ph-0151
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Zoladex® (goserelin acetate)

Policy Number: PH-0151

Subcutaneous

 

Last Review Date: 10/03/2022

Date of Origin: 11/28/2011

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, 11/2017, 02/2018, 05/2018, 04/2019, 04/2020, 04/2021, 04/2022, 10/2022

Precertification requirements do not apply for this policy. Pre-payment claim edits are applied to diagnosis criteria within this policy.

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
  • Endometriosis: Coverage will be provided for 6 months and is NOT eligible for renewal.
  • Endometrial Thinning: Coverage will be provided for 2 doses only (given 4 weeks apart) and is NOT eligible for renewal.
  • All other indications: Coverage will be provided for 12 months and may be renewed.
  1. Dosing Limits

A. Quantity Limit (max daily dose) [NDC Unit]:

  • 3.6mg injection – 1 injection every 28 days
  • 10.8mg injection – 1 injection every 12 weeks (Prostate and Breast Cancer only)

B. Max Units (per dose and over time) [HCPCS Unit]:

  • Prostate & Breast Cancer – 3 billable units every 84 days
  • All Other Indications – 1 billable unit every 28 days
  1. Initial Approval Criteria 1

Coverage is provided in the following conditions:

  • Patient is at least 18 years of age; AND

Universal Criteria 1,2

  • Females of reproductive potential have a negative pregnancy test prior to start of therapy and will use an effective method of nonhormonal contraception during treatment and for 12 weeks after treatment (Note: This excludes use in patients receiving palliative treatment of advanced breast cancer); AND

Breast Cancer † 2,3

  • Patient is a pre- or peri-menopausal woman or a male with suppression of testicular steroidogenesis; AND
  • Patient’s disease is hormone receptor-positive; AND
    • Used in combination with adjuvant endocrine therapy; OR
    • Used in combination with endocrine therapy for recurrent unresectable or metastatic disease; OR
    • Used as palliative treatment for advanced disease

          Prostate Cancer † 1-3

    Dysfunctional Uterine Bleeding (Endometrial Thinning) † 2

  • Used prior to endometrial ablation

Endometriosis † 2

  • Patient has not received prior-treatment with a gonadotropin releasing hormone (GnRH) agonist for this indication within a 6-month prior period

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

  1. Renewal Criteria 1

Coverage can be renewed based upon the following criteria:

  • Patient continues to meet the universal and other indication-specific relevant criteria identified in section III; AND
  • Absence of unacceptable toxicity from the drug.  Examples of unacceptable toxicity include: severe QT/QTc interval prolongation, severe hyperglycemia and diabetes, cardiovascular toxicity (e.g., myocardial infarction, stroke, etc.), hypercalcemia, severe injection site injury, tumor flare phenomenon, severe hypersensitivity reactions, etc.; AND

Prostate Cancer/Breast Cancer

  • Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread

Endometriosis/ Dysfunctional Uterine Bleeding (Endometrial Thinning)

  • May not be renewed
  1. Dosage/Administration 1,4

Indication

Dose

Breast cancer

Administer 3.6 mg depot every 4 weeks

OR

Administer 10.8 mg depot every 12 weeks

Dysfunctional Uterine Bleeding (Endometrial Thinning)

(3.6 mg only) Administer 3.6 mg for 1 or 2 doses with each depot given 28 days apart.

  • When 1 depot is given, endometrial ablation surgery should be performed at 4 weeks. If 2 depots are given, surgery should be performed within 2-4 weeks following the second depot dosage.

Endometriosis

(3.6 mg only) Administer 3.6 mg depot every 28 days for 6 months

Prostate Cancer

Stage B2-C Prostatic Carcinoma

  • Administer 3.6 mg depot 8 weeks before radiotherapy, followed in 28 days by 10.8 mg depot. Alternatively, four injections of 3.6 mg depot can be administered at 28-day intervals, two depots prior to and two during radiotherapy.

