Last Review Date: 04/04/2024

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, 04/2023, 04/2024

1. Length of Authorization

Coverage will be provided for 6 months and may be renewed.

2. Dosing Limits

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

• Portrazza 800mg/50mL single-dose vial: 2 vials every 21 days

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

• 800 billable units on Day 1 and 8 every 21 days

3. 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
• Patient has squamous cell histology; AND
• Used in combination with BOTH gemcitabine and cisplatin

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

4. 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, venous/arterial thromboembolic events, etc.

5. Dosage/Administration ¹

6. 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

7. References

1. Portrazza [package insert]. Indianapolis, IN; Eli Lilly and Company; November 2015. Accessed February 2024.
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

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. 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 Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A