ModifiedHealth NetPolicy CP PMN.72

Metformin ER (Fortamet; Glumetza)

Defines medical necessity criteria, prior authorization requirements, dosing limits, contraindications, and coverage parameters for extended‑release metformin products (Fortamet, Glumetza and generics) for members of Health Net/Centene-affiliated plans.

Policy Summary

PayerHealth Net

PolicyMetformin ER (Fortamet; Glumetza)

Policy CodePolicy CP PMN.72

Change TypeCriteria revised to include genericsapproval preferences updated

Effective DateDec 1, 2015

Next Review Date

Key ActionSubmit prior authorization with office chart notes and labs showing diagnosis of type 2 diabetes mellitus and that approval criteria are met.

SourceLink

POLICY UPDATE CHANGES

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

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

2000max daily dose mg

2tablets/day

12 monthsapproval duration

lactic acidosisboxed warning

Coverage and Medical Necessity Criteria

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Initial Therapy

Covered when ALL of the following are met:

Initial Approval - Type 2 DM: 1. Diagnosis of type 2 diabetes mellitus (type 2 DM).

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

Initial Approval - ER metformin intolerance: 3. Member has experienced clinically significant adverse effects to extended‑release metformin (e.g., Glucophage XR) or has contraindication(s) to its excipients.

Initial Approval - Brand product requests: 4. If the request is for brand Fortamet or Glumetza, the member has experienced clinically significant adverse effects to generic Fortamet/Glumetza or has contraindication(s) to their excipients.

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

Approval duration: Medicaid/HIM 12 months; Commercial 12 months or duration of request, whichever is less.

Continuation Therapy

Covered for continuation when ALL of the following are met:

Continued Therapy - Eligibility: 1. Member meets one of the following: a) currently receiving the medication via a Centene benefit or has previously met initial approval criteria; or b) member is in a continuity‑of‑care situation as defined by state/product regulations.

Continued Therapy - Clinical response: 2. Member is responding positively to therapy.

Continued Therapy - Dose increase: 3. If the 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.dose <= 2000 mg/day; tablets <= 2/day

Approval duration: Medicaid/HIM 12 months; Commercial 12 months or duration of request, whichever is less.

Other Diagnoses/Indications

For other diagnoses or indications (must meet 1 of 2):

Other Indications Pathway: a) For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), follow the no coverage criteria policy for the relevant line of business (CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, CP PMN.255 for Medicaid).

Other Indications Pathway: b) For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), follow the non‑formulary policy for the relevant line of business (CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, CP PMN.16 for Medicaid).

Other Indications Pathway: c) If the drug has had a recent label change (within the last 6 months) not yet reflected in this policy, or the requested use (diagnosis, age, dosing) is not listed under section III and criterion a/b do 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, CP.PMN.53 for Medicaid).

Coverage is not authorized for members with type 1 diabetes mellitus or for treatment of diabetic ketoacidosis. Non‑FDA approved (off‑label) indications are likewise excluded from coverage unless the request is supported with sufficient documentation of efficacy and safety in accordance with the applicable off‑label or non‑formulary policies (see CP.CPA.09 for commercial, HIM.PA.154 for Health Insurance Marketplace, and CP PMN.53 for Medicaid) or other evidence of coverage documents.

None specified.

Metformin ER is contraindicated in patients with severe renal impairment (eGFR <30 mL/min/1.73 m2) and in those with acute or chronic metabolic acidosis, including diabetic ketoacidosis. There is a boxed warning for lactic acidosis. Use of Metformin ER for patients with these conditions or risks is considered not medically appropriate.

None specified.

