Target Agents:

 **Note - Medications listed below will only be approved for the FDA approved diagnoses listed in this policy.  Use of GLP1-agonist medications for diagnoses not listed in this policy is considered investigational unless excluded by contract.**

Adlyxin is FDA approved as adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Byetta is FDA approved as adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Bydureon/Bydureon BCise is FDA approved as adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Mounjaro is FDA approved as adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Ozempic is FDA approved

•     : as adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
•      .to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease

Rybelsus is FDA approved as adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Trulicity is FDA approved:

• as adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
• to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease

Victoza is FDA approved:

·       as adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

·       to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease

Initial Evaluation

I.                Target Agent(s) may be considered medically necessary when ALL of the following are met:

A.     If the requested agent is a preferred GLP-1, then ONE of the following:

                                                                          i.     Information has been provided that indicates the patient has been treated with a preferred agent (starting on samples is not approvable) within the past 90 days OR

                                                                         ii.     The prescriber states the patient has been treated with preferred agent within the past 90 days (starting on samples is not approvable) AND is at risk if therapy is changed OR

B.     ALL of the following:

                                                                          i.     The patient has a diagnosis of type 2 diabetes mellitus AND

      ii.   ONE of the following:

1. The patient's age is within FDA labeling for the requested indication for the requested agent OR

2. There is support for using the requested agent for the patient's age for the requested indication AND

      iii.   The patient's diagnosis has been confirmed by lab tests (e.g. A1c greater than or equal to 6.5%) (lab tests required) AND

                                                                         iv.     ONE of the following:

1.     The requested agent is a preferred GLP-1/GIP agent OR

2.     The requested agent is a non-preferred agent GLP-1/GIP agent AND the patient has TWO of the following:

a. The patient has tried and had inadequate response after at least 90 day trial of therapy, has intolerance, hypersensitivity, or FDA labeled contraindication to semaglutide (Ozempic OR Rybelsus) OR

b. The patient has tried and had inadequate response after at least 90 day trial of therapy, has intolerance, hypersensitivity, or FDA labeled contraindication to dulaglutide (Trulicity) OR

C. The patient has tried and had inadequate response after at least 90 day trial of therapy, has intolerance, hypersensitivity, or FDA labeled contraindication to tirzepatide (Mounjaro) OR

AND

C. The patient will NOT be using the requested agent in combination with a DPP-4 containing agent (e.g.,alogliptin/metformin, alogliptin/pioglitazone, BrynovinJanuvia, Janumet, Janumet XR, Jentadueto, Jentadueto XR, Kombiglyze XR, Nesina, Onglyza, Tradjenta, Trijardy, Zituvio, Zituvimet, Zituvimet XR) AND

D. The patient will NOT be using the requested agent in combination with another GLP-1 receptor agonist agent (e.g., Saxenda, Wegovy, Zepbound, Bydureon, Byetta, Exenatide, Mounjaro, Ozempic, Rybelsus, Trulicity, Victoza) AND

E. The patient does NOT have any FDA labeled contraindications to the requested agent AND

F.     For quantity limit, BOTH of the following:

i. ONE of the following:

1.  The requested quantity (dose) does NOT exceed the program quantity limit

OR

2.    The requested quantity (dose) exceeds the program limit AND ONE of the following:

                                                                          I.     The requested agent is Mounjaro 2.5mg AND the intended use is for maintenance therapy, then BOTH of the following:

a. The patient has an inability to use an FDA labeled strength indicated for maintenance therapy AND

        b. The patient has had clinial benefit on the lower requested strength from baseline (prior to initiation of the requested agent and strength) OR

                                                                         II.     BOTH of the following:

a. The requested agent does NOT have a maximum FDA labeled dose for the requested indication AND

b.  There is support for therapy with a higher dose for the requested indication OR

                                                                         III.     BOTH of the following:

a. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND

b.  There is support for why the requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does NOT exceed the program quantity limit OR

      IV.     BOTH of the following:

a. The requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND

b.  There is support for therapy with a higher dose for the requested indication AND

ii. ONE of the following:

                                                                          1.     The requested quantity (dose) does NOT exceed the program fill limit in the past 28 days OR

                                                                         2.     The requested quantity (dose) exceeds the program fill limit in the past 28 days AND ONE of the following:

                                                                        I.     The patient is switching to a different strength of the previously filled GLP-1 agent AND ONE of the following:

a. The patient has had an inadequate response and is switching to a higher strength OR

b. The patient has had an intolerance with the previously filled GLP-1 agent and is switching to a lower strength OR

     II.   The patient is switching to a different GLP-1 agent AND ONE of the following:

a. The patient has had an inadequate response and is switching to a different GLP-1 agent OR

b. The patient has an intolerance or hypersensitivity to the previously filled GLP-1 agent or strength that is not expected to occur with the requested agent OR

c. The patient has an FDA labeled contraindication to the previously filled GLP-1 agent that is not expected to occur with the requested agent

E. The patient will NOT be using the requested agent in combination with a DPP-4 containing agent (e.g.,Januvia, Janumet, Janumet XR, Jentadueto, Jentadueto XR, Kazano, Kombiglyze XR, Nesina, Onglyza, Oseni, Tradjenta, Zituvio, Zituvimet) AND

F. The patient will NOT be using the requested agent in combination with another GLP-1 receptor agonist agent (e.g., Saxenda, Wegovy, Zepbound, Bydureon, Byetta, Exenatide, Mounjaro, Ozempic, Rybelsus, Trulicity, Victoza) AND

G. The patient does NOT have any FDA labeled contraindications to the requested agent.

Length of Approval: 12 months; Quantity limit approval may be for 1 month if within quantity limit and replacing another GLP-1 agent/strength or for titration dose extension request.

Renewal Evaluation

I.                Renewal of Target Agent(s) may be considered medically necessary when all of the following are met:

A.      The patient has been previously approved for the requested agent through the plan’s Prior Authorization process AND

B.     The patient has had clinical benefit with the requested agent AND

C.    The patient does NOT have any FDA labeled contraindications to the requested agent AND

D.    ONE of the following:

1.       The requested quantity (dose) does not exceed the program quantity limit OR

2.       ALL of the following:

                                                                                                                         a.      The requested quantity (dose) is greater than the program quantity limit AND

                                                                                                                         b.      The requested quantity (dose) is greater than the maximum FDA labeled dose for the requested indication AND

                                                                                                                          c.      Information has been provided in support of therapy with a higher dose for the requested indication 

Length of Approval: 12 months