CurrentViva HealthPolicy IC-0043

Fulvestrant: Faslodex®; Fulvestrant Ψ (Intramuscular)

Defines coverage, clinical criteria, dosing, renewal, authorized duration, applicable HCPCS and NDC codes, and covered ICD-10 diagnoses for fulvestrant (Faslodex and specified manufacturers) for Viva Health members. Addresses breast, ovarian, endometrial cancers and uterine sarcoma indications and related combination regimens and testing requirements.

Policy Summary

PayerViva Health

PolicyFulvestrant: Faslodex®; Fulvestrant Ψ (Intramuscular)

Policy CodePolicy IC-0043

Change TypeNo material change

Effective DateJan 1, 2012

Next Review Date

Key ActionInitial authorization provided for 6 months; may be renewed if renewal criteria are met (disease response, continued meeting of indication-specific criteria, absence of unacceptable toxicity).

POLICY UPDATE CHANGES

No material clinical or coverage changes.

4Covered Indications (major disease groups)

3HCPCS / J-codes listed

70+Covered ICD-10 diagnosis codes listed

Coverage Summary

Scope: Defines coverage, clinical criteria, dosing, renewal, authorized duration, applicable HCPCS and NDC codes, and covered ICD-10 diagnoses for fulvestrant (Faslodex and specified manufacturers) for Viva Health members, addressing breast, ovarian, endometrial cancers and uterine sarcoma indications and related combination regimens and testing requirements. Coverage stance: Covered with criteria. Background: Fulvestrant is an intramuscular estrogen receptor antagonist indicated and recommended by compendia for various hormone receptor-positive gynecologic and breast malignancies; dosing differs by indication with 500 mg and 250 mg schedules and includes specified loading and maintenance regimens.

General Initial Approval Criteria

Coverage is provided when ALL of the following are met:

ALL of the following

Patient is at least 18 years of age
Patient is postmenopausal, premenopausal with ovarian ablation/suppression, or male (sex assigned at birth)
Patient has recurrent unresectable (local or regional), advanced, or metastatic disease
Patient has hormone receptor (HR)-positive, HER2-negative disease with no visceral crisis

Condition-specific Initial and Subsequent Therapy Criteria

Breast Cancer - First-line or Subsequent Therapy

Coverage provided when ALL of the following condition-specific requirements are met (multiple alternative regimens allowed):

ALL of the following

Therapy setting
- Used as first-line therapy; AND used as a single agent
- Used as first-line therapy in combination with a CDK 4/6 inhibitor (abemaciclib, palbociclib, or ribociclib)
- Used in combination with a non-steroidal aromatase inhibitor (anastrozole or letrozole)
- Used in combination with inavolisib and palbociclib in patients with PIK3CA activating mutation positive disease as determined by an FDA-approved or CLIA-compliant test
- Used as subsequent therapy as a single agent
- Used as subsequent therapy in combination with a non-steroidal aromatase inhibitor (anastrozole or letrozole)
- Used as subsequent therapy in combination with a CDK 4/6 inhibitor if a CDK 4/6 inhibitor was not previously used
- Used in combination with everolimus
- Used in combination with alpelisib in patients with PIK3CA activating mutation positive disease as determined by an FDA-approved or CLIA-compliant test
- 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
- Used after disease progression or recurrence after one or more prior lines of endocrine therapy (including one line containing a CDK4/6 inhibitor)
- Used as single agent or in combination with trastuzumab in HR-positive, HER2-positive disease as determined by an FDA-approved or CLIA-compliant test
- Used in combination with trastuzumab and neratinib for stage IV (M1) HER2-negative disease with activating HER2 mutation as third line and beyond
Progression/relapse criteria (alternatives)
- Patient has had disease progression on adjuvant endocrine therapy or disease relapse within 12 months of adjuvant endocrine therapy completion
- Used for disease that has progressed on at least one endocrine-based regimen in the metastatic setting
- Used for disease recurrence on or within 12 months of completing adjuvant therapy
When an aromatase inhibitor is used in males, suppression of testicular steroidogenesis with a gonadotropin releasing hormone (GnRH) analog is required

Ovarian Cancer (Epithelial, Fallopian Tube, Primary Peritoneal)

Coverage provided when ALL of the following are met:

ALL of the following

Used as single agent therapy
Patient has recurrent low-grade serous carcinoma
Patient has previously received treatment with an aromatase inhibitor (letrozole, anastrozole, exemestane)

Continuation / Renewal Criteria

Renewal Criteria

Coverage may be renewed when ALL of the following are met:

ALL of the following

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

Prior Authorization

Authorization length and renewal

Initial authorization is for 6 months. Renewal may be granted if renewal criteria are met, including continued satisfaction of the indication-specific criteria, documented disease response (stabilization or tumor shrinkage), and absence of unacceptable toxicity.

