Prior Auth Protocol

FDA Approved Indications:

Partial onset seizures in patients with epilepsy 4 years of age and older weighing more than 20 kg
Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy
Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy

Health Net Approved Indications and Usage Guidelines:

Diagnosis of partial onset seizures, myoclonic seizures or primary generalized tonic-clonic seizures

AND

Medical justification must be provided why patient cannot take generic levetiracetam tablets or liquid

Coverage is Not Authorized For:

Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.

General Information:

Spritam utilizes Aprecia's proprietary ZipDose Technology platform, a groundbreaking advance that uses three-dimensional printing (3DP) to produce a porous formulation that rapidly disintegrates with a sip of liquid. While 3DP has been used previously to manufacture medical devices, this approval marks the first time a drug product manufactured with this technology has been approved by the FDA.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
levetiracetam, immediate-release tablets, liquid (Keppra)	250 to 1500 mg/day PO BID based on age and indication	1500 mg/day

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Spritam	Partial Onset Seizures Adults and pediatric patients 4 years and older weighing over 40 kg: 500 mg PO BID; increase as needed and tolerated by 500 mg PO BID every 2 weeks to a maximum recommended dose of 1500 mg PO BID Pediatric patients 4 years and older weighing 20 to 40 kg: 250 mg PO BID; increase by 250 mg PO BID every two weeks to a maximum of 750 mg PO BID Myoclonic Seizures in Adults and Pediatric Patients 12 Years of Age and Older 500 mg PO BID; increase by 500 mg PO BID every 2 weeks to recommended dose of 1500 mg PO BID Primary Generalized Tonic-Clonic Seizures in Patients 6 Years of Age and Older Adults and pediatric patients 6 years and older weighing over 40 kg: 500 mg PO BID; increase as needed and tolerated by 500 mg PO BID every 2 weeks to a maximum recommended dose of 1500 mg PO BID	Length of Benefit

Spritam

Partial Onset Seizures

Adults and pediatric patients 4 years and older weighing over 40 kg:
500 mg PO BID; increase as needed and tolerated by 500 mg PO BID every 2 weeks to a maximum recommended dose of 1500 mg PO BID
Pediatric patients 4 years and older weighing 20 to 40 kg:
250 mg PO BID; increase by 250 mg PO BID every two weeks to a maximum of 750 mg PO BID

Myoclonic Seizures in Adults and Pediatric Patients 12 Years of Age and Older
500 mg PO BID; increase by 500 mg PO BID every 2 weeks to recommended dose of 1500 mg PO BID

Primary Generalized Tonic-Clonic Seizures in Patients 6 Years of Age and Older
Adults and pediatric patients 6 years and older weighing over 40 kg: 500 mg PO BID; increase as needed and tolerated by 500 mg PO BID every 2 weeks to a maximum recommended dose of 1500 mg PO BID

Length of Benefit

Product Availability:

Tablets: 250 mg, 500 mg, 750 mg, 1000 mg

References:

1. Spritam [Prescribing Information] East Windsor, NJ: Aprecia Pharmaceuticals Company; July 2015.

2. levetiracetam [Prescribing Information] Morgantown, WV; Mylan Pharmaceuticals Inc.. June 2015. Accessed at: http://dailymed.nlm.nih.gov/dailymed/getFile.cfm?setid=0a987d59-560f-4650-96ec-31aec81953b5&type=pdf&name=0a987d59-560f-4650-96ec-31aec81953b5, November 3, 2015.