EXELON, Rivastigmine Form

Rivastigmine, as rivastigmine tartrate (Exelon® capsules for oral use) and rivastigmine transdermal system (Exelon® Patch), is an acetylcholinesterase inhibitor. FDA Approved Indication(s) Exelon is indicated for treatment of • Mild to moderate dementia of the Alzheimer’s type (AD) • Mild to moderate dementia associated with Parkinson’s disease (PDD) Exelon patch is also indicated for treatment of severe AD. Policy/Criteria Provider must submit documentation (including such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that rivastigmine is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Alzheimer’s Dementia (must meet all):

1. Diagnosis of AD;
   2. Age ≥ 18 years;
   3. Member meets one of the following (a or b): a. Failure of ≥ 3 month trial of donepezil at doses ≥ 10 mg per day or galantamine 24 mg per day; b. Both of the following (i and ii):
      i. Member has intolerance or contraindication to both donepezil and galantamine ii. Failure of ≥ 3 month trial of memantine at doses ≥ 20 mg/day, unless contraindicated or clinically significant adverse effects are experienced;
2. If Exelon patch requested, member must use generic rivastigmine patches, unless contraindicated or clinically adverse effects are experienced;

3. Dose does not exceed one of the following (a or b):
   a. Oral, both of the following (i and ii):
   i. 12 mg per day;
   ii. 2 capsules per day; b. Transdermal: 13.3 mg (1 patch) per 24 hours. Approval duration: 12 months Page 1 of 6

   CLINICAL POLICY Rivastigmine B. Parkinson’s Disease Dementia (must meet all):

4. Diagnosis of PDD;
   2. Age ≥ 18 years;
   3. Failure of ≥ 3 month trial of donepezil at doses ≥ 10 mg per day, unless contraindicated or clinically significant adverse effects are experienced;
5. If Exelon patch requested, member must use generic rivastigmine patches, unless contraindicated or clinically adverse effects are experienced;
6. Dose does not exceed one of the following (a or b):
   a. Oral, both of the following (i and ii):
   i. 12 mg per day;
   ii. 2 capsules per day; b. Transdermal: 13.3 mg (1 patch) per 24 hours. Approval duration: 12 months C. Other diagnoses/indications (must meet 1 or 2):
7. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.PMN.255 for Medicaid; or b. For drugs NOT on the PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.PMN.16 for Medicaid; or
8. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.PMN.53 for Medicaid.
   II. Continued Therapy A. All Indications in Section I (must meet all):
9. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
10. If Exelon patch requested, member must use generic rivastigmine patches, unless contraindicated or clinically adverse effects are experienced;

11. If request is for a dose increase, new dose does not exceed one of the following (a or b):
    a. Oral, both of the following (i and ii): i. 12 mg per day;
    ii. 2 capsules per day;
    b. Transdermal: 13.3 mg (1 patch) per 24 hours.
    Approval duration: 12 months Page 2 of 6

    CLINICAL POLICY Rivastigmine B. Other diagnoses/indications (must meet 1 or 2):

12. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.PMN.255 for Medicaid; or b. For drugs NOT on the PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.PMN.16 for Medicaid; or

13. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.PMN.53 for Medicaid.
    III. Diagnoses/Indications for which coverage is NOT authorized:
    A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.PMN.53 for Medicaid or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key AD: Alzheimer’s dementia FDA: Food and Drug Administration PDD: Parkinson’s disease dementia Appendix B: Therapeutic Alternatives
    This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
    Dosing Regimen Drug Name Dose Limit/ Maximum Dose AD: 23 mg/day PDD: 10 mg/day AD: 24 mg/day donepezil (Aricept®) galantamine (Razadyne®) AD: 5 mg PO QD titrated up to 23 mg PO QD PDD: 5 mg PO QD titrated up to 10 mg PO QD AD (Razadyne): 4 mg PO BID titrated up to 12 mg PO BID AD (Razadyne ER): 8 mg PO QD titrated up to 24 mg PO QD AD (Namenda): 5 mg PO QD titrated up to 10 mg PO BID AD (Namenda XR): 7 mg PO QD titrated to 28 mg PO QD memantine (Namenda®, Namenda® XR) AD (Namenda): 20 mg/day AD (Namenda XR): 28 mg/day Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Page 3 of 6

    CLINICAL POLICY Rivastigmine Appendix C: Contraindications/Boxed Warnings • Contraindication(s): known hypersensitivity to rivastigmine, other carbamate derivatives or other components of the formulation; history of application site reaction with rivastigmine transdermal patch suggestive of allergic contact dermatitis, in the absence of negative allergy testing • Boxed warning(s): none reported V. Dosage and Administration
    Indication Dosing Regimen AD Patch: 9.5 mg/24 hours or 13.3 mg/24 hours QD Initial dose: initiate treatment with 1.5 mg PO BID Oral formulations: • • Dose titration: after a minimum of 2 weeks, if tolerated, increase dose to 3 mg PO BID and further to 4.5 mg PO BID and 6 mg PO BID if tolerate with a minimum of 2 weeks at each dose PDD Patch: 9.5 mg/24 hours or 13.3 mg/24 hours QD Initial dose: initiate treatment with 1.5 mg PO BID Oral formulations: • • Dose titration: after a minimum of 4 weeks, if tolerated, increase dose to 3 mg PO BID and further to 4.5 mg PO BID and 6 mg PO BID if tolerate with a minimum of 4 weeks at each dose Maximum Dose Patch: 13.3 mg/24 hours transdermally Oral formulations: 12 mg/day Patch: 13.3 mg/24 hours transdermally Oral formulations: 12 mg/day VI. Product Availability
    • Generic rivastigmine capsules: 1.5 mg, 3 mg, 4.5 mg, 6 mg • Exelon patches: 4.6 mg/24 hours, 9.5 mg/24 hours, 13.3 mg/24 hours • Generic rivastigmine patches: 4.6 mg/24 hours, 9.5 mg/24 hours, 13.3 mg/24 hours VII.