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 requesting coverage 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 DateFeb 5, 2027

Last ReviewFeb 5, 2027

Next Review DateNot scheduled

Key ActionSubmit office visit notes documenting the diagnosis, relevant history, physical evaluation, and medication history.

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 updated to require use as monotherapy or in combination with abemaciclib.

Removed quantity limits for Fareston (toremifene), Inluriyo (imlunestrant), and Orserdu (elacestrant) from this policy.

Added coverage criteria for Inluriyo (imlunestrant) for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer after progression on at least one line of endocrine therapy.

Removed coverage criteria for Arimidex (anastrozole), Aromasin (exemestane), and Evista (raloxifene).

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

Updated Faslodex (fulvestrant) coverage to apply under both the pharmacy and medical benefits.

Added Cligavyx (fulvestrant) to the policy.

6Brand drugs addressed

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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 DateFeb 5, 2027

Last ReviewFeb 5, 2027

Next Review DateNot scheduled

Key ActionSubmit office visit notes documenting the diagnosis, relevant history, physical evaluation, and medication history.

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 updated to require use as monotherapy or in combination with abemaciclib.

Removed quantity limits for Fareston (toremifene), Inluriyo (imlunestrant), and Orserdu (elacestrant) from this policy.

Removed coverage criteria for Arimidex (anastrozole), Aromasin (exemestane), and Evista (raloxifene).

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

Updated Faslodex (fulvestrant) coverage to apply under both the pharmacy and medical benefits.

Added Cligavyx (fulvestrant) to the policy.

6Brand drugs addressed

Maximum authorization period

J9395Faslodex HCPCS code added

3Quantity limits removed

4Products added or expanded

Drug-Specific Coverage Criteria

Fareston (toremifene) — Metastatic Breast Cancer

Fareston (toremifene) may be considered medically necessary for metastatic breast cancer when ALL of the following criteria are met:

ALL of the following

The individual is a postmenopausal female.
The individual has estrogen receptor-positive or estrogen receptor-unknown tumors.
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)

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 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 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) — ESR1-Mutated Breast Cancer

Inluriyo (imlunestrant) may be considered medically necessary when ALL of the following criteria are met:

ALL of the following

The individual is aged 18 years or older.
The individual has estrogen receptor (ER)-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer.
The individual has experienced disease progression following at least 1 line of endocrine therapy.
ONE of the following
- Inluriyo (imlunestrant) is used as monotherapy.
- Inluriyo (imlunestrant) is used in combination with abemaciclib.

Orserdu (elacestrant) — ESR1-Mutated Breast Cancer

Orserdu (elacestrant) may be considered medically necessary 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 estrogen receptor (ER)-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer.
The individual has experienced disease progression following at least 1 line of endocrine therapy.
The dose is limited to 345 mg per day.<= 345 mg/day

Veppanu (vepdegestrant) — ESR1-Mutated Breast Cancer

Veppanu (vepdegestrant) may be considered medically necessary when ALL of the following criteria are met:

ALL of the following

The individual is aged 18 years or older.
The individual has estrogen receptor (ER)-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer.
The individual has experienced disease progression following at least 1 line of endocrine therapy.
ONE of the following
- The individual has tried and had an inadequate response or intolerance to elacestrant or imlunestrant.
- Documentation shows actual or anticipated gastrointestinal intolerance (e.g., history of colitis) or dyslipidemia with elacestrant or imlunestrant.

Reauthorization

Reauthorization may be approved for up to 12 months 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.

Applicable Billing Codes

HCPCS CodesHCPCS

J9395	Injection, fulvestrant, (Faslodex), 25 mg
J9999	Not otherwise specified, antineoplastic drugs (used to report Cligavyx)

Faslodex (fulvestrant)HCPCSCovered

J9395

HCPCS code for Faslodex (fulvestrant)

Authorization and Documentation Requirements

Prior Authorization

Fareston Prior Authorization

Prior authorization is required for Fareston (toremifene). Submit documentation that the individual has metastatic breast cancer, is a postmenopausal female, has an estrogen receptor-positive or unknown tumor, and has tried generic toremifene with inadequate response or intolerance. The dose must not exceed 60 mg per day.

Postmenopausal female with metastatic breast cancer
Estrogen receptor-positive or unknown tumor
Inadequate response or intolerance to generic toremifene
Maximum dose: 60 mg per day

Prior Authorization

Cligavyx or Faslodex Prior Authorization

Prior authorization is required for Cligavyx or Faslodex (fulvestrant). Document an eligible HR-positive breast cancer indication, applicable menopausal and HER2 status, disease progression or prior endocrine-therapy history when required, and prior inadequate response or intolerance to generic fulvestrant.