Drug Coding and Dose Limits

Identified GPIs for generic ER metformin productsmixed

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

Identified GPIs for generic ER metformin products (alternate grouping)mixed

No codes listed

inv-09: Maximum daily dose — 2,000 mg/day

Maximum daily dose2,000 mg/day

Dosing regimen (examples)Fortamet: start 500 mg PO QD, titrate by ≤500 mg/week to effect; Glumetza: 500 mg PO with evening meal, increase by 500 mg every 1–2 weeks

Policy threshold applicationDose must not exceed 2,000 mg/day for initial and continued therapy (approval will be denied if >2,000 mg/day)

inv-10: Maximum tablets per day — 2 tablets/day

Maximum tablets per day2 tablets per day

Applies to initial and continued therapy2 tablets/day limit enforced for both initial approval and dose increases on continuation

Approval consequenceRequests exceeding 2 tablets/day will not meet dose threshold criteria

Prior Authorization, Documentation, and Provider Responsibilities

Prior Authorization

Prior Authorization Required

Prior authorization is required for Metformin ER (Fortamet/Glumetza and generics). Provider must obtain prior authorization before dispensing when indicated by member's benefit plan.

Affected products: Fortamet, Glumetza, and their generics.
Approval duration: Medicaid/HIM 12 months; Commercial 12 months or duration of request, whichever is less.

Denial Risk

Documentation and Indication Risk

Requests lacking adequate clinical documentation or that do not clearly demonstrate the member meets all approval criteria may be denied. Providers should ensure submitted records support the diagnosis and prior therapy history.

Denial risk if chart notes, labs, or clinical information do not substantiate Type 2 diabetes diagnosis or listed adverse effects/contraindications.
Coverage exclusions: requests for non‑FDA indicated uses (see policy) and diabetic ketoacidosis are not authorized.
Refer to state Medicaid provisions where applicable (Medicaid precedence).

Documentation Required

Required Documentation

Provider must submit supporting documentation with the prior authorization request, such as office chart notes, laboratory results, and other relevant clinical information demonstrating the member meets all approval criteria.

Documentation should confirm diagnosis of Type 2 diabetes mellitus and prior intolerance or contraindication to immediate‑release metformin and/or other ER metformin formulations as required by criteria.
If requesting brand Fortamet/Glumetza, include documentation showing clinically significant adverse effects to generic equivalents or contraindications to generic excipients.
Include dosing information to verify request does not exceed approved dose limits (e.g., ≤2,000 mg/day or 2 tablets/day as specified).

Note

Provider Contractual Obligations

By submitting claims or prior authorization requests, providers attest they are bound by their contractual terms and by this clinical policy. Unauthorized distribution or use of this policy is prohibited.

Providers are independent contractors; the Health Plan does not control clinical judgment.
Submitting a claim or providing services to members implies agreement to the policy terms where no separate contract exists.

Definitions and Scope Notes

inv-20: Metformin ER — definition and examples (Fortamet, Glumetza)

DefinitionMetformin extended‑release (ER): oral biguanide antidiabetic formulations used to improve glycemic control in adults with type 2 diabetes mellitus

Brand examplesFortamet, Glumetza

Dosing noteBoth Fortamet and Glumetza have maximum recommended doses of 2,000 mg/day per prescribing/dosing guidance

inv-21: Clinical policy scope — reminder that policy is not medical advice; providers retain clinical responsibility

Policy is not medical adviceThis clinical policy does not constitute medical advice, medical treatment, or medical care and is not intended to dictate to providers how to practice medicine.

Provider responsibilityProviders are expected to exercise professional medical judgment and are solely responsible for the medical advice and treatment of members.

Patient consultationMembers should consult with their treating physician for diagnosis and treatment decisions.

inv-22: Provider status — providers are independent contractors, not employees/agents of the Health Plan

Provider statusProviders referenced in this clinical policy are independent contractors who exercise independent judgment and are not employees or agents of the Health Plan.

Contractual bindingProviders, members, and representatives are bound by the terms and conditions expressed in their contracts or by submitting claims for payment.

Health Plan controlThe Health Plan has no control or right of control over providers' independent medical judgment.

OpenPayer

Metformin ER (Fortamet; Glumetza)

Coverage and Medical Necessity Criteria

Drug Coding and Dose Limits

Prior Authorization, Documentation, and Provider Responsibilities

Definitions and Scope Notes

Background and Clinical Context