WHA

SOLIQUA (insulin glargine and lixisenatide) 

SELF ADMINISTRATION- INJECTABLE

Indication for Prior Authorization:
  • Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
  • Limitations of Use:
    • Soliqua® has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis
    • Soliqua® is not recommended for use in combination with any other product containing a GLP-1 receptor agonist
    • Soliqua® is not indicated for use in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis
    • Soliqua® has not been studied in patients with gastroparesis and is not recommended in patients with gastroparesis
    • Soliqua® has not been studied in combination with prandial insulin
Coverage Criteria:
  • Patient has a diagnosis of Type 2 diabetes, AND
  • Failure of at least one preferred agent(s): Victoza®, Byetta®, Bydureon®, Bydureon BCise®, Ozempic®, Rybelsus®, Trulicity®, AND
  • Failure of Adlyxin™, AND
  • Current A1C greater than 7 but less than 10 while compliant on oral therapy and Adlyxin™, AND
  • Failure, intolerance, or contraindication to metformin at maximum effective therapeutic dose of 1,500 mg/day or maximum tolerated dose, unless contraindicated. Unless contraindicated, the member must currently adhere to maximal tolerated dose of metformin.
    • An A1C level must be taken after a minimum of 3 months since last metformin dose change with confirmation in the pharmacy claims adjudication history of patient compliance with the treatment regimen, AND
  • Concurrent administration with any dipeptidyl peptidase-4 (DPP-4) inhibitor or any other glucagon-like peptide-1 (GLP-1) agonist is not approvable
Dosing:
  • Recommended starting dose: 
    • In patients naive 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:15 units (15 units insulin glargine/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: 30 units (30 units insulin glargine/10 mcg lixisenatide) given subcutaneously once daily. 
    • Discontinue therapy with basal insulin or a GLP-1 receptor agonist prior to initiation of Soliqua®
  • Maximum dose: 60 units daily (60 units insulin glargine/20 mcg lixisenatide)
  • Titrate the dosage upwards or downwards by two to four units every week until the desired fasting plasma glucose is achieved
  • Administer Soliqua® subcutaneously once a day within the hour prior to the first meal of the day 
Coverage Duration:
  • Initial: 1 year
  • Renewal: 1 year
Authorization is Not Covered for the Following:

The following conditions, and other uses of this drug for indications not listed in this policy, do not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics Committee.

  • Treatment of Type 1 diabetes
  • Treatment of ketoacidosis
  • Appetite suppression or treatment of obesity
Additional Information:
  • Soliqua® is contraindicated during episodes of hypoglycemia
  • Anaphylaxis and Serious Hypersensitivity Reactions: Inform and closely monitor patients with a history of anaphylaxis or angioedema with another GLP-1 receptor agonist for allergic reactions, because it is unknown whether such patients will be predisposed to anaphylaxis with lixisenatide. Soliqua® is contraindicated in patients with known hypersensitivity to lixisenatide or insulin glargine
  • Pancreatitis: Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been reported post-marketing in patients treated with GLP-1 receptor agonists. If pancreatitis is suspected, promptly discontinue Soliqua® and initiate appropriate management. If pancreatitis is confirmed, restarting Soliqua® is not recommended. Consider antidiabetic therapies other than Soliqua® in patients with a history of pancreatitis
  • Never Share a Soliqua® Prefilled Pen Between Patients: prefilled pens must never be shared between patients, even if the needle is changed. Sharing of the pen poses a risk for transmission of blood-borne pathogens
  • Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen: Changes in insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) may affect glycemic control and predispose to hypoglycemia or hyperglycemia
  • Overdose Due to Medication Errors: Soliqua® contains two drugs: insulin glargine and lixisenatide. Administration of more than 60 units of Soliqua® daily can result in overdose of the lixisenatide component. Do not exceed the 20 mcg maximum recommended dose of lixisenatide or use with other glucagon-like peptide-1 receptor agonists
  • Hypoglycemia
  • Acute Kidney Injury: Soliqua® is not recommended in patients with end-stage renal disease 
  • Immunogenicity:  Patients may develop antibodies to insulin and lixisenatide, components of Soliqua®, following treatment
  • Hypokalemia
  • Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma Agonists: Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR)-gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin-containing products. Fluid retention may lead to or exacerbate heart failure
Review History:
  • 10/8/20- Annual review. Updated to new format
  • 4/22/20- Annual review. No changes
References:

Soliqua [package insert]. Bridgewater (NJ): Sanofi-Aventis U.S. LLC; 2020.

Last review date: December 1, 2023