Centene fulvestrant coverage & prior auth update

Coverage Criteria for Fulvestrant (Faslodex)

Initial Approval — Breast Cancer

Covered when ALL of the following are met for Initial Approval — Breast Cancer:

Initial — Breast Cancer: 1. Diagnosis of advanced breast cancer (recurrent, stage III, or stage IV [metastatic]).

Initial — Breast Cancer: 2. Prescribed by or in consultation with an oncologist.

Initial — Breast Cancer: 3. Age ≥ 18 years.

Initial — Breast Cancer: 4. One of the following: (a) disease is HR-positive (ER/PR-positive) OR (b) disease is triple negative (ER-, PR-, HER2-).

Initial — Breast Cancer: 5. For Faslodex requests, member must use fulvestrant product if available unless contraindicated or clinically significant adverse effects are experienced.

Initial — Breast Cancer: 6. Request meets one of the following: (a) Dose does not exceed 500 mg three times in the first month then once monthly; OR (b) Dose 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 Approval — Ovarian/Fallopian Tube/Primary Peritoneal Cancer (off-label)

Covered when ALL of the following are met for Initial Approval — Ovarian/Fallopian Tube/Primary Peritoneal Cancer (off-label):

Initial — Low-grade serous carcinoma: 1. Diagnosis of ovarian, fallopian tube, or primary peritoneal cancer.

Initial — Low-grade serous carcinoma: 2. Prescribed by or in consultation with an oncologist.

Initial — Low-grade serous carcinoma: 3. Disease is classified as low-grade serous carcinoma.

Initial — Low-grade serous carcinoma: 4. Prescribed as single-agent (monotherapy) therapy.

Initial Approval — Endometrial Carcinoma (off-label)

Covered when ALL of the following are met for Initial Approval — Endometrial Carcinoma (off-label):

Initial — Endometrial Carcinoma: 1. Diagnosis of endometrial carcinoma.

Initial — Endometrial Carcinoma: 2. Prescribed by or in consultation with an oncologist.

Initial — Endometrial Carcinoma: 3. Disease is classified as grade 1 or 2 endometrioid carcinoma.

Initial — Endometrial Carcinoma: 4. Fulvestrant is prescribed for one of the following: (a) recurrent or metastatic disease; OR (b) disease not suitable for primary surgery.

Initial Approval — Uterine Sarcoma (off-label)

Covered when ALL of the following are met for Initial Approval — Uterine Sarcoma (off-label):

Initial — Uterine Sarcoma: 1. Diagnosis of uterine sarcoma.

Initial — Uterine Sarcoma: 2. Prescribed by or in consultation with an oncologist.

Initial — Uterine Sarcoma: 3. Disease is one of: (a) low-grade endometrial stromal sarcoma; (b) adenosarcoma without sarcomatous overgrowth; or (c) HR-positive (ER/PR-positive) uterine sarcoma.

Initial — Uterine Sarcoma: 4. Fulvestrant is prescribed in one of the following settings: following total hysterectomy; for vaginal or pelvic recurrence; for recurrent or metastatic disease; for disease not suitable for primary surgery; or for extrauterine disease.

Continuation Therapy

Covered when ALL of the following are met for Continuation Therapy (All Indications in Section I):

Continuation Therapy: 1. Member is currently receiving fulvestrant via Centene benefit, or documentation supports member has received fulvestrant for a covered indication for at least 30 days.

Continuation Therapy: 2. Member is responding positively to therapy.

Continuation Therapy: 3. For Faslodex requests, member must use fulvestrant product if available unless contraindicated or clinically significant adverse effects are experienced.

Continuation Therapy: 4. If request is for a dose increase, new dose must meet one of the following: (a) not exceed 500 mg once monthly; OR (b) be 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.

Covered indications and dosing

Covered when meeting NCCN-based indications and dosing requirements (examples below reflect text in this document):

Breast cancer indications: HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women: monotherapy for those not previously treated with endocrine therapy; monotherapy after progression on endocrine therapy; combination therapy with ribociclib as initial endocrine-based therapy or following progression; combination with palbociclib or abemaciclib after progression on endocrine therapy.

