AZILECT, Rasagiline Mesylate Form

Rasagiline (Azilect®) is a monoamine oxidase (MAO)-B inhibitor (MAOI).
FDA Approved Indication(s) Azilect is indicated for the treatment of Parkinson’s disease (PD). Policy/Criteria Provider must submit documentation (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 Azilect is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Parkinson’s Disease (must meet all):

1. Diagnosis of PD;
   2. Age ≥ 18 years;
   3. Failure of selegiline at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced;
2. If request is for brand Azilect, member must use generic rasagiline, unless contraindicated or clinically significant adverse effects are experienced;
3. Dose does not exceed 1 mg (1 tablet) per day.
   Approval duration: 12 months B. Other diagnoses/indications (must meet 1 or 2):
4. 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 formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: HIM.PA.33 for health insurance marketplace; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: HIM.PA.103 for health insurance marketplace; or

5. 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 Page 1 of 5

   CLINICAL POLICY Rasagiline criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: HIM.PA.154 for health insurance marketplace.
   II. Continued Therapy A. Parkinson’s Disease (must meet all):

6. 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);
   2. Member is responding positively to therapy;
   3. If request is for a dose increase, new dose does not exceed 1 mg (1 tablet) per day.
      Approval duration: 12 months B. 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 formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: HIM.PA.33 for health insurance marketplace; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: HIM.PA.103 for health insurance marketplace; 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: HIM.PA.154 for health insurance marketplace.
   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 – HIM.PA.154 for health insurance marketplace or evidence of coverage documents.
   IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration MAO: monoamine oxidase MAOI: monoamine oxidase inhibitor PD: Parkinson’s disease
   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.
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   CLINICAL POLICY Rasagiline Drug Name Dosing Regimen selegiline (Eldepryl®) 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. 5 mg PO BID Dose Limit/ Maximum Dose 10 mg/day Appendix C: Contraindications/Boxed Warnings • Contraindication(s): concomitant use of meperidine, tramadol, methadone, propoxyphene dextromethorphan, St. John’s wort, cyclobenzaprine, or another (selective or non- selective) MAO inhibitor • Boxed warning(s): none reported V. Dosage and Administration
   Indication Monotherapy or as adjunct therapy without levodopa Adjunct therapy with levodopa ± other PD drugs (e.g., dopamine agonist, amantadine, anticholinergic) VI. Product Availability
   Tablets: 0.5 mg, 1 mg Dosing Regimen 1 mg PO QD Maximum Dose 1 mg/day 0.5-1 mg PO QD 1 mg/day VII.