vp-0043
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Faslodex® (fulvestrant) (Intramuscular)

Policy Number: VP-0043

Last Review Date: 06/03/2019

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

ry & Confidential

© 2019 Magellan Health, Inc.

I. Length of Authorization

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

II. Dosing Limits

     A. Quantity Limit (max daily dose) [Pharmacy Benefit]:

  • Faslodex 250 mg/5 mL injection: 6 vials first 28 days initially, as a load, then 2 vials per 28 days, thereafter as maintenance

     B. Max Units (per dose and over time) [Medical Benefit]:

Endometrial Cancer/Uterine Sarcoma

    •  
    • 10 units every 28 days

Breast Cancer/Ovarian Cancer Loading Dosing:

  • 20 units every 14 days for 3 doses

Maintenance Dosing:

  • 20 units every 28 days

III. Initial Approval Criteria

      Coverage is provided in the following conditions:

      Breast Cancer †

  • 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 in combination with ribociclib as initial endocrine based therapy ; OR

      • Used in combination with a CDK 4/6-inhibitor (e.g., ribociclib, palbociclib or abemaciclib) and patient has progressed on endocrine therapy ; OR

      • Used in combination with everolimus and patient has received prior endocrine therapy within the previous 12 months; OR

      • Used as single agent therapy; OR

    • Patient has HR-positive, HER2-negative disease and has not previously received endocrine therapy ; OR

o Patient has HR-positive disease and progressed on endocrine therapy ; 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 Cancers) ‡

  • Used as single agent therapy; AND

  • Patient has recurrent, low-grade serous carcinoma

     Uterine Adenocarcinoma ‡

  • 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 for metastatic or unresectable disease excluding patients with cervical involvement undergoing brachytherapy without external beam radiation therapy (EBRT) that is not suitable for primary surgery; OR

    • Adjuvant treatment for locally advanced or metastatic disease; OR

    • Used as hormonal therapy for recurrent or disseminated metastatic disease; OR

    • Used in patients with limited disease of the uterus that is not suitable for primary surgery

     Uterine Sarcoma ‡

  • Used as single agent therapy; AND

  • Used for low-grade, stages II-IV endometrial stromal sarcoma (ESS) OR for ER/PR positive stages II-IV uterine leiomyosarcoma (uLMS); AND

    • Used following total hysterectomy; OR

    • Patient has resectable isolated metastases or disseminated metastases; OR

    • Patient has radiologically isolated vaginal or pelvic recurrence; OR

o Used for disease that is not suitable for primary surgery

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

IV. Renewal Criteria

     Coverage can be renewed based upon the following criteria:

  • Patient continues to meet the criteria 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 the following: bleeding abnormalities, increased exposure in patients with hepatic impairment, severe injection site reactions, etc.

V. Dosage/Administration

Indication

Dose

Loading Dose:

Breast Cancer,

  • 500 mg intramuscularly on Days 1, 15, 29

Ovarian Cancer

Maintenance Dose:

o  500 mg IM every 28 days

Endometrial

250 mg by IM injection every 4 weeks for at least 8 weeks. Therapy should be

Cancer,

continued until evidence of progressive disease or adverse effects prevent further

Uterine

treatment.

Sarcoma

VI. Billing Code/Availability Information

Jcode:

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

  • Faslodex* 250 mg/5 mL injection: 00310-0720-xx

*Available generically

VII. References

  1. Faslodex [package insert]. Wilmington, DE; AstraZeneca Pharmaceuticals LP; March 2019. Accessed May 2019.

  2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for fulvestrant. National Comprehensive Cancer Network, 2018. 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 May 2019.

  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.

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. First Coast Service Options, Inc. Local Coverage Determination (LCD): Fulvestrant (Faslodex®) (L33998). Centers for Medicare & Medicaid Services, Inc. Updated on 6/8/2018 with effective date 6/14/2018. Accessed May 2019.

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

ICD‐10

ICD‐10 Description

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

C53.0

Malignant neoplasm of endocervix

C54.0

Malignant neoplasm of isthmus uteri

C54.1

Malignant neoplasm of endometrium

ICD‐10

ICD‐10 Description

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

Z85.3

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) and Local Coverage Determinations (LCDs) 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):

Jurisdiction(s): N

NCD/LCD Document (s): L33998

https://www.cms.gov/medicare-coverage-database/search/lcd-date- search.aspx?DocID=L33998&bc=gAAAAAAAAAAAAA==

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