Basal Insulin - ST, NF
Indications for Prior Authorization
Basaglar Tempo pen (insulin glargine), Semglee (insulin glargine), Semglee (insulin glargine-yfgn), Insulin glargine-yfgn
-
For diagnosis of Diabetes Mellitus
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 the treatment of diabetic ketoacidosis.
Tresiba (insulin degludec)
-
For diagnosis of Diabetes Mellitus
Indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus.Limitations of Use: Not recommended for the treatment of diabetic ketoacidosis.
Criteria
Basaglar Tempo pen, Semglee, Insulin Glargine-yfgn
Step Therapy
Length of Approval: 12 Month(s)
For diagnosis of Diabetes mellitus
- Requested drug is being used for a Food and Drug Administration (FDA)-approved indication AND
- Trial and failure to a minimum 30-day supply, contraindication, or intolerance to three of the following:
- Lantus (insulin glargine)
- Tresiba (insulin degludec)
- Toujeo (insulin glargine) [A]
- Basaglar Kwikpen (insulin glargine)
- Rezvoglar Kwikpen (insulin glargine)
Basaglar Tempo pen, Semglee, Insulin Glargine-yfgn
Non Formulary
Length of Approval: 12 Month(s)
For diagnosis of Diabetes mellitus
- Requested drug is being used for a Food and Drug Administration (FDA)-approved indication AND
- Both of the following:
- Submission of medical records (e.g., chart notes) confirming the patient has experienced intolerance (e.g., allergy to excipient) to three of the following formulary alternatives that have the same active ingredient:
- Lantus (insulin glargine)
- Toujeo (insulin glargine) [A]
- Basaglar Kwikpen (insulin glargine)
- Rezvoglar Kwikpen (insulin glargine)
- Submission of medical records confirming the formulary alternative(s) have not been effective AND valid clinical rationale provided explaining how the Non-Formulary or Excluded Medication is expected to provide benefit when the formulary alternative(s) have not been shown to be effective despite having the same active ingredient
Tresiba
Non Formulary
Length of Approval: 12 Month(s)
For diagnosis of Diabetes mellitus
- Requested drug is being used for a Food and Drug Administration (FDA)-approved indication AND
- Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure to a minimum 30 days supply, contraindication, or intolerance to three of the following:
- Lantus (insulin glargine)
- Toujeo (insulin glargine) [A]
- Basaglar Kwikpen (insulin glargine)
- Rezvoglar Kwikpen (insulin glargine)
P & T Revisions
2024-10-23, 2024-08-06, 2024-06-05, 2023-12-15, 2023-11-15, 2023-10-27, 2023-05-25, 2023-03-31, 2023-02-24, 2023-01-31, 2023-01-04, 2022-06-17, 2022-05-03, 2022-03-02, 2022-02-03, 2021-11-03, 2021-05-21, 2020-10-21, 2020-05-27
References
- Basaglar Prescribing Information. Eli Lilly and Company. Indianapolis, IN. July 2021.
- Garber AJ, Abrahamson MJ, Barzilay JI, et al. Consensus Statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the Comprehensive Type 2 Diabetes Management Algorithm – 2020 Executive Summary. https://www.endocrinepractice.org/action/showPdf?pii=S1530-891X%2820%2935066-7. Accessed April 14,2022.
- Semglee Prescribing Information. Mylan Specialty L.P. Morgantown, WV. October 2022.
- Insulin Glargine-yfgn Prescribing Information. Mylan Specialty L.P. Morgantown, WV. July 2021.
- Tresiba Prescribing Information. Novo Nordisk A/S. Bagsvaerd, Denmark. July 2022.
End Notes
- Newer basal insulin formulations (glargine U300, degludec U100 and U200) have more prolonged and stable pharmacokinetic and pharmacodynamic characteristics than glargine U100 and detemir [2]. Randomized control trials have reported equivalent glycemic control and lower rates of severe or confirmed hypoglycemia, particularly nocturnal hypoglycemia.
Revision History
- 2024-10-23: Removed Levemir as preferred alternative and as a target from NF criteria
- 2024-08-06: Implemented drug-specific NF criteria for Basaglar Tempo.
- 2024-06-05: Update to NF criteria
- 2023-12-15: Add insulin glargine-YFGN as target to mirror criteria
- 2023-11-15: Updated guideline
- 2023-10-27: Program update to remove Basaglar Kwikpen and Rezvoglar as targets. Basaglar Kwikpen and Rezvoglar added as additional preferred alternatives.
- 2023-05-25: 2023 Annual Review - updated references
- 2023-03-31: Added new Rezvoglar as a target in the ST criteria
- 2023-02-24: Updated per PA team request to remove "Brand" before "Brand Insulin Glargine-yfgn"
- 2023-01-31: Added new formulation of Levemir Flexpen to guideline
- 2023-01-04: Added Basaglar tempo pen to criteria.
- 2022-06-17: Annual review: Updated ST therapy to include full "trial and failure, contraindication, or intolerance" verbiage. March P&T update effective 7.1.22 to ST therapy requiring trial of 3 alts instead of 2.
- 2022-05-03: Updated GL name to include "- ST, NF"
- 2022-03-02: Updated criteria
- 2022-02-03: Updated references. Added NF section.
- 2021-11-03: Added insulin-yfgn as a target in the ST to mirror Semglee. Added additional Semglee GPIs, updated background and references.
- 2021-05-21: Annual Review: updated semglee indication section and updated references - no changes to criteria
- 2020-10-21: Added semglee as a target and changed GL name to basal insulin
- 2020-05-27: Annual review, no changes to clinical criteria updated references.
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