CurrentViva Health PlanPolicy IC-0043

Fulvestrant

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This policy governs prior authorization, dosing, initial approval, renewal, and administration requirements for fulvestrant products, including Faslodex, generic fulvestrant, and Cligavyx, for specified breast, ovarian, fallopian tube, primary peritoneal, endometrial, and uterine sarcoma cancers.

Policy Summary

PayerViva Health Plan

PolicyFulvestrant

Policy CodePolicy IC-0043

Change TypeNo material change

Effective DateN/A

Last ReviewAug 4, 2026

Next Review DateN/A

Key ActionSubmit prior authorization documentation showing the diagnosis, disease status, hormone receptor and HER2 status, and qualifying HER2 testing when applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial authorization validity

6 monthsRenewal authorization interval

18+Minimum member age

500 mgStandard Cligavyx loading dose

≥2.0

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CurrentViva Health PlanPolicy IC-0043

Fulvestrant

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Policy Summary

PayerViva Health Plan

PolicyFulvestrant

Policy CodePolicy IC-0043

Change TypeNo material change

Effective DateN/A

Last ReviewAug 4, 2026

Next Review DateN/A

Key ActionSubmit prior authorization documentation showing the diagnosis, disease status, hormone receptor and HER2 status, and qualifying HER2 testing when applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial authorization validity

6 monthsRenewal authorization interval

18+Minimum member age

500 mgStandard Cligavyx loading dose

≥2.0

HER2/CEP17 threshold

PAPrior authorization

Covered Indications

Breast cancer

Covered for breast cancer when all applicable criteria are met:

Breast cancer baseline and qualifying pathway

Baseline criteria
- Member is at least 18 years of age; member is postmenopausal, premenopausal with ovarian ablation or suppression, or male (sex assigned at birth); and member has recurrent unresectable local or regional disease, advanced disease, or metastatic disease.Age ≥18
  When an aromatase inhibitor is used in males, suppression of testicular steroidogenesis with a GnRH analog is required.
ONE qualifying breast cancer pathway
- ALL of the following
  - Member has hormone receptor-positive, HER2-negative disease with no visceral crisis.
- ALL of the following
  - Member has hormone receptor-positive, HER2-positive disease as determined by an FDA-approved or CLIA-compliant test.
  - Treatment setting
    Fulvestrant is used as a single agent.
    Fulvestrant is used in combination with trastuzumab.
- ALL of the following
  - Member has stage IV (M1) HER2-negative disease with an activating HER2 mutation.
  - Fulvestrant is used in combination with trastuzumab and neratinib or tucatinib as third-line or later therapy.
    The required combination and line of therapy must be documented.

Ovarian, fallopian tube, and primary peritoneal cancer

Covered for ovarian, fallopian tube, or primary peritoneal cancer when all criteria are met:

Gynecologic cancer criteria

Fulvestrant is used as single-agent therapy.
Member has recurrent low-grade serous carcinoma.Recurrent low-grade serous carcinoma
Member previously received treatment with an aromatase inhibitor such as letrozole, anastrozole, or exemestane.
Prior aromatase inhibitor therapy is required.

Uterine sarcoma

Covered for uterine sarcoma when all criteria are met:

Uterine sarcoma criteria

Fulvestrant is used as single-agent therapy.
Member has low-grade endometrial stromal sarcoma or adenosarcoma without sarcomatous overgrowth, and the uterine sarcoma is estrogen receptor/progesterone receptor positive.Low-grade ESS or adenosarcoma without sarcomatous overgrowth
ER/PR positivity is required.

Continuation and renewal therapy

Renewal is covered when all criteria are met:

Continuation and renewal criteria

Member continues to meet the relevant indication-specific criteria, including applicable concomitant-therapy requirements identified for the initial authorization.
Disease response is demonstrated by stabilization of disease or a decrease in the size of the tumor or tumor spread.
There is no unacceptable toxicity from fulvestrant.
Examples of unacceptable toxicity include bleeding abnormalities and severe injection-site reactions, including sciatica, neuralgia, neuropathic pain, and peripheral neuropathy.

Coverage for endometrial carcinoma requires grade 1 or 2 endometrioid adenocarcinoma histology. Fulvestrant may be used as single-agent therapy or with abemaciclib, but the combination is limited to estrogen receptor-positive tumors. Coverage excludes disease unsuitable for primary surgery with suspected or gross cervical involvement; locoregional recurrence without prior radiation to the recurrence site or after vaginal brachytherapy only; and disease confined to the vagina or paravaginal soft tissue after surgical exploration for locoregional recurrence.

