Asset Publisher

vp-0043

print Print Back Back

Fulvestrant: Faslodex®; Fulvestrant Ψ

Policy Number: VP-0043

 

Intramuscular

 

Last Review Date: 12/07/2023

Date of Origin: 01/01/2012

Dates Reviewed: 03/2012, 06/2012, 09/2012, 12/2012, 03/2013, 06/2013, 09/2013, 12/2013, 03/2014, 06/2014, 09/2014, 12/2014, 03/2015, 05/2015, 08/2015, 11/2015, 02/2016, 05/2016, 08/2016, 11/2016, 02/2017, 05/2017, 08/2017, 09/2017, 11/2017, 02/2018, 05/2018, 09/2018, 12/2018, 03/2019, 04/2019, 06/2019, 09/2019, 12/2019, 03/2020, 06/2020, 09/2020, 03/2021, 03/2022, 03/2023, 12/2023

FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill.

  1. Length of Authorization

Coverage will be provided for 6 months and may be renewed.

  1. Dosing Limits
  1. Quantity Limit (max daily dose) [NDC Unit]:
  • 250 mg/5 mL single-dose prefilled syringe: 6 syringes first 29 days initially (loading doses), then 2 syringes per 28 days thereafter as maintenance
  1. Max Units (per dose and over time) [HCPCS Unit]:

Ovarian Cancer

  • Loading Dosing: 20 billable units on day 1 and 10 billable units on days 15 and 29
  • Maintenance Dosing: 10 billable units every 28 days

Endometrial Cancer

  • 10 billable units every 28 days

Breast Cancer/Uterine Sarcoma

  • Loading Dosing: 20 billable units every 14 days for 3 doses
  • Maintenance Dosing: 20 billable units every 28 days
  1. Initial Approval Criteria 1-3

Coverage is provided in the following conditions:

  • Patient is at least 18 years of age; AND

Breast Cancer † 1-3,4,7,10-13,16,17

  • Patient is postmenopausal, premenopausal with ovarian ablation/suppression, or male with suppression of testicular steroidogenesis; AND
    • Patient has locally advanced or metastatic disease; AND
      • Patient has hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative disease; AND
      • Patient does not have symptomatic visceral disease; AND
      • Used as subsequent therapy in combination with capivasertib ; AND
      • Patient has the presence of one or more PIK3CA/AKT1 activating mutations or PTEN loss of function alterations in tumor tissue, as determined by an FDA-approved or CLIA-compliant testv; AND
              • Used for disease that has progressed on at least one endocrine-based regimen in the metastatic setting; OR
              • Used for disease recurrence on or within 12 months of completing adjuvant therapy; OR
    • Patient has advanced, metastatic, or recurrent unresectable invasive disease; AND
      • Patient has hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative disease with no visceral crisis; AND
                • Used as initial therapy; AND
        • Used as a single agent ; OR
        • Used in combination with a CDK 4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) ; OR
        • Used in combination with a non-steroidal aromatase inhibitor (i.e., anastrozole or letrozole) ; OR
                • Used as subsequent therapy in patients; AND
      • Used as a single agent ; OR
      • Used in combination with a CDK 4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) if a CDK 4/6 inhibitor was not previously used ; OR
      • Used in combination with everolimus ; OR
      • Used in combination with alpelisib in patients who have PIK3CA activating mutation positive disease as determined by an FDA-approved or CLIA-compliant testv ; OR
      • Patient has HR-positive, HER2-positive* disease as determined by an FDA-approved or CLIA-compliant testv; AND
              • Used as a single agent or in combination with trastuzumab; OR
    • Patient has recurrent unresectable or metastatic inflammatory disease ; AND
      • Patient has hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative disease with no visceral crisis; AND
              • Used as initial therapy; AND
                  • Used as a single agent; OR
                  • Used in combination with a non-steroidal aromatase inhibitor (i.e., anastrozole or letrozole); OR
                  • Used in combination with a CDK 4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) if disease progression on adjuvant endocrine therapy (ET) or with early disease relapse within 12 months of adjuvant ET completion; OR
              • Used as subsequent therapy; AND
                  • Used as a single agent; OR
                  • Used in combination with a non-steroidal aromatase inhibitor (i.e., anastrozole or letrozole); OR
                  • Used in combination with everolimus; OR
                  • Used in combination with a CDK 4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) if a CDK 4/6 inhibitor was not previously used; OR
                  • Used in combination with alpelisib in patients who have PIK3CA activating mutation positive disease; OR
      • Patient has HR-positive, HER2-positive* disease as determined by an FDA-approved or CLIA-compliant testv; AND
              • Used as a single agent or in combination with trastuzumab

