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L.5.01.489
Glumetza (metformin extended, modified-release)Fortamet (metformin extended, osmotic-release)
Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.
Metformin is an oral biguanide antidiabetic medication indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. Extended-release formulations of metformin provide similar glycemic control to immediate-release metformin and only differ in drug delivery technology and inactive ingredients. According to guidelines published by the American Diabetes Association (ADA), metformin as a first-line therapy has beneficial effects on A1c, is weight neutral, does not cause hypoglycemia, and reduces cardiovascular mortality. Guidelines do not prefer any one formulation of metformin and do not differentiate among extended-release products.
Prior authorization is required for Fortamet (metformin ER osmotic-release) and Glumetza (metformin ER modified-release).
Initial Review
Fortamet (metformin ER osmotic-release) maybe considered medically necessary for individuals 18 years of age or older when ALL of the following criteria are met:
Confirmed diagnosis of type 2 diabetes mellitus documented in medical records;
Intolerance or failure of metformin products is documented in medical records. Greater than or equal to at least 3 month trial of BOTH immediate-release metformin and generic Glucophage XR (metformin extended-release); Intolerance and/or failure of metformin products is documented in medical records as evidenced by ONE of the following:
Documented intolerance along with attempted intervention(s) to minimize adverse effects where appropriate (dose titration, dose reduction, administered with food, etc.); OR
Documented inadequate response supported by hemoglobin A1c before and after adequate trial of metformin products; AND
Submission of article(s) published in peer-reviewed medical literature showing the requested product is likely to be more efficacious than generic Glucophage XR (metformin extended-release tablets).
Length of Approval: 12 months
Glumetza (metformin ER modified-release) may be considered medically necessary for individuals 18 years of age or older when ALL of the following criteria are met:
Confirmed diagnosis of type 2 diabetes mellitus documented in medical records;
Intolerance or failure of metformin products is documented in medical records. Greater than or equal to at least 3-month trial of immediate-release metformin, generic Glucophage XR (metformin extended-release), AND Fortamet (metformin ER osmotic-release). Intolerance and/or failure of metformin products is documented in medical records as evidenced by ONE of the following:
Documented intolerance along with attempted intervention(s) to minimize adverse effects where appropriate (dose titration, dose reduction, administered with food, etc.) OR
Documented inadequate response supported by Hemoglobin A1c before and after adequate trial of metformin products; AND
Submission of article(s) published in peer-reviewed medical literature showing the requested product is likely to be more efficacious than generic Glucophage XR (metformin extended-release) and Fortamet ER (metformin ER osmotic-release).
Length of Approval: 12 months
Renewal Request
Fortamet (metformin ER osmotic-release) or Glumetza (metformin ER modified-release) may be approved for continuation of therapy when ALL of the following criteria are met:
Individual has been previously approved through BCBSMS PA process;
Clinical documentation submitted shows improvement in glucose control since addition of requested medication;
Individual does not have any contraindication(s) to therapy with the requested agent; AND
Dose requested is within the FDA-approved prescribing information for the medication requested.
State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [ie, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
Medication Failure
Medication failure is defined as disease progression at generally accepted doses (for >3 months use) as appropriate for the disease state being treated. Dosages below the recommended dose for the specific condition being treated and/or experience of common side effects of medication will not be considered medication failure or lack of response for the purpose of this review.
BCBSMS determines patient medication trial and adherence by a review of pharmacy claims data over the preceding twelve months. Additional information may be requested on a case-by-case basis to allow for proper review. If individual is new to BCBSMS and pharmacy records are needed to confirm medication trials and adherence, it is the responsibility of the individual and/or requesting provider to obtain said records and to submit them to BCBSMS upon request. Medical records from the provider that list previously prescribed medications will not be sufficient to show medication trials or adherence.
Medication Intolerance
Medication intolerance is defined as the inability to digest, metabolize, or mitigate the expected adverse effects of a prerequisite medication for ≥4 weeks use as evidenced by documented attempted intervention(s) to minimize sensitivity where appropriate (i.e., dose titration, dose reduction, administered with food, administration at different times of day, use of alternative formulation(s) etc.) and claims history. Experience of common side effects of medication will not be considered medication intolerance for the purpose of this review.
04/01/2016: New policy added.
05/31/2016: Policy number L.5.01.489 added.
06/13/2016:Approved by Pharmacy & Therapeutics (P&T) Committee.
02/07/2017: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.
02/06/2018: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.
02/05/2019: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Added drug names to the top of the policy. First policy statement updated to change "Fortamet ER" to "Fortamet." Sources updated. Effective 01/01/2019.
11/01/2020: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Initial review criteria for Fortamet and Glumetza updated regarding documentation of intolerance or failure of metformin products and to change "1-month trial" to "3-month trial." Added renewal criteria for continuation of therapy. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and to define investigative. Sources updated.
02/01/2023: Policy Exceptions updated to add the following: State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.
03/20/2025: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy description updated regarding metformin. Policy statement criteria updated with minor changes. Policy Guidelines updated regarding medication failure and medication intolerance. Sources updated.
American Diabetes Association Professional Practice Committee; Introduction and Methodology: Standards of Care in Diabetes—2024. Diabetes Care 1 January 2024; 47 (Supplement_1): S1–S4. https://doi.org/10.2337/dc24-SINT
Fortamet prescribing information. Actavis Laboratories FL, Inc. April 2017. Last accessed November 2024.
Glucophage and Glucophage XR prescribing information. Bristol-Myers Squibb Company. April 2017. Last accessed November 2024.
Glumetza prescribing information. Santarus, Inc. March 2024. Last accessed November 2024.
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