vp-0257
print Print Back Back

Yondelis® (trabectedin) (Intravenous)

Policy Number: VP-0257

Last Review Date: 06/01/2021

Date of Origin: 12/04/2015                                                                                                                       

Dates Reviewed: 12/2015, 07/2016, 02/2017, 05/2017, 08/2017, 11/2017, 02/2018, 05/2018, 09/2018, 12/2018, 03/2019, 06/2019, 09/2019, 12/2019, 03/2020, 06/2020, 09/2020, 12/2020, 06/2021

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]:
  • 1 mg vial for injection: 8 vials every 21 days
  1. Max Units (per dose and over time) [HCPCS Unit]:
  • STS/uLMS
    • 40 billable units every 21 days
  • Myxoid Liposarcoma
    • 80 billable units every 21 days

III. Initial Approval Criteria 1

Coverage is provided in the following conditions:

  • Patient is at least 18 years of age; AND

Universal Criteria 1

  • Left ventricular ejection fraction (LVEF) is within normal limits prior to initiating therapy and will be assessed at regular intervals (e.g., every 3 months) during treatment; AND
  • Used as single agent therapy; AND

Soft Tissue Sarcoma (STS) ‡ Ф 1-4

  • Patient has unresectable or metastatic liposarcoma or leiomyosarcoma ; AND
    • Used as subsequent therapy after an anthracycline-containing regimen (e.g., doxorubicin, etc.); OR
  • Used as neo-adjuvant or adjuvant therapy for myxoid liposarcoma; AND
    • Patient has a diagnosis of one of the following sub-types of soft tissue sarcoma:
      • Retroperitoneal/Intra-abdominal; AND
        • Used pre-operatively for primary or recurrent disease; OR
        • Used post-operatively for disease at high risk of local recurrence or becoming metastatic (excludes use for low-grade tumors)
      • Extremity/Body Wall, Head/Neck; AND
        • Used for stage II-IV disease
  • Used as palliative therapy; AND
    • Patient has a diagnosis of one of the following sub-types of soft tissue sarcoma:
      • Angiosarcoma
      • Rhabdomyosarcoma; AND
        • Used as subsequent therapy for advanced or metastatic pleomorphic rhabdomyosarcoma
      • Retroperitoneal/Intra-abdominal; AND
        • Used as subsequent therapy for recurrent unresectable or stage IV disease
      • Extremity/Body Wall, Head/Neck; AND
        • Used as subsequent therapy for advanced or metastatic disease with disseminated metastases
      • Solitary Fibrous Tumor

Uterine Sarcoma 2,5

  • Patient has uterine leiomyosarcoma; AND
  • Used as subsequent therapy after an anthracycline-containing regimen (e.g., doxorubicin, etc.); AND
    • Patient has unresectable, metastatic or recurrent disease; OR
    • Patient has disease that is not suitable for primary surgery

FDA approved indication(s); Compendia recommended indication(s); Ф Orphan Drug

IV. Renewal Criteria 1

Authorizations can be renewed based on the following criteria:

  • Patient continues to meet universal and other 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: cardiomyopathy, rhabdomyolysis, hepatotoxicity and/or severe hepatic impairment, capillary leak syndrome (CPS), severe neutropenia/neutropenic sepsis, extravasation resulting in tissue necrosis, etc.; AND
  • Left ventricular ejection fraction (LVEF) has not had an absolute decrease of ≥ 15% from baseline OR is not below the lower limit of normal (LLN) with an absolute decrease of ≥ 5% (LVEF results must be within the previous 3 months)

V. Dosage/Administration 1

Indication

Dose

Soft Tissue Sarcoma/Uterine Sarcoma

1.5 mg/m² administered intravenously (IV) every 21 days, until disease progression or unacceptable toxicity

Myxoid Sarcomas

1-3 mg/m² administered intravenously (IV) every 21 days, until disease progression or unacceptable toxicity

VI. Billing Code/Availability Information

HCPCS Code:

  • J9352 - Injection, trabectedin, 0.1 mg: 1 billable unit = 0.1 mg

NDC:

  • Yondelis 1 mg vial for injection: 59676-0610-xx

VII. References

  1. Yondelis [package insert].  Horsham, PA; Janssen Products, LP; June 2020. Accessed April 2021.
  2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) trabectedin. 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 April 2021.
  3. Demetri GD, von Mehren M, Jones RL, et al. Efficacy and Safety of Trabectedin or Dacarbazine for Metastatic Liposarcoma or Leiomyosarcoma After Failure of Conventional Chemotherapy: Results of a Phase III Randomized Multicenter Clinical Trial. J Clin Oncol. 2016;34(8):786-793.
  4. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Soft Tissue Sarcoma 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 April 2021.
  5. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Uterine Neoplasms Version 2.2021. National Comprehensive Cancer Network, 2020. 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 April 2021.
  6. Palmetto GBA. Local Coverage Article (LCA): Billing and Coding: Chemotherapy (A56141). Centers for Medicare & Medicaid Services, Inc. Updated on 11/12/2020 with effective date 11/19/2020. Accessed April 2021.

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

C22.3

Angiosarcoma of liver

C47.0

Malignant neoplasm of peripheral nerves of head, face and neck

C47.10

Malignant neoplasm of peripheral nerves of unspecified upper limb, including shoulder

C47.11

Malignant neoplasm of peripheral nerves of right upper limb, including shoulder

C47.12

Malignant neoplasm of peripheral nerves of left upper limb, including shoulder

C47.20

Malignant neoplasm of peripheral nerves of unspecified lower limb, including hip

C47.21

Malignant neoplasm of peripheral nerves of right lower limb, including hip

C47.22

Malignant neoplasm of peripheral nerves of left lower limb, including hip

C47.3

Malignant neoplasm of peripheral nerves of thorax

C47.4

Malignant neoplasm of peripheral nerves of abdomen

C47.5

Malignant neoplasm of peripheral nerves of pelvis

C47.6

Malignant neoplasm of peripheral nerves of trunk, unspecified

C47.8

Malignant neoplasm of overlapping sites of peripheral nerves and autonomic nervous system

C47.9

Malignant neoplasm of peripheral nerves and autonomic nervous system, unspecified

C48.0

Malignant neoplasm of retroperitoneum

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

C49.0

Malignant neoplasm of connective and soft tissue of head, face and neck

C49.10

Malignant neoplasm of connective and soft tissue of unspecified upper limb, including shoulder

C49.11

Malignant neoplasm of connective and soft tissue of right upper limb, including shoulder

C49.12

Malignant neoplasm of connective and soft tissue of left upper limb, including shoulder

C49.20

Malignant neoplasm of connective and soft tissue of unspecified lower limb, including hip

C49.21

Malignant neoplasm of connective and soft tissue of right lower limb, including hip

C49.22

Malignant neoplasm of connective and soft tissue of left lower limb, including hip

C49.3

Malignant neoplasm of connective and soft tissue of thorax

C49.4

Malignant neoplasm of connective and soft tissue of abdomen

C49.5

Malignant neoplasm of connective and soft tissue of pelvis

C49.6

Malignant neoplasm of connective and soft tissue of trunk, unspecified

C49.8

Malignant neoplasm of overlapping sites of connective and soft tissue

C49.9

Malignant neoplasm of connective and soft tissue, unspecified

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

Z85.831

Personal history of malignant neoplasm of soft tissue

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): J&M

NCD/LCD/LCA Document (s): A56141

https://www.cms.gov/medicare-coverage-database/search/article-date-search.aspx?DocID=A56141&bc=gAAAAAAAAAAA

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