|
Effective Date
|
Date of Origin
|
|
04-01-2024
|
|
FDA APPROVED 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
|
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
|
|
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:
- 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
|
-
- 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
- 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
- The patient’s medication history includes use of a prerequisite agent in the past 90 days OR
- The patient has an intolerance or hypersensitivity to ONE prerequisite agent that is not expected to occur with the requested agent OR
- 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_ 04-01-2024
|
