ModifiedmhnPolicy CP.PHAR.424

Clinical Policy: Fulvestrant (Faslodex Injection)

Medical necessity and prior authorization criteria for fulvestrant (Faslodex Injection) for advanced breast cancer and selected off-label gynecologic cancers; applies to providers requesting coverage.

Policy Summary

Payermhn

PolicyFulvestrant (Faslodex Injection) coverage criteria

Policy CodePolicy CP.PHAR.424

Change TypeClinical and operational updates (criteria alignment, generic redirection, coding additions)

Effective DateMay 14, 2019

Next Review Date

Key ActionSubmit prior authorization with clinical documentation that member meets listed criteria and include appropriate HCPCS code for the fulvestrant product.

SourceLink

POLICY UPDATE CHANGES

Revised policy/criteria section to also include generic fulvestrant and added redirection to generic fulvestrant for all indications.

Removed stage II and IIIA disease references from endometrial carcinoma criteria and removed adjuvant therapy for stage IV disease from endometrial carcinoma criteria for consolidation.

Added additional criteria options for recurrent and extrauterine disease for uterine carcinoma criteria per NCCN.

For breast cancer, added triple negative disease option per NCCN; for ovarian/fallopian tube/primary peritoneal, endometrial, and uterine cancers, added requirement for monotherapy per NCCN.

Added HCPCS codes J9393 and J9394 in addition to J9395 for fulvestrant product-specific coding.

500 mgmaximum recommended monthly dose

6 monthstypical initial approval

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Coverage and Medical Necessity Criteria

Initial Therapy - Low-grade serous ovarian/fallopian tube/primary peritoneal cancer

Covered when ALL of the following are met

Low-grade serous carcinoma criteria: 1. Diagnosis of ovarian, fallopian tube, or primary peritoneal cancer; 2. Prescribed by or in consultation with an oncologist; 3. Disease is classified as low-grade serous carcinoma; 4. Prescribed as single-agent (monotherapy) therapy; 5. For Faslodex requests, member must use fulvestrant, if available, unless contraindicated or clinically significant adverse effects are experienced; 6. Dose is within FDA maximum limit for any FDA-approved indication or is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN.

Initial Therapy - Endometrial carcinoma

Covered when ALL of the following are met

Endometrial carcinoma criteria: 1. Diagnosis of endometrial carcinoma; 2. Prescribed by or in consultation with an oncologist; 3. Disease is classified as grade 1 or 2 endometrioid carcinoma; 4. Fulvestrant is prescribed for either: a) recurrent or metastatic disease OR b) disease not suitable for primary surgery; 5. Prescribed as single-agent (monotherapy) therapy; 6. For Faslodex requests, member must use fulvestrant, if available, unless contraindicated or clinically significant adverse effects are experienced; 7. Dose is within FDA maximum limit for any FDA-approved indication or is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN.

Initial Therapy - Uterine sarcoma

Covered when ALL of the following are met

Uterine sarcoma criteria: 1. Diagnosis of uterine sarcoma; 2. Prescribed by or in consultation with an oncologist; 3. Disease is classified as one of: a) low-grade endometrial stromal sarcoma; b) adenosarcoma without sarcomatous overgrowth; c) HR-positive (ER/PR-positive) uterine sarcoma; 4. Fulvestrant is prescribed in one of the following settings: a) following total hysterectomy; b) for vaginal or pelvic recurrence; c) for recurrent or metastatic disease; d) for disease not suitable for primary surgery; e) for extrauterine disease; 5. Prescribed as single-agent (monotherapy) therapy; 6. For Faslodex requests, member must use fulvestrant, if available, unless contraindicated or clinically significant adverse effects are experienced; 7. Dose is within FDA maximum limit for any FDA-approved indication or is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN.

Continuation Therapy

Covered when ALL of the following are met

Continuation therapy criteria: 1. Member is currently receiving fulvestrant via the Centene benefit, or documentation supports that the member has received fulvestrant for at least 30 days; 2. Member is responding positively to therapy; 3. For Faslodex requests, member must use fulvestrant, if available, unless contraindicated or clinically significant adverse effects are experienced; 4. If the request is for a dose increase, the new dose meets one of the following: a) does not exceed 500 mg once monthly; OR b) is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN.

Medically Necessary Indications

Covered when ALL of the following are met for the specified indications:

Breast cancer - Monotherapy: HR-positive, HER2-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy OR HR-positive advanced breast cancer in postmenopausal women with disease; prescribed as monotherapy.

Dosing: 500 mg IM on Days 1, 15, 29 then once monthly thereafter (maximum: 500 mg three times in first month then once monthly).

Breast cancer - Combination: HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib as initial endocrine-based therapy or following progression on endocrine therapy; or in combination with palbociclib or abemaciclib in women with progression after endocrine therapy.

Ribociclib 600 mg PO QD 21/7; Palbociclib 125 mg PO QD 21/7; Abemaciclib 150 mg PO BID (clinical note: pre/perimenopausal women should receive LHRH agonist when treated with combination).

Other tumor types per NCCN: Policy includes coverage options for uterine, endometrial, ovarian, fallopian tube, and primary peritoneal cancers with updated criteria per NCCN; monotherapy requirement applied for specified off-label tumor types.

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider submits sufficient documentation demonstrating efficacy and safety in accordance with the applicable off‑label use policies (see CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or evidence of coverage documents.

