mcp_byetta_victoza_pa_guidelines_08_2010

8/7/2019 MCP_Byetta_Victoza_PA_Guidelines_08_2010

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Last Review: 8/2010

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PHARMACY PRIOR AUTHORIZATION

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

FDA IndicationsByetta

(exenatide) and Victoza

(liraglutide)

Type 2 diabetes mellitus: As adjunctive therapy to diet and exercise to improve glycemiccontrol in adult patients with type 2 diabetes mellitus

Used as monotherapy or in combination with other drugs used to treat type 2 diabetesmellitus. However, combined use with insulin has not been studied.

Dosage FormsByetta

(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

DosageNOTE: 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 hoursor more apart). Initiation with this dose reduces the incidence and severity of GI adverseeffects.

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 theincidence and severity of GI adverse effects.

Maintenance dosage: After 1 week, increase the dose to 1.2 mg SC once daily. Mayincrease 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 GuidelinesPrior authorization personnel will review the request for prior authorization and apply theclinical guidelines to assess the medical necessity of the request for a prescription forByetta or Victoza. If the guidelines are met, the reviewer will prior authorize theprescription. If the guidelines are not met, the prior authorization request will be referredto a physician reviewer for a medical necessity determination. Such a request for priorauthorization will be approved when, in the professional judgment of the physicianreviewer, the services are medically necessary to meet the medical needs of therecipient.Mercy Care Plan: For Byetta and VictozaMercy 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 regimenof maximized dosage* of a combinationof the following medications:

1) Metformin AND2) A sulfonylurea AND3) A thiazolidinedioneORIf member has a documented contraindication to ANY of the following:

Metformin Sulfonylureas

ThiazolidinedionesThen, 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 beenestablished)

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


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*Note: Drugs should be titrated to the maximally effective dose (commonly, only 50% to 66% of the FDA maxdose)

Prior Authorization RequirementsInitial ApprovalApprove for 3 months. A repeat A1c and patient weight are required for reauthorization.

RenewalApprove 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 RenewalsApprove 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 InformationMedical Management of type 2 diabetes: A Consensus Algorithm from The ADA and theEuropean Association for the Study of Diabetes (EASD)January 2009The 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 of6.5% Treatment goals: Standard glycemic control (A1C target 7.07.9%). Intensive glycemic control (target A1C


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Conversely, less-stringent A1C goals than the general goal of

mcp_byetta_victoza_pa_guidelines_08_2010

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