CurrentViva HealthPolicy IC-0043

Fulvestrant: Faslodex®; Fulvestrant (Intramuscular)

Outlines medical necessity, dosing, indications, authorization length, renewal criteria, billing codes (HCPCS/NDC), and covered ICD-10 diagnoses for fulvestrant for commercial (non-Medicare) members of Viva Health. Includes specific coverage criteria for breast, ovarian, endometrial cancers and uterine sarcoma.

Policy Summary

PayerViva Health

PolicyFulvestrant: Faslodex®; Fulvestrant (Intramuscular)

Policy CodePolicy IC-0043

Change TypeNo material change

Effective DateJan 1, 2012

Next Review Date

Key ActionPrior authorization is required and coverage is provided for 6 months on initial approval; dosing regimens and indication-specific criteria must be documented.

POLICY UPDATE CHANGES

No material changes

4Covered primary cancer indications

3Named combination partners

3NDC manufacturers listed

Coverage Summary

Outlines medical necessity, dosing, covered ICD-10 diagnoses, and authorization length for fulvestrant in commercial (non‑Medicare) members. Indications covered include HR‑positive advanced or metastatic breast cancer (with multiple specified first‑line, subsequent, and post‑CDK4/6 scenarios), recurrent low‑grade serous ovarian cancer (epithelial/fallopian tube/primary peritoneal), grade 1–2 endometrioid endometrial carcinoma, and selected uterine sarcomas. Initial authorization is provided for 6 months with renewal allowed when criteria are met. Overall coverage stance: covered_with_criteria.

Initial Therapy Criteria

Initial Approval Criteria

Coverage is provided when ALL of the following are met:

ALL of the following

General patient criteria
- Age and endocrine status: Patient is at least 18 years of age
- Endocrine status: Patient is postmenopausal, premenopausal with ovarian ablation/suppression, or male (sex assigned at birth)
- Disease extent: Patient has recurrent unresectable (local or regional), advanced, or metastatic disease
HR+/HER2- with no visceral crisis: Patient has hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative disease with no visceral crisis
Indication-specific criteria (ONE of applies)
- Breast Cancer - first-line or combination uses
  - Context: Used as first-line therapy
  - Regimens (ONE of)
    Single agent: Used as a single agent
    CDK4/6 combination: Used in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib)
    Aromatase inhibitor combination: Used in combination with a non-steroidal aromatase inhibitor (anastrozole or letrozole)

Continuation / Renewal Criteria

Renewal Criteria

Coverage may be renewed when ALL of the following apply:

Renewal requirements

Continues to meet initial criteria: Patient continues to meet the indication-specific relevant criteria (concomitant therapy requirements, performance status, etc.) identified in Initial Approval Criteria
Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread
Tolerability: Absence of unacceptable toxicity from the drug (examples: bleeding abnormalities, severe injection site reactions including sciatica, neuralgia, neuropathic pain, peripheral neuropathy)

Applicable Codes

HCPCS codes for fulvestrantHCPCSCovered

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

NDCs (designated products)NDCCovered

00310-0720-xx	Faslodex 250 mg/5 mL single-dose prefilled syringe (multi-sourced generic available)
00591-5019-xx	Fulvestrant 250 mg/5 mL single-dose prefilled syringe (Teva) - 505(b)(2) NDA product
63323-0715-xx	Fulvestrant 250 mg/5 mL single-dose prefilled syringe (Fresenius Kabi) - 505(b)(2) NDA product

Covered diagnosis codes (ICD-10)ICD-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

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Provider Actions & Billing

Prior Authorization

Initial prior authorization required

Prior authorization (PA) is required for fulvestrant. Initial approval is provided for 6 months. Dosing regimens and indication-specific criteria must be documented when requesting authorization.

Affected HCPCS codes: J9395, J9393, J9394
Document dosing regimens (loading and maintenance) and indication-specific criteria

Billing Rule

Billing units and HCPCS mapping

Report fulvestrant using the specified HCPCS codes. One billable unit equals 25 mg. Follow the policy’s loading and maintenance billable unit schedules for each indication (breast/uterine sarcoma, ovarian, endometrial) when submitting claims.

HCPCS codes: J9395, J9393, J9394
Billable unit definition: 1 billable unit = 25 mg

Documentation Required

Mutation testing documentation for targeted combinations

When coverage is requested for combinations that require mutation or HER2 status, document results from an FDA-approved or CLIA-compliant test for the applicable biomarker(s) (PIK3CA, AKT1, PTEN, or HER2).

Alpelisib or inavolisib combinations: document PIK3CA activating mutation by an FDA-approved or CLIA-compliant test
Capivasertib combinations: document PIK3CA or AKT1 activating mutations or PTEN alterations by an FDA-approved or CLIA-compliant test
Trastuzumab-containing regimens / HER2-positive options: document HER2 status per FDA-approved or CLIA-compliant testing (IHC or dual-probe ISH criteria as specified)

Documentation Required

Concomitant therapy and endocrine status

Document concomitant endocrine suppression as applicable: for males receiving an aromatase inhibitor, document suppression of testicular steroidogenesis with a GnRH analog; for premenopausal or perimenopausal women receiving fulvestrant, document use of an LHRH (GnRH) agonist per clinical practice standards when required.

