MYFEMBREE (relugolix, estradiol hemihydrate, and norethindrone acetate)

MYFEMBREE (relugolix, estradiol hemihydrate, and norethindrone acetate)

Self-Administration-Oral

Indications for Prior Authorization:

Heavy Menstrual Bleeding Associated With Uterine Leiomyomas (Fibroids) - Indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women.

Pain Associated With Endometriosis - Indicated for the management of moderate to severe pain associated with endometriosis in premenopausal women. 

Limitation of Use:

• Use should be limited to 24 months due to the risk of continued bone loss, which may not be reversible. 

Coverage Criteria:

For diagnosis of heavy menstrual bleeding associated with uterine leiomyomas (fibroids):

• Dose does not exceed 1 tablet (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) daily, AND
• Patient is 18 years of age or older, AND
• Patient has a 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
• Patient has had a previous interventional therapy to reduce bleeding (e.g., uterine-artery embolization and magnetic resonance-guided focused ultrasonography)

For diagnosis of pain associated with endometriosis: 

• Dose does not exceed 1 tablet (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) daily, AND
• Patient is 18 years of age or older, AND
• Patient has a diagnosis of moderate to severe pain associated with endometriosis, 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:
  • Danazol, OR
  • Combination (estrogen/progesterone) oral contraceptive, OR
  • Progestins, OR
  • Patient has had surgical ablation to prevent recurrence
     

Reauthorization Criteria:

For diagnosis of heavy menstrual bleeding associated with uterine leiomyomas (fibroids):

• Dose does not exceed 1 tablet (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) daily, AND
• Patient has improvement in bleeding associated with uterine leiomyomas (fibroids) (e.g., significant/sustained reduction in menstrual blood loss per cycle, improved quality of life, etc.), AND
• Treatment duration of therapy has not exceeded a total of 24 months

For diagnosis of pain associated with endometriosis: 

• Dose does not exceed 1 tablet (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) daily, AND
• Patient has improvement in pain associated with endometriosis (e.g., improvement in dysmenorrhea and nonmenstrual pelvic pain), AND
• Treatment duration of therapy has not exceeded a total of 24 months

Dosing:

• 1 tablet (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) orally once daily at approximately the same time.

• 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 (P&T) Committee.

Additional Information:

• Recommended dose: one tablet orally once daily

• Start Myfembree as early as possible after the onset of menses but no later than seven days after menses has started

• The recommended total duration of treatment with Myfembree is 24 months due to the risk of continued bone loss which may not be reversible

• Contraindications

  • High risk of arterial, venous thrombotic, or thromboembolic disorder

  • Pregnancy

  • Known osteoporosis

  • Current or history of breast cancer or other hormone-sensitive malignancies

  • Known hepatic impairment or disease

  • Undiagnosed abnormal uterine bleeding

  • Known hypersensitivity to components of Myfembree

• Avoid use of Myfembree with oral P-gp inhibitors

• Avoid use with combined P-gp and strong CYP3A inducers, as the exposure of the components of Myfembree may be decreased

Policy Updates:

• 11/16/2021 – New policy approved by P&T

• 05/16/2023 – Updated criteria.

References:

• Myfembree Prescribing Information. Myovant Sciences, Inc. Brisbane, CA. August 2022.

• 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 June 8, 2021.

• Stewart EA. Uterine Fibroids (Leiomyomas): Treatment Overview. UpToDate. Available by subscription at: https://www.uptodate.com. Accessed June 8, 2021.

• Al-Hendy A, Lukes AS, Poindexter A, et al. LIBERTY: Long-term Extension Study Demonstrating One-year Efficacy and Safety of Relugolix Combination Therapy in Women with Symptomatic Uterine Fibroids. ASRM Scientific Congress & Expo. October

• Nezhat, C., Vang, N. et al. Optimal Management of Endometriosis and Pain. Obstetrics & Gynecology: October 2019 - Vol. 134, Issue 4, p 834-839.