Last Review: 8/2010

PHARMACY PRIOR AUTHORIZATION

Clinical Guideline
Glucagon-like peptide-1 (GLP-1) agonists (incretin mimetics)
Byetta® (exenatide), Victoza® (liraglutide)

FDA Indications
® ®
Byetta (exenatide) and Victoza (liraglutide)
 Type 2 diabetes mellitus: As adjunctive therapy to diet and exercise to improve glycemic
control in adult patients with type 2 diabetes mellitus
 Used as monotherapy or in combination with other drugs used to treat type 2 diabetes
mellitus. However, combined use with insulin has not been studied.

Dosage Forms
®
Byetta (exenatide)
 5 mcg/dose in 1.2 mL prefilled pen (60 doses)
 10 mcg/dose in 2.4 mL prefilled pen (60 doses)
®
Victoza (liraglutide)
 6 mg/ml, 3ml prefilled pen
Dosage
NOTE: When initiating therapy, consider reducing the dose of concomitantly administered insulin secretagogues
(e.g., sulfonylureas) to reduce the risk of hypoglycemia.

®
Byetta (exenatide)
 Initial dosage: 5 mcg SC twice a day, at any time within the 60-minute period before the
morning and evening meals (or before the 2 main meals of the day, approximately 6 hours
or more apart). Initiation with this dose reduces the incidence and severity of GI adverse
effects.
 Maintenance dosage: After 1 month, the dose can be increased to 10 mcg twice daily.
The maximum recommended dose is 20mcg per day
 Byetta should not be administered after a meal.
 Adolescents and children: safe and effective use has not been established.
®
Victoza (liraglutide)
 Initial dosage: 0.6 mg SC once daily for 1 week. Initiation with this dose reduces the
incidence and severity of GI adverse effects.
 Maintenance dosage: After 1 week, increase the dose to 1.2 mg SC once daily. May
increase to a maximum recommended dose of 1.8 mg SC once daily.
 Adolescents and children: safe and effective use has not been established.

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Authorization Guidelines
Prior authorization personnel will review the request for prior authorization and apply the
clinical guidelines to assess the medical necessity of the request for a prescription for
Byetta or Victoza. If the guidelines are met, the reviewer will prior authorize the
prescription. If the guidelines are not met, the prior authorization request will be referred
to a physician reviewer for a medical necessity determination. Such a request for prior
authorization will be approved when, in the professional judgment of the physician
reviewer, the services are medically necessary to meet the medical needs of the
recipient.
Mercy Care Plan: For Byetta and Victoza
Mercy Healthcare Group: For Byetta. Note: Victoza is non-formulary and not covered
For patients who meet all of the following:
 Diagnosis of type 2 diabetes mellitus
 18 years of age, or older
 Recent weight is documented
 A1c between 7.6% and 9% within 30 days prior to starting treatment
 Completion of a 6-month compliant regimen of maximized dosage* of a combination
of the following medications:
1) Metformin AND
2) A sulfonylurea AND
3) A thiazolidinedione
OR
If member has a documented contraindication to ANY of the following:
 Metformin
 Sulfonylureas
 Thiazolidinediones
Then, completion of a 6-month compliant regimen of maximized dosage* of a
combination of the oral medicines that are tolerated AND long-acting insulin
(such as Lantus)
 Will not use in combination with insulin (the safety of this combination has not been
established)
 Is not prescribed solely for weight loss (benefit exclusion)
 Does not have any contraindications to the use of these medications, such as:
 History of, or current symptoms of pancreatitis
 History of hypersensitivity to any product components
 Severe gastroparesis that requires use of medication
 Severe renal impairment (creatinine clearance <30 ml/min) or end-stage renal disease
 Liraglutide is contraindicated in patients with a personal or family history of medullary
thyroid carcinoma and in patients with multiple endocrine neoplasia syndrome type 2
(MEN2). [Black Box Warning]
Mercy Care Advantage: Please refer to Mercy Care Advantage PA guidelines at
http://www.mercycareplan.com/MCA/PrescriptionDrug.aspx

