ModifiedPremera Blue Cross of WashingtonPolicy 5.01.618

Selective Estrogen Receptor Modulators and Down Regulators

Customize your policy alerts

Sign up for premerabluecrossofwashington Policy 5.01.618 alerts

Get alerted when Policy 5.01.618 changes without checking for updates manually.

Monitor payer policy activity

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

This policy governs medical-necessity and prior-authorization criteria for brand selective estrogen receptor modulators and selective estrogen receptor down-regulators used primarily for hormone-receptor-positive breast cancer. It applies to providers submitting requests under the pharmacy benefit and, for Faslodex, the pharmacy or medical benefit.

Policy Summary

PayerPremera Blue Cross of Washington

PolicySelective Estrogen Receptor Modulators and Down Regulators

Policy CodePolicy 5.01.618

Change TypeModified

Effective DateNovember 1, 2026

Next Review DateN/A

Key ActionSubmit office visit notes documenting the diagnosis, relevant history, physical evaluation, medication history, and applicable medical-necessity criteria.

SourceLink

POLICY UPDATE CHANGES

Fareston (toremifene) criteria were updated to limit quantity to 30 tablets per 30 days.

A quantity limit per 30 days was added for Orserdu (elacestrant).

References to non-formulary exception reviews were removed.

Coverage criteria for Orserdu (elacestrant) treatment of breast cancer were added.

Faslodex (fulvestrant) criteria were expanded to include treatment of certain individuals with breast cancer in combination with Truqap (capivasertib).

Added coverage criteria for Veppanu (vepdegestrant) for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer.

Updated Inluriyo (imlunestrant) criteria to require use as monotherapy or in combination with another therapy.

5Drugs with coverage criteria

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.

ModifiedPremera Blue Cross of WashingtonPolicy 5.01.618

Selective Estrogen Receptor Modulators and Down Regulators

Customize your policy alerts

Sign up for premerabluecrossofwashington Policy 5.01.618 alerts

Get alerted when Policy 5.01.618 changes without checking for updates manually.

Monitor payer policy activity

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

Policy Summary

PayerPremera Blue Cross of Washington

PolicySelective Estrogen Receptor Modulators and Down Regulators

Policy CodePolicy 5.01.618

Change TypeModified

Effective DateNovember 1, 2026

Next Review DateN/A

Key ActionSubmit office visit notes documenting the diagnosis, relevant history, physical evaluation, medication history, and applicable medical-necessity criteria.

SourceLink

POLICY UPDATE CHANGES

Fareston (toremifene) criteria were updated to limit quantity to 30 tablets per 30 days.

A quantity limit per 30 days was added for Orserdu (elacestrant).

References to non-formulary exception reviews were removed.

Coverage criteria for Orserdu (elacestrant) treatment of breast cancer were added.

Faslodex (fulvestrant) criteria were expanded to include treatment of certain individuals with breast cancer in combination with Truqap (capivasertib).

Added coverage criteria for Veppanu (vepdegestrant) for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer.

Updated Inluriyo (imlunestrant) criteria to require use as monotherapy or in combination with another therapy.

5Drugs with coverage criteria

12 monthsInitial authorization

12 monthsReauthorization

30 tablets/30 daysFareston quantity limit

N/AMedicare Advantage

Drug-Specific Coverage Criteria

Fareston (toremifene)

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

All required criteria

ALL of the following
- The individual is a postmenopausal female.
- The tumor is estrogen receptor-positive or estrogen receptor-unknown.
- The individual has tried and had an inadequate response or intolerance to generic toremifene.
- The dose does not exceed 60 mg per day.60 mg per day

Faslodex (fulvestrant)

Faslodex may be considered medically necessary when one covered indication applies and the generic fulvestrant requirement is met:

All required criteria

One covered indication
- Treatment of HR-positive, HER2-negative advanced breast cancer in postmenopausal women who have not previously been 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 in combination with ribociclib in postmenopausal women 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 women with disease progression following endocrine therapy.

Inluriyo (imlunestrant)

Inluriyo may be considered medically necessary for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer when all of the following criteria are met:

All required criteria

The individual is 18 years of age or older.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.At least 1 line of endocrine therapy
Treatment regimen

Orserdu (elacestrant)

Orserdu may be considered medically necessary for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer when all of the following criteria are met:

All required criteria

The individual is a postmenopausal female or a male aged 18 years or older.Postmenopausal female or 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.At least 1 line of endocrine therapy
The dose does not exceed 345 mg per day.345 mg per day

Veppanu (vepdegestrant)

Veppanu may be considered medically necessary for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer when all of the following criteria are met:

All required criteria

The individual is 18 years of age or older.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.At least 1 line of endocrine therapy
Prior therapy or exception

Initial and reauthorization duration

All listed drugs may be approved for up to 12 months initially and for up to 12 months on reauthorization when the applicable criteria are met:

Authorization duration

The applicable drug-specific coverage criteria are met.
For reauthorization, chart notes demonstrate that the individual continues to show a positive clinical response to therapy.
Required for continuation authorization.
The authorization period does not exceed 12 months.Up to 12 months initially and on reauthorization

This medical policy does not apply to Medicare Advantage.