Males on an aromatase inhibitor: document GnRH analog use to suppress testicular steroidogenesis
Premenopausal/perimenopausal women: document LHRH agonist use when applicable

Background

Fulvestrant (Faslodex®) is an intramuscular estrogen receptor antagonist used primarily in hormone receptor‑positive advanced or metastatic breast cancer and in selected gynecologic malignancies (ovarian, endometrial, uterine sarcoma). Dosing varies by indication with specified loading and maintenance regimens (e.g., breast cancer/uterine sarcoma: 500 mg IM on Days 1, 15, 29 then 500 mg every 28 days; ovarian: 500 mg Day 1, 250 mg Days 15 and 29 then 250 mg every 28 days; endometrial: 250 mg every 28 days), and billable units are mapped as 1 billable unit = 25 mg. Some combination regimens require documentation of companion diagnostic testing (FDA‑approved or CLIA‑compliant) to confirm actionable mutations (e.g., PIK3CA, AKT1, PTEN) or HER2 status per the policy.

Definitions

Billable unit1 billable unit = 25 mg fulvestrant for HCPCS codes J9395/J9393/J9394

HER2-positive overexpressionDefined by IHC 3+, or dual-probe ISH criteria (HER2/CEP17 ratio and average HER2 copy number) and specific combinations with IHC per policy

Policy Summary

PayerViva Health

PolicyFulvestrant: Faslodex®; Fulvestrant (Intramuscular)

Policy CodePolicy IC-0043

Change TypeNo material change

Effective DateJan 1, 2012

Next Review Date

Key ActionPrior authorization is required and coverage is provided for 6 months on initial approval; dosing regimens and indication-specific criteria must be documented.

On This Page

Additional clinical context (ONE of)

Progression on adjuvant ET: Patient has had disease progression on adjuvant endocrine therapy (ET) or disease relapse within 12 months of adjuvant ET completion
Relapse or progression: Patient has had disease relapse, recurrence, or progression on or within 12 months of completing adjuvant endocrine therapy

Breast Cancer - subsequent therapy

Context: Used as subsequent therapy
Regimens (ONE of)
- Single agent: Used as a single agent
- Aromatase inhibitor combination: Used in combination with a non-steroidal aromatase inhibitor (anastrozole or letrozole)
- CDK4/6 if not prior: Used in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) if a CDK4/6 inhibitor was not previously used
- Everolimus combination: Used in combination with everolimus
- Alpelisib combination: Used in combination with alpelisib in patients with PIK3CA activating mutation positive disease as determined by an FDA-approved or CLIA-compliant test
- Capivasertib combination: Used in combination with capivasertib in patients with PIK3CA or AKT1 activating mutations or PTEN alterations, as determined by an FDA-approved or CLIA-compliant test
Clinical requirement (ONE of)
- Progressed on endocrine regimen: Used for disease that has progressed on at least one endocrine-based regimen in the metastatic setting
- Recurrence within 12 months: Used for disease recurrence on or within 12 months of completing adjuvant therapy

Breast Cancer - after prior endocrine plus CDK4/6

Context: Used after disease progression or recurrence after one or more prior lines of endocrine therapy (ET), including one line containing a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib)
HER2 status-based options (ONE of)
- HR-positive, HER2-positive disease: Patient has HR-positive, HER2-positive disease as determined by an FDA-approved or CLIA-compliant test
- HR+/HER2+ regimen options
  - Single agent or trastuzumab: Used as a single agent
  - Combination with trastuzumab: Used in combination with trastuzumab
- HER2-mutant stage IV: Patient has stage IV (M1) HER2-negative disease with activating HER2 mutation
- HER2-mutant regimen: Used in combination with trastuzumab and neratinib as third line and beyond therapy
- Triple negative or HR-positive after CDK4/6: Patient has triple negative disease; OR Patient has hormone receptor positive disease
- Prior CDK4/6: Patient has previously received CDK4/6 inhibitor therapy

Endometrial Carcinoma (uterine neoplasms)

Single agent: Used as single agent therapy
Histology: Patient has grade 1 or 2 endometrioid adenocarcinoma histology
Tumor volume/growth pace: Used in patients with a small tumor volume or an indolent growth pace
One of the uses (ONE of)
- Adjuvant stage IV: Adjuvant treatment for stage IV disease
- Disseminated metastases: Treatment for disseminated metastases or locoregional recurrence
- Primary extrauterine not for surgery: Primary treatment in patients with locoregional extrauterine disease that is not suitable for primary surgery
- Primary distant metastatic: Primary treatment in patients with distant metastatic disease

Uterine Sarcoma (uterine neoplasms)

Single agent: Used as single agent therapy
Tumor volume/growth pace: Used in patients with a small tumor volume or an indolent growth pace
Histologies (ONE of)
- Low-grade ESS: Low-grade endometrial stromal sarcoma (ESS)
- Adenosarcoma without sarcomatous overgrowth
- ER/PR positive uterine sarcoma
Treatment setting (ONE of)
- Post-hysterectomy stage II-IV: Used following total hysterectomy for stage II-IV disease
- Metastatic or recurrent: Used for metastatic or recurrent disease
- Primary treatment: Used as primary treatment
Surgical suitability/diagnosis (ONE of)
- Not suitable for primary surgery: Disease is not suitable for primary surgery (disease not amenable to resection or patient not suitable for surgery based on comorbidities)
- Extrauterine disease diagnosis: Patient has extrauterine disease diagnosed by biopsy or myomectomy

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