GIP/GLP-1 Agonists – NC Standard

Restricted Product(s)

• Mounjaro™ (tizepatide)

FDA Approved Use

• As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Criteria for Approval of Restricted Product(s)

1. The patient is 18 years of age or older; AND 
2. The patient has a diagnosis of type 2 diabetes mellitus (medical record documentation required); AND 
3. The patient has tried and failed two of the following preferred products: Ozempic, Rybelsus, Trulicity, or Victoza; OR 
   1. The provider has submitted a written, clinical rational as to why the patient cannot take the preferred GLP-1 products due to a true adverse drug reaction, intolerance, or FDA labeled contraindication; AND 
4. The patient’s medication history includes one or more of the following: an agent containing metformin, sulfonylurea, or insulin in the past 90 days; OR 
   1. The patient has tried and had an inadequate response, has an intolerance, or hypersensitivity to one of the following agents: metformin, sulfonylurea, or an insulin; OR 
   2. The patient has an FDA labeled contraindication to metformin; AND 
5. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.
   
   Duration of Approval: 365 days (1 year)

Quantity Limit Exception Criteria

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND 
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND 
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR 
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).
   
   Duration of Approval: 365 days (1 year)

References

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q1 annually.

January 2023: Criteria update: Mounjaro 2.5mg QL changed to 4 pens per 180 days. Written clinical rational required for members unable to utilize preferred GLP-1 products.
June 2022: No change to criteria. Corrected formatting.
May 2022: Original utilization management policy issued.