Unproven / Exclusions

Coverage is provided only when the specific criteria listed in this policy are met. The general initial approval requires the patient to be ≥ 18 years, to be postmenopausal (or premenopausal with ovarian ablation/suppression) or male, to have recurrent unresectable, advanced, or metastatic disease, and to have HR-positive, HER2-negative disease with no visceral crisis. Condition-specific approvals (breast, ovarian, endometrial, uterine sarcoma) require the listed therapy settings, progression/relapse conditions, prior therapy constraints, and any required biomarker or HER2 testing as specified in the criteria. When an aromatase inhibitor is used in males, GnRH analog testicular suppression is required. Renewal is limited to cases meeting the renewal criteria (continued indication-specific criteria, disease response, and absence of unacceptable toxicity).

Applicable Codes

Covered HCPCS Codes (drug billing)HCPCSCovered

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 (listed products)NDC

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
63323-0715-xx	Fulvestrant 250 mg/5 mL single-dose prefilled syringe (Fresenius Kabi) - 505(b)(2) NDA

Covered ICD-10 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

Billing units: 1 billable unit = 25 mg of fulvestrant for the listed HCPCS J-codes. Example: 500 mg = 20 billable units; report J9395 / J9393 / J9394 in 25 mg units consistent with dosing and follow the listed loading and maintenance billable unit schedules per indication.

Provider Actions / Billing & Documentation

Billing Rule

HCPCS units and billing

Report fulvestrant J-codes (J9395, J9393, J9394) in 25 mg billable units consistent with dosing. Follow loading and maintenance schedules when determining units to bill (example: 500 mg = 20 billable units).

1 billable unit = 25 mg (J9395/J9393/J9394)
Example: 500 mg dose = 20 billable units
Follow indication-specific loading/maintenance unit schedules

Documentation Required

Biomarker testing for targeted combinations

When fulvestrant is used in combination regimens requiring targeted therapy, confirm activating mutations or HER2 status with an FDA‑approved or CLIA‑compliant test as specified (e.g., PIK3CA or AKT1 activating mutations for alpelisib/inavolisib/capivasertib combinations; HER2 status where required). Document test type and result.

PIK3CA or AKT1 activating mutation must be confirmed by an FDA‑approved or CLIA‑compliant test when required
HER2 status must be determined by an FDA‑approved or CLIA‑compliant test where required

Documentation Required

Concomitant therapy requirement for males

If an aromatase inhibitor is used in males, suppression of testicular steroidogenesis with a GnRH (LHRH) analog is required and should be documented in the medical record.

Document use of GnRH/LHRH analog when aromatase inhibitor is given to males

Prior Authorization

Authorization length and renewal

Background

Background: Fulvestrant is administered intramuscularly as an estrogen receptor antagonist. Dosing varies by indication: for breast cancer and uterine sarcoma the recommended schedule is a 500 mg loading dose on Days 1, 15, and 29 with a 500 mg maintenance dose every 28 days; for ovarian cancer the loading regimen is 500 mg on Day 1 and 250 mg on Days 15 and 29 with 250 mg every 28 days maintenance; for endometrial carcinoma the maintenance dose is 250 mg every 28 days. Initial authorizations are provided for 6 months and may be renewed per the renewal criteria.

Definitions

Billable unit1 billable unit = 25 mg of fulvestrant (per listed HCPCS J-codes)

505(b)(2) NDARegulatory designation for certain manufacturer products (Teva, Fresenius Kabi) not rated therapeutically equivalent in the FDA Orange Book

Policy Summary

PayerViva Health

PolicyFulvestrant: Faslodex®; Fulvestrant Ψ (Intramuscular)

Policy CodePolicy IC-0043

Change TypeNo material change

Effective DateJan 1, 2012

Next Review Date

On This Page

OpenPayer

Fulvestrant: Faslodex®; Fulvestrant Ψ (Intramuscular)

Coverage Summary

General Initial Approval Criteria

Condition-specific Initial and Subsequent Therapy Criteria

Continuation / Renewal Criteria

Unproven / Exclusions

Applicable Codes

Provider Actions / Billing & Documentation

Clinical Evidence & References

Background

Revision History