Loading...

    Explore
    • Policy Monitoring
    • Live Policy Feed
    • Billing Codes
    • NPI Medicare & Medicaid
    • Healthcare Providers
    • Health Insurance Payers
    • States
    • Service Lines
    • Taxonomy Codes
    Lookup tools
    • Billing Code Lookup
    • CPT Modifier Lookup
    • Provider Taxonomy Code Lookup
    • Healthcare Provider & Facility Lookup
    • Health Insurance Payer Lookup
    • Payer Contact Directory

    Policy & Benchmark Tools

    • Prior Authorization Lookup
    • Coverage Criteria Lookup
    • Timely Filing Lookup
    • Billing Code Reimbursement Rates
    • Payer Comparison Dashboard
    • Facility Comparison Dashboard
    • All tools

    Company

    • About OpenPayer
    • Data Sources
    • Trek Health
    OpenPayerby Trek Health
    LinkedInYouTube

    © 2026 Trek Health. All rights reserved.

    OpenPayer is built and maintained by Trek Health.

    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsMHN Inluriyo (imlunestrant) Coverage | OpenPayer
    Ask Trek AI about this page
    CurrentmhnPolicy CP.PHAR.754

    Imlunestrant (Inluriyo) coverage for ER+/HER2- ESR1-mutated advanced/metastatic breast cancer

    Customize your policy alerts

    Sign up for mhn Policy CP.PHAR.754 alerts

    Get alerted when Policy CP.PHAR.754 changes without checking for updates manually.

    Monitor payer policy activity

    Receive email alerts as soon as relevant payer policies are published or updated.

    Defines medical necessity and prior authorization requirements for Inluriyo (imlunestrant) for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer after progression on endocrine therapy; applies to commercial, HIM, and Medicaid lines of business.

    Policy Summary
    Payermhn
    PolicyImlunestrant (Inluriyo) coverage for ER+/HER2- ESR1-mutated advanced/metastatic breast cancer
    Policy CodePolicy CP.PHAR.754
    Change TypeNo material change
    Effective DateDec 1, 2025
    Next Review Date
    Key ActionSubmit prior authorization with documentation demonstrating diagnosis, ESR1 mutation, prior endocrine therapy, clinician specialty, dosing, and contraception/suppression as applicable.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    400 mg/daystandard daily dosing
    600 mg/day

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    max with CYP3A inducer
    12 monthsapproval duration
    200 mg/daymin continued dose
    ≥18age requirement

    Coverage Criteria

    Initial Therapy

    Covered when ALL of the following are met

    Initial Approval - Breast Cancer: 1) Diagnosis of breast cancer; 2) Prescribed by or in consultation with an oncologist; 3) Age ≥ 18 years; 4) Disease is ER-positive AND HER2-negative AND ESR1-mutated AND advanced or metastatic (including locally advanced); 5) Disease has progressed following at least one line of endocrine therapy; 6) If premenopausal or perimenopausal female, treated with ovarian ablation or receiving ovarian suppression; 7) If biological male, receiving an agent to suppress testicular steroidogenesis (e.g., GnRH agonist); 8) For brand Inluriyo requests, member must use generic imlunestrant if available unless contraindicated or clinically significant adverse effects; 9) Request meets one of the following: a) dose does not exceed i) 400 mg (2 tablets) per day, or ii) 600 mg (3 tablets) per day if receiving a concomitant strong CYP3A inducer (e.g., carbamazepine, fosphenytoin, phenytoin, rifampin); OR b) dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).see node text

    Approval duration: 12 months

    Continuation Therapy

    Continued therapy covered when ALL of the following are met

    Continuation Therapy - Breast Cancer: 1) Currently receiving medication via Centene benefit, or documentation supports member has received Inluriyo for at least 30 days; 2) Member is responding positively to therapy; 3) Dose is ≥ 200 mg per day; 4) For brand Inluriyo requests, member must use generic imlunestrant if available unless contraindicated or clinically significant adverse effects; 5) If request is for a dose increase, meets one of the following: a) new dose does not exceed i) 400 mg (2 tablets) per day, or ii) 600 mg (3 tablets) per day if receiving a concomitant strong CYP3A inducer (e.g., carbamazepine, fosphenytoin, phenytoin, rifampin); OR b) new dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).see node text

