Health Net relugolix coverage & Prior Auth

Coverage Criteria

Initial Therapy - Prostate Cancer (Orgovyx)

Covered when ALL of the following are met for Orgovyx (prostate cancer):

Orgovyx initial: 1. Diagnosis of prostate cancer; 2. Request is for Orgovyx; 3. Prescribed by or in consultation with an oncologist or urologist; 4. Age >= 18 years; 5. For brand Orgovyx requests, member must use generic relugolix if available unless contraindicated or intolerant; 6. Initial loading dose does not exceed 360 mg (3 tablets) on day 1; 7. Maintenance dose does not exceed 120 mg (1 tablet) per day, or 240 mg (2 tablets) per day if co-administered with rifampin and combination use is unavoidable; 8. Prescribed regimen must be FDA-approved or recommended by NCCN, or dose supported by practice guidelines or peer-reviewed literature for relevant off-label use; Approval duration: 12 months

Initial Therapy - Heavy Menstrual Bleeding (Myfembree)

Covered when ALL of the following are met for Myfembree (uterine fibroids):

Myfembree HMB initial: 1. Diagnosis of uterine leiomyomas (fibroids) confirmed by ultrasound; 2. Request is for Myfembree; 3. Prescribed by or in consultation with a gynecologist or reproductive endocrinologist; 4. Age > 18 years; 5. Member has experienced heavy menstrual bleeding for at least 2 consecutive cycles; 6. Failure of a 3-month trial of a combination estrogen-progestin contraceptive agent (see Appendix B for examples); 7. Member has not already received >= 24 cumulative months of Myfembree therapy; 8. Dose does not exceed 40 mg relugolix (1 tablet) per day. Approval duration: 12 months; Total duration should not exceed 24 months

Initial Therapy - Endometriosis Pain (Myfembree)

Covered when ALL of the following are met for Myfembree (endometriosis pain):

Myfembree endometriosis initial: 1. Diagnosis of pain due to endometriosis; 2. Request is for Myfembree; 3. Prescribed by or in consultation with a gynecologist or reproductive endocrinologist; 4. Age >= 18 years; 5. Failure of a 3-month trial within the last year of agents from specified drug classes (NSAID and/or oral or depot injectable progestin or progestin-containing contraceptive) unless clinically significant adverse effects or contraindications; 6. Member has not already received >= 24 cumulative months of Myfembree therapy; 7. Dose does not exceed 40 mg relugolix (1 tablet) per day; Approval duration: 12 months; Total duration should not exceed 24 months

Continuation Therapy

Covered when ALL of the following are met for continuation:

Continued therapy general: 1. Member is currently receiving medication via Centene benefit or documentation supports current use and at least 30 days of therapy; 2. Request is for the same product (Orgovyx or Myfembree) as previously approved; 3. Member is responding positively to therapy as evidenced by clinical improvement; 4. Member has not exceeded cumulative limits (Myfembree <= 24 months); 5. If dose increase requested, new dose must not exceed specified limits (Orgovyx: 120 mg/day standard or 240 mg/day if combined with rifampin and unavoidable; Myfembree: 40 mg/day). Approval duration: 12 months

Indication-specific coverage

Covered when ALL of the following are met (per indication-specific summary in this part of the policy):

Myfembree initial therapy: Patient has diagnosis of heavy menstrual bleeding due to uterine fibroids OR endometriosis-associated pain; prescriber documents indication; treatment is for up to 24 months; no contraindications present (see Appendix C)duration <= 24 months

Myfembree dosing: 1 tablet PO QD

Orgovyx therapy: Patient has diagnosis of prostate cancer; prescriber documents indication; dosing follows loading 360 mg PO day 1 then 120 mg PO QD maintenance (increase to 240 mg PO QD if unavoidable combined P-gp and strong CYP3A inducers are coadministered)as specified

Avoid combined P-gp and strong CYP3A inducers if possible

Non-FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider submits sufficient documentation of efficacy and safety consistent with the plan’s off‑label use policies (see CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP PMN.53 for Medicaid).

Myfembree is contraindicated in patients who are pregnant and in those at high risk of arterial, venous, or thromboembolic events; it is also contraindicated in patients with current or prior breast cancer or other hormone‑sensitive cancers, known osteoporosis, known hepatic impairment or disease, undiagnosed abnormal uterine bleeding, or known hypersensitivity to components of Myfembree. These contraindications and boxed warnings are detailed in Appendix C and reflected in the policy’s prescriber and denial guidance.

Routine continuation of Myfembree beyond 24 months is not consistent with the policy’s recommended cumulative treatment duration; requests to continue therapy past this limit must include supporting clinical justification documenting ongoing benefit and absence of contraindications.

