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    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsPremera SERMs & SERDs Prior Auth Policy | OpenPaye…
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    ModifiedPremera Blue Cross of WashingtonPolicy 5.01.618

    Selective Estrogen Receptor Modulators and Down Regulators

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    This policy governs medical-necessity and prior-authorization criteria for selected brand SERMs and SERDs used to treat metastatic or advanced hormone-receptor-positive breast cancer. It applies to providers submitting requests for Fareston, Cligavyx, Faslodex, Inluriyo, Orserdu, and Veppanu.

    Policy Summary
    PayerPremera Blue Cross of Washington
    PolicySelective Estrogen Receptor Modulators and Down Regulators
    Policy CodePolicy 5.01.618
    Change TypeModified
    Effective DateFebruary 5, 2027
    Next Review DateNot specified
    Key ActionSubmit documentation showing the applicable receptor and mutation results, disease stage or progression, prior endocrine therapies and responses or intolerances, combination therapy, and requested dose.
    SourceLink
    POLICY UPDATE CHANGES

    Coverage criteria were added for Veppanu (vepdegestrant) for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer.

    Inluriyo (imlunestrant) criteria were revised to require use as monotherapy or in combination with abemaciclib.

    Cligavyx (fulvestrant) was added to the policy.

    Quantity limits for Fareston, Inluriyo, and Orserdu were removed from this policy because quantity limits are addressed in Drug Quantity Management policy 5.01.656.

    Faslodex (fulvestrant) coverage criteria were expanded to apply to both the pharmacy and medical benefits.

    6Covered brand drugs
    12 monthsInitial and renewal approval period
    60 mg/dayMaximum Fareston and fulvestrant dose
    400 mg/dayMaximum Inluriyo dose
    345 mg/dayMaximum Orserdu dose
    200 mg/dayMaximum Veppanu dose

    Coverage Criteria Overview

    Fareston initial therapy

    Fareston may be considered medically necessary when all of the following are met.

    Fareston criteria

    • Eligibility and treatment requirements

      • Postmenopausal status: The individual is a postmenopausal female.
      • Tumor receptor status: The tumor is estrogen-receptor positive or of unknown receptor status.
      • Generic toremifene trial: The individual has tried generic toremifene and had an inadequate response or intolerance.
      • Dose limit: The dose is limited to 60 mg per day.60 mg/day

    Cligavyx and Faslodex initial therapy

    Cligavyx and Faslodex may be considered medically necessary when the applicable criteria are met.

    Fulvestrant brand criteria

    • Covered indications

      • Endocrine-naive postmenopausal disease: Treatment of HR-positive, HER2-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy.
      • Progression after endocrine therapy: Treatment of HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy.
      • Ribociclib combination: Treatment of HR-positive, HER2-negative advanced or metastatic breast cancer in combination with ribociclib in postmenopausal women as initial endocrine-based therapy or following disease progression on endocrine therapy.
      • Palbociclib or abemaciclib combination: Treatment of HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression following endocrine therapy.
      • Truqap combination: Treatment in combination with Truqap (capivasertib) for adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA, AKT1, or PTEN alterations, who have progressed on at least one endocrine-based regimen in the metastatic setting or had recurrence on or within 12 months of completing adjuvant therapy.At least 1 endocrine-based metastatic regimen; or recurrence on or within 12 months of completing adjuvant therapy
    • Generic fulvestrant trial: The individual has tried generic fulvestrant and had an inadequate response or intolerance.

    Inluriyo initial therapy

    Inluriyo may be considered medically necessary when all of the following are met.

    Inluriyo criteria

    • Age: The individual is aged 18 years or older.>=18 years
    • Diagnosis: The individual has ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer.
    • Prior endocrine therapy: The individual has experienced disease progression following at least 1 line of endocrine therapy.At least 1 line

    • Administration

      • Monotherapy: Inluriyo is used as monotherapy.
      • Combination therapy: Inluriyo is used in combination with abemaciclib.
    • Dose limit: The dose is limited to 400 mg per day.400 mg/day

    Orserdu initial therapy

    Orserdu may be considered medically necessary when all of the following are met.

