Perindopril/Amlodipine (Prestalia) Form

Perindopril/amlodipine (Prestalia®) is a combination of an angiotensin converting enzyme (ACE) inhibitor and dihydropyridine calcium channel blocker. FDA Approved Indication(s) Prestalia is indicated for the treatment of hypertension to lower blood pressure: • • As initial therapy in patients likely to need multiple drugs to achieve their blood pressure In patients not adequately controlled with monotherapy goals 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 Prestalia is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Hypertension (must meet all):

1. Diagnosis of hypertension;

2. Medical justification supports inability to use the individual generic components of perindopril and amlodipine concurrently;

   3. Dose does not exceed both of the following (a and b): a. 14 mg/10 mg per day; b. 1 tablet per day. Approval duration: 12 months or duration of request, whichever is less 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: CP.CPA.190 for commercial 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: CP.CPA.190 for commercial and CP.PMN.16 for Medicaid; or Page 1 of 5

   CLINICAL POLICY
   Perindopril/Amlodipine

   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: CP.CPA.09 for commercial and CP.PMN.53 for Medicaid.
      II. Continued Therapy A. Hypertension (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);
3. Member is responding positively to therapy;

4. If request is for a dose increase, new dose does not exceed both of the following (a and b): a. 14 mg/10 mg per day; b. 1 tablet per day. Approval duration: 12 months or duration of request, whichever is less B. Other diagnoses/indications (must meet 1 or 2):

   1. 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: CP.CPA.190 for commercial 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: CP.CPA.190 for commercial 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: CP.CPA.09 for commercial 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 policy – CP.CPA.09 for commercial and CP.PMN.53 for Medicaid, or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key ACE: angiotensin converting enzyme FDA: Food and Drug Administration Page 2 of 5

   CLINICAL POLICY
   Perindopril/Amlodipine 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 perindopril (Aceon®) amlodipine (Norvasc®) 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 Dose Limit/Maximum Dose 16 mg/day 10 mg/day Dosing Regimen 2 to 16 mg PO QD 2.5 to 10 mg PO QD Appendix C: Contraindications/Boxed Warnings • Contraindication(s): o In patients with history of angioedema o In patients with hypersensitivity to perindopril, to any other ACE inhibitor, or to amlodipine o In patients with diabetes when co-administered with aliskiren o In combination with a neprilysin inhibitor (e.g., sacubitril) o Use within 36 hours of switching to or from sacubitril/valsartan • Boxed warning(s): fetal toxicity. Discontinue Prestalia as soon as pregnancy is detected V. Dosage and Administration Indication Hypertension 3.5 mg/2.5 mg perindopril/amlodipine Dosing Regimen Maximum Dose 14/10 mg per day PO QD, adjust dose every 1 to 2 weeks according to blood pressure goals VI. Product Availability Tablets: 3.5 mg/2.5 mg, 7 mg/5 mg, 14 mg/10 mg VII.