Clinical Background

Approximately two-thirds of breast cancers express estrogen receptor alpha. Estrogen-receptor-positive tumors depend on estrogen signaling for growth, survival, and progression, making the estrogen-receptor pathway an important treatment target.

Selective estrogen receptor modulators (SERMs) and selective estrogen receptor down-regulators (SERDs) are endocrine therapies that block estrogen-receptor function or signaling. This policy addresses Fareston (toremifene), Cligavyx and Faslodex (fulvestrant), Inluriyo (imlunestrant), Orserdu (elacestrant), and Veppanu (vepdegestrant) for specified hormone-receptor-positive advanced or metastatic breast cancer indications. Some SERMs may also have estrogenic effects on bone, including reducing bone loss, improving bone mineral density, and reducing vertebral-fracture risk.

Clinical Definitions

HER2-negative

IHC 0HER2-negative

IHC 1+HER2-negative

IHC 2+HER2-negative when there is no amplification on in situ hybridization

ER-positive

DefinitionA tumor with detectable estrogen-receptor expression

Policy useUsed in the indications for Inluriyo, Orserdu, and Veppanu

Disease settingAdvanced or metastatic breast cancer

Initial Authorization

Initial authorization may be approved when the applicable product-specific medical-necessity criteria below are met. The product's FDA dosage and administration information applies.

ONE applicable product pathway

Fareston: The Fareston criteria are met for treatment of metastatic breast cancer.
Cligavyx or Faslodex: The Cligavyx or Faslodex criteria are met for an eligible hormone-receptor-positive advanced or metastatic breast cancer indication, including an applicable endocrine-therapy or combination-therapy indication.
Inluriyo: The Inluriyo criteria are met for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer after progression following at least one line of endocrine therapy.

Continuation Authorization

Continuation authorization may be approved for up to 12 months when ALL of the following criteria are met:

Continuation therapy

The applicable drug-specific coverage criteria remain satisfied.
Chart notes demonstrate that the individual continues to show a positive clinical response to therapy.

Required Prior Therapy

Step	Requested medication	Prior therapy or assessment required
1	Fareston (toremifene)	Try generic toremifene and document inadequate response or intolerance.

Step	Requested medication	Prior therapy or assessment required
1	Cligavyx or Faslodex (fulvestrant)	Try generic fulvestrant and document inadequate response or intolerance.

Step	Requested medication	Prior therapy or assessment required
1	Veppanu (vepdegestrant)	Try or assess elacestrant or imlunestrant; document inadequate response or intolerance, or actual or anticipated gastrointestinal intolerance or dyslipidemia.

Drug Dosage and Quantity Information

Fareston (toremifene)

DrugFareston (toremifene)

Maximum dose60 mg

FrequencyPer day

Inluriyo (imlunestrant)

DrugInluriyo (imlunestrant)

Maximum dose400 mg

FrequencyPer day

Policy Summary

PayerPremera Blue Cross of Washington

PolicySelective Estrogen Receptor Modulators and Down Regulators

Policy CodePolicy 5.01.618

Change TypeModified

Effective DateFeb 5, 2027

Last ReviewFeb 5, 2027

Next Review DateNot scheduled

Key ActionSubmit office visit notes documenting the diagnosis, relevant history, physical evaluation, and medication history.

SourceLink

On This Page

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

The dose is limited to 400 mg per day.<= 400 mg/day

The dose is limited to 200 mg daily.<= 200 mg/day

Covered indications include specified HR-positive advanced or metastatic breast cancer settings, including use with ribociclib, palbociclib, abemaciclib, or Truqap when policy criteria are met
Document postmenopausal status when required by the selected indication
For Truqap combination therapy, document adult status, HR-positive/HER2-negative locally advanced or metastatic disease, qualifying PIK3CA/AKT1/PTEN alterations, and progression or recurrence after endocrine-based therapy
Maximum dose requirements and HER2-negative testing definitions must be satisfied
Inadequate response or intolerance to generic fulvestrant is required

Prior Authorization

Inluriyo Prior Authorization

Prior authorization is required for Inluriyo (imlunestrant). Submit records confirming that the individual is at least 18 years old and has ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with progression after at least one line of endocrine therapy. Identify whether Inluriyo will be used as monotherapy or with abemaciclib, and ensure the dose does not exceed 400 mg per day.

