ModifiedPremera Blue Cross of WashingtonPolicy 5.01.618

Selective Estrogen Receptor Modulators and Down Regulators

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Coverage criteria, documentation requirements, coding information, evidence review, references, and history for selective estrogen receptor modulators and down-regulators used in breast cancer treatment and risk reduction.

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 ActionDocument the requested drug’s diagnosis, biomarker findings, prior therapy, treatment combination, and dose limitation in the prior authorization request.

SourceLink

POLICY UPDATE CHANGES

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.

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

Updated Orserdu (elacestrant) criteria to add a quantity limit per 30 days.

5Drugs with drug-specific coverage criteria

Up to 12 monthsInitial authorization period

Up to 12 months

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ModifiedPremera Blue Cross of WashingtonPolicy 5.01.618

Selective Estrogen Receptor Modulators and Down Regulators

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Sign up for premerabluecrossofwashington Policy 5.01.618 alerts

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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 ActionDocument the requested drug’s diagnosis, biomarker findings, prior therapy, treatment combination, and dose limitation in the prior authorization request.

SourceLink

POLICY UPDATE CHANGES

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.

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

Updated Orserdu (elacestrant) criteria to add a quantity limit per 30 days.

5Drugs with drug-specific coverage criteria

Up to 12 monthsInitial authorization period

Up to 12 months

Reauthorization period

30 tablets/30 daysFareston quantity limit

ER+/HER2−/ESR1-mutatedVeppanu disease profile

Coverage Criteria

Fareston initial therapy

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

Fareston criteria: The individual is a postmenopausal female with metastatic breast cancer and an estrogen receptor-positive or estrogen receptor-unknown tumor; has tried and had an inadequate response or intolerance to generic toremifene; and the dose is limited to 60 mg per day.60 mg per day

Faslodex initial therapy

Faslodex may be considered medically necessary when the individual meets one covered indication and has tried and had an inadequate response or intolerance to generic fulvestrant.

Faslodex criteria

Covered indications
- Previously untreated endocrine-sensitive disease: Treatment of hormone-receptor-positive, HER2-negative advanced breast cancer in a postmenopausal woman not previously treated with endocrine therapy.
- Progression after endocrine therapy: Treatment of hormone-receptor-positive advanced breast cancer in a postmenopausal woman with disease progression following endocrine therapy.
- Combination with ribociclib: Treatment of hormone-receptor-positive, HER2-negative advanced or metastatic breast cancer in a postmenopausal woman as initial endocrine-based therapy or following disease progression on endocrine therapy, in combination with ribociclib.
- Combination with palbociclib or abemaciclib: Treatment of hormone-receptor-positive, HER2-negative advanced or metastatic breast cancer in a woman with disease progression following endocrine therapy, in combination with palbociclib or abemaciclib.
- Combination with Truqap: Treatment in combination with Truqap (capivasertib) for an adult with hormone-receptor-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.At least one PIK3CA, AKT1, or PTEN alteration
Required prior therapy: The individual has tried and had an inadequate response or intolerance to generic fulvestrant.

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; has ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer; has experienced disease progression following at least one line of endocrine therapy; uses Inluriyo as monotherapy or in combination with abemaciclib; and the dose is limited to 400 mg per day.Age 18 years or older; dose not to exceed 400 mg per day

Orserdu initial therapy

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

Orserdu criteria: The individual is a postmenopausal female or a male aged 18 years or older; has ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer; has experienced disease progression following at least one line of endocrine therapy; and the dose is limited to 345 mg per day.Age 18 years or older for males; dose not to exceed 345 mg per day

Veppanu initial therapy

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

Veppanu criteria

Disease and treatment requirements: The individual is aged 18 years or older; has ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer; and has experienced disease progression following at least one line of endocrine therapy.
Required prior therapy or intolerance
- Prior inadequate response or intolerance: The individual has tried and had an inadequate response or intolerance to elacestrant or imlunestrant.
- Expected intolerance or dyslipidemia: Documentation shows actual or anticipated gastrointestinal intolerance, such as a history of colitis, or dyslipidemia with elacestrant or imlunestrant.
  Examples include a history of colitis.

Continuation therapy

Reauthorization may be approved when all of the following are met.

Continuation criteria: The applicable drug-specific coverage criteria remain met, and chart notes demonstrate that the individual continues to show a positive clinical response to therapy.Authorization up to 12 months

Breast cancer risk reduction

Risk-reducing medication may be considered for women who meet both of the following conditions.

Risk-reduction criteria: The woman is at increased risk for breast cancer and is at low risk for adverse medication effects.

The USPSTF recommends against routine use of risk-reducing medication in women who are not at increased risk.

Veppanu initial therapy

Veppanu coverage criteria were added for the specified advanced or metastatic breast cancer indication.

Veppanu indication: The patient has ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer.

The available policy text identifies this indication but does not provide the complete criterion set in this section.