Ovarian Cancer (Epithelial, Fallopian Tube, or Primary Peritoneal Cancer) ‡ 4,9,14

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

Endometrial Adenocarcinoma (Uterine Neoplasms) ‡ 4,8,15

  • Used as single agent therapy; AND
  • Patient has grade 1 or 2 endometrioid histology; AND
            • Used in patients with a small tumor volume or an indolent growth pace; AND
            • Used as ONE of the following:
            • Adjuvant treatment for stage IV disease; OR
            • Treatment for disseminated metastases or locoregional recurrence; OR
            • Primary treatment in patients undergoing sequential EBRT for locoregional extrauterine disease that is not suitable for primary surgery; OR
            • Primary treatment in patients with distant metastatic disease

Uterine Sarcoma (Uterine Neoplasms) ‡ 4,15

  • Used as single agent therapy; AND
            • Used in patients with a small tumor volume or an indolent growth pace; AND
  • Used for low-grade endometrial stromal sarcoma (ESS), adenosarcoma without sarcomatous overgrowth, or ER/PR positive uterine sarcoma; AND
      • Used following total hysterectomy for stage II-IV disease; OR
      • Used for metastatic or recurrent disease; OR
      • Used for disease that is not suitable for primary surgery

*HER2-positive overexpression criteria 16

  • Immunohistochemistry (IHC) assay 3+; OR
  • Dual-probe in situ hybridization (ISH) assay HER2/CEP17 ratio2.0 AND average HER2 copy number 4.0 signals/cell; OR
  • Dual-probe in situ hybridization (ISH) assay AND concurrent IHC indicating one of the following:
          • HER2/CEP17 ratio 2.0 AND average HER2 copy number < 4.0 signals/cell AND concurrent IHC 3+; OR
          • HER2/CEP17 ratio < 2.0 AND average HER2 copy number 6.0 signals/cell AND concurrent IHC 2+ or 3+; OR
    • HER2/CEP17 ratio < 2.0 AND average HER2 copy number ≥ 4.0 and < 6.0 signals/cell AND concurrent IHC 3+

v If confirmed using an immunotherapy assay-http://www.fda.gov/companiondiagnostics

FDA Approved Indication(s); Compendia Recommended Indication(s); Ф Orphan Drug

  1. Renewal Criteria 1-3

Coverage can be renewed based upon the following criteria:

  • Patient continues to meet the indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; AND
  • Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread; AND
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: bleeding abnormalities, severe injection site reactions (including sciatica, neuralgia, neuropathic pain, and peripheral neuropathy), etc.
  1. Dosage/Administration 1-3,8,9,17

Indication

Dose

Breast Cancer

Loading Dose:

  • Administer 500 mg intramuscularly (IM) on Days 1, 15, 29

Maintenance Dose:

  • Administer 500 mg IM every 28 days until disease progression or unacceptable toxicity

***Note: For premenopausal and perimenopausal women, administer a luteinizing hormone-releasing hormone (LHRH) agonist according to current clinical practice standards. For men, consider administering a LHRH agonist according to current clinical practice standards.

