vp-0521
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Padcev™ (enfortumab vedotin-ejfv) (Intravenous)

Policy Number: VP-0521

Last Review Date: 01/06/2020

Date of Origin: 01/06/2020

Dates Reviewed: 01/2020

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]:
  • Padcev 20 mg single-dose vial: 15 vials of each 28-day cycle
  • Padcev 30 mg single-dose vial: 15 vials of each 28-day cycle
  1. Max Units (per dose and over time) [HCPCS Unit]:
  • 125 mg on days 1, 8 and 15 of every 28-day cycle

III. Initial Approval Criteria 

Coverage is provided in the following conditions:

  • Patient must be at least 18 years old; AND
  • Used as a single agent; AND
  • Patient does not have uncontrolled diabetes mellitus (i.e., baseline serum glucose > 250 mg/dL or hemoglobin A1C ≥ 8%); AND
  • Patient does not have pre-existing peripheral neuropathy of Grade ≥ 2; AND
  • Patient does not have active central nervous system (CNS) metastases; AND

Bladder Cancer/Urothelial Carcinoma †

  • Patient has a diagnosis of unresectable locally advanced or metastatic Urothelial Carcinoma; AND
  • Used as subsequent therapy; AND
  • Patient experienced disease progression or recurrence after receiving treatment with the following:
    • Platinum-based therapy (i.e., carboplatin, cisplatin, etc.) in any setting; AND
    • Immune checkpoint inhibitor therapy with a PD-directed agent (i.e., nivolumab, pembrolizumab, atezolizumab, avelumab, durvalumab, etc.)

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: severe hyperglycemia or diabetic ketoacidosis, severe peripheral neuropathy, ocular disorders including vision changes, severe skin reactions, etc.

V. Dosage/Administration

Indication

Dose

Urothelial Carcinoma

Administer 1.25 mg/kg (up to a maximum of 125 mg for patients ≥100 kg)

administered as an intravenous infusion over 30 minutes on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.

VI. Billing Code/Availability Information

HCPCS Code:

  • J9999 – Not otherwise classified, antineoplastic drugs

NDC:

  • Padcev 20 mg single-dose vial: 51144-0020-xx
  • Padcev 30 mg single-dose vial: 51144-0030-xx

VII. References

  1. Padcev [package insert]. Northbrook, IL; Astellas Pharma US, Inc; December 2019. Accessed December 2019.
  2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for enfortumab vedotin. National Comprehensive Cancer Network, 2019. 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 December 2019.
  3. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Bladder Cancer. Version 4.2019. National Comprehensive Cancer Network, 2019. 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 December 2019.
  4. Rosenberg JE, O'Donnell PH, Balar AV, et al. Pivotal Trial of Enfortumab Vedotin in Urothelial Carcinoma After Platinum and Anti-Programmed Death 1/Programmed Death Ligand 1 Therapy. J Clin Oncol. 2019 Oct 10;37(29):2592-2600.
  5. Gupta S, Sonpavde G, Grivas P, et al. Defining “platinum-ineligible” patients with metastatic urothelial cancer (mUC). J Clin Oncol. 2019 Mar 1;37(7_suppl):451.
  6. Fahrenbruch R, Kintzel P, Bott AM, et al. Dose Rounding of Biologic and Cytotoxic Anticancer Agents: A Position Statement of the Hematology/Oncology Pharmacy Association. J Oncol Pract. 2018 Mar;14(3):e130-e136.
  7. Hematology/Oncology Pharmacy Association (2019). Intravenous Cancer Drug Waste Issue Brief. Retrieved from http://www.hoparx.org/images/hopa/advocacy/Issue-Briefs/Drug_Waste_2019.pdf
  8. Bach PB, Conti RM, Muller RJ, et al. Overspending driven by oversized single dose vials of cancer drugs. BMJ. 2016 Feb 29;352:i788.

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

C67.0

Malignant neoplasm of trigone of bladder

C67.1

Malignant neoplasm of dome of bladder

C67.2

Malignant neoplasm of lateral wall of bladder

C67.3

Malignant neoplasm of anterior wall of bladder

C67.4

Malignant neoplasm of posterior wall of bladder

C67.5

Malignant neoplasm of bladder neck

C67.6

Malignant neoplasm of ureteric orifice

C67.7

Malignant neoplasm of urachus

C67.8

Malignant neoplasm of overlapping sites of bladder

C67.9

Malignant neoplasm of bladder, unspecified

Z85.51

Personal history of malignant neoplasm of bladder

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), Articles 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/Article): 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