ModifiedPremera Blue Cross of WashingtonPolicy 5.01.618
Selective Estrogen Receptor Modulators and Down Regulators
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This policy governs medical-necessity coverage and prior authorization for specified brand SERMs and SERDs used primarily to treat advanced, metastatic, or recurrent hormone-receptor-positive breast cancer. It applies to providers submitting requests for Fareston, Cligavyx, Faslodex, Inluriyo, Orserdu, or 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
Last ReviewOct 13, 2026
Next Review DateN/A
Key ActionSubmit office visit notes documenting the diagnosis, relevant history, physical evaluation, and medication history to support medical-necessity criteria.
Added Veppanu (vepdegestrant) coverage criteria for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer.
Added Cligavyx (fulvestrant) to the policy effective February 5, 2027.
Updated Inluriyo (imlunestrant) criteria to require use as monotherapy or in combination with abemaciclib.
Removed quantity limits for Fareston, Inluriyo, and Orserdu from this policy because quantity limits are addressed under Policy 5.01.656 Drug Quantity Management.
Removed reference to non-formulary exception reviews.
6Brand products named in the policy
12 months
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Maximum initial authorization period
60 mg/dayFareston, Cligavyx, and Faslodex dose limit
400 mg/dayInluriyo dose limit
345 mg/dayOrserdu dose limit
200 mg/dayVeppanu dose limit
Coverage Criteria
Fareston (toremifene) — Initial Therapy
Fareston (toremifene) may be considered medically necessary for the treatment of metastatic breast cancer when ALL of the following criteria are met:
ALL of the following
The individual is a postmenopausal female.
The tumor is estrogen receptor-positive or of unknown estrogen receptor status.
The individual has tried and had an inadequate response or intolerance to generic toremifene.
The dose is limited to 60 mg per day.<= 60 mg/day
Cligavyx (fulvestrant) and Faslodex (fulvestrant) — Initial Therapy
Cligavyx (fulvestrant) and Faslodex (fulvestrant) may be considered medically necessary when ALL of the following criteria are met:
ALL of the following
ONE of the following
Treatment of hormone-receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in a postmenopausal woman who has not previously been treated with endocrine therapy.
Treatment of HR-positive advanced breast cancer in a postmenopausal woman with disease progression following endocrine therapy.
Treatment of 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.
Treatment of HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in a woman with disease progression following endocrine therapy.
Treatment in combination with Truqap (capivasertib) for an adult with HR-positive, HER2-negative locally advanced or metastatic breast cancer 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.
Inluriyo (imlunestrant) — Initial Therapy
Inluriyo (imlunestrant) may be considered medically necessary for the treatment of adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer when ALL of the following criteria are met:
ALL of the following
The individual is aged 18 years or older.>= 18 years
The individual has ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer.
The individual has experienced disease progression following at least one line of endocrine therapy.
ONE of the following
Inluriyo (imlunestrant) is used as monotherapy.
Orserdu (elacestrant) — Initial Therapy
Orserdu (elacestrant) may be considered medically necessary for the treatment of ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer when ALL of the following criteria are met:
ALL of the following
The individual is a postmenopausal female or a male aged 18 years or older.
The individual has ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer.
The individual has experienced disease progression following at least one line of endocrine therapy.
The dose is limited to 345 mg per day.<= 345 mg/day
Veppanu (vepdegestrant) — Initial Therapy
Veppanu (vepdegestrant) may be considered medically necessary for the treatment of ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer when ALL of the following criteria are met:
ALL of the following
The individual is aged 18 years or older.>= 18 years
The individual has ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer.
The individual has experienced disease progression following at least one line of endocrine therapy.
ONE of the following
The individual has tried and had an inadequate response or intolerance to elacestrant or imlunestrant.
Continuation Therapy — Reauthorization
Reauthorization may be considered for all drugs listed in this policy when ALL of the following criteria are met:
ALL of the following
The applicable drug-specific coverage criteria continue to be met.
Chart notes demonstrate that the individual continues to show a positive clinical response to therapy.
This medical policy does not apply to Medicare Advantage.