Uterine Sarcoma

Loading Dose:

  • Administer 500 mg intramuscularly (IM) on Days 1, 15, 29

Maintenance Dose:

Administer 500 mg IM every 28 days until disease progression or unacceptable toxicity

Ovarian Cancer

Loading Dose:

  • Administer 500 mg intramuscularly (IM) on Day 1 and 250 mg IM on Days 15 and 29

Maintenance Dose:

  • Administer 250 mg IM every 28 days until disease progression or unacceptable toxicity

Endometrial Cancer

Administer 250 mg by IM injection every 4 weeks for at least 8 weeks until disease progression or unacceptable toxicity.

  1. Billing Code/Availability Information

HCPCS Code:

  • 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

NDC:

  • Faslodex* 250 mg/5 mL single-dose prefilled syringe: 00310-0720-xx
  • Fulvestrant 250 mg/5 mL single-dose prefilled syringe (Teva): 00591-5019-xx
  • Fulvestrant 250 mg/5 mL single-dose prefilled syringe (Fresenius Kabi): 63323-0715-xx

  • * Available as a multi-sourced generic.
  • Ψ Designated products approved by the FDA as a 505(b)(2) NDA of the innovator product. These products are not rated as therapeutically equivalent to their reference listed drug in the Food and Drug Administration’s (FDA) Orange Book and are therefore considered single source products based on the statutory definition of “single source drug” in section 1847A(c)(6) of the Act. For a complete list of all approved 505(b)(2) NDA products please reference the latest edition of the Orange Book: 

 Approved Drug Products with Therapeutic Equivalence Evaluations | Orange Book | FDA

  1. References
  1. Faslodex [package insert]. Wilmington, DE; AstraZeneca Pharmaceuticals LP; January 2021. Accessed November 2023.
  2. Fulvestrant [package insert]. North Wales, PA; Teva Pharmaceuticals USA; November 2021. Accessed November 2023.
  3. Fulvestrant [package insert]. Lake Zurich, IL; Fresenius Kabi; September 2021. Accessed November 2023.
  4. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for fulvestrant. National Comprehensive Cancer Network, 2023. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed November 2023.
  5. Chia S, Gradishar W, Mauriac L, et al. Double-blind, randomized placebo-controlled trial of fulvestrant compared with exemestane after prior nonsteroidal aromatase inhibitor therapy in postmenopausal women with hormone-receptor positive, advanced breast cancer: results from EFECT. J Clin Oncol 2008; 26:1664-1670.
  6. Mauriac L, Romieu G, Bines J. Activity of fulvestrant versus exemestane in advanced breast cancer patients with or without visceral metastases: data from the EFECT trial. Breast Cancer Res Treat 2009; 117:69-75.
  7. Di Leo A, Jerusalem G, Petruzelka L, et al. Results of the CONFIRM phase III trial comparing fulvestrant 250 mg with fulvestrant 500 mg in postmenopausal women with estrogen receptor-positive advanced breast cancer. J Clin Oncol 2010; 28:4594-4600.
  8. Covens AL, Filiaci V, Gersell D. Phase II study of fulvestrant in recurrent/metastatic endometrial carcinoma: a Gynecologic Oncology Group study.  Gynecol Oncol. 2011 Feb;120(2):185-8. doi: 10.1016/j.ygyno.2010.10.015. Epub 2010 Nov 13.
  9. Argenta PA, Thomas SG, Judson PL, et al. A phase II study of fulvestrant in the treatment of multiply-recurrent epithelial ovarian cancer. Gynecol Oncol. 2009 May;113(2):205-209.
  10. Robertson JFR, Bondarenko IM, Trishkina E, et al. Fulvestrant 500 mg versus anastrozole 1 mg for hormone receptor-positive advanced breast cancer (FALCON): an international, randomised, double-blind, phase 3 trial. Lancet. 2016;388(10063):29973005. doi:10.1016/S0140-6736(16)32389-3.
  11. Robertson JF, Osborne CK, Howell A, et al. Fulvestrant versus anastrozole for the treatment of advanced breast carcinoma in postmenopausal women: a prospective combined analysis of two multicenter trials. Cancer. 2003;98(2):229238. doi:10.1002/cncr.11468.
  12. Cristofanilli M, Turner NC, Bondarenko I, et al. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial [published correction appears in Lancet Oncol. 2016 Apr;17 (4):e136] [published correction appears in Lancet Oncol. 2016 Jul;17 (7):e270]. Lancet Oncol. 2016;17(4):425439. doi:10.1016/S1470-2045(15)00613-0.
  13. Sledge GW Jr, Toi M, Neven P, et al. MONARCH 2: Abemaciclib in Combination With Fulvestrant in Women With HR+/HER2- Advanced Breast Cancer Who Had Progressed While Receiving Endocrine Therapy. J Clin Oncol. 2017;35(25):28752884. doi:10.1200/JCO.2017.73.7585.
  14. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Ovarian Cancer Including Fallopian Tube Cancer and Primary Peritoneal Cancer Version 1.2023. National Comprehensive Cancer Network, 2023. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Guidelines, go online to NCCN.org. Accessed February 2023.
  15. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Uterine Neoplasms Version 1.2023. National Comprehensive Cancer Network, 2022. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Guidelines, go online to NCCN.org. Accessed February 2023.
  16. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer, Version 4.2023. National Comprehensive Cancer Network, 2023. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Guidelines, go online to NCCN.org. Accessed November 2023.
  17. Turner NC, Oliveira M, Howell SJ, et al; CAPItello-291 Study Group. Capivasertib in Hormone Receptor-Positive Advanced Breast Cancer. N Engl J Med. 2023 Jun 1;388(22):2058-2070. doi: 10.1056/NEJMoa2214131.

