ModifiedCentenePolicy CP.PMN.72

Metformin ER (Fortamet, Glumetza)

Coverage and prior authorization criteria for extended-release metformin products (Fortamet, Glumetza and generics) for treatment of type 2 diabetes mellitus for Centene lines of business.

Policy Summary

PayerCentene

PolicyMetformin ER (Fortamet, Glumetza)

Policy CodePolicy CP.PMN.72

Change TypeMaterial revisions (generics included, IL HIM bypass, approval duration updated)

Effective DateDec 1, 2015

Next Review Date

Key ActionProvider must submit documentation (office notes, lab results, or other clinical information) supporting that the member meets all approval criteria for type 2 diabetes mellitus.

SourceLink

POLICY UPDATE CHANGES

Revised policy/criteria section to also include generic Fortamet and generic Glumetza.

Added step therapy bypass for Illinois HIM per IL HB 5395.

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

2000 mg/dayMaximum daily dose allowed

2 tablets/dayMaximum tablets per day allowed

12 monthsStandard approval duration

IL HIM bypassStep therapy exception

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Coverage and Medical Necessity Criteria

Initial Therapy

Covered when ALL of the following are met:

Type 2 DM initial criteria: 1. Diagnosis of type 2 diabetes mellitus;

Immediate‑release metformin intolerance/contraindication: 2. Member has experienced clinically significant adverse effects to immediate‑release metformin or has contraindication(s) to its excipients;

For Illinois HIM requests, the step therapy requirement to trial immediate‑release metformin does not apply per IL HB 5395 (effective 1/1/2026).

ER Glucophage XR intolerance/contraindication: 3. Member has experienced clinically significant adverse effects to extended‑release metformin (Glucophage XR) or has contraindication(s) to its excipients;

Brand product step for Fortamet/Glumetza: 4. If request is for brand Fortamet or brand Glumetza, member has experienced clinically significant adverse effects to generic Fortamet/Glumetza or has contraindication(s) to its excipients;

Dose limits: 5. Dose does not exceed both of the following: (a) 2,000 mg per day; and (b) 2 tablets per day.<= 2000 mg/day; <= 2 tablets/day

Continued Therapy

Covered when ALL of the following are met:

Continuation eligibility: 1. 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 enrolled in a state/product with continuity of care regulations;

Clinical response: 2. Member is responding positively to therapy;

Dose increase limits: 3. If request is for a dose increase, the new dose does not exceed both of the following: (a) 2,000 mg per day; and (b) 2 tablets per day.<= 2000 mg/day; <= 2 tablets/day

Other Diagnoses/Indications

For other/unlisted indications:

Recent label change pathway: 1. If the drug has undergone a label change within the last 6 months that is not yet reflected in this policy (e.g., new indication, age expansion, dosing), follow one of the applicable policies: (a) for drugs on formulary/PDL use the no coverage criteria policy for the relevant line of business (CP.CPA.190 for commercial, HIM.PA.33 for HIM, CP.PMN.255 for Medicaid); or (b) for drugs NOT on formulary/PDL use the non‑formulary policy for the relevant line of business (CP.CPA.190 for commercial, HIM.PA.103 for HIM, CP.PMN.16 for Medicaid).

Off‑label request pathway: 2. If the requested use (diagnosis, age, dosing) is not specifically listed under 'Diagnoses/Indications for which coverage is NOT authorized' AND criterion 1 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 HIM, CP.PMN.53 for Medicaid).

See referenced policies for process.

Coverage is not authorized for indications that are not FDA‑approved and are not specifically addressed in this policy unless the provider supplies sufficient documentation of efficacy and safety consistent with the applicable off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid), or other applicable evidence of coverage documents.

For Medicaid members, if a state Medicaid coverage provision conflicts with the coverage provisions in this clinical policy, the state Medicaid provisions take precedence. Refer to the applicable state Medicaid manual for specific coverage rules.

Use of metformin ER for type 1 diabetes mellitus or for diabetic ketoacidosis is not covered / not medically necessary under this policy.

Coding and Dose Limits

Identified GPIs for genericsmixed

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

inv-08: Maximum daily dose — 2000 mg/day

Maximum daily dose2,000 mg per day

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

Titration incrementMay titrate in increments of no more than 500 mg/week

inv-09: Maximum tablets per day — 2 tablets/day

Maximum tablets per day2 tablets per day

Dose limit applies to initial and continued therapyDose increases must not exceed 2 tablets/day for continuation or escalation requests

Prior Authorization, Documentation, and Provider Guidance

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 has the diagnosed condition and meets all approval criteria, including evidence of type 2 diabetes mellitus and prior adverse effects or contraindications to required step-therapy agents where applicable.

Prior authorization verifies member meets criteria for type 2 diabetes mellitus.
Include documentation of adverse effects or contraindications to immediate‑release metformin and metformin ER (Glucophage XR) and to generic Fortamet/Glumetza when step therapy applies.
Dose limits: ≤2,000 mg/day and ≤2 tablets/day.

Note

State Medicaid Precedence

When state Medicaid coverage provisions conflict with this clinical policy for Medicaid members, the state Medicaid manual takes precedence. Providers should follow state‑specific addenda and Medicaid manuals for coverage requirements and continuity of care regulations.

Background and Rationale

Metformin extended‑release (ER) formulations such as Fortamet and Glumetza are oral biguanide antihyperglycemic agents indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. These products are not effective for type 1 diabetes or diabetic ketoacidosis and include contraindications and boxed warnings (for example, risks of lactic acidosis and contraindication in severe renal impairment).

Definitions and Clinical Thresholds

inv-19: Metformin ER — Extended-release formulation of metformin (Fortamet, Glumetza) used to improve glycemic control in adults with type 2 diabetes mellitus.

DefinitionExtended‑release formulation of metformin (Fortamet, Glumetza) used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

Not indicated forNot effective for type 1 diabetes mellitus or diabetic ketoacidosis

Formulation classOral biguanide antidiabetic agent (extended‑release)

inv-20: Severe renal impairment contraindication — Contraindication defined as eGFR < 30 mL/min/1.73 m2.

Contraindication thresholdSevere renal impairment defined as eGFR < 30 mL/min/1.73 m2

Other contraindicationsKnown hypersensitivity to metformin; acute or chronic metabolic acidosis, including diabetic ketoacidosis

Policy Revision History

2025-11-05policy_revision

Revised policy/criteria section to include generic Fortamet and generic Glumetza; preferences reviewed and updated.

2025-11-13policy_revisionLatest

Added step therapy bypass for Illinois HIM per IL HB 5395 (effective 1/1/2026); references reviewed and updated.