Download Branded extended-release metformin, dru424

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
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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
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