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

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

C50.112

Malignant neoplasm of central portion of left female breast

C50.119

Malignant neoplasm of central portion of unspecified female breast

C50.121

Malignant neoplasm of central portion of right male breast

C50.122

Malignant neoplasm of central portion of left male breast

C50.129

Malignant neoplasm of central portion of unspecified male breast

C50.211

Malignant neoplasm of upper-inner quadrant of right female breast

C50.212

Malignant neoplasm of upper-inner quadrant of left female breast

C50.219

Malignant neoplasm of upper-inner quadrant of unspecified female breast

C50.221

Malignant neoplasm of upper-inner quadrant of right male breast

C50.222

Malignant neoplasm of upper-inner quadrant of left male breast

C50.229

Malignant neoplasm of upper-inner quadrant of unspecified male breast

C50.311

Malignant neoplasm of lower-inner quadrant of right female breast

C50.312

Malignant neoplasm of lower-inner quadrant of left female breast

C50.319

Malignant neoplasm of lower-inner quadrant of unspecified female breast

C50.321

Malignant neoplasm of lower-inner quadrant of right male breast

C50.322

Malignant neoplasm of lower-inner quadrant of left male breast

C50.329

Malignant neoplasm of lower-inner quadrant of unspecified male breast

C50.411

Malignant neoplasm of upper-outer quadrant of right female breast

C50.412

Malignant neoplasm of upper-outer quadrant of left female breast

C50.419

Malignant neoplasm of upper-outer quadrant of unspecified female breast

C50.421

Malignant neoplasm of upper-outer quadrant of right male breast

C50.422

Malignant neoplasm of upper-outer quadrant of left male breast

C50.429

Malignant neoplasm of upper-outer quadrant of unspecified male breast

C50.511

Malignant neoplasm of lower-outer quadrant of right female breast

C50.512

Malignant neoplasm of lower-outer quadrant of left female breast

C50.519

Malignant neoplasm of lower-outer quadrant of unspecified female breast

C50.521

Malignant neoplasm of lower-outer quadrant of right male breast

C50.522

Malignant neoplasm of lower-outer quadrant of left male breast

C50.529

Malignant neoplasm of lower-outer quadrant of unspecified male breast

C50.611

Malignant neoplasm of axillary tail of right female breast

C50.612

Malignant neoplasm of axillary tail of left female breast

C50.619

Malignant neoplasm of axillary tail of unspecified female breast

C50.621

Malignant neoplasm of axillary tail of right male breast

C50.622

Malignant neoplasm of axillary tail of left male breast

C50.629

Malignant neoplasm of axillary tail of unspecified male breast

C50.811

Malignant neoplasm of overlapping sites of right female breast

C50.812

Malignant neoplasm of overlapping sites of left female breast

C50.819

Malignant neoplasm of overlapping sites of unspecified female breast

C50.821

Malignant neoplasm of overlapping sites of right male breast

C50.822

Malignant neoplasm of overlapping sites of left male breast

C50.829

