Omega-3-Acid Ethyl Esters (Lovaza) Form

Omega-3-acid ethyl esters (Lovaza®) is a combination of ethyl esters of omega 3 fatty acids, principally eicosapentaenoic acid and docosahexaenoic acid. FDA Approved Indication(s) Lovaza is indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. Limitation(s) of use: • The effect of Lovaza on the risk for pancreatitis has not been determined. • The effect of Lovaza on cardiovascular mortality and morbidity has not been determined. 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 Lovaza is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Hypertriglyceridemia (must meet all):

1. Diagnosis of hypertriglyceridemia;
2. Age ≥ 18 years;
3. Fasting triglycerides ≥ 500 mg/dL (lab must be dated within 90 days);

4. Failure of a ≥ 3 consecutive month trial of fibrate therapy in the last 6 months at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced;

   5. If request is for brand Lovaza, member must use generic omega-3-acid ethyl esters, unless contraindicated or clinically significant adverse effects are experienced;
   6. Dose does not exceed 4 g (4 capsules) per day. Approval duration: 6 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): Page 1 of 5

   CLINICAL POLICY Omega-3-Acid Ethyl Esters 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.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.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.PMN.53 for Medicaid.
      II. Continued Therapy A. Hypertriglyceridemia (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);
5. Member is responding positively to therapy;
6. If request is for brand Lovaza, member must use generic omega-3-acid ethyl esters, unless contraindicated or clinically significant adverse effects are experienced;

7. If request is for a dose increase, new dose does not exceed 4 g (4 capsules) per day. Approval duration: 12 months 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.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.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.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. Page 2 of 5

   CLINICAL POLICY Omega-3-Acid Ethyl Esters IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration 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 and may require prior authorization. Drug Name Dosing Regimen fenofibrate (TriCor®) gemfibrozil (Lopid®) 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. 48-145 mg PO QD 600 mg PO BID Dose Limit/ Maximum Dose 145 mg/day 1,200 mg/day Appendix C: Contraindications/Boxed Warnings • Contraindication(s): patients with known hypersensitivity (e.g., anaphylactic reaction) to Lovaza or any of its components • Boxed warning(s): none reported V. Dosage and Administration
   Indication Hypertriglyceridemia Dosing Regimen 4 g PO QD or 2 g PO BID Maximum Dose 4 g/day VI. Product Availability
   Capsule: 1 g VII.