    Orserdu criteria

    • Age and sex or menopausal status

      • Postmenopausal female: The individual is a postmenopausal female.
      • Adult male: The individual is a male aged 18 years or older.>=18 years
    • Diagnosis: The individual has ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer.
    • Prior endocrine therapy: The individual has experienced disease progression following at least 1 line of endocrine therapy.At least 1 line
    • Dose limit: The dose is limited to 345 mg per day.345 mg/day

    Veppanu initial therapy

    Veppanu may be considered medically necessary when all of the following are met.

    Veppanu criteria

    • Age: The individual is aged 18 years or older.>=18 years
    • Diagnosis: The individual has ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer.
    • Prior endocrine therapy: The individual has experienced disease progression following at least 1 line of endocrine therapy.At least 1 line

    • Prior SERD treatment or intolerance

      • Inadequate response or intolerance: The individual has tried elacestrant or imlunestrant and had an inadequate response or intolerance.
      • Adverse-effect risk: Documentation shows actual or anticipated gastrointestinal intolerance, such as a history of colitis, or dyslipidemia with elacestrant or imlunestrant.
    • Dose limit: The dose is limited to 200 mg daily.200 mg/day

    Continuation therapy

    Reauthorization requires continued fulfillment of drug-specific coverage criteria and evidence of positive clinical response.

    • Drug-specific criteria: The applicable drug-specific coverage criteria continue to be met.
    • Clinical response: Chart notes demonstrate that the individual continues to show a positive clinical response to therapy.

    This medical policy does not apply to Medicare Advantage.

    Billing and Coding

    HCPCSHCPCS
    J9395Injection, fulvestrant, (Faslodex), 25 mg
    HCPCSHCPCS
    J9999Not otherwise specified, antineoplastic drugs (used to report Cligavyx)
    HCPCS code for FaslodexHCPCS
    J9395Faslodex (fulvestrant)

    Authorization and Documentation Requirements

    Prior Authorization

    Fareston Authorization

    Before requesting Fareston (toremifene), confirm that the individual is a postmenopausal female with metastatic breast cancer and an estrogen receptor-positive or unknown tumor, has tried generic toremifene with inadequate response or intolerance, and will receive no more than 60 mg per day.

    Prior Authorization

    Cligavyx or Faslodex Authorization

    Cligavyx or Faslodex (fulvestrant) may be authorized for an applicable approved indication when the individual meets the relevant disease, menopausal, and treatment-history requirements and has tried generic fulvestrant with inadequate response or intolerance.

    • HR-positive, HER2-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy.
    • HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy.
    • HR-positive, HER2-negative advanced or metastatic breast cancer in combination with ribociclib for initial endocrine-based therapy or after progression on endocrine therapy.
    • HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib after progression following endocrine therapy.
    • In combination with Truqap (capivasertib) for adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA, AKT1, or PTEN alterations and progression on at least one endocrine-based metastatic regimen, or recurrence on or within 12 months of completing adjuvant therapy.
    • HER2-negative status is defined as 0 or 1+ intensity on immunohistochemical testing, or 2+ intensity on immunohistochemical testing with no amplification on in situ hybridization.
    Prior Authorization

    Inluriyo Authorization

    Inluriyo (imlunestrant) may be authorized for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer after progression following at least one line of endocrine therapy.

    • The individual must be at least 18 years old.
    • Use must be as monotherapy or in combination with abemaciclib.
    • The dose is limited to 400 mg per day.
    Prior Authorization

    Orserdu Authorization

    Orserdu (elacestrant) may be authorized when the individual meets the age or menopausal-status, biomarker, disease-setting, and treatment-history requirements for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer.

    • The individual must be a postmenopausal female or a male aged 18 years or older.
    • The individual must have experienced disease progression following at least one line of endocrine therapy.
    • HER2-negative status requires 0 or 1+ intensity on immunohistochemical testing, or 2+ intensity with no amplification on in situ hybridization.
    • The dose is limited to 345 mg per day.
    Prior Authorization

    Veppanu Authorization

    Veppanu (vepdegestrant) may be authorized for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer after progression following at least one line of endocrine therapy, when the prior-SERD requirement is satisfied.

    • The individual must be at least 18 years old.
    • The individual must have experienced disease progression following at least one line of endocrine therapy.
    • The individual must have tried elacestrant or imlunestrant with inadequate response or intolerance, or records must show actual or anticipated gastrointestinal intolerance, such as a history of colitis, or dyslipidemia with either drug.
    • The dose is limited to 200 mg daily.
    Note

    Initial Authorization Period

    All drugs listed in the policy may be approved for an initial authorization period of up to 12 months when the applicable drug-specific coverage criteria are met.