    Approval duration: 12 months

    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 in accordance with applicable off‑label use policies (for example, CP.CPA.09 for commercial, HIM.PA.154 for marketplace, and CP.PMN.53 for Medicaid) or other evidence of coverage documents. Requests for non‑FDA uses should include supporting clinical evidence per those off‑label policies to be considered for authorization.

    Initial Therapy

    Initial Therapy

    Initial: See coverage.initial therapy nodes: ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer; prescribed by or in consultation with an oncologist; age ≥ 18 years; progression after at least one line of endocrine therapy; ovarian ablation/ovarian suppression for premenopausal/perimenopausal females; testicular suppression for biological males; generic imlunestrant preference for brand requests; dosing limits of 400 mg/day (2 tablets) or 600 mg/day (3 tablets) with concomitant strong CYP3A inducer, or guideline/peer-reviewed literature-supported off-label dosing with submitted evidence.

    Continuation / Renewal Criteria

    Continuation Therapy

    Criteria for continued coverage

    Continuation: See coverage.continued therapy nodes: member currently receiving Inluriyo or has received at least 30 days; documented clinical benefit/response; dose ≥ 200 mg/day; generic imlunestrant must be used for brand requests if available unless contraindicated or adverse effects; dose increase requests must not exceed 400 mg/day (or 600 mg/day with strong CYP3A inducer) unless supported by practice guidelines/peer-reviewed literature with submitted evidence.

    Provider Actions & Requirements

    Prior Authorization

    Prior Authorization Required

    Prior authorization is required for Inluriyo (imlunestrant) for all lines of business. Providers must submit clinical documentation demonstrating the member meets the applicable initial or continuation therapy criteria in this policy. Approval duration is 12 months when criteria are met.

    • Applies to all requests for Inluriyo (generic imlunestrant requests subject to brand-consideration rules)
    • Submit via the normal prior authorization process
    Step Therapy

    Therapeutic Alternatives / Brand Consideration

    Generic imlunestrant must be used when available for both initial and continued therapy. A brand (Inluriyo) request will only be considered when the prescriber documents that the generic is contraindicated or the member experienced clinically significant adverse effects with the generic. Step-therapy alternatives (see Appendix B) should be considered prior to approval when clinically appropriate.

    • Brand exception requires clinical rationale documenting contraindication or intolerable adverse reaction to generic imlunestrant

    Coding & Dose Minimums

    Minimum continued dose
    Minimum continued dose>= 200 mg/day
    ContextIf dose is reduced to < 200 mg/day, therapy should be discontinued (per dosing guidance).
    Approval duration (continuation)12 months

    Step Therapy / Brand Exceptions

    StepRequirement
    1
    For brand Inluriyo (imlunestrant) requests, member must use generic imlunestrant if available unless contraindicated or clinically significant adverse effects are experienced.

    Quantity Limits & Dosing

    imlunestrant (tablet 200 mg) — quantity limits
    Product & strengthImlunestrant (tablet) 200 mg
    Standard maximumMax 2 tablets (400 mg) per day
    Maximum with strong CYP3A inducerMax 3 tablets (600 mg) per day when receiving a concomitant strong CYP3A inducer

    Site of Care

    Note

    No site‑of‑care restriction specified

    No specific site‑of‑care restrictions are stated in this policy; home administration is permitted where clinically appropriate.