Initial Therapy Criteria

Initial Therapy - Summary

Initial therapy rules depend on indication; see criteria sets for required elements.

Initial therapy summary: Initial authorization requires meeting indication-specific criteria including prescriber specialty, age >=18, prior trials where required (e.g., contraceptives or NSAIDs/progestins for gynecologic indications), dose limits (Orgovyx loading 360 mg day 1; maintenance 120 mg/day normally; Myfembree 40 mg relugolix/day), and cumulative duration limits for Myfembree (<=24 months).

Initial therapy dosing

Dosing and alternatives for initial therapy:

Orgovyx initial: Loading dose 360 mg PO on day 1 then 120 mg PO QD maintenance; avoid combined P-gp and strong CYP3A inducers (e.g., rifampin); if unavoidable, increase maintenance to 240 mg PO QDas per PI

Orgovyx tablet 120 mg available

Continuation Criteria

Continuation - Orgovyx/Myfembree

Continuation of therapy requirements:

Orgovyx continuation: Member is currently receiving medication via Centene benefit or documentation supports current use >=30 days; request is for Orgovyx; for brand Orgovyx, member must use generic relugolix if available unless contraindicated; member is responding positively to therapy; dose increases must meet dose limits or be supported by guidelines/literature; approval duration 12 months.

Myfembree continuation

Continuation therapy conditions noted in the policy

Myfembree continuation: Member has not received > 24 months of Myfembree therapy; continuation requests must document ongoing benefit and absence of contraindications<=24 months total therapy

Policy emphasizes 24-month cumulative treatment duration

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Orgovyx and Myfembree. Submit clinical documentation to support that the member meets all approval criteria. Failure to submit required documentation may result in denial or a request for additional information.

Affected products: Orgovyx (relugolix), Myfembree (relugolix/estradiol/norethindrone)
Prior authorization required with submission of chart notes, relevant lab results, imaging (e.g., ultrasound for fibroids), and other clinical information

Prior Authorization

Duration Limitation

Approval durations and limits differ by indication. For Myfembree: initial approval duration is 12 months; total cumulative therapy should not exceed 24 months. Requests for continuation should document prior approval history and cumulative duration to ensure total therapy does not exceed 24 months.

Myfembree: Initial approval = 12 months; total duration should not exceed 24 months
Continuation requests must document prior approvals and cumulative months of therapy

Step Therapy Requirements

Step	Requirement	Duration / Notes
1
Trial of an NSAID and/or oral or depot injectable progestin or a progestin-containing contraceptive prior to Myfembree for endometriosis-related pain
3-month trial within the last year required unless clinically significant adverse effects or all listed agents are contraindicated; see Appendix B for examples

Alternative Class	Examples (see Appendix B)	Notes
Combination estrogen‑progestin agents
Ethinyl estradiol combination products (see list above for progestin partners)
Typical regimen: 1 tablet PO QD; consider per formulary/prior authorization rules before Myfembree approval

Quantity Limits and Dosing

Relugolix (Orgovyx) — Dose limits

Initial loading dose (Orgovyx)≤ 360 mg on day 1 (3 tablets)

Standard maintenance dose (Orgovyx)≤ 120 mg per day (1 tablet)

Maintenance dose with interacting inducer (Orgovyx)Up to 240 mg per day (2 tablets) if co-administered with combined P-gp and strong CYP3A inducers and unavoidable

Relugolix (component of Myfembree) — Dose limits

Daily relugolix limit (Myfembree)≤ 40 mg relugolix per day (1 tablet)

Approval duration noteInitial approval duration: 12 months; total Myfembree therapy should not exceed 24 months

Definitions and Background

Relugolix is a gonadotropin‑releasing hormone (GnRH) receptor antagonist available as single‑entity relugolix (Orgovyx) for prostate cancer and as a fixed‑dose combination with estradiol and norethindrone acetate (Myfembree) for gynecologic indications. Orgovyx dosing uses a 360 mg oral loading dose on day 1 followed by 120 mg/day maintenance (maintenance may be increased to 240 mg/day if unavoidable when co‑administered with combined P‑gp and strong CYP3A inducers). Myfembree is supplied as a fixed‑dose tablet containing relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg and is indicated for heavy menstrual bleeding due to uterine fibroids and moderate to severe endometriosis‑associated pain with a maximum recommended cumulative duration of 24 months.

Relugolix — Definition

Drug classGonadotropin-releasing hormone (GnRH) receptor antagonist

Primary adult indication (Orgovyx)Treatment of advanced/prostate cancer as described in prescribing information

Mechanism summaryAntagonizes GnRH receptors to reduce gonadotropin and sex steroid production

OpenPayer

Relugolix (Orgovyx) and Relugolix/Estradiol/Norethindrone (Myfembree) Coverage Criteria