Line of Business: Medi-Cal Effective Date: August 16, 2017 Revision Date: August 16, 2017 Alzheimer Disease Agents Drug Class Prior Authorization Protocol This policy has been developed through review of medical literature, consideration of medical necessity, generally accepted medical practice standards, and approved by the IEHP Pharmacy and Therapeutics Subcommittee. Drugs: Aricept (donepezil, donepezil ODT), Exelon (rivastigmine), Exelon (rivastigmine transdermal patch), Namenda (memantine), Namenda XR (memantine ER), Namzaric (memantine, donepezil ER), Razadyne (galantamine), Razadyne ER (galantamine ER) FDA Approved Indications: Aricept (donepezil), Donepezil ODT, Galantamine oral solution, Namenda (memantine), Namenda XR (memantine ER), Namzaric (memantine, donepezil ER), Razadyne (galantamine), Razadyne ER (galantamine ER) Exelon (rivastigmine), Exelon (rivastigmine transdermal patch) Alzheimer dementia Parkinson-related dementia
Policy/ * Generic-mandatory protocol applies. Please refer to the Brand Name Drug Request Policy. A. Drug: Exelon (rivastigmine transdermal patch)* b. Parkinson s disease dementia : i. Failure or clinically significant adverse effects to two formulary cholinesterase inhibitors (e.g. donepezil, donepezil ODT, rivastigmine, galantamine) ii. Documented difficulty swallowing (i.e. dysphagia) AND failure or clinically significant adverse effects to formulary donepezil ODT b. Parkinson s disease dementia: iii. Failure or clinically significant adverse effects to rivastigmine capsule iv. Documented difficulty swallowing (i.e. dysphagia) B. Drug: Galantamine Oral Solution* a. Failure or clinically significant adverse effects to two formulary cholinesterase inhibitors (e.g. donepezil, donepezil ODT, rivastigmine, galantamine) b. Documented difficulty swallowing (i.e. dysphagia) AND failure or clinically significant adverse effects to formulary donepezil ODT
C. Drug: Namenda XR (memantine ER) a. Failure or clinically significant adverse effects to formulary memantine 12 months D. Drug: Namzaric (memantine, donepezil ER) a. Medical justification why formulary donepezil and Namenda ER cannot be used concurrently E. Drug: Razadyne ER (galantamine ER)* a. Failure or clinically significant adverse effects to two formulary cholinesterase inhibitors (e.g. donepezil, donepezil ODT, rivastigmine, galantamine)
Clinical Justification: Current Pharmacologic Treatment of Dementia: A Clinical Practice Guideline from the American College of Physicians and the American Academy of Family Physicians 2008 Recommendation 1: Clinicians should base the decision to initiate a trial of therapy with a cholinesterase inhibitor or memantine on individualized assessment (Grade: weak recommendation, moderate-quality evidence) o The decision to initiate therapy should be based on evaluation of benefits and risks associated with an individual patient o Although the evidence shows statistically significant benefits of treatment with some cholinesterase inhibitors and memantine for all kinds of dementia, these benefits, on average, are not clinically significant for cognition and are modest for global assessments. o Limited evidence suggests, but does not demonstrate conclusively, that a subgroup of patients achieves clinically important improvement. o Evidence is insufficient to determine the optimal duration of therapy. o A beneficial effect, if any, would generally be observed within 3 months on the basis of duration of trails. o No evidence demonstrates when it is appropriate to stop the treatment if the patient becomes unresponsive or shows decline in various domains of dementia. o If slowing decline is no longer a goal, treatment with memantine or a cholinesterase inhibitor is no longer appropriate. Recommendation 2: Clinicians should base the choice of pharmacologic agents on tolerability, adverse effect profile, ease of use and cost of medication. The evidence is insufficient to compare the effectiveness of different pharmacologic agents for the treatment of dementia. (Grade: weak recommendation, low quality-evidence) o Because few trials compare one drug with another, evidence about effectiveness is insufficient to support the choice of specific drugs for the treatment of dementia. Recommendation 3: There is an urgent need for further research on the clinical effectiveness of pharmacologic management of dementia Effectiveness of Cholinesterase Inhibitors and Memantine for Treating Dementia: Evidence Review for a Clinical Practice Guideline 2008
96 publications representing 59 unique studies were eligible for this review Both cholinesterase inhibitors and memantine had consistent effects in the domains of cognition and global assessment, but summary estimates showed small effect sizes Clinically important differences were not consistently evaluated or demonstrated in these two domains for all drugs Outcomes in the domains of behavior and quality of life were evaluated less frequently and showed less consistent effects Direct comparison among these drugs are limited and do not suggest important differences References: 1. Qaseem A, Snow V, Cross JT, et al. Current pharmacologic treatment of dementia: a clinical practice guideline from the American College of Physicians and the American Academy of Family Physicians. Ann Intern Med. 2008; 148(5): 370. 2. Raina P, Santaguida P, Ismaila A, et al. Ann Intern Med. 2008; 148(5): 379. 3. Namzaric [package insert]. Cincinnati, Ohio: Forest Pharmaceuticals Inc.; Feb 2015. 4. Aricept [package insert]. New York, NY: Pfizer Inc.; July 2015. 5. Exelon [package insert]. East Hanover, NH: Novartis Pharmaceuticals Inc.; Oct 2013. 6. Exelon Patch [package insert]. East Hanover, NH: Novartis Pharmaceuticals Inc.; Feb 2015. 7. Razadyne [package insert]. Titusville, NJ: Janssen Pharmaceuticals Inc.; July 2013. 8. Namenda [package insert]. Cincinnati, Ohio: Forest Pharmaceuticals Inc.; Oct, 2013. Change Control Date Change 08/16/2017 Removed Galantamine 4 mg/ml oral solution from Medi-Cal Formulary Added Memantine 5 mg tablet and 10 mg tablet to Medi-Cal Formulary