Malignant neoplasm of overlapping sites of unspecified male breast

C50.911

Malignant neoplasm of unspecified site of right female breast

C50.912

Malignant neoplasm of unspecified site of left female breast

C50.919

Malignant neoplasm of unspecified site of unspecified female breast

C50.921

Malignant neoplasm of unspecified site of right male breast

C50.922

Malignant neoplasm of unspecified site of left male breast

C50.929

Malignant neoplasm of unspecified site of unspecified male breast

C54.0

Malignant neoplasm of isthmus uteri

C54.1

Malignant neoplasm of endometrium

C54.2

Malignant neoplasm of myometrium

C54.3

Malignant neoplasm of fundus uteri

C54.8

Malignant neoplasm of overlapping sites of corpus uteri

C54.9

Malignant neoplasm of corpus uteri, unspecified

C55

Malignant neoplasm of uterus, part unspecified

C56.1

Malignant neoplasm of right ovary

C56.2

Malignant neoplasm of left ovary

C56.3

Malignant neoplasm of bilateral ovaries

C56.9

Malignant neoplasm of unspecified ovary

C57.00

Malignant neoplasm of unspecified fallopian tube

C57.01

Malignant neoplasm of right fallopian tube

C57.02

Malignant neoplasm of left fallopian tube

C57.10

Malignant neoplasm of unspecified broad ligament

C57.11

Malignant neoplasm of right broad ligament

C57.12

Malignant neoplasm of left broad ligament

C57.20

Malignant neoplasm of unspecified round ligament

C57.21

Malignant neoplasm of right round ligament

C57.22

Malignant neoplasm of left round ligament

C57.3

Malignant neoplasm of parametrium

C57.4

Malignant neoplasm of uterine adnexa, unspecified

C57.7

Malignant neoplasm of other specified female genital organs

C57.8

Malignant neoplasm of overlapping sites of female genital organs

C57.9

Malignant neoplasm of female genital organ, unspecified

Z85.3

Personal history of malignant neoplasm of breast

Z85.43

Personal history of malignant neoplasm of ovary

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A

Medicare Part B Administrative Contractor (MAC) Jurisdictions

Jurisdiction

Applicable State/US Territory

Contractor

E (1)

CA, HI, NV, AS, GU, CNMI

Noridian Healthcare Solutions, LLC

F (2 & 3)

AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ

Noridian Healthcare Solutions, LLC

5

KS, NE, IA, MO

Wisconsin Physicians Service Insurance Corp (WPS)

6

MN, WI, IL

National Government Services, Inc. (NGS)

H (4 & 7)

LA, AR, MS, TX, OK, CO, NM

Novitas Solutions, Inc.

8

MI, IN

Wisconsin Physicians Service Insurance Corp (WPS)

N (9)

FL, PR, VI

First Coast Service Options, Inc.

J (10)

TN, GA, AL

Palmetto GBA, LLC

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA, LLC

L (12)

DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA)

Novitas Solutions, Inc.

K (13 & 14)

NY, CT, MA, RI, VT, ME, NH

National Government Services, Inc. (NGS)

15

KY, OH

CGS Administrators, LLC

 

 

 

 

FULVESTRANT® (Faslodex; Fulvestrant) Prior Auth Criteria
Proprietary Information. Restricted Access – Do not disseminate or copy without approval.
©2023, Magellan Rx Management

White MRx.PNG