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*Note: Drugs should be titrated to the maximally effective dose (commonly, only 50% to 66% of the FDA max
dose)
Prior Authorization Requirements
Initial Approval
Approve for 3 months. A repeat A1c and patient weight are required for reauthorization.
Renewal
Approve for 6 months.
Documentation Required:
 Recent A1c (within the last 30 days) documenting a reduction from pre-treatment A1c
 Recent weight
 Compliance with adjunctive diabetes medications (Review of Rx history)
Additional Renewals
Approve for 6 months
Documentation Required:
 Recent A1c (within the last 30 days) documenting a persistent reduction from pre-treatment
A1c
 Recent weight
 Compliance with adjunctive diabetes medications (Review of Rx history)
Additional Information
Medical Management of type 2 diabetes: A Consensus Algorithm from The ADA and the
European Association for the Study of Diabetes (EASD) January 2009
The algorithm takes into account the characteristics of the individual interventions, their synergies, and expense.
The goal is to achieve and maintain A1C levels of < 7%

Tier 1: Well-validated core therapies

 Step 1: Lifestyle Intervention (weight loss, increased activity) + Metformin
 Step 2: Lifestyle + Metformin + basal insulin OR sulfonylurea
 Step 3: Lifestyle + Metformin + start or intensify insulin (d/c sulfonylurea, if using)
Tier 2: Less well-validated therapies
 Step 1: Lifestyle Intervention (weight loss, increased activity) + Metformin
 Step 2: Lifestyle + Metformin + pioglitazone or GLP-1 agonist
 Step 3: Lifestyle + Metformin + pioglitazone + sulfonylurea, OR
 Step 3: Lifestyle + Metformin + basal insulin

2010 ADA Guidelines:

Utilization of A1c test:
 ADA affirms use of the A1C test to diagnose diabetes with a threshold of ≥6.5%
 Treatment goals:
 Standard glycemic control (A1C target 7.0–7.9%).
 Intensive glycemic control (target A1C <6.0%)
Preventing complications from diabetes by utilizing A1c:
 Lowering A1C to below or around 7% has been shown to reduce complications of type 1 and type 2
diabetes. Therefore, for microvascular, macrovascular and neuropathic disease prevention, the A1C goal
for nonpregnant adults in general is <7%.

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  Conversely, less-stringent A1C goals than the general goal of <7% may be appropriate for patients with a
history of severe hypoglycemia, limited life expectancy, advanced microvascular or macrovascular
complications, and extensive comorbid conditions and those with longstanding diabetes in whom the
general goal is difficult to attain despite diabetes self-management education, appropriate glucose
monitoring, and effective doses of multiple glucose-lowering agents including insulin.

Self Monitoring of Blood Glucose (SMBG)

The optimal frequency and timing of SMBG for patients with type 2 diabetes on noninsulin therapy is unclear. A
meta-analysis of SMBG in non–insulin-treated patients with type 2 diabetes concluded that some regimen of SMBG
was associated with a reduction in A1C of 0.4%. However, many of the studies in this analysis also included patient
education with diet and exercise counseling and, in some cases, pharmacologic intervention, making it difficult to
assess the contribution of SMBG alone to improved control. Several recent trials have called into question the
clinical utility and cost-effectiveness of routine SMBG in non–insulin-treated patients.
References
1. Gold Standard, Inc. Byetta. Clinical Pharmacology [database online]. Available at:
http://www.clinicalpharmacology.com. Accessed February 6, 2010.

2. Byetta [package insert]. San Diego, CA: Amylin Pharmaceuticals, Inc; October 2009.

3. American Diabetes Association. Standards of Medical Care in Diabetes—2010. Diabetes

Care [serial online]. 2010; 33: S11-S61. Available at:.
http://care.diabetesjournals.org/content/33/Supplement_1 Accessed on February 6, 2010.

4. Nathan DM, Buse JB, Davidson MB, et al., American Diabetes Association,
European Association for Study of Diabetes. Medical management of hyperglycemia in type 2
diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus
statement of the American Diabetes Association and the European Association for the
Study of Diabetes. Diabetes Care 2009; 32:193–203 Accessed on 5/6/10 at
http://care.diabetesjournals.org/content/32/1/193.full.pdf+html

5. AACE/ACE Diabetes Aligorithm for Glycemic Control December 2009. Available at

http://www.aace.com/pub/pdf/GlycemicControlAlgorithm.pdf and
http://www.aace.com/pub/pdf/GlycemicControlAlgorithmPPT.pdf