Palliative Treatment of Advanced Prostate Cancer

  • Administer 3.6 mg depot every 4 weeks

OR

  • Administer 10.8 mg depot every 12 weeks
  1. Billing Code/Availability Information

HCPCS Code:

  • J9202 – Goserelin acetate implant, per 3.6 mg: 1 billable unit = 3.6 mg

NDC:

  • Zoladex 10.8mg 3-Month Implant: 70720-0951-XX          
  • Zoladex 3.6mg Implant: 70720-0950-XX    
  1. References
  1. Zoladex 10.8mg [package insert]. Deerfield, IL; TerSera Therapeutics LLC; December 2020.  Accessed February 2022.
  2. Zoladex 3.6mg [package insert]. Deerfield, IL; TerSera Therapeutics LLC; December 2020. Accessed February 2022.
  3. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for goserelin acetate National Comprehensive Cancer Network, 2022.  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 2022.
  4. Noguchi S, Kim HJ, Jesena A, et al. Phase 3, open-label, randomized study comparing 3-monthly with monthly goserelin in pre-menopausal women with estrogen receptor-positive advanced breast cancer. Breast Cancer. 2016; 23(5): 771–779.  Published online 2015 Sep 9.  doi: 10.1007/s12282-015-0637-4
  5. First Coast Service Options, Inc. Local Coverage Article: Billing and Coding: Luteinizing Hormone-Releasing Hormone (LHRH) Analogs (A57655). Centers for Medicare & Medicaid Services, Inc. Updated on 11/21/2019 with effective date 10/03/2018. Accessed March 2022.
  6. National Government Services, Inc. Local Coverage Article: Billing and Coding: Luteinizing Hormone-Releasing Hormone (LHRH) Analogs (A52453). Centers for Medicare & Medicaid Services, Inc. Updated on 12/22/2021 with effective date 01/01/2022. Accessed March 2022.
  7. Novitas Solutions, Inc. Local Coverage Article: Billing and Coding: Luteinizing Hormone-Releasing Hormone (LHRH) Analogs (A56776). Centers for Medicare & Medicaid Services, Inc. Updated on 10/08/2021 with effective date 10/01/2021. Accessed March 2022.

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

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 female breast

C50.022

Malignant neoplasm of nipple and areola, left female breast

C50.029

Malignant neoplasm of nipple and areola, unspecified female 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

