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DrugOrilissa™ (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


MHCP Provider Call Center 651-431-2700 or 800-366-5411

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