Prior Auth Protocol

FDA Approved Indications:

For the treatment of moderate to severe dementia of the Alzheimer`s type in patients stabilized on:

memantine hydrochloride (10 mg twice daily or 28 mg extended-release once daily) and donepezil hydrochloride 10 mg, or
memantine hydrochloride (5 mg twice daily or 14 mg extended-release once daily) and donepezil hydrochloride 10 mg

Health Net Approved Indications and Usage Guidelines:

AND

Medical justification must be provided why individual generic components of donepezil and memantine cannot be used

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:

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Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
donepezil (Aricept/Aricept ODT)	Alzheimers dementia, mild to moderate: 5 mg PO QD at bedtime. If no response after 4 - 6 weeks, titrate dose to 10 mg QD. If no improvements after 4-8 weeks, consider discontinuation of therapy. Alzheimers dementia, moderate to severe: 5 mg PO QD at bedtime. If no response after 4 - 6 weeks, titrate dose to 10 mg daily at bedtime for three months then may increase to 23 mg at bedtime.	Alzheimers dementia, mild to moderate: 10 mg/day Alzheimers dementia, moderate to severe: 23 mg/day
Namenda (memantine)	Initial dose 5 mg PO QD. Increase by 5 mg per day in divided doses at one-week intervals to a maximum of 10 mg BID	20 mg/day
Namenda XR (memantine extended-release)	Initial dose 7 mg PO QD. Increase by 7 mg per day at one-week intervals to a maximum of 28 mg QD	28 mg/day

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Namzaric	One 28 mg memantine/10 mg donepezil capsule PO QD in the evening	Length of Benefit

Product Availability:

Capsules: 14 mg/ 10mg, 28 mg/10 mg memantine extended-release/donepezil

References:

1. Namzaric [Prescribing Information]. Forest Pharmaceuticals, Inc.: Clonshaugh, Dublin 17, Ireland; December 2014.

2. AHFS Drug Information Updates. Available at http://www.ahfsdruginformation.com. Accessed June 25, 2014.

3. Micromedex^R Healthcare Series [Internet database]. Greenwood Village, CO: Truven Health Analytics. Updated periodically. Accessed June 25, 2015.