ModifiedmhnPolicy CP.PHAR.623

Elacestrant (Orserdu) coverage for ER+/HER2- ESR1-mutated advanced or metastatic breast cancer

Defines medical necessity criteria, prior authorization, and continuation requirements for elacestrant (Orserdu) for Commercial, HIM/ICHRA, and Medicaid; affects prescribers, pharmacists, and prior authorization reviewers.

Policy Summary

Payermhn

PolicyElacestrant (Orserdu) coverage for ER+/HER2- ESR1-mutated advanced or metastatic breast cancer

Policy CodePolicy CP.PHAR.623

Change TypeMaterial revisions (step therapy bypass, dose/quantity and approval duration updates)

Effective DateJun 1, 2023

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of diagnosis, ER+/HER2- and ESR1 mutation, prior endocrine and CDK4/6 therapy (unless IL HIM bypass applies) and current dosing to support approval.

SourceLink

POLICY UPDATE CHANGES

Added step therapy bypass for Illinois HIM per IL HB 5395.

Extended Medicaid and HIM initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition.

In continued therapy, added minimum dose of 172 mg per prescribing information.

Revised quantity limit from 1 tablet per day to 3 tablets per day per PI dosing; maximum daily dose 345 mg.

Clarified diagnosis of postmenopausal women and definitions for menopausal status.

345 mg/daymax dose

3tablets/day

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Coverage Criteria

inv-01: Initial Therapy — Covered when ALL of the following are met for initial approval

Covered when ALL of the following are met for initial approval:

Initial Approval - Breast Cancer: 1) Member meets one of the following: (a) diagnosis of advanced, recurrent unresectable, or stage IV (M1) metastatic breast cancer; OR (b) diagnosis of inflammatory breast cancer with no response to preoperative systemic therapy; 2) Prescribed by or in consultation with an oncologist; 3) Age ≥ 18 years; 4) For Orserdu requests, member must use elacestrant if available unless contraindicated or intolerant; 5) Disease is ER-positive, HER2-negative, and ESR1-mutated; 6) Member meets one of the following: (a) disease progressed following at least one line of endocrine therapy; OR (b) member has visceral crisis (severe organ dysfunction with rapid progression); 7) Member has received prior treatment with a CDK4/6 inhibitor (except for Illinois HIM requests per IL HB 5395); 8) If biological female, member is postmenopausal or premenopausal treated with ovarian ablation/suppression; 9) Used as single-agent therapy; 10) Requested dose meets one of the following: (a) dose does not exceed both i) 345 mg per day and ii) 3 tablets per day; OR (b) dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).all criteria required

Prescribed regimen must be FDA-approved or recommended by NCCN

inv-02: Continuation Therapy — Covered when ALL of the following are met for continued therapy

Covered when ALL of the following are met for continued therapy:

Continuation Therapy - Breast Cancer: 1) Member is currently receiving Orserdu via the benefit, or documentation supports current use for a covered indication and member has received therapy for at least 30 days; 2) Member is responding positively to therapy; 3) Dose of Orserdu is ≥ 172 mg per day; 4) For Orserdu requests, member must use elacestrant if available unless contraindicated or intolerant; 5) If request is for a dose increase, the request meets one of the following: (a) new dose does not exceed both i) 345 mg per day and ii) 3 tablets per day; OR (b) new dose is supported by practice guidelines or peer-reviewed literature (prescriber must submit supporting evidence).all criteria required

Prescribed regimen must be FDA-approved or recommended by NCCN

Non‑FDA approved indications are not covered by this policy unless the request includes sufficient documentation of safety and efficacy consistent with the applicable off‑label use policy. For Commercial members, refer to policy CP.CPA.09; for HIM/ICHRA, refer to HIM.PA.154; and for Medicaid, refer to CP.PMN.53. If required documentation meeting those off‑label standards is not provided, the indication will not be authorized.

Where a state Medicaid program has specific coverage provisions that conflict with this clinical policy, the Medicaid state provisions take precedence. Reviewers and providers should follow the applicable state Medicaid manual or program guidance for coverage determinations when differences exist between state rules and this policy.

Uses that are not specifically listed as covered indications in this policy and that lack adequate supporting evidence under the referenced off‑label use policies are considered not medically necessary. Requests for such off‑label uses should include evidence meeting the off‑label criteria in the referenced policies (CP.CPA.09, HIM.PA.154, CP.PMN.53); absent that evidence, coverage will be denied as not medically necessary.

Initial Therapy

inv-21: Initial Therapy — initial approval criteria for Orserdu

Covered when ALL of the following are met for initial approval:

Initial Therapy - Orserdu specific: 1) Diagnosis: advanced, recurrent unresectable, or stage IV (M1) metastatic breast cancer OR inflammatory breast cancer unresponsive to preoperative systemic therapy; 2) Prescribed by or in consultation with an oncologist; 3) Age ≥ 18 years; 4) Use elacestrant (Orserdu) product if available unless contraindicated; 5) Tumor: ER-positive, HER2-negative, and ESR1-mutated; 6) Progression after at least one line of endocrine therapy OR presence of visceral crisis; 7) Prior CDK4/6 inhibitor exposure required (IL HIM exception applies); 8) Female patients must be postmenopausal or premenopausal with ovarian suppression/ablation; 9) Single-agent use; 10) Dose limitation: not to exceed 345 mg/day and 3 tablets/day unless supported by guidelines or literature (prescriber to provide evidence).all criteria required