    • Submit the requested clinical information for the full initial authorization period.
    Step Therapy

    Generic-to-Brand Step Therapy

    Generic-to-brand step therapy is required before authorization of the applicable brand products. Document an inadequate response or intolerance to the corresponding generic product.

    • Fareston requires a trial of generic toremifene.
    • Cligavyx or Faslodex requires a trial of generic fulvestrant.
    Step Therapy

    Prior SERD Step Therapy

    Before Veppanu authorization, document a trial of elacestrant or imlunestrant with inadequate response or intolerance, unless the record supports an exception based on actual or anticipated gastrointestinal intolerance or dyslipidemia with either drug.

    • Acceptable exception documentation may include a history of colitis or other gastrointestinal intolerance.
    • Document dyslipidemia when it is the reason for avoiding elacestrant or imlunestrant.
    Documentation Required

    Medical Records

    Submit medical records demonstrating that medical-necessity criteria are met for the requested drug and indication.

    • Office visit notes containing the diagnosis, relevant history, physical evaluation, and medication history.
    • Include additional supporting chart records needed to establish eligibility, prior treatment, response or intolerance, and ongoing clinical status.
    Documentation Required

    Drug-Specific Supporting Documentation

    Drug-specific supporting documentation must substantiate the requested indication and every applicable eligibility requirement.

    • Provide ER and HR status, HER2 testing results, and ESR1 mutation results when required.
    • Document metastatic, advanced, or locally advanced disease status and disease progression where applicable.
    • Document age or postmenopausal status as required for the drug.
    • Provide endocrine-therapy and SERD treatment history, including inadequate response, intolerance, or qualifying exception.
    • Document the requested regimen, combination therapy when applicable, and dose.
    Denial Risk

    When Drug-Specific Criteria Are Not Met

    Authorization may be denied when the request does not meet the drug-specific coverage criteria or lacks sufficient documentation of medical necessity.

    • Diagnosis or disease setting is not an applicable advanced, metastatic, or locally advanced breast cancer indication.
    • Required ER, HR, HER2, or ESR1 biomarker status is absent, inconsistent, or not supported by testing.
    • Required age or postmenopausal-status criteria are not met.
    • Required prior endocrine therapy, generic product trial, or prior-SERD trial is absent, or inadequate response, intolerance, or an allowed exception is not documented.
    • The requested combination, regimen, or dose does not meet the applicable criteria or dose limit.
    • Required medical records or supporting clinical documentation are not submitted.
    Denial Risk

    Ongoing Response Required for Renewal

    For reauthorization, chart notes must demonstrate that the individual continues to show a positive clinical response to therapy and continues to meet the drug-specific coverage criteria.

    • Renewal may be denied when ongoing positive clinical response is not documented.
    Denial Risk

    Investigational or Non-FDA-Concordant Use

    Requests must align with the product's U.S. Food and Drug Administration (FDA) dosage and administration prescribing information. Investigational use or use that is not FDA-concordant is not covered under this policy.

    • Ensure the requested product, indication, regimen, and dose are consistent with FDA-approved product use.

    Clinical Background

    Approximately two-thirds of breast cancers express estrogen receptor alpha. These estrogen-receptor-positive tumors depend on estrogen-receptor signaling for growth and progression. Selective estrogen receptor modulators (SERMs) and selective estrogen receptor down-regulators (SERDs) are endocrine therapies that block estrogen-receptor function or signaling. Some SERMs also have estrogenic effects on bone and may help prevent bone loss, improve bone mineral density, and reduce vertebral-fracture risk.