Initial Therapy Requirements

Fareston initial therapy

Fareston may be considered medically necessary for initial therapy when all of the following criteria are met:

All required criteria

The individual is a postmenopausal female.
The tumor is estrogen receptor-positive or estrogen receptor-unknown.
The individual has tried and had an inadequate response or intolerance to generic toremifene.
The dose does not exceed 60 mg per day.60 mg per day

Faslodex initial therapy

Reauthorization Requirements

Continuation therapy

Reauthorization may be approved for up to 12 months when all continuation criteria are met:

Continuation criteria

The drug-specific coverage criteria continue to be met.
Chart notes demonstrate a continued positive clinical response to therapy.
The reauthorization period does not exceed 12 months.Up to 12 months

Billing and Coding

Covered HCPCS CodesHCPCSCovered

J9395

Injection, fulvestrant, (Faslodex), 25 mg

Authorization and Submission Guidance

Prior Authorization

Benefit and Authorization Routing

Route requests according to the applicable benefit. Fareston (toremifene), Inluriyo (imlunestrant), Orserdu (elacestrant), and Veppanu (vepdegestrant) are managed through the pharmacy benefit; Faslodex (fulvestrant) is managed through both the pharmacy and medical benefits.

Submit authorization requests through the applicable pharmacy or medical benefit pathway.
All listed medications are subject to the product's FDA dosage and administration prescribing information.

Documentation Required

Required Clinical Records

Submit medical records demonstrating that the applicable medical-necessity criteria are met. Records should clearly support the diagnosis, relevant history, examination findings, treatment history, and requested drug.

Office visit notes containing the diagnosis, relevant history, physical evaluation, and medication history.

Required Prerequisite Therapy

Step	Before coverage of	Required prior therapy	Requirement
1	Fareston (toremifene)	Generic toremifene	Must have tried generic toremifene with an inadequate response or intolerance.

Step	Before coverage of	Required prior therapy	Requirement
1	Faslodex (fulvestrant)	Generic fulvestrant	Must have tried generic fulvestrant with an inadequate response or intolerance.

Step	Before coverage of	Required prior therapy	Requirement or exception
1	Veppanu (vepdegestrant)	Elacestrant or imlunestrant	Must have tried elacestrant or imlunestrant with an inadequate response or intolerance, unless documentation shows actual or anticipated gastrointestinal intolerance, such as a history of colitis, or dyslipidemia with either drug.

Dose and Dispensing Limits

Fareston Maximum Dose

DrugFareston (toremifene)

Maximum dose60 mg per day

Dose restrictionThe dose is limited to 60 mg per day

Inluriyo Maximum Dose

DrugInluriyo (imlunestrant)

Maximum dose400 mg per day

Dose restrictionThe dose is limited to 400 mg per day

Clinical Background

Approximately two-thirds of breast cancers express estrogen receptor alpha. Estrogen-receptor-positive breast tumors depend on estrogen receptor signaling for growth and progression, providing the rationale for therapies that inhibit estrogen receptor function and signaling.

Clinical Definitions

HER2-Negative Definition

DefinitionHER2-negative status

Immunohistochemical testing0 or 1+ intensity

Immunohistochemical testing with confirmatory testing2+ intensity with no amplification on in situ hybridization

Policy Summary

PayerPremera Blue Cross of Washington

PolicySelective Estrogen Receptor Modulators and Down Regulators

Policy CodePolicy 5.01.618

Change TypeModified

Effective DateNovember 1, 2026

Next Review DateN/A

Key ActionSubmit office visit notes documenting the diagnosis, relevant history, physical evaluation, medication history, and applicable medical-necessity criteria.

SourceLink

On This Page

Treatment in combination with Truqap (capivasertib) of 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 regimen in the metastatic setting, or recurrence on or within 12 months of completing adjuvant therapy.

The individual has tried and had an inadequate response or intolerance to generic fulvestrant.

Inluriyo is used as monotherapy.

Inluriyo is used in combination with abemaciclib.

The dose does not exceed 400 mg per day.400 mg per day

The individual has tried and had an inadequate response or intolerance to elacestrant or imlunestrant.

Documentation shows actual or anticipated gastrointestinal intolerance, such as a history of colitis, or dyslipidemia with elacestrant or imlunestrant.