Billing and Diagnostic Coding

Covered HCPCS CodesHCPCSCovered

J9395	Injection, fulvestrant, 25 mg; 1 billable unit = 25 mg
J9393	Injection, fulvestrant (teva), not therapeutically equivalent to J9395, 25 mg; 1 billable unit = 25 mg
J9394	Injection, fulvestrant (fresenius kabi) not therapeutically equivalent to J9395, 25 mg; 1 billable unit = 25 mg
J9999	Not otherwise classified, antineoplastic drugs
C9399	Unclassified drugs or biologicals (Hospital Outpatient Use Only)

Covered NDC CodesNDCCovered

83831-0159-xx	Cligavyx 250 mg/5ml single-dose prefilled syringe (Avyxa Pharma)
00310-0720-xx	Faslodex 250 mg/5 mL single-dose prefilled syringe
00591-5019-xx	Fulvestrant 250 mg/5 mL single-dose prefilled syringe (Teva)
63323-0715-xx	Fulvestrant 250 mg/5 mL single-dose prefilled syringe (Fresenius Kabi)

Covered Diagnosis CodesICD-10Covered

C48.1	Malignant neoplasm of specified parts of peritoneum
C48.2	Malignant neoplasm of peritoneum, unspecified
C48.8	Malignant neoplasm of overlapping sites of retroperitoneum and peritoneum
C50.011	Malignant neoplasm of nipple and areola, right female breast
C50.012	Malignant neoplasm of nipple and areola, left female breast
C50.019	Malignant neoplasm of nipple and areola, unspecified female breast
C50.021	Malignant neoplasm of nipple and areola, right male breast
C50.022	Malignant neoplasm of nipple and areola, left male breast
C50.029	Malignant neoplasm of nipple and areola, unspecified male breast
C50.111	Malignant neoplasm of central portion of right female breast

1–10 of 85

1/9

HER2/CEP17 ratio

Dual-probe ISH ratio thresholdHER2/CEP17 ratio ≥ 2.0

Ratio ≥2.0 with average copy number ≥4.0Qualifies when dual-probe ISH shows a HER2/CEP17 ratio ≥2.0 and average HER2 copy number ≥4.0 signals/cell

Ratio ≥2.0 with average copy number <4.0Requires concurrent IHC 3+

Ratio <2.0 with average copy number ≥6.0Requires concurrent IHC 2+ or 3+

Ratio <2.0 with average copy number 4.0 to <6.0Requires concurrent IHC 3+

Average HER2 copy number

Authorization and Documentation Requirements

Prior Authorization

Six-Month Prior Authorization

Prior authorization is required for fulvestrant. Initial authorization is valid for 6 months (180 days), and renewal may be requested every 6 months (180 days) thereafter.

Initial authorization term: 180 days.
Renewal interval: every 180 days.

Documentation Required

Initial Approval Requirements

Submit documentation showing that the member is at least 18 years old and that the applicable indication-specific approval criteria are met.

Breast cancer: Postmenopausal, premenopausal with ovarian ablation/suppression, or male (sex assigned at birth); recurrent unresectable local or regional, advanced, or metastatic disease; and HR-positive/HER2-negative disease without visceral crisis, or HR-positive/HER2-positive disease confirmed by an FDA-approved or CLIA-compliant test. Fulvestrant may be used alone or with trastuzumab for HER2-positive disease. For stage IV (M1) HER2-negative disease with an activating HER2 mutation, use must be with trastuzumab plus neratinib or tucatinib as third-line or later therapy.

Therapy Overview

Fulvestrant is an intramuscular estrogen receptor-directed therapy used in selected hormone-responsive breast and gynecologic cancers. Covered uses include specified breast cancer pathways and recurrent low-grade serous ovarian, fallopian tube, or primary peritoneal carcinoma, as well as selected endometrial carcinoma and uterine sarcoma. Administration is intramuscular; treatment generally continues until disease progression or unacceptable toxicity, with dosing varying by indication.