Coding Information

Covered HCPCS CodesHCPCSCovered

J9395

Injection, fulvestrant, (Faslodex), 25 mg

Provider Requirements and Review Considerations

Prior Authorization

Document Drug-Specific Prior Authorization Criteria

Prior authorization requests must identify the requested drug and document the applicable drug-specific SERM or SERD medical-necessity criteria. Include the diagnosis, biomarker status, menopausal or age requirements, prior endocrine therapy and disease progression when applicable, combination therapy, and dose limits.

Fareston (toremifene): postmenopausal female with metastatic breast cancer and estrogen receptor-positive or unknown tumors; inadequate response or intolerance to generic toremifene; dose limited to 60 mg/day.
Faslodex (fulvestrant): document an applicable HR-positive advanced or metastatic breast cancer indication, including endocrine-therapy history and any required combination therapy; inadequate response or intolerance to generic fulvestrant.
Inluriyo (imlunestrant): age 18 or older; ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer; progression after at least one line of endocrine therapy; monotherapy or combination with abemaciclib; dose limited to 400 mg/day.
Orserdu (elacestrant): postmenopausal female or male age 18 or older; ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer; progression after at least one line of endocrine therapy; dose limited to 345 mg/day.
Veppanu (vepdegestrant): age 18 or older; ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer; progression after at least one line of endocrine therapy; inadequate response or intolerance to elacestrant or imlunestrant, or documented/anticipated gastrointestinal intolerance or dyslipidemia with either drug; dose limited to 200 mg/day.

Clinical Background

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

Definitions

HER2-negative

IHC result0 intensity on immunohistochemical testing

IHC result1+ intensity on immunohistochemical testing

IHC result2+ intensity on immunohistochemical testing with no amplification on in situ hybridization

SERM/SERD

SERMSelective estrogen receptor modulator

SERDSelective estrogen receptor down-regulator

PurposeEndocrine therapy drug classes designed to block estrogen receptor function and signaling

Drug-Specific Initial Therapy

Fareston medical necessity criteria

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

Fareston: The individual is a postmenopausal female with metastatic breast cancer and an estrogen receptor-positive or estrogen receptor-unknown tumor; has tried and had an inadequate response or intolerance to generic toremifene; and the dose is limited to 60 mg per day.60 mg per day

Faslodex medical necessity criteria

Faslodex may be considered medically necessary when the individual meets at least one covered indication and has tried and had an inadequate response or intolerance to generic fulvestrant.

Faslodex

Covered indications

Reauthorization

Reauthorization may be approved for up to 12 months when all of the following are met.

Reauthorization criteria: The applicable drug-specific coverage criteria remain met, and chart notes demonstrate that the individual continues to show a positive clinical response to therapy.Up to 12 months

Required Step Therapy

Step	Required prior therapy	Requested medication
1	Try generic toremifene and document an inadequate response or intolerance.	Fareston (toremifene)

Step	Required prior therapy	Requested medication
1	Try generic fulvestrant and document an inadequate response or intolerance.	Faslodex (fulvestrant)

Step	Required prior therapy	Requested medication
1	Try elacestrant or imlunestrant and document an inadequate response or intolerance; alternatively, document actual or anticipated gastrointestinal intolerance or dyslipidemia with either drug.	Veppanu (vepdegestrant)

Dose and Quantity Limits

Fareston dose limit

DrugFareston (toremifene)

Dose limit60 mg per day

Covered useTreatment of metastatic breast cancer when applicable coverage criteria are met

Inluriyo dose limit

DrugInluriyo (imlunestrant)

Dose limit400 mg per day

Covered useTreatment of ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer when applicable coverage criteria are met

Benefit and Site-of-Care Management

Billing Rule

Faslodex uses pharmacy and medical benefits

Faslodex (fulvestrant) is managed through both the pharmacy and medical benefits. Submit and bill the claim under the applicable benefit for the service being provided.

Pharmacy benefit
Medical benefit

Billing Rule

Use the pharmacy benefit for these medications

Fareston (toremifene), Inluriyo (imlunestrant), Orserdu (elacestrant), and Veppanu (vepdegestrant) are managed through the pharmacy benefit.

Fareston
Inluriyo
Orserdu
Veppanu

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 ActionDocument the requested drug’s diagnosis, biomarker findings, prior therapy, treatment combination, and dose limitation in the prior authorization request.

SourceLink

On This Page

Dose limitation: The dose is limited to 200 mg daily.200 mg daily

Where applicable, HER2-negative status requires 0 or 1+ immunohistochemical intensity, or 2+ intensity without amplification on in situ hybridization.

Step Therapy

Required Prior Therapy

Before requesting coverage for a drug with a required prior trial, document the generic product trial, the treatment outcome, and the reason it was stopped or is unsuitable. A failure to establish the required prior therapy may result in denial.