Prescribed regimen must be FDA-approved or recommended by NCCN

inv-22: Initial Therapy — initial approval and duration (Medicaid/HIM duration updates)

Initial approval and duration (policy operational updates):

Continuation Therapy

inv-23: Continuation Therapy — continuation requirements for Orserdu

Continuation requirements for Orserdu:

Continued Therapy: 1) Member has been on Orserdu for at least 30 days and is currently receiving therapy under the benefit or documentation confirms current use; 2) Member demonstrates clinical response to therapy; 3) Current dose is ≥ 172 mg/day; 4) Use elacestrant product if available unless contraindicated or intolerant; 5) Any dose increase must not exceed 345 mg/day and 3 tablets/day unless supported by practice guidelines or peer-reviewed literature (prescriber must submit supporting evidence).all required

Approval duration per line of business applies

inv-24: Continued Therapy — continued therapy requirements updated (minimum dose threshold added)

Continued therapy requirements updated (operational/clinical revision):

Continued therapy dosing: Must meet minimum continued therapy dose of 172 mg per prescribing information.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. Provider must obtain prior authorization for Orserdu and include documentation supporting that the member meets all approval criteria. Initial approval duration: for Medicaid and HIM (including Illinois HIM where applicable) initial approvals are extended to 12 months; other lines of business follow standard initial approval durations per payer policy.

Initial approval duration for Medicaid and HIM extended to 12 months for this maintenance medication for a chronic condition (2Q 2026 update).
Prior authorization required for Orserdu; requests lacking prior authorization or failing to meet step therapy requirements may be denied.

Documentation Required

Required Clinical Documentation

Providers must submit supporting clinical documentation with the prior authorization request. Acceptable documentation includes office chart notes, relevant laboratory results, tumor biomarker testing (including ESR1 mutation status), prior treatment records (including prior endocrine therapies and CDK4/6 inhibitor therapy), and consultation notes when applicable.

Step Therapy Requirements

Step	Requirement	Coverage label
1	Prior treatment with a CDK4/6 inhibitor (e.g., palbociclib, abemaciclib, ribociclib) is required before approval of Orserdu.	Prior CDK4/6 inhibitor required
Exception	For Illinois HIM requests, the step therapy requirement for prior CDK4/6 inhibitor does not apply per IL HB 5395.	Bypass for IL HIM per IL HB 5395

Line of Business	Step therapy rule	Coverage label
Illinois HIM	Step therapy is bypassed for Orserdu requests in Illinois HIM per IL HB 5395.	Bypass applied
All other lines of business (Commercial, Medicaid, ICHRA, etc.)	Standard step therapy applies: prior CDK4/6 inhibitor required before Orserdu approval.	Standard step therapy applies

Drug Codes and Dosing Information

Drug codes / product availabilityNDC | mixed

NDC not listed	NDCs not provided in this section of the document
86 mg	Tablets: 86 mg
345 mg	Tablets: 345 mg

Dose thresholds — inv-07

Minimum dose for continued therapy≥ 172 mg per day

Maximum daily dose345 mg per day

Maximum tablets per day3 tablets per day

Quantity Limits

Elacestrant (Orserdu) — inv-27

Maximum daily dose345 mg per day

Maximum tablets per day3 tablets per day

Available tablet strengths86 mg and 345 mg tablets

Elacestrant (Orserdu) — inv-28

Quantity limit value3 (tablets per day)

Related maximum doseUp to 345 mg/day when using three 86 mg tablets or one 345 mg tablet

Policy change noteQuantity limit revised from 1 to 3 tablets/day per PI dosing modifications (2Q 2024/2025 reviews)

Definitions

Postmenopausal definition (Appendix D) — inv-18

Definition — Postmenopausal (examples)Prior bilateral oophorectomy; age ≥ 60 years; amenorrhea ≥ 12 months with post‑menopausal labs; chemotherapy‑induced amenorrhea ≥ 12 months with post‑menopausal labs; on tamoxifen with post‑menopausal labs; or documented ovarian ablation/suppression

When used in criteriaIf female, member must be postmenopausal or premenopausal treated with ovarian ablation/suppression (see Appendix D)

LimitationsMenopausal status cannot be determined in those receiving ovarian function suppression

Visceral crisis definition — inv-19

Definition — Visceral crisisSevere organ dysfunction with rapid disease progression as assessed by signs/symptoms and laboratory studies; not merely presence of visceral metastases

Implication for therapy

Background

Elacestrant (Orserdu) is an oral selective estrogen receptor degrader indicated for the treatment of estrogen receptor (ER)–positive, HER2‑negative, ESR1‑mutated advanced or metastatic breast cancer after progression on at least one line of endocrine therapy. The agent is administered orally and dosing references in this policy follow the product prescribing information and related clinical evidence; updates to dosing, quantity limits, and program applicability are reflected in the policy history.

Site of Care

Note

Orserdu is oral for outpatient/home administration

Orserdu is an oral medication intended for outpatient/home administration per the prescribing information; document intended site-of-care as outpatient/home when submitting the PA.

Route of administration: oral (PO)