CurrentmhnPolicy CP.PHAR.623

Elacestrant (Orserdu)

Clinical policy defining medical necessity criteria, prior authorization requirements, dosing limits, continuation criteria, and coverage exclusions for elacestrant (Orserdu) across Commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyElacestrant (Orserdu)

Policy CodePolicy CP.PHAR.623

Change TypeClarified; Revised quantity and continuation dosing

Effective DateJun 1, 2023

Next Review Date

Key ActionProvider must submit documentation demonstrating member meets all approval criteria.

POLICY UPDATE CHANGES

2Q 2024 annual review: clarified diagnosis of postmenopausal women and revised quantity limit from 1 tablet per day to 3 tablets per day per PI dosage modifications for adverse reactions; references reviewed and updated.

2Q 2025 annual review: in continued therapy, added minimum dose of 172 mg per prescribing information; Appendix B updated therapeutic alternative dosing.

Policy created 03.03.23; P&T approval date 05.23.

1FDA-approved indication (ER+/HER2-/ESR1-mutated advanced/metastatic breast cancer)

172 mgMinimum continuation dose

345 mgMaximum daily dose

86 mg, 345 mgTablet strengths

Coverage Summary

Coverage stance: Covered with criteria for elacestrant (Orserdu) for treatment of ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer after progression on at least one line of endocrine therapy. The policy requires use of elacestrant (Orserdu) when available and aligns with the FDA-approved indication and NCCN recommendations. Approval is contingent on meeting the detailed initial and continuation criteria in the policy (e.g., diagnosis, oncologist involvement, age ≥ 18, disease characteristics, prior CDK4/6 inhibitor exposure, and dosing limits), consistent with the FDA label and NCCN guidance.

Initial Approval Criteria — Breast Cancer

Initial Approval Criteria - Breast Cancer

Covered when ALL of the following are met:

ALL of the following

Diagnosis options
- advanced, recurrent unresectable, or stage IV (M1) metastatic breast cancer
- inflammatory breast cancer with no response to preoperative systemic therapy
Prescribed by or in consultation with an oncologist
Age ≥ 18 years
For Orserdu requests, member must use elacestrant, if available, unless contraindicated or clinically significant adverse effects are experienced
Operational: use elacestrant when available
Disease characteristics (all required)
- Estrogen receptor (ER) positive
- HER2-negative
- Estrogen receptor 1 (ERS1)-mutated
Progression criteria
- Disease has progressed following at least one line of endocrine therapy (e.g., exemestane, fulvestrant, anastrozole, letrozole, tamoxifen)
- Member has visceral crisis defined as severe organ dysfunction assessed by signs/symptoms, labs, and rapid progression of disease
  Visceral crisis is not mere presence of visceral metastases
Member has received prior treatment with a CDK4/6 inhibitor (e.g., palbociclib, abemaciclib, ribociclib)
If biological female, member is postmenopausal or premenopausal treated with ovarian ablation/suppression
See Appendix D for menopause diagnostic criteria
Used as a single agent therapy
Dose limits
- Option a (standard): Dose does not exceed both (i) 345 mg per day and (ii) 3 tablets per day
- Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)
Prescribed regimen must be FDA-approved or recommended by NCCN

Initial Approval Criteria — Other Indications

Initial Approval Criteria - Other diagnoses/indications

Covered when ONE of the following is met:

ANY of the following

If drug underwent label change within last 6 months not reflected here, follow formulary/no-coverage or non-formulary policies referenced (CP.CPA.190; HIM.PA.33; CP.PMN.255; HIM.PA.103; CP.PMN.16)
If requested use not listed under section III and above does not apply, refer to off-label use policies (CP.CPA.09; HIM.PA.154; CP.PMN.53)

Continuation (Renewal) Criteria — Breast Cancer

Continuation (Renewal) Criteria - Breast Cancer

Covered when ALL of the following are met for members currently receiving Orserdu:

