COVERED USES:

FDA Approved Indications:

Diabetes mellitus type 2, as adjunctive therapy in patients taking metformin, a sulfonylurea, a thiazolidinedione, a combination of metformin and a sulfonylurea or a thiazolidinedione, but have not achieved adequate glycemic control.

Requests for a non-FDA approved ("off-label") indication requires the proposed indication be listed in either the American Hospital Formulary System (AHFS), USP-DI, or Drugdex and is considered subject to evaluation of the prescriber's medical rationale, formulary alternatives, the available published evidence-based research and whether the proposed use is determined to be experimental/investigational.

AGE RESTRICTIONS:

NA

PRESCRIBER RESTRICTIONS:

NA

REQUIRED MEDICAL INFORMATION:

For initiation of treatment, a prior authorization form and relevant chart notes documenting medical rationale are required and for continuation of therapy, ongoing documentation of successful response to the medication may be necessary.

CRITERIA:

All of the following criteria are required:

• HbA1C is greater than 7%, but less than 10%
• Failed or contraindicated to maximum effective dose of sulfonylurea and metformin (2000mg a day) concurrently for a minimum of 90 days.
• Failure is defined as HbA1c greater than 7%

When criteria are met, Exenatide maybe authorized up to six months in quantities of one pen fill injection per month. After initial 6 months approval, patient should demonstrate at least a 10% decrease in HgbA1C, otherwise the therapy should be discontinued. However, exenatide may be continued if patient has reached glycemic target at less than 7% regardless of the magnitude of drop in HbA1c. Authorization shall be renewed at least annually to check for therapy benefit.

EXCLUSION CRITERIA:

• Patients with type 1 DM
• Patients with known hypersensitivity to exenatide
• Patients with severe gastroparesis

COVERAGE DURATION:

Initial authorization up to 6 months and reauthorization up to one year.