Biomarker and Disease Definitions

HER2-positive overexpression

IHC definitionImmunohistochemistry (IHC) assay 3+

Dual-probe ISH definitionHER2/CEP17 ratio ≥2.0 and average HER2 copy number ≥4.0 signals/cell

ISH with ratio ≥2.0 and copy number <4.0Concurrent IHC 3+

ISH with ratio <2.0 and copy number ≥6.0Concurrent IHC 2+ or 3+

ISH with ratio <2.0 and copy number 4.0 to <6.0Concurrent IHC 3+

Hormone receptor and HER2 status

HR-positive, HER2-negative disease

Initial Authorization Criteria

Renewal Authorization Criteria

Renewal therapy

Renewal may be authorized every 6 months when all continuation criteria are met:

Continuation requirements

Member continues to meet the applicable indication-specific criteria and concomitant-therapy requirements.Every 6 months
Disease is stable or reduced in size or spread.
There is no unacceptable toxicity from fulvestrant.
Examples include bleeding abnormalities and severe injection-site reactions, including sciatica, neuralgia, neuropathic pain, and peripheral neuropathy.

Prerequisite Therapy

Step	Requirement	Applies to
1	Prior treatment with an aromatase inhibitor, such as letrozole, anastrozole, or exemestane, is required before fulvestrant therapy.	Recurrent low-grade serous carcinoma of the ovary, fallopian tube, or primary peritoneum

Product Dosing and Quantity Limits

Faslodex and generic fulvestrant

IndicationOvarian cancer

Loading quantity20 billable units on day 1 and 10 billable units on days 15 and 29

Maintenance quantity10 billable units every 28 days

Faslodex and generic fulvestrant

IndicationAll other indications

Loading quantity20 billable units every 14 days for 3 doses

Maintenance quantity20 billable units every 28 days

Administration Requirements

Billing Rule

Use the required administration setting

Administer fulvestrant intramuscularly. For premenopausal and perimenopausal women, administer an LHRH agonist according to current clinical practice standards.

Site of care: office.
For men, consider administering an LHRH agonist according to current clinical practice standards.

Policy Summary

PayerViva Health Plan

PolicyFulvestrant

Policy CodePolicy IC-0043

Change TypeNo material change

Effective DateN/A

Last ReviewAug 4, 2026

Next Review DateN/A

Key ActionSubmit prior authorization documentation showing the diagnosis, disease status, hormone receptor and HER2 status, and qualifying HER2 testing when applicable.

SourceLink

On This Page

Average copy number ≥4.0 signals/cellQualifies when the HER2/CEP17 ratio is ≥2.0

Average copy number <4.0 signals/cellWith a HER2/CEP17 ratio ≥2.0, concurrent IHC 3+ is required

Average copy number ≥6.0 signals/cellWith a HER2/CEP17 ratio <2.0, concurrent IHC 2+ or 3+ is required

Average copy number ≥4.0 and <6.0 signals/cellWith a HER2/CEP17 ratio <2.0, concurrent IHC 3+ is required

Ovarian, fallopian tube, or primary peritoneal cancer: Single-agent therapy for recurrent low-grade serous carcinoma after prior aromatase inhibitor treatment.

Endometrial carcinoma: Single-agent therapy or combination therapy with abemaciclib for estrogen receptor-positive tumors, in grade 1 or 2 endometrioid adenocarcinoma.

Uterine sarcoma: Single-agent therapy for low-grade endometrial stromal sarcoma or adenosarcoma without sarcomatous overgrowth when the uterine sarcoma is ER/PR-positive.

When an aromatase inhibitor is used in a male member, suppression of testicular steroidogenesis with a GnRH analog is required.

Prior Authorization

Prior Authorization Applies

Fulvestrant is subject to utilization management and prior authorization based on the indication and the drug's cost.

Prior authorization is considered for the indication and drug cost.
The utilization-management requirement applies to this medical-benefit prescription drug.

Step Therapy

Prior Aromatase Inhibitor Requirement

For recurrent low-grade serous carcinoma of the ovary, fallopian tube, or primary peritoneum, document prior aromatase inhibitor therapy before requesting fulvestrant.

Required prior therapy includes letrozole, anastrozole, or exemestane.
Fulvestrant must be used as single-agent therapy.
Disease must be recurrent low-grade serous carcinoma.

Documentation Required

Cancer Diagnosis and Biomarker Documentation

Document the cancer diagnosis, disease status, hormone-receptor status, and HER2 test results supporting the requested indication.

