vp-0043
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Faslodex® (fulvestrant) (Intramuscular)

Policy Number: VP-0043

Last Review Date: 03/01/2021

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

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.

I. Length of Authorization

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

II. Dosing Limits

  1. Quantity Limit (max daily dose) [NDC Unit]:
  • Faslodex 250 mg/5 mL prefilled injection: 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 units on day 1 and 10 units on days 15 and 29

Maintenance Dosing:

  • 10 units every 28 days

Endometrial Cancer

  • 10 units every 28 days

Breast Cancer/Uterine Sarcoma

Loading Dosing:

  • 20 units every 14 days for 3 doses

Maintenance Dosing:

  • 20 units every 28 days

III. Initial Approval Criteria 1

Coverage is provided in the following conditions:

  • Patient is at least 18 years of age; AND

Breast Cancer † 1,2,5,8-11

  • Patient is postmenopausal, premenopausal with ovarian ablation/suppression, or male with suppression of testicular steroidogenesis; AND
  • Disease is advanced, metastatic, or recurrent; AND
    • Patient has hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative disease; AND
              • Used as initial therapy; AND
      • Used as a single agent ; OR
      • Used in combination with ribociclib ; OR
      • Used in combination with palbociclib or abemaciclib in patients without visceral crisis ; OR
      • Used in combination with a non-steroidal aromatase inhibitor (i.e., anastrozole, letrozole, etc.) in patients without visceral crisis; OR
              • Used as subsequent 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 everolimus in patients without visceral crisis; OR
      • Used in combination with alpelisib in patients without visceral crisis and patient has PIK3CA mutation positive disease; OR
    • Patient has HR-positive, HER2-positive disease ; AND
          •  
        • Used as a single agent or in combination with trastuzumab

Ovarian Cancer (epithelial, fallopian tube, or primary peritoneal cancer) ‡ 2,7,12

  • Used as single agent therapy; AND
  • Patient has recurrent or persistent low-grade serous carcinoma; AND
  • Will not be used for immediate treatment of biochemical relapse (i.e., rising CA-125 and no radiographic evidence of disease)

Endometrial Adenocarcinoma (Uterine Neoplasms) ‡ 2,6,13

  • 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:
          •  
    • Primary treatment in patients undergoing both brachytherapy and external beam radiation therapy (EBRT) with cervical involvement that is not suitable for surgery; OR
          •  
    • Primary treatment in patients with disease limited to the uterus or extrauterine disease that is not suitable for primary surgery; OR
    • Primary treatment in patients with distant metastatic disease; OR
    • Adjuvant treatment for locally advanced or metastatic (stage III-IV) disease; OR
    • Treatment for disseminated metastases or locoregional recurrence

Uterine Sarcoma (Uterine Neoplasms) ‡ 2,13

  • 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) OR for ER/PR positive uterine leiomyosarcoma (uLMS); 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

FDA Approved Indication(s); Compendia Recommended Indication(s)

IV. Renewal Criteria 1

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, etc.

V. Dosage/Administration 1,6,7

Indication

Dose

Breast Cancer & Uterine Sarcoma

Loading Dose:

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

Maintenance Dose:

  • 500 mg IM every 28 days

Ovarian Cancer

Loading Dose:

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

Maintenance Dose:

  • 250 mg IM every 28 days

Endometrial Cancer

250 mg by IM injection every 4 weeks for at least 8 weeks. Therapy should be continued until evidence of progressive disease or adverse effects prevent further treatment.

VI. Billing Code/Availability Information

HCPCS Code:

  • J9395 – Injection, fulvestrant, 25 mg; 1 billable unit = 25 mg

NDC:

  • Faslodex* 250 mg/5 mL single-dose prefilled injections: 00310-0720-xx

*Available generically

VII. References

  1. Faslodex [package insert]. Wilmington, DE; AstraZeneca Pharmaceuticals LP; January 2021. Accessed February 2021.
  2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for fulvestrant. National Comprehensive Cancer Network, 2021. 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 February 2021.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. 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.
  9. 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.
  10. 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.
  11. 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.
  12. 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 2.2020. National Comprehensive Cancer Network, 2021. 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 2021.
  13. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Uterine Neoplasms Version 1.2021. National Comprehensive Cancer Network, 2021. 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 2021.

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

C56.9

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

Z85.43

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: http://www.cms.gov/medicare-coverage-database/search/advanced-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