CurrentmhnPolicy CP.PMN.72

Clinical Policy: Metformin ER (Fortamet, Glumetza)

Coverage and prior authorization criteria for extended‑release metformin formulations (Fortamet, Glumetza, and generics) used as adjunct to diet and exercise for adults with type 2 diabetes mellitus across Centene-affiliated health plans.

Policy Summary

Payermhn

PolicyClinical Policy: Metformin ER (Fortamet, Glumetza)

Policy CodePolicy CP.PMN.72

Change TypeRevised — includes genericsupdated Commercial approval duration

Effective DateDec 1, 2015

Next Review Date

Key ActionObtain prior authorization with documentation showing diagnosis of type 2 diabetes, intolerance or contraindication to immediate‑release metformin (and other ER formulations when applicable), and that dose limits are not exceeded.

SourceLink

POLICY UPDATE CHANGES

Policy/criteria section was revised to also include generic Fortamet and generic Glumetza.

Approval duration for Commercial line of business was revised to 12 months or duration of request, whichever is less.

2000 mg/dayMax daily dose (Metformin ER)

12 monthsTypical approval duration

AdultsFDA indication

eGFR <30Contraindication

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Coverage Criteria — Metformin ER

Initial Therapy — Type 2 Diabetes Mellitus

Covered when ALL of the following are met:

ALL of the following

Diagnosis of type 2 DM
Intolerance_IR_metformin: Member has experienced clinically significant adverse effects to immediate-release metformin or has contraindication(s) to its excipients
Intolerance_ER_Glucophage_XR: Member has experienced clinically significant adverse effects to extended-release metformin (Glucophage XR) or has contraindication(s) to its excipients
Brand_request_step: 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
Dose_limit: Dose does not exceed the following: (a) 2,000 mg per day; and (b) 2 tablets per day<= 2000 mg/day; <= 2 tablets/day

ALL of the following

Approval_duration_Medicaid_HIM: Approval duration: Medicaid/HIM - 12 months
Approval_duration_Commercial: Approval duration: Commercial - 12 months or duration of request, whichever is less

Continued Therapy — Type 2 Diabetes Mellitus

Continued therapy is authorized when ALL of the following are met:

ALL of the following

Prior_use_or_approval: Member meets one of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria; OR (b) currently receiving medication and is enrolled in a state/product with continuity of care regulations
Response: Member is responding positively to therapy
Dose_limit_if_increase: If request is for a dose increase, new dose does not exceed the following: (a) 2,000 mg per day; and (b) 2 tablets per day<= 2000 mg/day; <= 2 tablets/day

ALL of the following

Coverage is not authorized for certain diagnoses and clinical states. Specifically, requests for therapy for Type 1 diabetes mellitus and for diabetic ketoacidosis are excluded from coverage. In addition, use of metformin ER for non‑FDA approved indications not addressed in this policy is not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with applicable off‑label use policies (see related policies).

Metformin ER is contraindicated in patients with severe renal impairment (eGFR < 30 mL/min/1.73 m2) and in those with known hypersensitivity to metformin. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, is also a contraindication; the drugs carry a boxed warning for lactic acidosis.

Requests for indications that are not FDA‑approved and are not specifically addressed in this policy are handled under the payer's off‑label use policies. Such requests are not authorized unless the provider submits sufficient supporting documentation of safety and efficacy per the applicable off‑label policies (for example, CP.CPA.09 for commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid). Providers should reference those policies when submitting clinical rationale for non‑FDA indications.

Coding and Dose Limits

Formulation GPIsmixed

GPI 27250050007520	Generic Glucophage XR (GPI 27250050007520)
GPI 27250050007530	Generic Glucophage XR (GPI 27250050007530)
GPI 27250050007560	Generic Fortamet (GPI 27250050007560)
GPI 27250050007570	Generic Fortamet (GPI 27250050007570)
GPI 27250050007580	Generic Glumetza (GPI 27250050007580)
GPI 27250050007590	Generic Glumetza (GPI 27250050007590)

inv-06: Maximum daily dose — ≤ 2,000 mg/day

Maximum daily dose≤ 2,000 mg per day (policy-specified maximum for Metformin ER)