    Clinical Definitions

    HER2-negative
    DefinitionHER2-negative status is 0 or 1+ intensity on immunohistochemical testing.
    IHC result requiring additional testingA 2+ intensity result on immunohistochemical testing requires in situ hybridization testing.
    Negative interpretationHER2-negative status may also be established when a 2+ immunohistochemical result has no amplification on in situ hybridization.
    ESR1-mutated breast cancer
    Disease characteristicAdvanced or metastatic breast cancer with an ESR1 mutation.
    Required receptor statusThe disease is estrogen-receptor positive and HER2-negative.
    Specified therapiesThis disease characteristic is required under the criteria for Inluriyo, Orserdu, and Veppanu.
    ESR1 mutation
    BiomarkerA mutation in the estrogen receptor 1 gene.
    Testing contextIn the Inluriyo study, ESR1 mutation status was determined using blood circulating tumor DNA analysis.
    Mutation scope in studyThe Inluriyo study testing was limited to specific mutations in the ligand-binding domain.
    PFS
    Full termProgression-free survival.
    DefinitionAn efficacy measure reflecting the time until disease progression or death.
    Use in evidencePFS was used as an efficacy outcome in the clinical studies summarized in this policy.
    OS
    Full termOverall survival.
    DefinitionAn efficacy measure reflecting the time until death from any cause.
    Use in evidenceOS was reported as an additional or comparative efficacy outcome in the clinical studies summarized in this policy.
    ORR
    Full termObjective response rate.
    DefinitionThe proportion of individuals whose disease achieves a predefined response.
    Use in evidenceORR was reported as an efficacy outcome in the clinical studies summarized in this policy.
    ESR1 mutation
    BiomarkerA tumor biomarker involving mutation of the estrogen receptor 1 gene.
    Veppanu study testingESR1 mutation status was determined using blood circulating tumor DNA testing.
    Study populationThe Veppanu study included individuals whose tumors carried ESR1 mutations.
    ER-positive, HER2-negative breast cancer
    Estrogen-receptor statusThe breast cancer is positive for estrogen receptors.
    HER2 statusThe breast cancer is negative for human epidermal growth factor receptor 2.
    Combined definitionER-positive, HER2-negative breast cancer is breast cancer that is positive for estrogen receptors and negative for HER2.
    Progression-free survival (PFS)
    Full termProgression-free survival.
    DefinitionTime from treatment initiation until disease progression or death.
    Veppanu study assessmentIn the Veppanu study, PFS was assessed by blinded independent central review using RECIST version 1.1.

    Initial Therapy

    Fareston

    Fareston may be considered medically necessary for metastatic breast cancer when all of the following are met.

    Fareston criteria

    • Postmenopausal status: The individual is a postmenopausal female.
    • Tumor receptor status: The tumor is estrogen-receptor positive or of unknown receptor status.
    • Generic toremifene trial: The individual has tried generic toremifene and had an inadequate response or intolerance.
    • Dose limit: The dose is limited to 60 mg per day.60 mg/day

    Cligavyx and Faslodex

    Cligavyx and Faslodex may be considered medically necessary for an eligible HR-positive advanced or metastatic breast-cancer indication when all applicable criteria are met.

    Fulvestrant brand criteria

    • Covered indication

      • HR-positive, HER2-negative advanced breast cancer in a postmenopausal woman not previously treated with endocrine therapy.
      • HR-positive advanced breast cancer in a postmenopausal woman with disease progression following endocrine therapy.
      • HR-positive, HER2-negative advanced or metastatic breast cancer in combination with ribociclib in a postmenopausal woman as initial endocrine-based therapy or following disease progression on endocrine therapy.
      • HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in a woman with disease progression following endocrine therapy.
      • HR-positive, HER2-negative locally advanced or metastatic breast cancer in an adult individual receiving Truqap (capivasertib), with one or more PIK3CA, AKT1, or PTEN alterations, who has progressed on at least one endocrine-based regimen in the metastatic setting or had recurrence on or within 12 months of completing adjuvant therapy.At least 1 endocrine-based metastatic regimen; or recurrence on or within 12 months of completing adjuvant therapy
    • Generic fulvestrant trial: The individual has tried generic fulvestrant and had an inadequate response or intolerance.

    Inluriyo

    Inluriyo may be considered medically necessary for adults meeting all of the following criteria.

    Inluriyo criteria

    • Age: The individual is aged 18 years or older.>=18 years
    • Biomarker and disease status: The individual has ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer.
    • Disease progression: The individual has experienced disease progression following at least 1 line of endocrine therapy.At least 1 line

    • Administration

      • Inluriyo is used as monotherapy.
      • Inluriyo is used in combination with abemaciclib.
    • Dose: The dose is limited to 400 mg per day.400 mg/day

    Orserdu

    Orserdu may be considered medically necessary for eligible adults meeting all of the following criteria.

