Faslodex (fulvestrant) — HCPCS J9395

CareCost Estimate · Billing Cheat Sheet
AstraZeneca + Fresenius Kabi / generics 250 mg / 5 mL prefilled syringe Bilateral IM monthly (after loading) Reviewed: May 2, 2026 ASP: Q2 2026
HCPCS
J9395
25 mg = 1 unit
Dose
20 units
500 mg · 2 syringes
Modifier
JZ
Single-dose syringe, no waste
Admin CPT
96402
Chemo IM (hormonal)
Medicare ASP+6%
$4.938
/25 mg unit · $98.76/dose
BILLER ERROR TRAP — J9395 is per 25 mg, NOT per 1 mg. 500 mg dose = 20 units, NOT 500 units. Most other oncology J-codes are 1 mg = 1 unit; Faslodex is the exception. Cross-check unit basis on every claim.

Codes & NDC

HCPCS J9395J9395 — "Inj, fulvestrant, 25 mg" (NOS) — branded Faslodex + most generics
HCPCS J9394J9394 — "Inj, fulvestrant (Fresenius Kabi), 25 mg" — manufacturer-specific generic; ASP separate
NDC (originator)00310-0720-50 — AZ Faslodex, 2 syringes/carton
NDC (Fresenius gx)63323-698-05 — use J9394
Syringe250 mg / 5 mL (50 mg/mL) prefilled, single-dose, SafetyGlide needle
BenefitMedical (provider buy-and-bill); CDK4/6 combo agent on pharmacy benefit

Dosing — HR+/HER2- mBC

  • Loading: 500 mg IM Days 1, 15, 29
  • Maintenance: 500 mg IM monthly thereafter
  • Each dose = 2 × 250 mg / 5 mL syringes (one IM in EACH buttock)
  • Hepatic impairment (Child-Pugh B): 250 mg (= 10 units, ONE syringe)
  • Year-1 typical: 14 doses (3 loading + 11 monthly)
  • Year-1 total: 280 units

Bilateral IM technique

  • ONE 5 mL slow IM injection (1–2 min) in RIGHT buttock
  • ONE 5 mL slow IM injection (1–2 min) in LEFT buttock
  • Max IM volume per site = 5 mL → 10 mL total dose mandates 2 sites
  • Document BOTH sites in encounter note
  • Bill drug ONCE (20 units) and admin (96402) ONCE per encounter
Anticoagulation: consider INR check before injection in patients on warfarin/DOACs — gluteal IM hematoma risk.

CDK4/6 + targeted combos

ComboCo-agent (oral, pharmacy benefit)Setting
+ palbociclibIbrance 125 mg PO 21/28d2L+ (PALOMA-3)
+ ribociclibKisqali 600 mg PO 21/28d1L or 2L (MONALEESA-3)
+ abemaciclibVerzenio 150 mg PO BID2L+ (MONARCH-2)
+ alpelisibPiqray 300 mg PO daily — PIK3CA-mut only2L+ post-AI (SOLAR-1)
+ capivasertibTruqap 400 mg PO BID 4on/3offPost-AI w/ AKT/PI3K/PTEN alt (CAPItello-291)
MonoNone1L postmenopausal (FALCON)
Concurrent PA: submit Faslodex PA + CDK4/6 PA together. Ref combo regimen in Faslodex PA letter to prevent step-therapy denial.

ICD-10 — HR+/HER2- breast cancer

CodeFor
C50.xMalignant neoplasm of breast (4th=quadrant, 5th=laterality)
C50.411 / .412Upper-outer quadrant R/L (most common site)
Z17.0Estrogen receptor positive status (supplementary)
Z78.0Postmenopausal status (supplementary)
C79.51Bone mets (very common in HR+/HER2- mBC)
C78.7Liver mets
C77–C79.xOther secondary sites as applicable
HR+/HER2- pathology required. ICD-10 alone insufficient for PA — submit IHC ER/PR + IHC/ISH HER2 results.

Endocrine class compare

ClassDrugRouteBilling
SERD (IM)Faslodex (fulvestrant)IM monthlyJ9395 medical
Oral SERDOrserdu (elacestrant)PO dailyPharmacy
AI non-steroidalAnastrozole, letrozolePO dailyPharmacy (gx)
AI steroidalExemestanePO dailyPharmacy (gx)
SERMTamoxifenPO dailyPharmacy (gx)
GnRH agonistGoserelin, leuprolideSC implant / IM depotMedical (J-code)
Faslodex = only IV/IM endocrine therapy on medical benefit. Premenopausal use requires concurrent ovarian suppression (GnRH agonist).

Admin & modifiers

CodeWhen
96402Primary — Chemo SC/IM, hormonal antineoplastic. Bill ONCE per encounter (even with bilateral IM).
96401NOT appropriate — non-hormonal SC/IM chemo
96372NOT appropriate — therapeutic IM (under-pays)
Modifier JZRequired — single-dose syringe, no waste (per 7/1/2023 CMS rule)
Modifier JWRare — Faslodex dosed in whole syringes; only if mid-administration discard occurs
RT / LTNOT used — bilateral IM is standard technique, not paired procedure

Payer requirements (May 2026)

PayerPADocumentation
UnitedHealthcareYesHR+/HER2- pathology + menopausal status + regimen + concurrent CDK4/6 PA
AetnaYesSame; CPB 0173 hormonal therapy for breast cancer
BCBSYesNCCN-aligned per plan
Cigna / EvernorthYesHR+/HER2- + concurrent CDK4/6 PA if combo
Generic vs branded: generic fulvestrant (J9395 / J9394) often less PA-restricted than branded was pre-genericization. Combo PA still gates the encounter.

Medicare reimbursement (Q2 2026)

FieldValue
ASP + 6% (J9395)$4.938 / 25 mg unit (effective 4/1 – 6/30/2026)
500 mg dose$98.76 (20 units × $4.938)
250 mg hepatic dose$49.38 (10 units)
Year-1 (14 doses)~$1,382.64
Steady-state (12 doses)~$1,185/year
J9394 (Fresenius)Verify CMS ASP file separately

Site of care

SettingPOSNotes
Physician oncology office11Strongly preferred — bilateral IM is quick
Ambulatory infusion suite49Preferred
Oncology ASC24Acceptable
Hospital outpatient22 / 19Disfavored — UHC/Aetna steer away

Patient assistance — AZ Access 360

  • Phone: 1-844-275-2360 (AstraZeneca Access 360)
  • Web: myaccess360.com
  • Faslodex Co-pay Program: commercial copay support (excludes Medicare/Medicaid)
  • AZ&MeRx PAP: free product for uninsured / underinsured
  • Generic mfr support: Fresenius Kabi, Sandoz, Zydus — lower cost, less robust copay
  • Foundations (Medicare): PAN, HealthWell, CancerCare — verify open mBC funds quarterly
  • CDK4/6 combo support (separate): Ibrance Direct (Pfizer), Kisqali Patient Support (Novartis), Verzenio Cares (Lilly)
W&P (no Boxed Warning): injection-site reactions (very common — bilateral IM), hepatic dysfunction (LFT monitoring), bleeding/coagulopathy (hematoma risk on anticoagulants), embryo-fetal toxicity, bone-health monitoring on long-term endocrine therapy.
Sources: FDA Faslodex label (NDA 21-344, 2024 rev), CMS ASP Q2 2026 (J9395 + J9394), AZ Access 360 (1-844-275-2360), NCCN Breast Cancer Guidelines, UHC/Aetna/BCBS oncology + hormonal therapy policies, AMA CPT 96402, SEER CanMED. carecostestimate.com/drugs/faslodex