Asset Publisher

vp-0267

print Print

Portrazza™ (necitumumab) (Intravenous)

Policy Number: VP-0267

Last Review Date: 04/04/2022

Date of Origin: 02/23/2016

Dates Reviewed: 02/2016, 01/2017, 05/2017, 08/2017, 11/2017, 02/2018, 05/2018, 04/2019, 04/2020, 04/2021, 04/2022

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 6 months and may be renewed.

II. Dosing Limits

  1. Quantity Limit (max daily dose) [NDC Unit]:
  • Portrazza 800mg/50mL single-dose vial: 2 vials every 21 days
  1. Max Units (per dose and over time) [HCPCS Unit]:
  • 800 billable units Day 1 and 8 every 21 days

III. Initial Approval Criteria 1

Coverage is provided in the following conditions:

  • Patient is at least 18 years of age; AND

Non-Small Cell Lung Cancer (NSCLC) 1-3

  • Used as first-line therapy for metastatic disease; AND
  • Disease has squamous cell histology; AND
  • Used in combination with BOTH gemcitabine and cisplatin

FDA Approved Indication(s); Compendia recommended indication(s); Ф Orphan Drug

IV. 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: cardiopulmonary arrest, hypomagnesemia, severe dermatologic toxicity, severe infusion reactions, and venous/arterial thromboembolic events, etc.

V. Dosage/Administration 1

Indication

Dose

Squamous Cell NSCLC

Administer 800 mg intravenously on Days 1 and 8 of each 3-week cycle prior to gemcitabine and cisplatin infusion. Continue until disease progression or unacceptable toxicity.

VI. Billing Code/Availability Information

HCPCS Code:

  • J9295 - Injection, necitumumab, 1 mg; 1 billable unit = 1 mg

NDC:

  • Portrazza 800 mg/50 mL single-dose vial: 00002-7716-xx

VII. References

  1. Portrazza [package insert]. Indianapolis, IN; Eli Lilly and Company; November 2015. Accessed March 2022.
  2. Thatcher N, Hirsch FR, Luft AV, et al SQUIRE Investigators.  Necitumumab plus gemcitabine and cisplatin versus gemcitabine and cisplatin alone as first-line therapy in patients with stage IV squamous non-small-cell lung cancer (SQUIRE): an open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2015;16(7):763. Epub 2015 Jun 1.
  3. Paz-Ares L, Mezger J, Ciuleanu TE, et al INSPIRE Investigators. Necitumumab plus pemetrexed and cisplatin as first-line therapy in patients with stage IV non-squamous non-small-cell lung cancer (INSPIRE): an open-label, randomised, controlled phase 3 study.  Lancet Oncol. 2015;16(3):328. Epub 2015 Feb 18.

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

C33

Malignant neoplasm of trachea

C34.00

Malignant neoplasm of unspecified main bronchus

C34.01

Malignant neoplasm of right main bronchus

C34.02

Malignant neoplasm of left main bronchus

C34.10

Malignant neoplasm of upper lobe, unspecified bronchus or lung

C34.11

Malignant neoplasm of upper lobe, right bronchus or lung

C34.12

Malignant neoplasm of upper lobe, left bronchus or lung

C34.2

Malignant neoplasm of middle lobe, bronchus or lung

C34.30

Malignant neoplasm of lower lobe, unspecified bronchus or lung

C34.31

Malignant neoplasm of lower lobe, right bronchus or lung

C34.32

Malignant neoplasm of lower lobe, left bronchus or lung

C34.80

Malignant neoplasm of overlapping sites of unspecified bronchus and lung

C34.81

Malignant neoplasm of overlapping sites of right bronchus and lung

C34.82

Malignant neoplasm of overlapping sites of left bronchus and lung

C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

Z85.118

Personal history of other malignant neoplasm of bronchus and lung

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): 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