Pharmacy Prior Authorization Criteria

Rybelsus (semaglutide)

For diagnosis of 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: (1) RYBELSUS is not recommended as a first-line therapy for patients who have inadequate glycemic control on diet and exercise because of the uncertain relevance of rodent C-cell tumor findings to humans. (2) RYBELSUS has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis. (3) RYBELSUS is not indicated for use in patients with type 1 diabetes mellitus.

Step Therapy

Length of Approval: 12 Month(s)

Requested drug is being used for a Food and Drug Administration (FDA)-approved indication

AND

AND

Trial and failure, contraindication, or intolerance to one of the following generics:

2022-06-16, 2022-05-31, 2022-01-10, 2021-07-22, 2020-12-14, 2019-12-20, 2019-11-06, 2019-09-23, 2019-09-20

American Diabetes Association. Standards of medical care in diabetes. Diabetes Care. 2022; 45 (suppl 1): S125-143.
Rybelsus Prescribing Information. Novo Nordisk A/S. Bagsvaerd, Denmark. September 2021.

2022-06-16: Added exclusion criteria for weight loss.
2022-05-31: Updated formatting, no changes to clinical criteria
2022-01-10: Annual review: Added diagnosis criteria for FDA approved indication based on ST program updates. Updated indications section to align with PI. Updated references.
2021-07-22: Addition of EHB formulary to guideline, no changes to criteria
2020-12-14: Annual review, no updates to clinical criteria
2019-12-20: IR wanted GLP containing step removed
2019-11-06: Addition of GLP containing step
2019-09-23: Updated criteria with GPI's for 3,7, 14 mg strengths
2019-09-20: New step therapy guideline created