    Definitions

    estrogen receptor (ER)
    AbbreviationER
    Full termestrogen receptor
    Use in policyUsed to define tumor hormone receptor status for coverage (ER-positive required).
    estrogen receptor-1 (ESR1)
    AbbreviationESR1
    Full termestrogen receptor-1
    RelevanceESR1 mutation required for coverage in advanced/metastatic breast cancer per policy criteria.

    Background

    Imlunestrant (Inluriyo) is an estrogen receptor antagonist indicated for adults with ER‑positive, HER2‑negative, ESR1‑mutated advanced or metastatic breast cancer whose disease has progressed following at least one line of endocrine therapy. The policy applies to adults aged ≥18 years and follows the pivotal trial design and NCCN guidance requiring ovarian or testicular suppression for premenopausal/perimenopausal females and males, respectively, where applicable.

    Coverage under this policy requires prior authorization demonstrating the clinical criteria are met (diagnosis, ESR1 mutation, prior endocrine therapy, oncologist involvement, and appropriate suppression when indicated). Standard dosing is 400 mg once daily (tablet formulation available as 200 mg tablets), with a maximum of 600 mg once daily if the member is receiving a concomitant strong CYP3A inducer. Approval durations for initial and continued therapy are generally 12 months when criteria are satisfied.

    Policy Summary
    Payermhn
    PolicyImlunestrant (Inluriyo) coverage for ER+/HER2- ESR1-mutated advanced/metastatic breast cancer
    Policy CodePolicy CP.PHAR.754
    Change TypeNo material change
    Effective DateDec 1, 2025
    Next Review Date
    Key ActionSubmit prior authorization with documentation demonstrating diagnosis, ESR1 mutation, prior endocrine therapy, clinician specialty, dosing, and contraception/suppression as applicable.
    SourceLink
    On This Page
    Coverage CriteriaInitial TherapyContinuation / Renewal CriteriaProvider Actions & RequirementsCoding & Dose MinimumsStep Therapy / Brand ExceptionsQuantity Limits & DosingSite of CareDefinitionsBackground
  1. See Appendix B for endocrine therapy alternatives (e.g., anastrozole, exemestane, fulvestrant, letrozole, tamoxifen, toremifene)
    2. Documentation Required

    Required Documentation

    Provide supporting clinical documentation with the PA request. Acceptable documentation includes office chart notes, relevant laboratory or molecular testing results (e.g., ESR1 mutation testing), imaging reports, treatment history, and progress notes documenting response to therapy.

    • Office chart notes documenting diagnosis of breast cancer and treating oncologist involvement
    • Pathology / molecular testing demonstrating ESR1 mutation and ER-positive, HER2-negative status
    • Records showing prior endocrine therapy and progression (at least one line)
    • For premenopausal/perimenopausal biological females: documentation of ovarian ablation or ongoing ovarian suppression
    • For biological males: documentation of agent suppressing testicular steroidogenesis
    • Documentation of current dosing and rationale if dose exceeds standard limits (see policy limits)
    • If brand requested: documentation of contraindication or significant adverse effects to generic imlunestrant
    Denial Risk

    Denial Triggers

    Requests lacking required documentation or not meeting the clinical criteria will be denied. Common denial reasons include missing mutation testing, no evidence of prior endocrine therapy failure, insufficient documentation of ovarian suppression when required, requests for non‑specified off‑label uses without supporting peer‑reviewed evidence, or failure to try/use generic imlunestrant when available without documented contraindication.

    • No documentation of ESR1 mutation or ER+/HER2- status
    • No evidence of prior endocrine therapy and documented progression
    • Missing documentation of ovarian suppression/ablation for premenopausal or perimenopausal females
    • Brand Inluriyo requested without documentation showing contraindication or intolerance to generic imlunestrant
    • Dose requests exceeding policy limits without supporting guideline or peer‑reviewed literature
    human epidermal growth factor receptor 2 (HER2)
    AbbreviationHER2
    Full termhuman epidermal growth factor receptor 2
    Policy useCoverage limited to HER2-negative disease per indication criteria.