For Fareston, document a trial of generic toremifene with inadequate response or intolerance.
For Faslodex, document a trial of generic fulvestrant with inadequate response or intolerance.
For Veppanu, document inadequate response or intolerance to elacestrant or imlunestrant, unless the record documents actual or anticipated gastrointestinal intolerance or dyslipidemia with one of those agents.

Documentation Required

Submit Complete Clinical Records

Submit medical records demonstrating that the applicable medical-necessity criteria are met. Records should support the diagnosis and relevant clinical history, evaluation, medication history, prior treatment response or intolerance, and current treatment response when requesting continuation.

Office visit notes containing the diagnosis, relevant history, physical evaluation, and medication history.
Pathology or laboratory documentation supporting receptor and mutation status when required, including ER, HER2, and ESR1 results.
Documentation of prior endocrine therapy, disease progression, inadequate response, intolerance, or other qualifying clinical circumstances.
For reauthorization, chart notes documenting that the individual continues to show a positive clinical response to therapy.

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Denial Risk

Failure to Meet Drug-Specific Criteria May Result in Denial

Coverage may be denied when the request does not satisfy the requested drug's clinical, demographic, biomarker, prior-treatment, combination-therapy, or dose requirements. The record must support the specific indication rather than only a general diagnosis of breast cancer.

Deny or pend requests lacking the required diagnosis, receptor or mutation status, or evidence of advanced or metastatic disease.
Deny requests that do not meet the applicable menopausal or age requirement, including the postmenopausal requirement for Fareston and specified Faslodex indications, or the age-18-or-older requirement for Inluriyo, Orserdu, and Veppanu.
Deny requests without required disease progression following endocrine therapy, required prior therapy, or qualifying intolerance when those criteria apply.
Deny requests that do not document an allowed monotherapy or combination regimen, including the specified Faslodex combinations or Inluriyo use with abemaciclib.
Deny requests exceeding the applicable dose limit: Fareston 60 mg/day, Inluriyo 400 mg/day, Orserdu 345 mg/day, or Veppanu 200 mg/day.

Denial Risk

Document Ongoing Clinical Response

Initial authorization may be approved for up to 12 months. Reauthorization may be approved for up to 12 months only when the drug-specific criteria remain satisfied and submitted chart notes document an ongoing positive clinical response.

Include current assessment and treatment-response documentation with each reauthorization request.
Continuation may be denied when the record does not document that the individual continues to respond positively to therapy.

Treatment of hormone-receptor-positive, HER2-negative advanced breast cancer in a postmenopausal woman not previously treated with endocrine therapy.

Treatment of hormone-receptor-positive advanced breast cancer in a postmenopausal woman with disease progression following endocrine therapy.

Treatment of hormone-receptor-positive, HER2-negative advanced or metastatic breast cancer in a postmenopausal woman as initial endocrine-based therapy or following disease progression on endocrine therapy, in combination with ribociclib.

Treatment of hormone-receptor-positive, HER2-negative advanced or metastatic breast cancer in a woman with disease progression following endocrine therapy, in combination with palbociclib or abemaciclib.

Treatment in combination with Truqap (capivasertib) for an adult with hormone-receptor-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.At least one PIK3CA, AKT1, or PTEN alteration

Required prior therapy: The individual has tried and had an inadequate response or intolerance to generic fulvestrant.

Inluriyo medical necessity criteria

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

Inluriyo: The individual is aged 18 years or older; has ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer; has experienced disease progression following at least one line of endocrine therapy; uses Inluriyo as monotherapy or in combination with abemaciclib; and the dose is limited to 400 mg per day.Age 18 years or older; dose not to exceed 400 mg per day

Orserdu medical necessity criteria

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

Orserdu: The individual is a postmenopausal female or a male aged 18 years or older; has ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer; has experienced disease progression following at least one line of endocrine therapy; and the dose is limited to 345 mg per day.Age 18 years or older for males; dose not to exceed 345 mg per day

Veppanu medical necessity criteria

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

Veppanu

Disease and treatment requirements: The individual is aged 18 years or older; has ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer; and has experienced disease progression following at least one line of endocrine therapy.
Required prior therapy or intolerance
- 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.
  Examples include a history of colitis.
Dose limitation: The dose is limited to 200 mg daily.200 mg daily

Orserdu dose limit

DrugOrserdu (elacestrant)

Dose limit345 mg per day

Covered useTreatment of ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer when applicable coverage criteria are met

Veppanu dose limit

DrugVeppanu (vepdegestrant)

Dose limit200 mg daily

Covered useTreatment of ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer when applicable coverage criteria are met

Fareston quantity limit

DrugFareston (toremifene)

Quantity limit30 tablets per 30 days

Related policyQuantity limits are addressed in policy 5.01.656 Drug Quantity Management

Orserdu quantity limit

DrugOrserdu (elacestrant)

Quantity limit periodPer 30 days

Specific quantityNot stated in this source window

Related policyQuantity limits are addressed in policy 5.01.656 Drug Quantity Management