Combination regimens require appropriate CDK4/6 dosing and LHRH agonist for pre-/perimenopausal women when applicable.

Dosing: Fulvestrant (Faslodex) 500 mg IM administered as two 5 mL injections into the buttocks on Days 1, 15, and 29, then once monthly thereafter.500 mg per administration visit

Maximum initial-month administrations: three 500 mg injections in first month (Days 1, 15, 29); maintenance 500 mg once monthly.

Gynecologic malignancies: Policy includes NCCN-aligned monotherapy options for selected gynecologic malignancies (low-grade serous ovarian/fallopian tube/primary peritoneal carcinoma; grade 1–2 endometrioid endometrial carcinoma; specific uterine sarcoma subtypes) when criteria are met.

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the prescriber provides sufficient documentation of efficacy and safety consistent with applicable off‑label use policies (see CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid). Requests for off‑label use should include clinical rationale and supporting evidence demonstrating that the indication is reasonable and supported by guidelines or peer‑reviewed literature.

Authorization of fulvestrant for off‑label indications requires submission of documentation per the applicable off‑label use policies referenced by this policy. The prescriber must provide evidence (for example, relevant guideline recommendations, peer‑reviewed literature, or other clinical justification) that supports the requested off‑label use in accordance with CP.CPA.09 (Commercial), HIM.PA.154 (Marketplace), or CP.PMN.53 (Medicaid). Lack of this documentation may result in denial of the request.

Fulvestrant is contraindicated in patients with a known hypersensitivity to fulvestrant. Use in members with documented hypersensitivity is not medically necessary and should not be authorized.

Coding and Dose Limits

No explicit CPT/HCPCS/NDC codes listed in this sectionmixed

No codes listed

Fulvestrant HCPCS codesHCPCS

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

Dose limit

Dose limit (initial month and maintenance)Dose does not exceed 500 mg three times in the first month (Days 1, 15, 29) then 500 mg once monthly thereafter; continuation dose does not exceed 500 mg once monthly.

Alternate evidence-based dosingA dose above 500 mg once monthly may be allowed if supported by practice guidelines or peer-reviewed literature with prescriber submission of evidence.

Administration detailsEach 500 mg administration is given as two 5 mL intramuscular injections (one in each buttock).

Maximum initial-month administrations

Maximum initial-month administrationsThree 500 mg injections in the first month administered on Days 1, 15, and 29.

Administration method

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for fulvestrant (including Faslodex) requests. Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria, including diagnosis, prior therapies, and any off‑label justification per applicable off‑label use policies (e.g., CP.CPA.09, HIM.PA.154, CP.PMN.53). Requests lacking adequate supporting documentation may be denied.

Affected HCPCS codes: J9393, J9394, J9395 — prior authorization required when billed under these codes.
Off‑label uses require submission of practice guidelines or peer‑reviewed literature supporting the prescribed regimen.

Documentation Required

Dosing and Administration Documentation

Document the dosing regimen and administration in the member’s chart. For fulvestrant (Faslodex) the standard regimen is 500 mg administered intramuscularly as two 5 mL injections (one in each buttock) on Days 1, 15, and 29, then once monthly thereafter. Maximum/limit: 500 mg three times during the first month then once monthly thereafter. For combination therapy with CDK4/6 inhibitors, document the combination regimen and any supportive agents (e.g., LHRH agonist for pre/perimenopausal women). Include dates and locations of injections, administered dose per administration, and clinical rationale if dosing differs from standard; prescriber must submit supporting evidence for off‑label dosing.

Background

Fulvestrant is an estrogen receptor antagonist indicated for use in hormone receptor (HR)–positive advanced or metastatic breast cancer, typically administered intramuscularly as a 500 mg dose given on Days 1, 15, and 29, then once monthly thereafter. It is used as monotherapy in certain postmenopausal women and may be given in combination with CDK4/6 inhibitors (for example, ribociclib, palbociclib, or abemaciclib) per guideline recommendations. The policy also allows selected off‑label monotherapy uses for specific gynecologic malignancies when supported by NCCN guidance or peer‑reviewed evidence.