ALL of the following

Member is currently receiving medication via Centene benefit, or documentation supports member has been receiving Orserdu for at least 30 days
Member is responding positively to therapy
Dose of Orserdu is ≥ 172 mg per day
Minimum continuation dose
For Orserdu requests, member must use elacestrant, if available, unless contraindicated or clinically significant adverse effects are experienced
Operational: use elacestrant when available
Dose increase conditions
- Option a (standard): New dose does not exceed both (i) 345 mg per day and (ii) 3 tablets per day
- New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)
Prescribed regimen must be FDA-approved or recommended by NCCN

Not Authorized Indications

Coverage is NOT authorized for the following:

ALL of the following

Non-FDA approved indications that are not addressed in this policy, unless there is sufficient documentation of efficacy and safety per off-label use policies (CP.CPA.09; HIM.PA.154; CP.PMN.53) or evidence of coverage documents

Provider Actions & Prior Authorization Requirements

Documentation Required

Support clinical criteria with documentation

Provider must submit office chart notes, laboratory results, and other clinical information demonstrating the member meets all approval criteria (e.g., diagnosis, ER/HER2/ERS1 status, prior endocrine and CDK4/6 therapy, menopausal status, and evidence of disease progression or visceral crisis).

Prior Authorization

Prescriber specialty requirement

Requests must be prescribed by or in consultation with an oncologist.

Prior Authorization

Use of elacestrant when available

For Orserdu requests, member must use elacestrant if available unless contraindicated or clinically significant adverse effects are experienced; prescriber must document the contraindication or adverse effects when applicable.

Billing Rule

Dose limits and evidence for off-label dosing

Doses above 345 mg/day or greater than 3 tablets per day require the prescriber to submit supporting practice guidelines or peer‑reviewed literature to justify the off‑label dosing.

Documentation Required

Continuation documentation

For renewal requests, documentation must show the member has been receiving Orserdu for at least 30 days and is responding positively to therapy; continued therapy must be at a dose of ≥172 mg/day and meet the listed dose‑increase conditions.

Background

Background: Elacestrant (Orserdu) is an oral estrogen receptor antagonist indicated for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer after progression on at least one line of endocrine therapy, consistent with the FDA-approved label. The policy aligns with the FDA label and NCCN guidance, and requires prior exposure to a CDK4/6 inhibitor. For biological females, the policy requires postmenopausal status or ovarian suppression/ablation; Appendix D provides the diagnostic criteria for menopause. The approved dosing for breast cancer is 345 mg PO once daily, with tablet strengths of 86 mg and 345 mg available.

Definitions: Visceral crisis — severe organ dysfunction as assessed by signs and symptoms, laboratory studies, and rapid progression of disease; not merely presence of visceral metastases.

Postmenopausal (per Appendix D) — menopause may be defined by any of: prior bilateral oophorectomy; age ≥ 60 years; age < 60 with ≥ 12 months amenorrhea without prior chemotherapy/tamoxifen/ovarian suppression and menopausal-range labs; chemotherapy-induced amenorrhea ≥ 12 months with serial labs in menopausal range; age < 60 on tamoxifen with menopausal-range FSH and estradiol; menopausal status cannot be determined in those receiving ovarian function suppression.

ERS1 — refers to Estrogen receptor 1 (ERS1).

Revision History

03.03.23policy_created

Policy created.

05.23p_and_t_approval

P&T approval for initial policy.

02.13.24annual_review

2Q 2024 annual review: clarified diagnosis of postmenopausal women per Appendix D criteria and revised quantity limit from 1 tablet per day to 3 tablets per day consistent with prescribing information; references reviewed and updated.

05.24p_and_t_approval

P&T approval of 2Q 2024 annual review changes.

02.04.25annual_reviewLatest

2Q 2025 annual review: added minimum continuation dose requirement of ≥172 mg/day for continued therapy; Appendix B therapeutic alternative dosing updated; references reviewed and updated.

05.25p_and_t_approval

P&T approval of 2Q 2025 annual review changes.

OpenPayer

Elacestrant (Orserdu)

Coverage Summary

Initial Approval Criteria — Breast Cancer

Initial Approval Criteria — Other Indications

Continuation (Renewal) Criteria — Breast Cancer

Not Authorized Indications

Provider Actions & Prior Authorization Requirements

Applicable Codes & Product Availability

Clinical Evidence & Guidelines

Background

Revision History

86 mg	Tablet strength
345 mg	Tablet strength