Dose guidanceIf glycemic control not achieved with 2,000 mg PO QD, consider trial of 1,000 mg PO BID (per dosing guidance)

Titration incrementsFortamet: may titrate in increments of no more than 500 mg/week; Glumetza: may increase in 500 mg increments every 1–2 weeks

inv-07: Maximum tablets per day — ≤ 2 tablets per day

Maximum tablets per day≤ 2 tablets per day (policy-specified limit)

Dose vs tablets noteDose limits (≤ 2,000 mg/day) and tablet limits (≤ 2 tablets/day) apply to initial and continued therapy and to dose increases

Typical tablet strengthsMetformin ER available as 500 mg and 1,000 mg extended-release tablets (product availability)

Provider Actions and Prior Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that the member meets all approval criteria for Fortamet/generic and Glumetza/generic.

Prior authorization required for Fortamet, Glumetza, and generics
Submit office chart notes, relevant labs, and other clinical documentation to demonstrate criteria are met
Approval durations: Medicaid/HIM — 12 months; Commercial — 12 months or duration of request, whichever is less

Denial Risk

Non‑FDA Indications / Off‑Label Requests

Requests for non‑FDA approved (off‑label) indications will be denied unless sufficient documentation of efficacy and safety is provided per the applicable off‑label use policies.

Off‑label requests require documentation per: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), CP.PMN.53 (Medicaid)
Type 1 diabetes mellitus and diabetic ketoacidosis are not authorized indications

Documentation Required

Documentation Requirements

Documentation required to support approval includes office visit notes, prior medication history demonstrating trials and adverse reactions/intolerances to other metformin formulations or generics, and relevant laboratory results. For brand requests, documentation must show adverse effects or contraindications to the generic equivalents.

Office chart notes documenting diagnosis of type 2 diabetes mellitus
Documentation of clinically significant adverse effects or contraindications to immediate-release metformin and to extended-release metformin (Glucophage XR)
If brand Fortamet/Glumetza requested, documentation of adverse effects or contraindications to generic Fortamet/Glumetza
Medication history showing prior trials and outcomes
Labs or other clinical data supporting ongoing benefit for continuation requests

Denial Risk

Provider Actions and Denial Risk

Provider actions that will result in denial: requests for use in Type 1 diabetes mellitus, diabetic ketoacidosis, or other non‑FDA approved indications without adequate off‑label documentation. Ensure requests conform to dose limits and step/formulation requirements specified in the policy.

Denial for Type 1 DM or diabetic ketoacidosis
Denial for non‑FDA indications lacking sufficient off‑label documentation per CP.CPA.09, HIM.PA.154, or CP.PMN.53
Dose limits: max 2,000 mg/day and max 2 tablets/day — requests exceeding limits will be denied
For formulation/brand step requirements: evidence of adverse effects or contraindications to other metformin formulations or generics must be provided

Background

Metformin extended‑release formulations (examples: Fortamet and Glumetza) are oral biguanide antihyperglycemics indicated as adjuncts to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Extended‑release preparations allow once‑daily dosing with titration as tolerated and are available in 500 mg and 1,000 mg tablet strengths.

These agents are not effective for type 1 diabetes or for treating diabetic ketoacidosis. They are contraindicated in patients with severe renal impairment (eGFR < 30 mL/min/1.73 m2) and in those with acute or chronic metabolic acidosis. Metformin products carry a boxed warning for the risk of lactic acidosis.

Revision History

2024-11-05annual_reviewLatest

1Q 2025 annual review updated policy/criteria to also include generic Fortamet and generic Glumetza; preferences reviewed and updated.

2022-04-27approval_duration_change

Approval duration for Commercial line of business revised to 12 months or duration of request, whichever is less.

2023-10-18annual_review

1Q 2024 annual review: references reviewed and updated.

2022-10-10template_update

Template changes applied to other diagnoses/indications and continued therapy section.

OpenPayer

Clinical Policy: Metformin ER (Fortamet, Glumetza)

Coverage Criteria — Metformin ER

Coding and Dose Limits

Provider Actions and Prior Authorization Requirements

Definitions

Background

Revision History