RYBELSUS (semaglutide)
SELF ADMINISTRATION
Indications for Prior Authorization:
- Adjunctive therapy to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
The following indications do not meet the criteria for use established by the Western Health Advantage Pharmacy and Therapeutics Committee:
- Treatment of Type 1 diabetes
- Treatment of ketoacidosis
- Appetite suppression or treatment of obesity
All of the following must be met as a condition(s) for coverage:
- Diagnosis of Type 2 diabetes confirmed by chart note documentation, AND
- Trial and failure of metformin
- DPP4 (dipeptidyl peptidase-4) inhibitors are not approvable with concurrent administration of GLP-1 (glucagon-like peptide-1) agonists
- Exenatide (Byetta®), Exenatide Extended-Release (Bydureon®, Bydureon BCise®), Liraglutide (Victoza®), Semaglutide (Ozempic®, Rybelsus®), Dulaglutide (Trulicity®) are the preferred agents
Dosing:
- Initial dosage:
- 3 mg once daily for 30 days. The 3 mg dose is intended for treatment initiation and is not effective for glycemic control.
- Dosage titration:
- After 30 days on the 3 mg dose, increase the dose to 7 mg once daily.
- Dose may be increased to 14 mg once daily if additional glycemic control is needed after at least 30 days on the 7 mg dose.
- Taking two 7 mg Rybelsus® tablets to achieve a 14 mg dose is not recommended, and thus is not approvable under prior authorization.
- Switching patients between Ozempic® and Rybelsus®
- Patients treated with Rybelsus® 14 mg daily can be transitioned to Ozempic® subcutaneous injection 0.5 mg once weekly. Patients can start Ozempic® the day after their last dose of Rybelsus®.
- Patients treated with once weekly Ozempic® 0.5 mg subcutaneous injection can be transitioned to Rybelsus® 7 or 14 mg. Patients can start Rybelsus® up to 7 days after their last injection of Ozempic®.
- There is no equivalent dose of Rybelsus® for Ozempic® 1 mg.
Approval:
- 1 year
Last review date: August 21, 2020