    Orserdu criteria

    • Age and sex or menopausal status

      • The individual is a postmenopausal female.
      • The individual is a male aged 18 years or older.>=18 years
    • Biomarker and disease status: The individual has ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer.
    • Disease progression: The individual has experienced disease progression following at least 1 line of endocrine therapy.At least 1 line
    • Dose: The dose is limited to 345 mg per day.345 mg/day

    Veppanu

    Veppanu may be considered medically necessary for eligible adults meeting all of the following criteria.

    Veppanu criteria

    • Age: The individual is aged 18 years or older.>=18 years
    • Biomarker and disease status: The individual has ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer.
    • Disease progression: The individual has experienced disease progression following at least 1 line of endocrine therapy.At least 1 line

    • Prior treatment or intolerance

      • The individual has tried elacestrant or imlunestrant and had an inadequate response or intolerance.
      • Documentation shows actual or anticipated gastrointestinal intolerance, such as a history of colitis, or dyslipidemia with elacestrant or imlunestrant.
    • Dose: The dose is limited to 200 mg daily.200 mg/day

    Reauthorization

    Reauthorization

    All drugs listed in the policy may be approved for up to 12 months when the drug-specific criteria remain met and chart notes demonstrate continued positive clinical response.

    Reauthorization requirements

    • Drug-specific criteria: The applicable drug-specific coverage criteria continue to be met.
    • Positive clinical response: Chart notes demonstrate that the individual continues to show a positive clinical response to therapy.

    Required Prior Therapy

    StepPrior therapyBrand therapyRequirement
    1Generic toremifeneFareston (toremifene)The individual must have tried generic toremifene and had an inadequate response or intolerance.
    StepPrior therapyBrand therapyRequirement
    1Generic fulvestrantCligavyx or Faslodex (fulvestrant)The individual must have tried generic fulvestrant and had an inadequate response or intolerance.
    StepPrior therapyBrand therapyException
    1Elacestrant or imlunestrantVeppanu (vepdegestrant)Prior therapy may be bypassed when documentation shows actual or anticipated gastrointestinal intolerance, such as a history of colitis, or dyslipidemia with elacestrant or imlunestrant.

    Dose and Quantity Parameters

    Fareston (toremifene) — maximum dose
    DrugFareston (toremifene).
    Maximum dose60 mg.
    FrequencyPer day.
    Cligavyx or Faslodex (fulvestrant) — maximum dose
    DrugsCligavyx or Faslodex (fulvestrant).
    Maximum dose60 mg.
    FrequencyPer day, where specified.
    Inluriyo (imlunestrant) — maximum dose
    DrugInluriyo (imlunestrant).
    Maximum dose400 mg.
    FrequencyPer day.
    Orserdu (elacestrant) — maximum dose
    DrugOrserdu (elacestrant).
    Maximum dose345 mg.
    FrequencyPer day.
    Veppanu (vepdegestrant) — maximum dose
    DrugVeppanu (vepdegestrant).
    Maximum dose200 mg.
    FrequencyDaily.

    Benefit and Site-of-Care Management

    Billing Rule

    Submit through the correct benefit

    Confirm the applicable benefit pathway before submitting the request. Fareston, Inluriyo, Orserdu, and Veppanu are managed through the pharmacy benefit; Cligavyx and Faslodex are managed through both the pharmacy and medical benefits.

    • Pharmacy benefit: Fareston, Inluriyo, Orserdu, and Veppanu.
    • Pharmacy and medical benefits: Cligavyx and Faslodex.
    Policy Summary
    PayerPremera Blue Cross of Washington
    PolicySelective Estrogen Receptor Modulators and Down Regulators
    Policy CodePolicy 5.01.618
    Change TypeModified
    Effective DateFebruary 5, 2027
    Next Review DateNot specified
    Key ActionSubmit documentation showing the applicable receptor and mutation results, disease stage or progression, prior endocrine therapies and responses or intolerances, combination therapy, and requested dose.
    SourceLink
    On This Page
    Coverage Criteria OverviewBilling and CodingAuthorization and Documentation RequirementsClinical BackgroundClinical DefinitionsInitial TherapyReauthorizationRequired Prior TherapyDose and Quantity ParametersBenefit and Site-of-Care Management

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