ph-0135
print Print Back Back

Vantas® (histrelin acetate)

Policy Number: PH-0135

Subcutaneous implant

Document Number: IC-0135

Last Review Date: 04/06/2021

Date of Origin: 06/21/2011

Dates Reviewed: 09/2011, 12/2011, 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, 5/2018, 04/2019, 04/2020, 04/2021

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

Coverage will be provided for 12 months and may be renewed.

  1. Dosing Limits

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

  • 50 mg implant: 1 per 12 months

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

  • 1 billable unit per 12 months
  1. Initial Approval Criteria 1,2

Coverage is provided in the following conditions:

Advanced Prostate Cancer †

  • Patient is 18 years or older

FDA Approved Indication(s)

  1. Renewal Criteria 1

Coverage can be renewed based upon the following criteria:

  • Patient continues to meet 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: QT/QTc interval prolongations, cardiovascular disease, spinal cord compression, urinary tract obstruction, severe hyperglycemia/diabetes, etc.
  1. Dosage/Administration 1

Indication

Dose

Prostate Cancer

One 50 mg implant inserted subcutaneously every 12 months

  1. Billing Code/Availability Information

HCPCS Code:

  • J9225 – Histrelin implant (Vantas), 50 mg: 1 billable unit = 50 mg

NDC:

  • Vantas 50 mg implant: 67979-0500-xx
  1. References
  1. Vantas [package insert]. Malvern, PA; Endo Pharmaceuticals Solutions, Inc; December 2020.  Accessed March 2020.
  2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for Histrelin acetate.  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 March 2021.
  3. 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 2021.
  4. 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 05/01/2020 with effective date 05/01/2020. Accessed March 2021.
  5. Novitas Solutions, Inc.  Local Coverage Article: Billing and Coding: Luteinizing Hormone-Releasing Hormone (LHRH) Analogs (A56776).  Centers for Medicare & Medicaid Services, Inc.  Updated on 11/08/2019 with effective date 11/14/2019.  Accessed March 2021.

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

C61

Malignant neoplasm of prostate

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: 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):

Jurisdiction(s):  N

NCD/LCD Document (s): A57655

https://www.cms.gov/medicare-coverage-database/search/document-id-search-results.aspx?DocID=A57655&bc=gAAAAAAAAAAA&   

Jurisdiction(s): H

NCD/LCD Document (s): A56776

https://www.cms.gov/medicare-coverage-database/search/article-date-search.aspx?DocID=A56776&bc=gAAAAAAAAAAA

Jurisdiction(s): 6, K

NCD/LCD Document (s): A52453

https://www.cms.gov/medicare-coverage-database/search/document-id-search-results.aspx?DocID=A52453&bc=gAAAAAAAAAAAAA%3d%3d&

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

 

 

 

VANTAS® (histrelin acetate) Prior Auth Criteria
Proprietary Information. Restricted Access – Do not disseminate or copy without approval.
©2021, Magellan Rx Management

White MRx.PNG