SEMGLEE (insulin glargine)

SEMGLEE (insulin glargine)

SELF ADMINISTRATION - INJECTABLE

Indication for Prior Authorization:

• Indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus
• Limitations of Use
  • Not recommended for treating diabetic ketoacidosis

Coverage Criteria:

• Patient has a diagnosis of type 1 or type 2 diabetes mellitus, AND
• For a diagnosis of type 2 diabetes mellitus: Patient is 18 years of age or older, AND
• Patient has tried and failed two preferred medications: insulin glargine (Lantus®, Toujeo®), insulin detemir (Levemir®), insulin degludec (Tresiba®)

Dosing:

• Recommended starting dose of Semglee™ in patients with type 1 diabetes should be approximately one-third of the total daily insulin requirements
• Recommended starting dose of Semglee™ in patients with type 2 diabetes who are not currently treated with insulin is 0.2 units/kg or up to 10 units once daily
• Individualize and adjust the dosage of Semglee™ based on the individual’s metabolic needs, blood glucose monitoring results and glycemic control goal
• Administer Semglee™ subcutaneously once daily at any time of day but at the same time every day

Coverage Duration:

• Initial: 1 year
• Reauthorization: 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 Committee.

Additional Information:

• Contraindications:
  • During episodes of hypoglycemia
  • In patients with hypersensitivity to insulin glargine or one of its excipients
• Semglee™ prefilled pens must never be shared between patients, even if the needle is changed
• Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen: Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) may affect glycemic control and predispose to hypoglycemia or hyperglycemia
• Additional warnings for: hypoglycemia, medication errors, hypokalemia, and fluid retention and heart failure with concomitant use of PPAR-gamma agonists

Review History:

• 2/16/21- Original review

References:

• Garber AJ, Abrahamson MJ, Barzilay JI, et al. American Association of Clinical Endocrinologists and American College of Endocrinology comprehensive diabetes management algorithm – 2018 executive summary. https://www.aace.com/sites/all/files/diabetes-algorithm-executive-summary.pdf. Accessed May 27,2020.
• Semglee™ Prescribing Information. Mylan Specialty, Morgantown, WV. June 2020.