C61

Malignant neoplasm of prostate

N80.00

Endometriosis of the uterus, unspecified

N80.01

Superficial endometriosis of the uterus

N80.02

Deep endometriosis of the uterus

N80.03

Adenomyosis of the uterus

N80.101

Endometriosis of right ovary, unspecified depth

N80.102

Endometriosis of left ovary, unspecified depth

N80.103

Endometriosis of bilateral ovaries, unspecified depth

N80.109

Endometriosis of ovary, unspecified side, unspecified depth

N80.111

Superficial endometriosis of right ovary

N80.112

Superficial endometriosis of left ovary

N80.113

Superficial endometriosis of bilateral ovaries

N80.119

Superficial endometriosis of ovary, unspecified ovary

N80.121

Deep endometriosis of right ovary

N80.122

Deep endometriosis of left ovary

N80.123

Deep endometriosis of bilateral ovaries

N80.129

Deep endometriosis of ovary, unspecified ovary

N80.201

Endometriosis of right fallopian tube, unspecified depth

N80.202

Endometriosis of left fallopian tube, unspecified depth

N80.203

Endometriosis of bilateral fallopian tubes, unspecified depth

N80.209

Endometriosis of unspecified fallopian tube, unspecified depth

N80.211

Superficial endometriosis of right fallopian tube

N80.212

Superficial endometriosis of left fallopian tube

N80.213

Superficial endometriosis of bilateral fallopian tubes

N80.219

Superficial endometriosis of unspecified fallopian tube

N80.221

Deep endometriosis of right fallopian tube

N80.222

Deep endometriosis of left fallopian tube

N80.223

Deep endometriosis of bilateral fallopian tubes

N80.229

Deep endometriosis of unspecified fallopian tube

N80.30

Endometriosis of pelvic peritoneum, unspecified

N80.311

Superficial endometriosis of the anterior cul-de-sac

N80.312

Deep endometriosis of the anterior cul-de-sac

N80.319

Endometriosis of the anterior cul-de-sac, unspecified depth

N80.321

Superficial endometriosis of the posterior cul-de-sac

N80.322

Deep endometriosis of the posterior cul-de-sac

N80.329

Endometriosis of the posterior cul-de-sac, unspecified depth

N80.331

Superficial endometriosis of the right pelvic sidewall

N80.332

Superficial endometriosis of the left pelvic sidewall

N80.333

Superficial endometriosis of bilateral pelvic sidewall

N80.339

Superficial endometriosis of pelvic sidewall, unspecified side

N80.341

Deep endometriosis of the right pelvic sidewall

N80.342

Deep endometriosis of the left pelvic sidewall

N80.343

Deep endometriosis of the bilateral pelvic sidewall

N80.349

Deep endometriosis of the pelvic sidewall, unspecified side

N80.351

Endometriosis of the right pelvic sidewall, unspecified depth

N80.352

Endometriosis of the left pelvic sidewall, unspecified depth

N80.353

Endometriosis of bilateral pelvic sidewall, unspecified depth

N80.359

Endometriosis of pelvic sidewall, unspecified side, unspecified depth

N80.361

Superficial endometriosis of the right pelvic brim

N80.362

Superficial endometriosis of the left pelvic brim

N80.363

Superficial endometriosis of bilateral pelvic brim

N80.369

Superficial endometriosis of the pelvic brim, unspecified side

N80.371

Deep endometriosis of the right pelvic brim

N80.372

Deep endometriosis of the left pelvic brim

N80.373

Deep endometriosis of bilateral pelvic brim

N80.379

Deep endometriosis of the pelvic brim, unspecified side

N80.381

Endometriosis of the right pelvic brim, unspecified depth

N80.382

Endometriosis of the left pelvic brim, unspecified depth

N80.383

Endometriosis of bilateral pelvic brim, unspecified depth

N80.389

Endometriosis of the pelvic brim, unspecified side, unspecified depth

N80.3A1

Superficial endometriosis of the right uterosacral ligament

N80.3A2

Superficial endometriosis of the left uterosacral ligament

N80.3A3

Superficial endometriosis of the bilateral uterosacral ligament(s)

N80.3A9

Superficial endometriosis of the uterosacral ligament(s), unspecified side

N80.3B1

Deep endometriosis of the right uterosacral ligament

N80.3B2

Deep endometriosis of the left uterosacral ligament

N80.3B3

Deep endometriosis of bilateral uterosacral ligament(s)

N80.3B9

Deep endometriosis of the uterosacral ligament(s), unspecified side

N80.3C1

Endometriosis of the right uterosacral ligament, unspecified depth

N80.3C2

Endometriosis of the left uterosacral ligament, unspecified depth

N80.3C3

Endometriosis of bilateral uterosacral ligament(s), unspecified depth

N80.3C9

Endometriosis of the uterosacral ligament(s), unspecified side, unspecified depth

