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Metformin ER Step Therapy Program Summary

Policy Number: PH-91056

This program applies to the Blue Partner, Commercial, GenPlus, SourceRx and Health Insurance Marketplace formularies.

POLICY REVIEW CYCLE                                                                                                                                            

Effective Date

Date of Origin   

04-01-2025           

FDA LABELED INDICATIONS AND DOSAGE

Agent(s)

FDA Indication(s)

Notes

Ref#

Glumetza®

(metformin ER modified release)

Tablet*

Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

*generic available

3

metformin HCL Tab ER Osmotic

Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

5

See package insert for FDA prescribing information:  https://dailymed.nlm.nih.gov/dailymed/index.cfm

CLINICAL RATIONALE

Diabetes

The American Diabetes Association (ADA) state the following concerning metformin:(2)

  • First-line therapy depends on comorbidities, patient-centered treatment factors, and management needs and generally includes metformin and comprehensive lifestyle modifications.
  • Metformin should be continued upon initiation of insulin therapy (unless contraindicated or not tolerated) for ongoing glycemic and metabolic benefits.

Safety

Metformin products have the following black box warning:

  • Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. Symptoms included malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Laboratory abnormalities included elevated blood lactate levels, anion gap acidosis, increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL.
  • Risk factors include renal impairment, concomitant use of certain drugs, age greater than or equal to 65 years old, radiological studies with contrast, surgery and other procedures, hypoxic states, excessive alcohol intake, and hepatic impairment. 
  • If lactic acidosis is suspected, discontinue metformin product and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended.

Metformin products carry the following contraindications:

  • Severe renal impairment: (eGFR below 30 mL/minute/1.73 m^2)
  • Known hypersensitivity to metformin
  • Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma

REFERENCES                                                                                                                                                                           

Number

Reference

1

Glumetza prescribing information. Salix Pharmaceuticals. August 2019.

2

ElSayed NA, Aleppo G, Bannuru RR, et al. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes-2024. Diabetes Care. 2023;47(Supplement_1):S158-S178. doi:10.2337/dc24-s009

3

Metformin ER Osmotic prescribing information. AiPing Pharmaceutical, Inc. February 2019.

POLICY AGENT SUMMARY STEP THERAPY

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

Targeted MSC

Available MSC

Final Age Limit

Preferred Status

Metformin HCl Tab ER 24HR Osmotic 1000 MG

1000 MG

M ; N ; O ; Y

Y

Metformin HCl Tab ER 24HR Osmotic 500 MG

500 MG

M ; N ; O ; Y

Y

Glumetza

Metformin HCl Tab ER 24HR Modified Release 1000 MG

1000 MG

M ; N ; O ; Y

O ; Y

Glumetza

Metformin HCl Tab ER 24HR Modified Release 500 MG

500 MG

M ; N ; O ; Y

O ; Y

CLIENT SUMMARY – STEP THERAPY

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

Client Formulary

Metformin HCl Tab ER 24HR Osmotic 1000 MG

1000 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Metformin HCl Tab ER 24HR Osmotic 500 MG

500 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Glumetza

Metformin HCl Tab ER 24HR Modified Release 1000 MG

1000 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Glumetza

Metformin HCl Tab ER 24HR Modified Release 500 MG

500 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

STEP THERAPY CLINICAL CRITERIA FOR APPROVAL

Module

Clinical Criteria for Approval

TARGET AGENT(S)

PREREQUISITE AGENT(S)

Glumetza (metformin modified release)*
metformin osmotic ER (generic Fortamet ER)

metformin ER (generic Glucophage XR)

 

*-generic available

Target Agent(s) will be approved when ONE of the following is met:

  1. The requested agent is eligible for continuation of therapy AND ONE of the following:

Agents Eligible for Continuation of Therapy

All target agents are eligible for continuation of therapy
    1. The patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days OR
    2. The prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed OR
  2. The patient’s medication history includes use of ONE prerequisite agent in the past 90 days OR
  3. The patient has an intolerance or hypersensitivity to ONE prerequisite agent that is not expected to occur with the requested agent OR
  4. The patient has an FDA labeled contraindication to ALL prerequisite agents available that is not expected to occur with the requested agent

Length of Approval: 12 months

This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.

Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.

 

 

 

Commercial _ PS _ Metformin_ER_ST _ProgSum_ 04-01-2025