Not otherwise specified, antineoplastic drugs (used to report Cligavyx)
Provider Actions and Authorization Requirements
Prior Authorization
Fareston Authorization
Submit documentation that the individual is a postmenopausal female with metastatic breast cancer and an estrogen receptor (ER)-positive or ER-unknown tumor. Fareston coverage also requires an inadequate response or intolerance to generic toremifene, with dosing limited to 60 mg per day.
Postmenopausal female with metastatic breast cancer
ER-positive or ER-unknown tumor
Inadequate response or intolerance to generic toremifene
Dose does not exceed 60 mg per day
Prior Authorization
Fulvestrant Brand Authorization: Cligavyx or Faslodex
For Cligavyx or Faslodex, document an eligible HR-positive advanced or metastatic breast-cancer indication and the required treatment history. Coverage requires an inadequate response or intolerance to generic fulvestrant.
Postmenopausal woman with HR-positive, HER2-negative advanced breast cancer not previously treated with endocrine therapy
Clinical Background
Approximately two-thirds of breast cancers express estrogen receptor alpha. Estrogen-receptor-positive tumors depend on estrogen-receptor signaling for growth and survival, making endocrine treatment an important therapeutic approach. Selective estrogen receptor modulators (SERMs) and selective estrogen receptor down-regulators (SERDs) are designed to block estrogen-receptor function or signaling; some SERMs also have estrogenic bone effects that may reduce bone loss and vertebral-fracture risk.
Clinical Definitions
HER2-negative
HER2-negative0 or 1+ intensity on immunohistochemical testing
HER2-negative with 2+ IHC2+ intensity on immunohistochemical testing with no amplification on in situ hybridization
Policy applicationThis status is specified for eligible advanced or metastatic breast-cancer treatments in the policy
HR-positive
HR-positiveBreast cancer that is positive for hormone receptors
Estrogen-receptor specificationThe policy separately specifies estrogen-receptor-positive status for Inluriyo, Orserdu, and Veppanu
Covered disease setting
Initial Therapy Criteria
Fareston Initial Therapy
Fareston may be considered medically necessary when ALL of the following are met.
Fareston criteria
ALL of the following
The individual is a postmenopausal female.
The individual has metastatic breast cancer with an estrogen-receptor-positive or unknown tumor.
The individual has tried generic toremifene and had an inadequate response or intolerance.
The requested dose is no more than 60 mg per day.60 mg/day maximum
Continuation Authorization
Continuation Authorization
All drugs listed in the policy may be approved for reauthorization when ALL of the following are met.
Reauthorization criteria
The drug-specific coverage criteria remain satisfied.
Chart notes demonstrate that the individual continues to show a positive clinical response to therapy.
Step Therapy Requirements
Product
Step therapy requirement
Coverage
Fareston (toremifene)
Trial of generic toremifene before Fareston.
Covered with criteria
Product
Step therapy requirement
Coverage
Cligavyx or Faslodex (fulvestrant)
Trial of generic fulvestrant before the brand product.
Covered with criteria
Product
Step therapy requirement
Coverage
Veppanu (vepdegestrant)
Trial or consideration of elacestrant or imlunestrant. The requirement may be met by inadequate response or intolerance, or by documented actual or anticipated gastrointestinal intolerance or dyslipidemia with either drug.
Covered with criteria
Dose and Quantity Limits
Quantity limit
Covered productsFareston, Cligavyx, or Faslodex
Maximum dose60 mg
FrequencyPer day; 60 mg/day maximum
Quantity limit
ProductInluriyo (imlunestrant)
Maximum dose400 mg
FrequencyPer day; 400 mg/day maximum
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
Last ReviewOct 13, 2026
Next Review DateN/A
Key ActionSubmit office visit notes documenting the diagnosis, relevant history, physical evaluation, and medication history to support medical-necessity criteria.
The individual has tried and had an inadequate response or intolerance to generic fulvestrant.
Inluriyo (imlunestrant) is used in combination with abemaciclib.
The dose is limited to 400 mg per day.<= 400 mg/day
Documentation shows actual or anticipated gastrointestinal intolerance (e.g., history of colitis) or dyslipidemia with elacestrant or imlunestrant.
