Soliqua® -Xultophy® - NC Standard

Restricted Product(s)

• SOLIQUA (insulin glargine/ lixisenatide) 
• XULTOPHY (insulin degludec/ liraglutide)

FDA Approved Use

• Soliqua 
  • For adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. 
• Xultophy 
  • For adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus inadequately controlled on basal insulin (less than 50 units daily) or liraglutide (less than or equal to 1.8 mg daily)

Criteria for Approval of Restricted Product(s)

1. The prescriber states the patient is currently being treated with the requested agent within the past 90 days AND is at risk if therapy is changed; OR 
2. The patient’s medication history includes use of insulin or an agent containing metformin or sulfonylurea within the past 90 days; OR 
3. The patient has an intolerance, hypersensitivity to ONE of the following agents: insulin, metformin, or a sulfonylurea; OR 
4. The patient has an FDA labeled contraindication to ALL of the following agents; insulins, metformin, and sulfonylureas; 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

March 2021: Criteria update: Increased QL for Soliqua to 6 pens per 30 days.
October 2020: Criteria change: Allow approval if currently taking and at risk if therapy changed, require trial of metformin/sulfonylurea/insulin/GLP-1.
June 2019: Criteria update: Update to Soliqua indication
Nov 2018: Add duration of approval to criteria
Nov 2017: Reformatted criteria; removed time requirement for the failure of single agents.
Mar 2017: Added new to market Xultophy to policy. Defined length of trial period on basal and/or GLP-1.
Dec 2016: Original utilization management criteria issued