Prior Auth Protocol

FDA Approved Indications:

Razadyne, Razadyne ER: For the treatment of mild to moderate dementia of the Alzheimer`s type
Namenda XR: For the treatment of moderate to severe dementia of the Alzheimer`s type

Health Net Approved Indications and Usage Guidelines:

For Razadyne/Razadyne ER:

Diagnosis of mild-to-moderate dementia

AND

Failure or clinically significant adverse effects to donepezil or Exelon^R

For Namenda XR:

Diagnosis of moderate dementia

AND

Failure or clinically significant adverse effects to donepezil or Exelon

Confirmed diagnosis of severe dementia

AND

Failure or clinically significant adverse effects to donepezil

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:

In a randomized double blind placebo controlled trial in 434 patients with chronic fatigue syndrome, there was no significant difference between Razadyne (galantamine) and placebo for Clinician Global Impression Scale or any of the secondary outcome measures.
Per the American Psychiatric Association practice guidelines for the treatment of Alzheimer`s, there is modest data that the combination of Namenda and Aricept^R is better than Aricept^R alone, and there is no evidence that the combination is better than monotherapy with Namenda.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
donepezil (Aricept^R/Aricept ODT^R)	Alzheimer's 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. Alzheimer's 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	Alzheimer dementia, mild to moderate 10 mg/day Alzheimer dementia, moderate to severe 23 mg/day
Exelon (rivastigmine)	Oral: 1.5 mg PO BID initially. Then titrate as tolerated with a minimum of 2 weeks between dose increases (4 weeks for dementia associated with Parkinson's Disease) to 3 mg BID, 4.5 mg BID, or 6 mg BID. Transdermal: Initiate with 4.6 mg TD QD; after a minimum of 4 weeks, increase to 9.5 mg QD, which is the minimum effective dose.	Oral: 12 mg/day Transdermal: 13.3 mg/24 hours

donepezil (Aricept^R/Aricept ODT^R)

Alzheimer's 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.
Alzheimer's 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

Alzheimer dementia, mild to moderate
10 mg/day
Alzheimer dementia, moderate to severe
23 mg/day

Exelon (rivastigmine)

Oral:
1.5 mg PO BID initially.
Then titrate as tolerated with a minimum of 2 weeks between dose increases (4 weeks for dementia associated with Parkinson's Disease) to 3 mg BID, 4.5 mg BID, or 6 mg BID.
Transdermal:
Initiate with 4.6 mg TD QD; after a minimum of 4 weeks, increase to 9.5 mg QD, which is the minimum effective dose.

Oral:
12 mg/day
Transdermal:
13.3 mg/24 hours

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Namenda XR	Initial dose 7 mg PO QD. Increase by 7 mg per day at one-week intervals to a maximum of 28 mg QD	Length of Benefit
Razadyne	4 mg PO BID initially. Then titrate as tolerated with a minimum of 4 weeks between dose increases to 8 mg BID and 12 mg BID.	Length of Benefit
Razadyne ER	8 mg PO QD initially. Then titrate as tolerated with a minimum of 4 weeks between dose increases to 16 mg daily and 24 mg daily	Length of Benefit

Product Availability:

Namenda XR Capsule: 7 mg, 14 mg, 21 mg, 28 mg

Namenda XR titration pack : 7 x 7 mg, 7 x 14 mg, 7 x 21 mg, 7 x 28 mg

Razadyne Tablet: 4 mg, 8 mg, 12 mg

Razadyne ER Capsule: 8 mg, 16 mg, 24 mg

Razadyne Oral Solution: 4 mg/mL

References:

1. Namenda XR^R [Prescribing Information] St. Louis, MO: Forest Pharmaceuticals Inc; September 2014.

2. Razadyne/Razadyne ER^R [Prescribing Information] Titusville, NJ: Ortho-McNeil-Janssen Pharmaceuticals, Inc; February 2015.

3. Aricept^R [Prescribing Information] Woodcliff Lake, NJ:Eisai Inc; September 2013.

4. Exelon^R [Prescribing Information] East Hanover, NJ: Novartis Pharmaceuticals; September 2013.

5. Trinh NH, Hoblyn J, Mohanty S and Yaffe K. Efficacy of cholinesterase inhibitors in the treatment of neuropsychiatric symptoms and functional impairment in Alzheimer Disease. JAMA 2003;289:2:210-216.

6. Blacker CV, Greenwood DT, Wesnes KA, et al. Effect of galantamine hydrobromide in chronic fatigue syndrome: a randomized, controlled trial. JAMA 2004;292(10):1195-204.

7. Tariot PN, Farlow MR, Grossberg GT, et al for the Memantine Study Group. Memantine treatment in patients with moderate to severe Alzheimer Disease already receiving donepezil; A Randomized controlled trial. JAMA 2004;201:3:317-324.

8. Rabins PV (2007). Guideline watch: Practice guideline for the treatment of patients with Alzheimers disease and other dementias, Second Edition. Arlington, VA: American Psychiatric Association. Available online at: http://psychiatryonline.org/pb/assets/raw/sitewide/practice_guidelines/guidelines/alzheimers.pdf. Accessed June 30, 2015.

9. Peskind ER, Potkin SG, Pomara N, et al. Memantine treatment in mild to moderate Alzheimer disease: a 24-week randomized, controlled trial. Am J Geri Psych. 2006;14(8):704-15.

10. The American Geriatrics Society. A Guide to Dementia Diagnosis & Treatment. Available at:http://www.americangeriatrics.org/. Accessed June 19, 2015.

11. AHFS Drug Information Updates. Available at http://www.ahfsdruginformation.com. Accessed June 19, 2015.

12. Micromedex^R Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed June 19, 2015.