Adult age: 18 years or older
ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer
Progression following at least 1 line of endocrine therapy
Monotherapy or combination with abemaciclib
Maximum dose: 400 mg per day

Prior Authorization

Orserdu Prior Authorization

Prior authorization is required for Orserdu (elacestrant). Document an adult patient who is a postmenopausal female or male age 18 or older with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer and progression after at least one line of endocrine therapy. The dose must not exceed 345 mg per day.

Postmenopausal female or male aged 18 years or older
ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer
Progression following at least 1 line of endocrine therapy
Maximum dose: 345 mg per day

Prior Authorization

Veppanu Prior Authorization

Prior authorization is required for Veppanu (vepdegestrant). Submit documentation that the individual is at least 18 years old and has ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with progression after at least one line of endocrine therapy. The dose must not exceed 200 mg daily.

Adult age: 18 years or older
ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer
Progression following at least 1 line of endocrine therapy
Maximum dose: 200 mg daily

Step Therapy

Generic Toremifene Step

Step therapy applies before Fareston. Document a trial of generic toremifene with inadequate response or intolerance before requesting Fareston.

Prior generic toremifene trial required
Document inadequate response or intolerance

Step Therapy

Generic Fulvestrant Step

Step therapy applies before Cligavyx or Faslodex. Document a trial of generic fulvestrant with inadequate response or intolerance before requesting either branded or authorized product.

Prior generic fulvestrant trial required
Document inadequate response or intolerance

Step Therapy

Prior Oral SERD Step for Veppanu

Veppanu requires a prior oral SERD step unless an exception is documented. Show inadequate response or intolerance to elacestrant or imlunestrant, or document an actual or anticipated contraindication such as gastrointestinal intolerance or dyslipidemia.

Prior inadequate response or intolerance to elacestrant or imlunestrant
Alternatively, document actual or anticipated gastrointestinal intolerance, such as a history of colitis, or dyslipidemia with either agent

Documentation Required

Required Medical Records

Submit complete medical records with each request. Office visit notes should document the diagnosis, relevant history, physical evaluation, and medication history supporting medical necessity.

Office visit notes
Diagnosis and relevant history
Physical evaluation
Medication history

Documentation Required

Veppanu Cardiac and Electrolyte Monitoring

Veppanu requires cardiac and electrolyte monitoring. Document ECG and electrolyte monitoring at baseline, approximately 4 weeks after initiation, and periodically as clinically indicated because QTc prolongation is a clinically meaningful safety consideration.

Baseline ECG and electrolyte monitoring
Repeat ECG and electrolytes approximately 4 weeks after initiation
Periodic monitoring as clinically indicated

Denial Risk

Failure to Meet Drug-Specific Criteria

Requests may be denied when drug-specific criteria are not met. Ensure the record supports the required diagnosis, age or menopausal status, ER/HER2/ESR1 or other biomarker results, prior endocrine or product-specific therapy, disease progression, dosing limits, and any other applicable criteria.

Diagnosis and disease stage must match the requested drug
Required age or menopausal status must be documented
Required receptor, HER2, ESR1, or other biomarker status must be documented
Required prior treatment, progression, response, or intolerance must be documented
Dose limits and other drug-specific requirements must be met

Denial Risk

Investigational or Non-FDA-Directed Use

Use outside the policy’s medically necessary criteria or applicable FDA-directed use may be considered investigational. The listed medications must be prescribed according to the product’s US Food and Drug Administration dosage and administration information and the applicable coverage criteria.

Confirm the requested use is medically necessary under the policy
Follow the product’s US FDA dosage and administration prescribing information
Non-FDA-directed or otherwise unqualified use may not be covered

Denial Risk

Document Clinical Response for Reauthorization

Continuation authorization requires evidence of ongoing benefit. Although authorization may be approved for up to 12 months, reauthorization may be denied if chart notes do not demonstrate that the individual continues to show a positive clinical response and meets the drug-specific coverage criteria.

Submit current chart notes for reauthorization
Document ongoing positive clinical response
Confirm continued satisfaction of drug-specific criteria

ESR1-mutated advanced or metastatic breast cancer

Disease stateAdvanced or metastatic breast cancer

Biomarker requirementThe breast cancer contains a mutation in the ESR1 gene

Products using this definitionInluriyo, Orserdu, and Veppanu

Orserdu: The Orserdu criteria are met for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer after progression following at least one line of endocrine therapy.

Veppanu: The Veppanu criteria are met for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer after progression following at least one line of endocrine therapy, including the required prior-therapy or intolerance condition.

Orserdu (elacestrant)

DrugOrserdu (elacestrant)

Maximum dose345 mg

FrequencyPer day

Veppanu (vepdegestrant)

DrugVeppanu (vepdegestrant)

Maximum dose200 mg

FrequencyDaily