Limitations of Use: Glumetza is not used for the treatment of type 1 diabetes or ketoacidosis (1).

Transcription

1 Federal Employee Program 1310 G Street, N.W. Washington, D.C Fax Subject: Glumetza Page: 1 of 5 Last Review Date: March 18, 2016 Glumetza Description Glumetza (extended-release metformin) Background Glumetza (extended-release metformin) is an oral antidiabetic medication used to improve glycemic control in adults with type 2 diabetes mellitus. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. Metformin works by helping to restore your body's proper response to the insulin you naturally produce. It also decreases the amount of sugar that your liver makes and that your stomach/intestines absorb. Glumetza is administered once daily with the evening meal. Glumetza is not a substitute for diet and exercise (1). Regulatory status FDA Approved Indications: Glumetza is a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes (1). Limitations of Use: Glumetza is not used for the treatment of type 1 diabetes or ketoacidosis (1). Glumetza carries a boxed warning regarding the risk of lactic acidosis, which may be fatal. Increased risk is associated with hypotensive states such as acute congestive heart failure and acute myocardial infarction. Glumetza is contraindicated in patients with renal impairment, metabolic acidosis or hypersensitivity to metformin hydrochloride. Before initiating therapy with Glumetza, evaluate the patient s renal function (1).

2 Subject: Glumetza Page: 2 of 5 Patients should be warned against excessive alcohol intake while taking Glumetza (1). Hematologic parameters of Vitamin B 12 levels should be measured annually due to the potential of metformin to lower levels (1). Safety and effectiveness in pediatric patients less than 18 years of age have not been established (1). Related policies SGLT2 Inhibitors Policy This policy statement applies to clinical review performed for pre-service (Prior Approval, Precertification, Advanced Benefit Determination, etc.) and/or post-service claims. Glumetza may be considered medically necessary in patients who are 18 years of age and older with type 2 diabetes mellitus. These patients should also have inadequate response, intolerance to all of the following: generic form of Glumetza, generic form of Glucophage ER, and immediate release metformin; patient must have none of the following: renal impairment with serum creatinine levels 1.5 mg/dl for men, 1.4 mg/dl for women or abnormal creatinine clearance, hepatic impairment and metabolic acidosis, including diabetic ketoacidosis. Glumetza is considered investigational in patients that are less than 18 years of age and in patients with any diagnosis other than type 2 diabetes mellitus. Prior-Approval Requirements Age 18 years of age or older Diagnoses Patient must have the following: Diabetes mellitus Type 2 AND the following: 1. Inadequate response or intolerance to ALL of following: a. Generic form of Glumetza b. Generic form of Glucophage ER

3 Subject: Glumetza Page: 3 of 5 c. Immediate release metformin AND NONE of the following: 1. Renal impairment with serum creatinine levels 1.5 mg/dl for men, 1.4 mg/dl for women or abnormal creatinine clearance 2. Hepatic impairment 3. Metabolic acidosis, including diabetic ketoacidosis Prior Approval Renewal Requirements Diagnoses Patient must have the following: Policy Guidelines Diabetes mellitus Type 2 Pre - PA Allowance None Prior - Approval Limits AND the following: 1. Inadequate response or intolerance to the generic form of Glumetza AND NONE of the following: 1. Renal impairment with serum creatinine levels 1.5 mg/dl for men, 1.4 mg/dl for women or abnormal creatinine clearance 2. Hepatic impairment 3. Metabolic acidosis, including diabetic ketoacidosis Quantity 500mg 360 tablets per 90 days OR 1000mg 180 tablets per 90 days Maximum daily limit of any combination: 2000mg Duration 12 months

4 Subject: Glumetza Page: 4 of 5 Prior Approval Renewal Limits Prior - Approval Limits Quantity 500mg 360 tablets per 90 days OR 1000mg 180 tablets per 90 days Maximum daily limit of any combination: 2000mg Duration 12 months Rationale Summary Glumetza is an oral, extended-release formulation of metformin that is indicated to improve glycemic control in adult patients with type 2 diabetes mellitus. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. Metformin works by helping to restore your body's proper response to the insulin you naturally produce. It also decreases the amount of sugar that your liver makes and that your stomach/intestines absorb. Glumetza is administered once daily with the evening meal.the safety and efficacy of Glumetza in pediatric patients has not been established (1). Prior approval is required to ensure the safe, clinically appropriate and cost effective use of Glumetza while maintaining optimal therapeutic outcomes. References 1. Glumetza [package insert]. Raleigh, NC; Salix Pharmaceuticals, Inc. April Policy History Date October 2015 December 2015 February 2016 March 2016 Action Addition to PA Annual review Addition of inadequate response, intolerance to all of the following: generic form of Glumetza, generic form of Glucophage ER. Also addition of the requirement of inadequate response, intolerance to the generic form of Glumetza in the renewal section Annual editorial review

5 Subject: Glumetza Page: 5 of 5 Keywords Policy number change from to This policy was approved by the FEP Pharmacy and Medical Policy Committee on March 18, 2016 and is effective on April 1, Deborah M. Smith, MD, MPH