N80.391

Superficial endometriosis of the pelvic peritoneum, other specified sites

N80.392

Deep endometriosis of the pelvic peritoneum, other specified sites

N80.399

Endometriosis of the pelvic peritoneum, other specified sites, unspecified depth

N80.40

Endometriosis of rectovaginal septum, unspecified involvement of vagina

N80.41

Endometriosis of rectovaginal septum without involvement of vagina

N80.42

Endometriosis of rectovaginal septum with involvement of vagina

N80.50

Endometriosis of intestine, unspecified

N80.511

 Superficial endometriosis of the rectum

N80.512

Deep endometriosis of the rectum

N80.519

Endometriosis of the rectum, unspecified depth

N80.521

Superficial endometriosis of the sigmoid colon

N80.522

Deep endometriosis of the sigmoid colon

N80.529

Endometriosis of the sigmoid colon, unspecified depth

N80.531

Superficial endometriosis of the cecum

N80.532

Deep endometriosis of the cecum

N80.539

Endometriosis of the cecum, unspecified depth

N80.541

Superficial endometriosis of the appendix

N80.542

Deep endometriosis of the appendix

N80.549

Endometriosis of the appendix, unspecified depth

N80.551

Superficial endometriosis of other parts of the colon

N80.552

Deep endometriosis of other parts of the colon

N80.559

Endometriosis of other parts of the colon, unspecified depth

N80.561

Superficial endometriosis of the small intestine

N80.562

Deep endometriosis of the small intestine

N80.569

Endometriosis of the small intestine, unspecified depth

N80.A0

Endometriosis in cutaneous scar

N80.A1

Endometriosis of bladder, unspecified depth

N80.A2

Superficial endometriosis of bladder

N80.A41

Deep endometriosis of bladder

N80.A42

Superficial endometriosis of right ureter

N80.A43

Superficial endometriosis of left ureter

N80.A49

Superficial endometriosis of bilateral ureters

N80.A51

Superficial endometriosis of unspecified ureter

N80.A52

Deep endometriosis of right ureter

N80.A53

Deep endometriosis of left ureter

N80.A59

Deep endometriosis of bilateral ureters

N80.A61

Deep endometriosis of unspecified ureter

N80.A62

Endometriosis of right ureter, unspecified depth

N80.A63

Endometriosis of left ureter, unspecified depth

N80.A69

Endometriosis of bilateral ureters, unspecified depth

N80.B1

Endometriosis of unspecified ureter, unspecified depth

N80.B2

Endometriosis of pleura

N80.B31

Endometriosis of lung

N80.B32

Superficial endometriosis of diaphragm

N80.B39

Deep endometriosis of diaphragm

N80.B4

Endometriosis of diaphragm, unspecified depth

N80.B5

Endometriosis of the pericardial space

N80.B6

Endometriosis of the mediastinal space

N80.C0

Endometriosis of cardiothoracic space

N80.C10

Endometriosis of the abdomen, unspecified

N80.C11

Endometriosis of the anterior abdominal wall, subcutaneous tissue

N80.C19

Endometriosis of the anterior abdominal wall, fascia and muscular layers

N80.C2

Endometriosis of the anterior abdominal wall, unspecified depth

N80.C3

Endometriosis of the umbilicus

N80.C4

Endometriosis of the inguinal canal

N80.C9

Endometriosis of extra-pelvic abdominal peritoneum

N80.D0

Endometriosis of other site of abdomen

N80.D1

Endometriosis of the pelvic nerves, unspecified

N80.D2

Endometriosis of the sacral splanchnic nerves

N80.D3

Endometriosis of the sacral nerve roots

N80.D4

Endometriosis of the obturator nerve

N80.D5

Endometriosis of the sciatic nerve

N80.D6

Endometriosis of the pudendal nerve

N80.D9

Endometriosis of the femoral nerve

N80.9

Endometriosis, unspecified

N92.4

Excessive bleeding in the premenopausal period

N92.5

Other specified irregular menstruation

N93.8

Other specified abnormal uterine and vaginal bleeding

Z85.46

Personal history of malignant neoplasm of prostate

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):

Jurisdiction(s):  N

NCD/LCD Document (s): A57655

 

https://www.cms.gov/medicare-coverage-database/new-search/search-results.aspx?keyword=a57655&areaId=all&docType=NCA%2CCAL%2CNCD%2CMEDCAC%2CTA%2CMCD%2C6%2C3%2C5%2C1%2CF%2CP

Jurisdiction(s):  L, H

NCD/LCD Document (s): A56776

 

https://www.cms.gov/medicare-coverage-database/new-search/search-results.aspx?keyword=a56776&areaId=all&docType=NCA%2CCAL%2CNCD%2CMEDCAC%2CTA%2CMCD%2C6%2C3%2C5%2C1%2CF%2CP

Jurisdiction(s): 6, K

NCD/LCD Document (s): A52453

 

https://www.cms.gov/medicare-coverage-database/new-search/search-results.aspx?keyword=a52453&areaId=all&docType=NCA%2CCAL%2CNCD%2CMEDCAC%2CTA%2CMCD%2C6%2C3%2C5%2C1%2CF%2CP

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

 

 

ZOLADEX® (goserelin acetate) Prior Auth Criteria
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