Oriahnn™

Drug - Oriahnn™ (Elagolix/Estradiol/Norethindrone Acetate; Elagolix) [Abbvie, Inc.]

September 2020

Therapeutic area - Pituitary Suppressive Agents, LHRH

Initial approval criteria

Patient age is ≥ 18 years AND
Patient is premenopausal AND
Patient has confirmed diagnosis of uterine leiomyomas (fibroids) with heavy menstrual bleeding AND
Oriahnn is prescribed by, or in consultation with, a specialist in gynecology or reproductive health AND
Patient has failed (or has a contraindication to) an adequate trial of one of the following therapies:
- Combination hormonal contraceptives OR
- Progestins (including oral or transdermal formulations, vaginal ring, intrauterine device, or injections) OR
- Tranexamic acid AND
Pregnancy is excluded prior to initiating treatment (within 7 days from the onset of menses) AND
Patients of childbearing potential will use effective non-hormonal contraception during treatment with Oriahnn and 1 week after stopping therapy AND
Patient does NOT have osteoporosis (defined as a Z score > -1.5 at spine and femur [total hip]) AND
Patient does not have hepatic impairment (Child-Pugh A, B, or C) or disease AND
Patient is not on concomitant strong organic anion transport polypeptide (OATP) 1B1 inhibitors (e.g., cyclosporine, gemfibrozil) or on rifampin AND
Patient does NOT have any of the following other contraindications to Oriahnn treatment:
- Known hypersensitivity to the active or inactive ingredients (e.g., elagolix, estradiol, norethindrone acetate, FD&C Yellow No 5) OR
- Current or history of breast cancer or other hormonally-sensitive malignancies OR
- Undiagnosed abnormal uterine bleeding OR
- High risk of arterial, venous thrombotic, or thromboembolic disorders, including the following:
  - Smokers > 35 years of age OR
  - Current or history of deep vein thrombosis or pulmonary embolism OR
  - Vascular disease (e.g., cerebrovascular disease, coronary artery disease, peripheral vascular disease) OR
  - Thrombogenic valvular or thrombogenic rhythm diseases of the heart (e.g., subacute bacterial endocarditis with valvular disease, or atrial fibrillation) OR
  - Inherited or acquired hypercoagulopathies OR
  - Uncontrolled hypertension OR
  - Headaches with focal neurological symptoms or have migraine headaches with aura if > 35 years of age

Renewal criteria

Patient must continue to meet the above criteria AND
Prescriber attestation that patient has had clinically meaningful response to treatment AND
Prescriber attestation that the patient does not have osteoporosis and provide the Z score (patient should not have a Z score > -1.5 at spine and femur [total hip]) AND
Patient has not experienced any treatment-restricting adverse effects (e.g., decreased bone density, hepatic impairment, thromboembolic disorders and vascular events, mood disorders/suicidal ideation)

Quantity limits

1 carton/28 days
Maximum total duration of 24 months

Background

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

Questions?

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