The dose is limited to 200 mg daily.<= 200 mg/day
Postmenopausal woman with HR-positive advanced breast cancer progressing after endocrine therapy
HR-positive, HER2-negative advanced or metastatic breast cancer used with ribociclib as initial endocrine-based therapy or after progression on endocrine therapy in a postmenopausal woman
HR-positive, HER2-negative advanced or metastatic breast cancer used with palbociclib or abemaciclib after progression on endocrine therapy
Adult with HR-positive, HER2-negative locally advanced or metastatic breast cancer receiving Truqap (capivasertib), with a PIK3CA, AKT1, or PTEN alteration and progression on at least one metastatic endocrine regimen or recurrence during or within 12 months after adjuvant therapy
Inadequate response or intolerance to generic fulvestrant
HER2-negative means IHC 0 or 1+, or IHC 2+ with no amplification by in situ hybridization
Prior Authorization
Inluriyo Authorization
For Inluriyo, document the individual’s age, tumor biomarkers, advanced or metastatic disease, prior endocrine therapy, and the planned regimen. Dosing is limited to 400 mg per day.
Age 18 years or older
ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer
Disease progression after at least one line of endocrine therapy
Used as monotherapy or in combination with abemaciclib
Dose does not exceed 400 mg per day
Prior Authorization
Orserdu Authorization
For Orserdu, document an eligible adult patient, the required biomarkers and disease stage, progression after endocrine therapy, and dosing within the policy limit.
Postmenopausal female or male aged 18 years or older
ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer
Disease progression after at least one line of endocrine therapy
Dose does not exceed 345 mg per day
HER2-negative means IHC 0 or 1+, or IHC 2+ with no amplification by in situ hybridization
Prior Authorization
Veppanu Authorization
For Veppanu, document the patient’s age, biomarker-confirmed disease, prior endocrine therapy and progression, and fulfillment of one of the prerequisite-therapy pathways. Dosing is limited to 200 mg daily.
Age 18 years or older
ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer
Disease progression after at least one line of endocrine therapy
Inadequate response or intolerance to elacestrant or imlunestrant, or documented actual or anticipated gastrointestinal intolerance (such as a history of colitis) or dyslipidemia with either drug
Dose does not exceed 200 mg daily
Denial Risk
Veppanu Step Requirement Not Met
Veppanu authorization is at risk for denial when the record does not show prior endocrine therapy with disease progression and one of the required elacestrant or imlunestrant pathways.
Document an inadequate response or intolerance to elacestrant or imlunestrant; or
Document actual or anticipated gastrointestinal intolerance or dyslipidemia associated with elacestrant or imlunestrant
A request lacking the required endocrine-treatment history or prerequisite-therapy documentation does not meet the step requirement
Step Therapy
Generic Toremifene Step
Before requesting Fareston, document a trial of generic toremifene and the outcome. Fareston requires an inadequate response or intolerance to the generic product.
Record the generic toremifene trial
Describe inadequate response or intolerance
Confirm the requested Fareston dose is no more than 60 mg per day
Step Therapy
Generic Fulvestrant Step
Before requesting Cligavyx or Faslodex, document a trial of generic fulvestrant and the outcome. The brand request requires an inadequate response or intolerance to generic fulvestrant.
Record the generic fulvestrant trial
Describe inadequate response or intolerance
Submit the applicable brand indication and treatment history
Documentation Required
Required Clinical Records
Submit the clinical records needed to establish medical necessity for the requested drug and indication.
Office visit notes containing the diagnosis, relevant history, physical evaluation, and medication history
Include current and prior therapy, treatment response, intolerance, and progression information
Documentation Required
Drug-Specific Supporting Documentation
Drug-specific supporting documentation must substantiate the tumor biology, disease extent, prior treatment, and progression requirements for the requested therapy.