Identify the diagnosis and disease status, including recurrent unresectable local or regional, advanced, metastatic, or stage IV/M1 disease when applicable.
Document HR status and HER2 status, including HER2-negative disease without visceral crisis when applicable.
For HER2-positive disease, provide results from an FDA-approved or CLIA-compliant test. Acceptable overexpression evidence includes IHC 3+; dual-probe ISH with HER2/CEP17 ratio ≥ 2.0 and average HER2 copy number ≥ 4.0 signals/cell; or qualifying concurrent ISH and IHC results: ratio ≥ 2.0 with average copy number < 4.0 and IHC 3+, ratio < 2.0 with average copy number ≥ 6.0 and IHC 2+ or 3+, or ratio < 2.0 with average copy number ≥ 4.0 and < 6.0 and IHC 3+.
If confirmed using an immunotherapy assay, document the assay and supporting result; FDA companion-diagnostic information is available at http://www.fda.gov/companiondiagnostics.

Step Therapy

Prior Aromatase Inhibitor Therapy

For the recurrent low-grade serous gynecologic carcinoma indication, document that the member previously received an aromatase inhibitor.

Document the prior agent and treatment history: letrozole, anastrozole, or exemestane.
This prerequisite applies before fulvestrant is authorized for recurrent low-grade serous ovarian, fallopian tube, or primary peritoneal carcinoma.

Documentation Required

Renewal Clinical Response and Tolerability

For renewal, document that the member continues to meet the applicable indication-specific criteria, including required concomitant therapy and other relevant clinical requirements, and is benefiting from and tolerating treatment.

Disease response demonstrated by stabilization or decrease in tumor size or tumor spread.
Continued fulfillment of indication-specific criteria identified for initial approval; prerequisite therapy is not itself a renewal requirement.
No unacceptable toxicity from fulvestrant, including bleeding abnormalities or severe injection-site reactions such as sciatica, neuralgia, neuropathic pain, or peripheral neuropathy.

Denial Risk

Excluded Endometrial Carcinoma Uses

Fulvestrant is not covered for specified endometrial carcinoma uses. Document that none of the following exclusion conditions applies.

Disease is not suitable for primary surgery in a member with suspected or gross cervical involvement.
Therapy is for locoregional recurrence in a member with no prior radiation therapy to the recurrence site or with previous vaginal brachytherapy only.
Therapy follows surgical exploration for locoregional recurrence when disease is confined to the vagina or paravaginal soft tissue.

Denial Risk

Renewal Failure Criteria

Renewal may be denied when the member no longer meets the indication-specific criteria, lacks documented response, or experiences unacceptable toxicity.

Failure to continue required indication-specific criteria or concomitant therapy.
Disease progression without stabilization or decrease in tumor size or tumor spread.
Unacceptable toxicity, including bleeding abnormalities or severe injection-site, sciatic, neuralgic, or peripheral neuropathic reactions.

Denial Risk

Indication-Specific Criteria Not Met

Initial authorization may be denied when the member is younger than 18 or when the requested use does not satisfy the applicable indication-specific criteria and documentation requirements.

Breast cancer criteria are not met, including required menopausal/sex status, disease status, HR/HER2 status, absence of visceral crisis when applicable, or required combination therapy.
Ovarian, fallopian tube, or primary peritoneal cancer criteria are not met, including recurrent low-grade serous histology, single-agent use, or prior aromatase inhibitor therapy.
Endometrial carcinoma criteria are not met, including required histology, treatment regimen, estrogen-receptor status for abemaciclib combination, or exclusion-condition documentation.
Uterine sarcoma criteria are not met, including low-grade ESS or adenosarcoma without sarcomatous overgrowth and ER/PR-positive status.
Required diagnosis, disease-status, receptor-status, HER2-testing, or prior-therapy documentation is absent or does not support the request.

Qualifying breast cancer disease without visceral crisis

HR-positive, HER2-positive diseaseMust be determined by an FDA-approved or CLIA-compliant test; fulvestrant may be used as a single agent or in combination with trastuzumab

HER2-negative disease with activating HER2 mutationStage IV (M1) disease; fulvestrant must be used with trastuzumab and neratinib or tucatinib as third-line or later therapy

Cligavyx

IndicationOvarian cancer

Loading dose500 mg on day 1 and 250 mg on days 15 and 29

Maintenance dose250 mg every 28 days

Cligavyx

IndicationAll other indications

Loading dose500 mg every 14 days for 3 doses

Maintenance dose500 mg every 28 days