Orilissa™
Drug - Orilissa™ (elagolix tablet) [Abbvie Inc.]
April 2019
Therapeutic area - GnRH Antagonist, Pituitary Supressant Agents
Initial approval criteria
- Patient age is ≥ 18 years AND
- Patient has confirmed diagnosis of endometriosis AND
- Patient has failed an adequate trial of the following therapies:
- non-steroidal anti-inflammatory drugs (NSAIDs) AND
- hormonal contraceptives (including oral or transdermal formulations, vaginal ring, or intrauterine device) AND
- gonadotropin-releasing hormone (GnRH) agonist (e.g., nafarelin [Synarel®], leuprolide [Lupron®], goserelin [Zoladex®])
- Elagolix is prescribed by or in consultation with an obstetrics/gynecology or reproductive specialist AND
- Pregnancy is excluded prior to initiating treatment AND
- Patient will use effective non-hormonal contraception during treatment with elagolix and 1 week after stopping therapy AND
- Patient does not have a Z score > -1.5 at spine and femur (total hip) or back AND
- Patient does not have severe hepatic impairment (Child-Pugh C) AND
- Patient is not on concomitant strong organic anion transport polypeptide (OATP) 1B1 inhibitor (e.g., cyclosporine, gemfibrozil)
- Initial approval is for 6 months
Renewal criteria
- Patient continues to meet the initial criteria AND
- Patient is considered to have clinically meaningful response to treatment
Quantity limits
- 150 mg tablets: 34 tabs per 34 days. Maximum treatment duration is 24 months
- 200 mg tablets: 68 tablets per 34 days. Maximum treatment duration is 6 months
Questions?
MHCP Provider Call Center 651-431-2700 or 800-366-5411
