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Metformin ER Step Therapy with Program Summary

Policy Number: PH-1056

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

POLICY REVIEW CYCLE                                                                                                                                                                           

Effective Date

Date of Origin 

4/1/2023

FDA APPROVED INDICATIONS AND DOSAGE

Agent(s)

FDA Indication(s)

Notes

Ref#

Fortamet®*
(metformin ER osmotic)

Tablet

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

*- generic available

1

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

Riomet ER™
(metformin ER)

Oral suspension

Adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older 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:

  • 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.(4)

REFERENCES                                                                                                                                                                           

Number

Reference

1

Fortamet prescribing information. Actavis Laboratories. March 2021.

2

Metformin ER prescribing information. Granules India Ltd.  April 2021.

3

Glumetza prescribing information. Salix Pharmaceuticals. August 2019.

4

American Diabetes Association.  Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes-2022.  Available at: https://diabetesjournals.org/care/issue/45/Supplement_1

5

Riomet ER prescribing information.  Sun Pharmaceutical Industries, Ltd.  August 2019.

 

POLICY AGENT SUMMARY STEP THERAPY

Agent Names

Strength

Targeted MSC

Available MSC

Preferred Status

Effective Date

RIOMET ER*Metformin HCl For Oral ER Susp 500 MG/5ML

M ; N ; O ; Y

N

METFORMIN HYDROCHLORIDE E*Metformin HCl Tab ER 24HR 500 MG

500 MG

M ; N ; O

O ; Y

METFORMIN HYDROCHLORIDE E*Metformin HCl Tab ER 24HR 750 MG

750 MG

M ; N ; O

O ; Y

FORTAMET*Metformin HCl Tab ER 24HR Osmotic 1000 MG

1000 MG

M ; N ; O ; Y

O ; Y

FORTAMET*Metformin HCl Tab ER 24HR Osmotic 500 MG

500 MG

M ; N ; O ; Y

O ; 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 For Oral ER Susp 500 MG/5ML

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

Metformin HCl Tab ER 24HR 500 MG

500 MG

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

Metformin HCl Tab ER 24HR 750 MG

750 MG

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

Fortamet

Metformin HCl Tab ER 24HR Osmotic 1000 MG

1000 MG

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

Fortamet

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)

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

metformin ER (generic Glucophage XR)

 

 

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:
    1. Information has been provided that indicates 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

Agents Eligible for Continuation of Therapy

All target agents are eligible for continuation of therapy
  1. The patient’s medication history includes use of a prerequisite agent in the past 90 days OR
  2. The patient has an intolerance or hypersensitivity to an available prerequisite agent that is not expected to occur with the requested agent OR
  3. 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 Step Therapy _ProgSum_ 4/1/2023