CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Inluriyo (imlunestrant)

Defines accepted indications, continuation criteria, exclusions, and billing code for Inluriyo (imlunestrant) for cancer treatment, including required evidentiary support and applicable lines of business.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyInluriyo (imlunestrant)

Policy CodePolicy N/A

Change TypeNew policy

Effective Date

Next Review Date

Key ActionTherapy must be supported by FDA labeling, CMS‑approved compendia, NCCN or ASCO guidelines, or peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements.

SourceLink

POLICY UPDATE CHANGES

New policy (policy history indicates New policy November 2025).

1Covered Indications (breast cancer)

4Explicit Exclusion Criteria

1HCPCS drug code listed

Coverage Summary

Coverage stance: Covered with criteria for Inluriyo (imlunestrant) when used as monotherapy for adult patients with ER-positive, HER2-negative, ESR1‑mutated advanced or metastatic breast cancer after disease progression following at least one line of endocrine therapy (with or without a CDK4/6 inhibitor). Use must be supported by FDA labeling, CMS‑approved compendia, NCCN or ASCO guidelines, or peer‑reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements. Billing code: J8999.

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Initial Therapy Criteria (Approved Indication)

Approved Indication - Breast Cancer

Covered when ALL of the following are met:

ALL of the following

Adult member: Patient is an adult member.
Diagnosis: ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer.
Prior therapy: Disease progression following at least one line of endocrine therapy +/- CDK4/6 inhibitor (examples: palbociclib, ribociclib, abemaciclib).
Single-agent use: Use as a single agent (monotherapy).
Evidentiary support: Use is supported by one of: FDA approved product labeling, CMS‑approved compendia, NCCN, ASCO clinical guidelines, or peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements.

Continuation Therapy / Exemption

Continuation Therapy Exemption to Policy

Continuation requests for a not-approvable medication shall be exempt from this Evolent policy provided ALL of the following are met:

ALL of the following

No disease progression: Member has not experienced disease progression on the requested medication.
Prior use within last year: Requested medication was used within the last year without a lapse of more than 30 days of having an active authorization.
No additional meds added: No additional medication(s) are being added to the continuation request.

Documentation Required

Continuation exemption documentation

Document that the member has not experienced disease progression on the requested medication; provide evidence that the requested medication was used within the last year without a lapse of more than 30 days of active authorization; and confirm that no additional medication(s) are being added to the continuation request.

Statement confirming no disease progression while on therapy
Dates/authorization history showing continuous use within past 12 months without >30-day lapse
Confirmation that the continuation request does not add any new medications

Exclusions / Not Covered

Exclusion Criteria / Not Covered

Not covered when ANY of the following exclusion criteria are met:

ANY of the following

Progression on Inluriyo: Disease progression while taking Inluriyo (imlunestrant).
Concurrent therapy: Concurrent use with other anticancer therapies.
Single dose limit: Dosing exceeds single dose limit of 400 mg.400 mg
Monthly tablet limit: Treatment exceeds the maximum limit of 56 (200 mg) tablets/month.56 (200 mg) tablets/month
Investigational/off-label insufficient evidence: Investigational use of Inluriyo (imlunestrant) with an off-label indication that is not sufficient in evidence or is not generally accepted by the medical community (insufficient evidence defined by criteria listed in policy).

Denial Risk

Exclusion-related denial risks

Claims for J8999 (imlunestrant) may be denied if any of the following apply: documented disease progression while taking Inluriyo; concurrent use with other anticancer therapies; dosing that exceeds the single dose limit of 400 mg; or treatment that exceeds the maximum limit of 56 (200 mg) tablets per month.

Disease progression on Inluriyo
Concurrent anticancer therapy
Single dose > 400 mg
Monthly quantity > 56 (200 mg tablets)

Provider Actions

Prior Authorization

Prior authorization processing

Evolent is responsible for processing all medication requests. Medications that are not authorized by Evolent may be deemed not approvable and therefore not reimbursable.

Documentation Required

Evidentiary support required

Therapy must be supported by FDA approved product labeling, CMS‑approved compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature that meets the requirements of the CMS Medicare Benefit Policy Manual Chapter 15.

Operational reminders: adhere to dosing and quantity limits — single dose must not exceed 400 mg and treatment must not exceed 56 (200 mg) tablets per month. For continuation exemption requests, document that the member has not experienced disease progression on Inluriyo, that the medication was used within the last year without an authorization lapse of more than 30 days, and that no additional medications are being added to the regimen.

Background & Definitions

Background / policy purpose: This policy defines accepted indications and clinical context for Inluriyo (imlunestrant) in cancer treatment, specifying use as monotherapy for adult patients with ER-positive, HER2-negative, ESR1‑mutated advanced or metastatic breast cancer after prior endocrine therapy. It requires evidentiary support from FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidelines, or appropriate peer‑reviewed literature. Continuation exemptions permit ongoing use of a not-approvable medication when there is no disease progression, prior use within the last year without a >30‑day authorization lapse, and no addition of other medications. Exclusion criteria include disease progression on Inluriyo, concurrent anticancer therapy, dosing above 400 mg per single dose, treatment exceeding 56 (200 mg) tablets per month, and investigational/off‑label uses lacking sufficient evidence. The HCPCS code for Inluriyo is J8999.

Definitions

Scope / Policy Notes