GLP-1 Agonist / Insulin Combination Agents (SOLIQUA, XULTOPHY)

GLP-1 Agonist / Insulin Combination Agents (SOLIQUA, XULTOPHY)

Self-Administration - subcutaneous injection

Diagnosis considered for coverage:

SOLIQUA (100 units/mL insulin glargine and 33 mcg/mL lixisenatide) (step therapy)
XULTOPHY (100 units/mL insulin degludec and 3.6 mcg/mL liraglutide) (prior authorization)

• Type 2 diabetes mellitus: Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. 
  • Limitations of Use: SOLIQUA 100/33 has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis. SOLIQUA 100/33 is not recommended for use in combination with any other product containing a GLP-1 receptor agonist. SOLIQUA 100/33 is not indicated for use in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. SOLIQUA 100/33 has not been studied in patients with gastroparesis and is not recommended in patients with gastroparesis. SOLIQUA 100/33 has not been studied in combination with prandial insulin. 
  • Limitations of Use: XULTOPHY 100/3.6 is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise because of the uncertain relevance of the rodent C-cell tumor findings to humans. XULTOPHY 100/3.6 is not recommended for use in combination with any other product containing liraglutide or another GLP-1 receptor agonist. XULTOPHY 100/3.6 is not indicated for use in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. XULTOPHY 100/3.6 has not been studied in combination with prandial insulin.

Coverage Criteria:

For diagnosis of type 2 diabetes mellitus (DM2):

• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication; AND
• Trial and failure (of a minimum 30-day supply), contraindication, or intolerance to one metformin-containing agent.

Dosing:

DM2:

• Soliqua:
  • In patients naïve to basal insulin or to a GLP-1 receptor agonist, currently on a GLP-1 receptor agonist or currently on less than 30 units of basal insulin daily:
    • The recommended starting dosage of SOLIQUA 100/33 is 15 units (15 units insulin glargine and 5 mcg lixisenatide) given subcutaneously once daily.
  • In patients currently on 30 to 60 units of basal insulin daily, with or without a GLP-1 receptor agonist:
    • The recommended starting dosage of SOLIQUA 100/33 is 30 units (30 units insulin glargine and 10 mcg lixisenatide) given subcutaneously once daily.
  • The maximum daily dosage is of SOLIQUA 100/33 is 60 units (60 units insulin glargine and 20 mcg lixisenatide) given subcutaneously once daily.
• Xultophy:
  • In patients naïve to basal insulin or to a GLP-1 receptor agonist:
    • The recommended starting dosage of XULTOPHY 100/3.6 is 10 units (10 units insulin degludec and 0.36 mg liraglutide) given subcutaneously once daily.
  • In patients currently on basal insulin daily, or a GLP-1 receptor agonist:
    • The recommended starting dosage of XULTOPHY 100/3.6 is 16 units (16 units insulin degludec and 0.58 mg liraglutide) given subcutaneously once daily.
  • The maximum daily dosage is of XULTOPHY 100/3.6 is 50 units (50 units insulin degludec and 1.8 mg liraglutide) given subcutaneously once daily.

Coverage Duration: 

• One (1) Year 

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Policy Updates:

• 12/01/2023 – New policy approved by WHA P&T Committee. (P&T, 11/14/23) 

References:

1. Soliqua Prescribing Information. Sanofi-aventis U.S. LLC. Bridgewater, NJ. June 2022. 
2. Xultophy Prescribing Information. Novo Nordisk Inc. Bagsvaerd, Denmark. June 2022.