This policy does not authorize use of fulvestrant for non–FDA approved indications unless the request is supported by adequate documentation per the applicable off‑label use policies referenced above (CP.CPA.09, HIM.PA.154, CP.PMN.53) or other authorized evidence of coverage.

Uses that are non‑FDA approved and not addressed within this policy will be considered not authorized absent adequate supporting evidence of efficacy and safety as required by the referenced off‑label use policies.

Requests for fulvestrant for indications that are not FDA‑approved and are not covered by this policy are not authorized unless the prescriber provides the documentation required by the off‑label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) demonstrating appropriate clinical support.

Regimens, Dosing, and Combination Therapies

Regimen	Indication / Line	Dose / Schedule	Coverage
Fulvestrant (monotherapy)
HR-positive, HER2-negative advanced breast cancer; postmenopausal women; used as monotherapy for patients not previously treated with endocrine therapy or following progression on endocrine therapy
Fulvestrant 500 mg IM: loading doses on Days 1, 15, and 29 (administered as two 5 mL injections, one in each buttock), then 500 mg IM once monthly; maximum dose = 500 mg three times in the first month then once monthly
Covered with criteria

Combination Regimen	Indication / Setting	Dose / Schedule	Coverage
Fulvestrant + Abemaciclib
HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women; used in women with disease progression after endocrine therapy
Fulvestrant 500 mg IM Days 1, 15, 29 then once monthly; Abemaciclib 150 mg PO twice daily (note: some references list 300 mg/day). Pre/perimenopausal women should receive LHRH agonist when treated with the combination.
Covered with criteria

Positioning by Treatment Line

first-line | second-line

Combination therapy line: Fulvestrant in combination with ribociclib as initial endocrine-based therapy or following disease progression; in combination with palbociclib or abemaciclib after progression on endocrine therapy.

first-line | second-line

Combination with CDK4/6 inhibitors: Used as initial endocrine-based therapy in combination with ribociclib or following progression on endocrine therapy; used in combination with palbociclib or abemaciclib after progression on endocrine therapy.

Biomarker and Diagnostic Requirements

HR (ER/PR), HER2 — biomarker requirements

Required biomarkersHormone receptor (ER and/or PR) status and HER2 status must be documented to determine eligibility for fulvestrant therapy.

HR definition for eligibilityHR refers to estrogen receptor (ER) and/or progesterone receptor (PR) positivity; HR-positive tumors are eligible per criteria.

HER2 roleHER2 testing required to confirm HER2-negative status for the HR-positive, HER2-negative indication; triple-negative breast cancer is separately listed in criteria.

HR, HER2 — HR-positive; HER2-negative

Primary biomarker requirementHR-positive (estrogen and/or progesterone receptor positive) tumors — eligible for fulvestrant per monotherapy and combination indications.

HER2 status for breast indication

Provider Requirements, Documentation, and Billing

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must submit documentation that the member meets all applicable clinical criteria (diagnosis, prescriber specialty, age, hormone receptor [HR] and HER2 status where applicable, prior endocrine therapy status, dosing regimen, and rationale for combination or off-label use). Approval is contingent on meeting the policy's specified criteria for the requested indication.

Prior authorization required before coverage is provided.
Prescriptions should be by or in consultation with an oncologist when specified in criteria.
Age and diagnostic criteria (e.g., advanced/metastatic disease, HR/HER2 status) must be documented.

Billing Rule

Prior Authorization and Coding

Billing Codes and Dosage Details

HCPCS Codes for FulvestrantHCPCS

J9393	Injection, fulvestrant (teva) not therapeutically equivalent to J9395, 25 mg.
J9394	Injection, fulvestrant (fresenius kabi) not therapeutically equivalent to J9395, 25 mg.
J9395	Injection, fulvestrant, 25 mg

Dosage per administration — 500 mg IM (administered as two 5 mL injections; 250 mg/5 mL per syringe)

Dose per administration500 mg intramuscular (IM) administered as two 5 mL injections (one in each buttock); each syringe contains 250 mg/5 mL.

Loading scheduleAdminister on Days 1, 15, and 29 (three doses in the first month) then once monthly thereafter.

Maximum initial dosingMaximum dosing described: 500 mg three times during the first month then once monthly for maintenance.

Background and Drug Information

Fulvestrant is an estrogen receptor antagonist indicated for HR‑positive, HER2‑negative advanced breast cancer in postmenopausal women and may be used as monotherapy or in combination with specified CDK4/6 inhibitors per FDA labeling and NCCN‑recommended regimens. Dosing commonly follows a loading and maintenance schedule of 500 mg IM on Days 1, 15, 29 then monthly for the approved breast cancer indications.

Defined Terms

hormone receptor (ER or PR) positive — HR-positive

DefinitionHormone receptor (ER or PR) positive: presence of estrogen receptor (ER) and/or progesterone receptor (PR) on tumor cells (HR-positive).

AbbreviationTerm abbreviated as HR in the policy (HR = hormone receptor).

Clinical relevanceHR-positive status is used to determine eligibility for fulvestrant monotherapy or combination regimens in advanced breast cancer.

human epidermal growth factor receptor 2 negative — HER2-negative

DefinitionHuman epidermal growth factor receptor 2 negative: tumor lacks overexpression or amplification of HER2 (HER2-negative).

Clinical implicationHER2-negative status is required for the HR-positive advanced breast cancer indications for fulvestrant (monotherapy and combinations).