Requested Drug and Dosage:
ICD-10 Diagnosis Code(s) for this request:
Qualifications for Coverage:
Initial Requests (please answer the questions below):
Does patient have ventriculoperitoneal shunts?
Has the patient’s diagnosis been confirmed by a genetic test confirming CLN2 disease?
Have results of an enzyme assay confirmed a deficiency of tripeptidyl peptidase 1 (TPP1) in this patient?
Have the patient’s baseline results of motor and language domains of the Hamburg CLN2 Clinical Rating
Scale been attached/faxed in with this request?
□ YES □NO
□ YES □NO
□ YES □NO
Renewal Requests (please answer the questions below):
Does the patient have an acute, unresolved localized infection on or around the device insertion site or
suspected or confirmed CNS infection?
Have the patient’s current results of motor domain of the Hamburg CLN2 Clinical Rating Scale been
attached/faxed in with this request?
Has the patient responded to therapy compared to pretreatment baseline with stability/lack of decline* in
motor function/milestones?
*: 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
□ YES □NO
□ YES □NO
□ YES □NO
Prescriber (or Staff) / Signature**
**: By completing this form, I hereby certify that the above request is true, accurate and complete. That the request is
medically necessary, does not exceed the medical needs of the member, and is clinically supported in the patient’s
medical records. I also understand that any misrepresentations or concealment of any information requested in the prior
authorization request may subject me to audit and recoupment.
Prior Authorization Vendor for ND