Aspirin/Dipyridamole (Aggrenox) Form

Aspirin/dipyridamole (Aggrenox®) is a combination antiplatelet agent. FDA Approved Indication(s) Aggrenox is indicated to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis.
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 Aggrenox is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Secondary Prevention of Stroke (must meet all):

1. Age ≥ 18 years;
   2. Medical history includes ischemic stroke or transient ischemic attack (TIA);
   3. Failure of aspirin (generic preferred) used as a single agent (e.g., stroke or TIA while on aspirin therapy);
2. Member is not a candidate for clopidogrel therapy due to contraindications or clinically significant adverse effects/drug interactions;
3. If request is for Aggrenox, member must use generic aspirin/dipyridamole, unless contraindicated or clinically significant adverse effects are experienced;
4. Dose does not exceed both of the following (a and b):
   a. 50 mg aspirin/400 mg extended-release dipyridamole per day; b. 2 capsules per day.
   Approval duration: 12 months
   B. Other diagnoses/indications (must meet 1 or 2):

5. 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 and CP.PMN.255 for Medicaid; or Page 1 of 5

   CLINICAL POLICY Aspirin/Dipyridamole 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 and CP.PMN.16 for Medicaid; or

   2. 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 and CP.PMN.53 for Medicaid.
      II. Continued Therapy A. Secondary Prevention of Stroke (must meet all):
   3. 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);
   4. Member is responding positively to therapy;
   5. If request is for Aggrenox, member must use generic aspirin/dipyridamole, unless contraindicated or clinically significant adverse effects are experienced;
6. If request is for a dose increase, new dose does not exceed both of the following (a and b):
   a. 50 mg aspirin/400 mg extended-release dipyridamole per day; b. 2 capsules 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 and CP.PMN.255 for Medicaid; 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 and CP.PMN.16 for Medicaid; or

   2. 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 and 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 – Page 2 of 5

   CLINICAL POLICY Aspirin/Dipyridamole HIM.PA.154 for health insurance marketplace and CP.PMN.53 for Medicaid, or evidence of coverage documents.
   IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration TIA: transient ischemic attack 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.
   Drug Name Dosing Regimen aspirin clopidogrel (Plavix®) 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. 50-325 mg PO QD
   75 mg PO QD
   Dose Limit/ Maximum Dose 325 mg/day 75 mg/day Appendix C: Contraindications/Boxed Warnings • Contraindication(s): o Hypersensitivity to any product ingredients
   o Patients with known allergy to nonsteroidal anti-inflammatory drugs (NSAIDs)
   o Patients with the syndrome of asthma, rhinitis, and nasal polyps
   • Boxed warning(s): none reported Appendix D: General Information • Aggrenox is not interchangeable with the individual components of aspirin and dipyridamole tablets. V. Dosage and Administration
   Indication Secondary prevention of stroke Dosing Regimen 1 capsule PO BID (morning and evening)
   Maximum Dose 2 capsules/day If there are intolerable headaches during initial treatment, switch to 1 capsule at bedtime and low-dose aspirin in the morning; resume twice daily dosing within 1 week
   VI. Product Availability
   Capsule: 25 mg aspirin/200 mg extended-release dipyridamole Page 3 of 5

   CLINICAL POLICY Aspirin/Dipyridamole VII.