Definitions and Biomarker Requirements

HR-positive definition

DefinitionHormone receptor–positive: estrogen or progesterone receptor (ER/PR) positive disease.

Abbreviation expansionHR = hormone receptor (refers to ER and/or PR).

Clinical relevanceUsed to determine eligibility for fulvestrant in HR-positive breast and select gynecologic indications per policy.

HER2-negative definition

DefinitionHuman epidermal growth factor receptor 2 (HER2) negative.

Clinical relevanceHER2-negative status is part of eligibility for monotherapy or combination regimens in breast cancer indications.

Line of Therapy

first-line | second-line

Line of therapy — Breast cancer: Monotherapy for HR-positive advanced breast cancer in postmenopausal women not previously treated with endocrine therapy; monotherapy for HR-positive disease after progression on endocrine therapy; combination with ribociclib as initial endocrine-based therapy or following progression; combination with palbociclib or abemaciclib after progression on endocrine therapy.

first-line | second-line

Breast cancer lines: Monotherapy for postmenopausal women not previously treated with endocrine therapy; combination with ribociclib as initial endocrine-based therapy or following progression; combination with palbociclib or abemaciclib after progression on endocrine therapy.

Approved Regimens and Combinations

Regimen	Indication / Line of therapy	Coverage status
{"text":"Fulvestrant + Ribociclib","status":""},{"text":"HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women — as initial endocrine-based therapy or following progression on endocrine therapy","status":""},{"text":"Covered","status":"covered"}
{"text":"Fulvestrant + Palbociclib","status":""},{"text":"HR-positive, HER2-negative advanced or metastatic breast cancer in women with disease progression after endocrine therapy","status":""},{"text":"Covered","status":"covered"}
{"text":"Fulvestrant + Abemaciclib","status":""},{"text":"HR-positive, HER2-negative advanced or metastatic breast cancer in women with disease progression after endocrine therapy","status":""},{"text":"Covered","status":"covered"}

Regimen	Indication / Line of therapy	Coverage status
{"text":"Fulvestrant monotherapy (Faslodex)","status":""},{"text":"HR-positive, HER2-negative advanced breast cancer in postmenopausal women — initial therapy for those not previously treated with endocrine therapy, or after progression on endocrine therapy","status":""},{"text":"Covered","status":"covered"}

Drug	Dosing / Schedule	Notes
{"text":"Fulvestrant (Faslodex)","status":""},{"text":"500 mg IM into buttocks as two 5 mL injections on Days 1, 15, and 29, then 500 mg once monthly thereafter","status":""},{"text":"Maximum dosing: 500 mg three times in the first month then once monthly","status":""}
{"text":"Ribociclib","status":""},{"text":"600 mg orally once daily for 21 consecutive days followed by 7 days off (28-day cycle)","status":""},{"text":"When used in combination with fulvestrant per regimen guidance","status":""}
{"text":"Palbociclib","status":""},{"text":"125 mg orally once daily for 21 consecutive days followed by 7 days off (28-day cycle)","status":""},{"text":"Used with fulvestrant after progression on endocrine therapy","status":""}
{"text":"Abemaciclib","status":""},{"text":"150 mg orally twice daily (note: some sources list 300 mg/day total)","status":""},{"text":"Used with fulvestrant after progression on endocrine therapy","status":""}
{"text":"LHRH agonist requirement","status":""},{"text":"Pre/perimenopausal women receiving fulvestrant plus palbociclib, abemaciclib, or ribociclib should also receive an LHRH agonist per current clinical practice standards","status":""},{"text":"Applies when combination therapy is used in pre/perimenopausal women","status":""}

Revision History and Policy Changes

2025-04-09criteria_revision

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

2024-05-23criteria_revision

Revised policy/criteria to include generic fulvestrant and added redirection to generic fulvestrant for all indications; removed stage II and IIIA references from endometrial carcinoma criteria and removed adjuvant therapy for stage IV disease for consolidation; added additional criteria options for recurrent and extrauterine disease for uterine carcinoma per NCCN; references reviewed and updated.

2023-01-06

OpenPayer

Fulvestrant (Faslodex Injection)