ORIAHNN (elagolix, estradiol, norethindrone)

ORIAHNN (elagolix, estradiol, norethindrone) 

SELF -ADMINISTRATION

Indication for Prior Authorization:

• Indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women

Limitation of Use:

• Limited to 24 months due to risk of continued bone loss, which may not be reversible

Coverage Criteria:

• Patient is 18 years of age or older, AND
• Diagnosis of heavy menstrual bleeding associated with uterine leiomyomas (fibroids), AND
• Patient is premenopausal, AND
• Prescribed by or in consultation with an obstetrics/gynecologist (OB/GYN) or reproductive endocrinologist, AND
• History of inadequate control of bleeding following a trial of at least 3 months, or history of intolerance or contraindication to one of the following:
  • Combination (estrogen/progesterone) oral contraceptive, OR
  • Progestins, OR
  • Tranexamic acid, OR
• Has had a previous interventional therapy to reduce bleeding (e.g., uterine-artery embolization and magnetic resonance-guided focused ultrasonography)

Reauthorization Criteria:

• Patient has improvement in bleeding associated with uterine leiomyomas (fibroids) (e.g., significant/sustained reduction in menstrual blood loss per cycle, improve quality of life, etc.), AND
• Treatment duration of therapy has not exceeded a total of 24 months

Dosing:

• Elagolix 300 mg/estradiol 1 mg/norethindrone 0.5 mg every morning and Elagolix 300 mg every evening
• Max duration of therapy: 24 months

Coverage Duration:

• Initial: 1 year
• Reauthorization: 1 year

Authorization is Not Covered for the Following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics Committee.

Review History:

• 7/29/2020- Original review

References:

• Oriahnn Prescribing Information. AbbVie Inc. North Chicago, IL. May 2020.
• Schlaff WD,Ackerman RT, Al-Hendy A, et al. Elagolix for Heavy Menstrual Bleeding in Women with Uterine Fibroids. N Engl J Med. 2020;382(4): 328-340. doi 10.1056/NEJMoa1904351.
• De La Cruz MS, Buchanan EM. Uterine Fibroids: Diagnosis and Treatment. Am Fam Physician. 2017 Jan 15;95 (2): 100-107. Available by subscription at: https://www.aafp.org/afp/2017/0115/p100.html. Accessed July 8, 2020
• De La Cruz MS, Buchanan EM. Uterine Fibroids: Diagnosis and Treatment. Am Fam Physician. 2017 Jan 15;95 (2): 100-107. Available by subscription at: https://www.aafp.org/afp/2017/0115/p100.html. Accessed July 8, 2020.
• American College of Obstetricians and Gynecologists. ACOG Committee Opinion. Management of acute abnormal uterine bleeding in nonpregnant reproductive-aged women. April 2013. Reaffirmed 2017.
• Wouk N, Helton M. Uterine Fibroids: Abnormal Uterine Bleeding in Premenopausal Women. Am Fam Physician. 2019 Apr 1; 99(7): 435-443. Available by subscription at: https://www.aafp.org/afp/2019/0401/p435.html. Accessed July 8, 2020.
• National Institute for Health and Care Excellence. (2020). Heavy menstrual bleeding: assessment and management. (NG88). Available at: https://www.nice.org.uk/guidance/ng88/chapter/Recommendations. Accessed July 8, 2020