ER or hormone-receptor status
HER2 results and, when applicable, immunohistochemistry and in situ hybridization results
ESR1 mutation status for Inluriyo, Orserdu, and Veppanu
PIK3CA, AKT1, or PTEN alteration for the Truqap combination indication
Advanced, metastatic, or locally advanced stage as applicable
Disease progression after endocrine therapy and the number and type of prior lines
Prior generic toremifene, generic fulvestrant, elacestrant, or imlunestrant trial and response or intolerance, as applicable
Documentation Required
Monitor QTc Risk With Veppanu
Monitor for Veppanu-associated QTc prolongation. Obtain ECG and electrolyte testing at baseline, approximately 4 weeks after initiation, and periodically thereafter as clinically indicated.
Baseline ECG and electrolytes
Repeat ECG and electrolytes approximately 4 weeks after starting therapy
Continue periodic monitoring as clinically indicated
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Denial Risk
Insufficient Response for Reauthorization
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. Without documented clinical benefit, continued coverage may be denied.
All drugs may be approved for up to 12 months
Document ongoing positive clinical response
Continue to document the applicable drug-specific eligibility criteria
HR-positive disease may be advanced or metastatic, depending on the applicable treatment criterion
ESR1-mutated
Disease characteristicAdvanced or metastatic breast cancer with an ESR1 mutation
Required forInluriyo, Orserdu, and Veppanu
Additional treatment contextFor these therapies, the policy also requires ER-positive and HER2-negative disease
ESR1m
Testing methodBlood circulating tumor DNA (ctDNA) analysis
AssayGuardant360 CDx
Mutation scopeLimited to specified ESR1 mutations in the ligand-binding domain
ER+, HER2-
ER statusEstrogen receptor-positive
HER2 statusHER2-negative
Disease typeBreast cancer characterized by both receptor findings
Specimen sourceTumor-derived circulating tumor DNA
Trial useThe Veppanu trial stratified and evaluated efficacy according to ESR1 mutation status
ER-positive, HER2-negative
Estrogen receptorPositive
Human epidermal growth factor receptor 2Negative
Disease definitionBreast cancer that is estrogen receptor positive and human epidermal growth factor receptor 2 negative
Cligavyx and Faslodex Initial Therapy
Cligavyx or Faslodex may be considered medically necessary when ALL applicable requirements are met.
Fulvestrant brand criteria
Covered indications
Treatment of HR-positive/HER2-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy.
Treatment of HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy.
Treatment of HR-positive/HER2-negative advanced or metastatic breast cancer with ribociclib in postmenopausal women as initial endocrine-based therapy or after progression on endocrine therapy.
Treatment of HR-positive/HER2-negative advanced or metastatic breast cancer with palbociclib or abemaciclib in women with disease progression following endocrine therapy.
Treatment with Truqap (capivasertib) in adults with HR-positive/HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN alterations and progression on at least one endocrine-based metastatic regimen, or recurrence on or within 12 months of completing adjuvant therapy.
Product requirements
The individual has tried generic fulvestrant and had an inadequate response or intolerance.
The requested dose is no more than 60 mg per day.60 mg/day maximum
Inluriyo Initial Therapy
Inluriyo may be considered medically necessary when ALL of the following are met.
Inluriyo criteria
The individual is aged 18 years or older.
The individual has ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer.
The individual has experienced disease progression following at least one line of endocrine therapy.
Treatment setting
Inluriyo is used as monotherapy.
Inluriyo is used in combination with abemaciclib.
The requested dose is no more than 400 mg per day.400 mg/day maximum
Orserdu Initial Therapy
Orserdu may be considered medically necessary when ALL of the following are met.
Orserdu criteria
Age and menopausal status
The individual is a postmenopausal female.
The individual is a male aged 18 years or older.
The individual has ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer.
The individual has experienced disease progression following at least one line of endocrine therapy.
The requested dose is no more than 345 mg per day.345 mg/day maximum
Veppanu Initial Therapy
Veppanu may be considered medically necessary when ALL of the following are met.
Veppanu criteria
The individual is aged 18 years or older.
The individual has ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer.
The individual has experienced disease progression following at least one line of endocrine therapy.
Prerequisite-drug conditions
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.
The requested dose is no more than 200 mg daily.200 mg/day maximum