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Effective Date: 07/01/2016 Title: Portrazza (Necitumumab)
Revision Date: 01/01/2017 Document: BI511:00
CPT Code(s): J9295
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Portrazza (necitumumab) requires prior authorization.

2)    Portrazza is used to treat a type of lung cancer.

3)    Portrazza is considered a specialty drug and is covered under the medical benefit.

Medical Statement

Portrazza (necitumumab) is considered medically necessary for patients meeting all of the following criteria:

1)    Diagnosis of metastatic squamous non-small cell lung cancer (NSCLC) AND

2)    Is used in combination with gemcitabine and cisplatin.


Portrazza (necitumumab) is considered experimental and investigational for the treatment of other solid tumors (not an all-inclusive list):

·       Colorectal cancer

·       Head and neck squamous cell carcinoma

·       Non-squamous NSCLC


Squamous Non-Small Cell Lung Cancer (NSCLC):

Necitumumab is a monoclonal antibody that blocks activity of epidermal growth factor receptor (EGFR), a protein commonly found on squamous non-small cell lung cancer (NSCLC).


Takeda and Nakagawa (2015) stated that dysregulation of EGFR signaling due to receptor over-expression or activating mutation is associated with cancer cell proliferation, metastasis, and survival.  They noted that EGFR has become an important therapeutic target for NSCLC, and several EGFR-targeted agents, such as tyrosine kinase inhibitors (TKIs) and monoclonal antibodies (mAbs), have been developed.  The EGFR-TKIs afatinib, Erlotinib, and Gefitinib have been approved by the Food and Drug Administration (FDA) for the treatment of advanced NSCLC, and sensitivity to these drugs has been shown to be associated with the presence of EGFR mutations.  Various mAbs to EGFR have also been evaluated in pre-clinical and clinical studies.  In particular, phase III clinical trials have shown a clinically significant survival benefit for addition of the anti-EGFR mAbs Cetuximab or necitumumab to a platinum doublet in chemotherapy-naive patients with advanced NSCLC. 


Sacco et al (2015) noted that over the past 2 decades, progress in the treatment of patients with metastatic squamous NSCLC has been limited.  The EGFR is involved in tumor progression and invasion and therefore it has become the target of several studies in lung cancer.  Strategies to block this pathway are focused on the development of small molecule (TKI) and mAbs.  Some mAbs have been studied in patients with advanced NSCLC.  For the first time, a fully human immunoglobulin G (IMC-11F8), subclass 1 (IgG1) mAb targeting the EGFR, in combination with standard chemotherapy (cisplatin + gemcitabine), has been shown to increase overall survival (OS) in chemo-naive patients with confirmed metastatic squamous cell histology.


In an open-label, phase III, multi-center, randomized controlled trial (RCT), Thatcher et al (2015) compared treatment with necitumumab plus gemcitabine and cisplatin versus gemcitabine and cisplatin alone in patients with previously untreated stage IV squamous NSCLC.  This study was carried out at 184 sites in 26 countries.  Patients aged 18 years or older with histologically or cytologically confirmed stage IV squamous NSCLC, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 and adequate organ function and who had not received previous chemotherapy for their disease were eligible for inclusion.  Enrolled patients were randomly assigned 1:1 to a maximum of six 3-week cycles of gemcitabine and cisplastin chemotherapy with or without necitumumab according to a block randomization scheme (block size of 4) by a telephone-based interactive voice response system or interactive web response system.  Chemotherapy was gemcitabine 1,250 mg/m (2) administered intravenously over 30 mins on days 1 and 8 of a 3-week cycle and cisplatin 75 mg/m (2) administered intravenously over 120 mins on day 1 of a 3-week cycle.  Necitumumab (800 mg), administered intravenously over a minimum of 50 mins on days 1 and 8, was continued after the end of chemotherapy until disease progression or intolerable toxic side effects occurred.  Randomization was stratified by ECOG performance status and geographical region.  Neither physicians nor patients were masked to group assignment because of the expected occurrence of acne-like rash -- a class effect of EGFR antibodies -- that would have unmasked most patients and investigators to treatment.  The primary end-point was OS, analyzed by intention-to-treat. 


Between January 7, 2010, and February 22, 2012, these researchers enrolled 1,093 patients and randomly assigned them to receive necitumumab plus gemcitabine and cisplatin (n = 545) or gemcitabine and cisplatin (n = 548).  Overall survival was significantly longer in the necitumumab plus gemcitabine and cisplatin group than in the gemcitabine and cisplatin alone group (median of 11.5 months [95 % confidence intervals [CI] 10.4 to 12.6]) versus 9.9 months [8.9 to 11.1]; stratified hazard ratio (HR) 0.84 [95 % CI: 0.74 to 0. 96; p = 0.01]).  In the necitumumab plus gemcitabine and cisplatin group, the number of patients with at least 1 grade-3 or worse adverse event was higher (388 [72 %] of 538 patients) than in the gemcitabine and cisplatin group (333 [62 %] of 541), as was the incidence of serious adverse events (257 [48 %] of 538 patients versus 203 [38 %] of 541).  More patients in the necitumumab plus gemcitabine and cisplatin group had grade 3 to 4 hypomagnesaemia (47 [9 %] of 538 patients in the necitumumab plus gemcitabine and cisplatin group versus 6 [1 %] of 541 in the gemcitabine and cisplatin group) and grade 3 rash (20 [4 %] versus 1 [less than 1 %]).  Including events related to disease progression, adverse events with an outcome of death were reported for 66 (12 %) of 538 patients in the necitumumab plus gemcitabine and cisplatin group and 57 (11 %) of 541 patients in the gemcitabine and cisplatin group; these were deemed to be related to study drugs in 15 (3 %) and 10 (2 %) patients, respectively.  Overall, these researchers found that the safety profile of necitumumab plus gemcitabine and cisplatin was acceptable and in line with expectations.  The authors concluded that these findings showed that the addition of necitumumab to gemcitabine and cisplatin chemotherapy improved OS in patients with advanced squamous NSCLC and represented a new first-line treatment option for this disease.


