Metformin ER (Fortamet, Glumetza) Form

Metformin extended-release [ER] (Fortamet®, Glumetza®) is an oral biguanide antidiabetic agent.
FDA Approved Indication(s) Fortamet and Glumetza are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (DM). Limitation(s) of use: Fortamet and Glumetza should not be used in patients with type 1 DM or for the treatment of diabetic ketoacidosis, as they would not be effective in these settings. 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 Fortamet and Glumetza are medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Type 2 Diabetes Mellitus (must meet all):

1. Diagnosis of type 2 DM;
   2. Member has experienced clinically significant adverse effects to immediate-release metformin or has contraindication(s) to its excipients;
2. Member has experienced clinically significant adverse effects to extended-release metformin (Glucophage® XR) or has contraindication(s) to its excipients;
   4. If request is for brand Fortamet/Glumetza, member has experienced clinically significant adverse effects to generic Fortamet/Glumetza or has contraindication(s) to its excipients;

3. Dose does not exceed any of the following (a and b): a. 2,000 mg per day; b. 2 tablets per day. Approval duration:
   Medicaid/HIM – 12 months Commercial – 12 months or duration of request, whichever is less Page 1 of 6

   CLINICAL POLICY Metformin ER 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, 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: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; 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 criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. Type 2 Diabetes Mellitus (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 any of the following (a and b): a. 2,000 mg per day; b. 2 tablets per day. Approval duration:
      Medicaid/HIM – 12 months Commercial – 12 months or duration of request, whichever is less 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: CP.CPA.190 for commercial, 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: Page 2 of 6

   CLINICAL POLICY Metformin ER CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and 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.CPA.09 for commercial, 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 – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents; B. Type 1 DM; C. Diabetic ketoacidosis. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key DM: diabetes mellitus ER: extended-release FDA: Food and Drug Administration GPI: generic product identifier 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 Dose Limit/ Maximum Dose 2,550 mg/day metformin (Glucophage) 500 mg PO BID or 850 mg PO QD, given with meals. Dosage increases should be made in increments of 500 mg weekly or 850 mg every 2 weeks, up to 2000 mg/day PO, given in divided doses 500 mg PO QD with the evening meal; may metformin ER (Glucophage XR) increase daily dose by 500 mg/week as needed
   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. 2,000 mg/day Appendix C: Contraindications/Boxed Warnings • Contraindication(s): severe renal impairment (eGFR < 30 mL/min/1.73 m2); known hypersensitivity to metformin; acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma • Boxed warning(s): lactic acidosis Page 3 of 6

   CLINICAL POLICY Metformin ER Appendix D: General Information • Generic Glucophage XR (GPI 27250050007520 or 27250050007530), generic Fortamet (GPI 27250050007560 or 27250050007570), and generic Glumetza (GPI 27250050007580 or 27250050007590) are identified with different GPI 14.
   • Glucophage XR uses dual hydrophilic polymer matrix systems, Fortamet uses single- composition osmotic technology, and Glumetza uses gastric retention technology. V. Dosage and Administration
   Indication Metformin ER (Fortamet) Dosing Regimen 500 mg PO QD; may titrate in increments of no more than 500 mg/week Maximum Dose 2,000 mg/day Metformin ER (Glumetza) If glycemic control is not achieved with 2,000 mg PO QD, consider a trial of 1,000 mg PO BID 500 mg PO QD with the evening meal; may increase the dose in 500 mg increments every 1-2 weeks
   2,000 mg/day VI. Product Availability
   Drug Name Metformin ER (Fortamet) Extended-release tablets: 500 mg, 1,000 mg Metformin ER (Glumetza) Extended-release tablets: 500 mg, 1,000 mg Product Availability VII.