The dose does not exceed 200 mg daily.200 mg daily

Faslodex may be considered medically necessary for initial therapy when one covered indication applies and the individual has tried generic fulvestrant with an inadequate response or intolerance:

All required criteria

One covered indication
- Treatment of HR-positive, HER2-negative advanced breast cancer in postmenopausal women who have not previously been 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 in combination with ribociclib in postmenopausal women 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 women with disease progression following endocrine therapy.
- Treatment in combination with Truqap (capivasertib) of 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 regimen in the metastatic setting, or recurrence on or within 12 months of completing adjuvant therapy.
The individual has tried and had an inadequate response or intolerance to generic fulvestrant.

Inluriyo initial therapy

Inluriyo may be considered medically necessary for initial therapy when all of the following criteria are met:

All required criteria

The individual is 18 years of age or older.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.At least 1 line of endocrine therapy
Treatment regimen
- Inluriyo is used as monotherapy.
- Inluriyo is used in combination with abemaciclib.
The dose does not exceed 400 mg per day.400 mg per day

Orserdu initial therapy

Orserdu may be considered medically necessary for initial therapy when all of the following criteria are met:

All required criteria

The individual is a postmenopausal female or a male aged 18 years or older.Postmenopausal female or 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.At least 1 line of endocrine therapy
The dose does not exceed 345 mg per day.345 mg per day

Veppanu initial therapy

Veppanu may be considered medically necessary for initial therapy when all of the following criteria are met:

All required criteria

The individual is 18 years of age or older.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.At least 1 line of endocrine therapy
Prior therapy or exception
- The individual has tried and had an inadequate response or intolerance to elacestrant or imlunestrant.
- Documentation shows actual or anticipated gastrointestinal intolerance, such as a history of colitis, or dyslipidemia with elacestrant or imlunestrant.
The dose does not exceed 200 mg daily.200 mg daily

Include supporting documentation such as biomarker results, prior endocrine therapy, treatment response or intolerance, and the requested dose when applicable.

Step Therapy

Generic Toremifene Trial Required

Before requesting Fareston, document that the individual has tried generic toremifene and experienced an inadequate response or intolerance.

Fareston criteria also require a postmenopausal female with estrogen-receptor-positive or estrogen-receptor-unknown metastatic breast cancer.
The Fareston dose is limited to 60 mg per day.

Step Therapy

Generic Fulvestrant Trial Required

Before requesting Faslodex, document that the individual has tried generic fulvestrant and experienced an inadequate response or intolerance.

The requested use must meet an applicable Faslodex indication, including qualifying HR-positive advanced or metastatic breast cancer treatment, specified endocrine-therapy history, or eligible combination therapy.
For HER2-negative criteria, document HER2 status as 0 or 1+ on immunohistochemistry, or 2+ on immunohistochemistry with no amplification on in situ hybridization.

Unsupported block type: step_therapy

Denial Risk

Drug-Specific Criteria Must Be Met

Requests may be denied when drug-specific coverage criteria are not established in the submitted record. Ensure the documentation supports the applicable cancer diagnosis, biomarker status, endocrine-therapy history, and required generic-drug trial.

Fareston: postmenopausal status, metastatic breast cancer, and estrogen-receptor-positive or unknown tumor status.
Faslodex: qualifying HR-positive indication, applicable HER2 status, and required generic fulvestrant trial.
Inluriyo, Orserdu, and Veppanu: applicable ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer criteria, progression after endocrine therapy, and required dose limits.
Missing or unsupported diagnosis, biomarker results, endocrine therapy, or generic-drug requirements can result in denial.

Denial Risk

Document Positive Clinical Response

For reauthorization, submit chart notes showing that the individual continues to meet the drug-specific coverage criteria and is demonstrating a positive clinical response to therapy. Continued authorization may be denied when no documented clinical response is provided.

Initial authorization and reauthorization may be approved for up to 12 months.
Include current response assessments and relevant treatment notes with continuation requests.

Orserdu Maximum Dose

DrugOrserdu (elacestrant)

Maximum dose345 mg per day

Dose restrictionThe dose is limited to 345 mg per day

Veppanu Maximum Dose

DrugVeppanu (vepdegestrant)

Maximum dose200 mg daily

Dose restrictionThe dose is limited to 200 mg daily

Fareston Quantity Limit

DrugFareston (toremifene)

Quantity limit30

UnitTablets per 30 days

Fareston Quantity Limit

DrugFareston (toremifene)

Quantity limit30 tablets

Limit periodPer 30 days

Orserdu Quantity Limit

DrugOrserdu (elacestrant)

Limit periodPer 30 days

Specific quantityNot stated in the document