On November 24, 2015, the FDA approved necitumumab (Portrazza) in combination with 2 forms of chemotherapy to treat patients with metastatic squamous NSCLC who have not previously received medication specifically for treating their advanced lung cancer based on the findings of the phase III clinical trial by Thatcher et al (2015).  However, necitumumab was not found to be an effective treatment in patients with non-squamous NSCLC.  The most common side effects of necitumumab are skin rash and hypomagnesemia, which can cause muscular weakness, seizure, irregular heartbeats and can be fatal.  Portrazza includes a boxed warning to alert health care providers of serious risks of treatment with necitumumab, including cardiac arrest and sudden death, as well as hypomagnesemia.


Experimental Indications:


Necitumumab is also being investigated in the treatment of other solid tumors; however, its effectiveness for these indications has not been established.


Colorectal Cancer


Dienstmann and Tabernero (2010) stated that necitumumab (IMC-11F8) is a fully human IgG1 mAb targeting the EGFR for the potential treatment of cancer, in particular NSCLC.  Pre-clinical studies indicated that the anti-tumor activity of necitumumab is either comparable with or superior to that of Cetuximab (a chimeric anti-EGFR mAb).  In a phase I clinical trial in patients with advanced solid malignancies, necitumumab displayed non-linear pharmacokinetic behavior.  The toxicity profile of necitumumab is acceptable, with skin toxicity being the most frequently reported adverse event in the phase I and II clinical trials conducted to date.  The authors stated that preliminary data from a phase II clinical trial of necitumumab in combination with chemotherapy for the first-line treatment of advanced colon cancer are promising. 


Furthermore, a phase II clinical trial on the use of IMC-11F8 in combination with chemotherapy in the treatment of colorectal cancer has been completed (Last updated:

January 22, 2014.


Head and Neck Squamous Cell Carcinoma


Cohen (2014) stated that over-expression of the EGFR is a common characteristic of

head and neck squamous cell carcinomas (HNSCC).  Cetuximab is a chimeric anti-EGFR mAb with multiple approved indications in HNSCC, including with radiation therapy (RT) for loco regionally advanced disease, as monotherapy after platinum progression, and with platinum/5-fluorouracil for recurrent or metastatic disease.  There remain, however, numerous unanswered questions regarding the optimal use of Cetuximab in HNSCC, including patient selection, its mechanisms of action and resistance, the effect of human papillomavirus status on outcomes, its role when combined with induction chemotherapy or adjuvant radiation, and optimal management of skin toxicity and hypersensitivity reactions.  In addition, a variety of other anti-EGFR agents (the multi-targeted small molecule TKIs lapatinib, dacomitinib, and afatinib and the anti-EGFR mAbs zalutumumab, nimotuzumab, and Panitumumab) are currently under investigation in phase II and III clinical trials in different HNSCC therapeutic settings.  The anti-EGFR TKI Erlotinib is currently in phase III development for oral cancer prevention.  Numerous other drugs are in earlier stages of development for HNSCC treatment, including novel anti-EGFR mAbs (MEHD7945A, necitumumab, and RO5083945), small-molecule TKIs (vandetanib, icotinib, and CUDC-101), EGFR anti-sense, various add-on therapies to radiation and chemotherapy (bevacizumab, interleukin-12, lenalidomide, alisertib, and VTX-2337), and drugs (temsirolimus, everolimus, OSI-906, dasatinib, and PX-866) intended to overcome resistance to anti-EGFR agents.  Overall, a wealth of clinical trial data is expected in the coming years, with the potential to modify significantly the approach to anti-EGFR therapy for HNSCC.


1)    Aetna Medical Clinical Policy Bulletin. Portrazza (necitumumab). Accessed at

2)    Portrazza Product Information. Eli Lilly. Indianapolis, IN. November 2015.

3)    Clinical Pharmacology. Accessed online 03/14/2016.


1)    Effective 1/1/2017: added J9295 as appropriate code for Portrazza.

Application to Products

This policy applies to all health plans and products administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet.  Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) or Certificate of Coverage (COC) for those plans or products insured by QualChoice.  In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC or COC, the SPD, EOC, or COC, as applicable, will prevail.  State and federal mandates will be followed as they apply.

Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
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