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Medication Policy Manual Policy No: dru424 Topic: Branded extended-release metformin Date of Origin: October 9, 2015 - metformin HCl ER, osmotic release (generic and Fortamet®) - metformin HCl ER, modified release (generic and Glumetza®) Committee Approval Date: October 9, 2015 Next Review Date: October 2016 Effective Date: April 1, 2016 IMPORTANT REMINDER This Medical Policy has been developed through consideration of medical necessity, generally accepted standards of medical practice, and review of medical literature and government approval status. Benefit determinations should be based in all cases on the applicable contract language. To the extent there are any conflicts between these guidelines and the contract language, the contract language will control. The purpose of medical policy is to provide a guide to coverage. Medical Policy is not intended to dictate to providers how to practice medicine. Providers are expected to exercise their medical judgment in providing the most appropriate care. Description Metformin is an oral medication used for first-line treatment of type 2 diabetes. Fortamet is an extended-release, once-daily formulation for which a generic is available. Glumetza is an extended-release, once-daily formulation that was developed using gastric retentive technology, for which a generic is not available. © 2015. OmedaRx. All rights reserved. dru424.0.1 Page 1 of 2 Policy/Criteria Fortamet, Glumetza, generic metformin HCl ER (osmotic release), and generic metformin HCl ER (modified release) are not considered medically necessary. Position Statement Fortamet - - There is an AB-rated generic product available for Fortamet, which is considered to be therapeutically equivalent to the branded product. Generic products are considered pharmaceutical equivalents with their branded counterparts, and are expected to have the same clinical effect and safety profile as the branded product when administered to patients under the conditions specified in the package labeling. Patients who are adherent, yet do not respond to equivalent doses of the generic/OTC product(s), are not likely to respond to the branded product. Given the high cost of Fortamet and availability of an affordable alternative that is therapeutically equivalent, limiting coverage in this manner reduces overall health care costs for both payers and patients, without compromising clinical outcomes or quality of care. Glumetza - - - - The most common adverse events associated with metformin use are gastrointestinal, but can often be managed through dose titration, dose reduction, and/or use of an extended-release product. Glumetza is an alternative formulation of long-acting metformin that uses patented technology to delay the release of metformin. Other long-acting formulations of metformin (Glucophage XR, Fortamet) are not directly substitutable with Glumetza, as they use different technologies to regulate drug release; however, all long acting forms of metformin are dosed once daily. There are no clinical trials that directly compare the tolerability of the different extended-release formulations of metformin. Prescribing information from the manufacturers report that nausea and diarrhea were reported in >5% of patients for each extended-release product, with no clear tolerability data that would indicate preference of one product over another. The cost of Glumetza ranges from ~$60-$133 per tablet, compared to less than $1 per tablet for some generic formulations. Given that Glumetza is another long-acting formulation for which there are multiple alternatives, and there is no proven clinical advantage, eliminating coverage will reduce overall health care costs for payers and patients, without compromising clinical outcomes or quality of care. References 1. Bristol Myers Squibb. Glucophage prescribing information. Princeton, NJ. August 2008. 2. Watson Laboratories. Fortamet prescribing information. Ft. Lauderdale, FL. July 2008. 3. Salix Pharmaceuticals. Glumetza prescribing information. Raleigh, NC. September 2014. © 2015. OmedaRx. All rights reserved. dru424.0.1 Page 2 of 2