Download CLINICAL MEDICAL POLICY

CLINICAL MEDICAL POLICY
Policy Name:
Portrazza™ (Necitumumab)
Policy Number:
MP-021-MD-PA
(Temporary policy number, final number to be determined)
Approved By:
Medical Management
Provider Notice Date:
06/01/16
Original Effective Date:
07/01/16
Annual Approval Date:
05/01/16
Revision Date:
05/17/16
Products:
Pennsylvania Medicaid
Application:
All participating hospitals and providers
Page Number(s):
4
Disclaimer
SM
Gateway Health (Gateway) medical payment and prior-authorization policy is intended to serve only as a general
reference resource regarding payment and coverage for the services described. This policy does not constitute
medical advice and is not intended to govern or otherwise influence medical decisions.
POLICY STATEMENT:
Gateway provides coverage under the medical benefits of the Company’s Medicaid products for medically necessary
Portrazza™ (Necitumumab) administration.
This policy is designed to address medical necessity guidelines that are appropriate for the majority of individuals with a
particular disease, illness or condition. Each person’s unique clinical circumstances warrants individual consideration,
based upon review of applicable medical records.
(Current applicable PA HealthChoices Agreement Section V. Program Requirements, B. Prior Authorization of Services, 1.
General Prior Authorization Requirements.)
DEFINITIONS:
Prior Authorization Review Panel – A panel of representatives from within the PA Department of Human Services who
have been assigned organizational responsibility for the review, approval and denial of all PH-MCO Prior Authorization
policies and procedures.
2
Eastern Cooperative Oncology Group (ECOG) Performance Status – One of the standard criteria for the measuring of
how a disease impacts a patient’s daily living abilities. It describes a patient’s level of functioning in terms of their ability
to care for themselves, daily activity and physical ability (walking, working etc.).
PROCEDURES
1. Portrazza™ is an epidermal growth factor receptor (EGFR) antagonist indicated, in combination with
gemcitabine and cisplatin, for the first-line treatment of patients with non-small cell lung cancer (NSCLC).
The following medical necessity criteria must be met in order for coverage to be provided:
a. The patient must be diagnosed with metastatic or advanced squamous cell NSCLC; AND
b. The patient is age 18 years or older; AND
c. The prescriber is a hematologist/oncologist; AND
d. The patient will receive or has received a cardiac assessment prior to initiation of Portrazza™; AND
e. The patient has an ECOG Performance Status of 0 – 1 and has tried cisplatin with gemcitabine dual
therapy and the Portrazza™ is being added due to disease progression; OR
f. The prescriber provides documentation explaining why the addition of Portrazza™ to cisplatin and
gemcitabine as first line therapy has benefits outweighing the increased risk of toxicity, adverse effects
and documented limited efficacy; OR
g. The patient has ECOG Performance Status of 2 and tried carboplatin with albumin-bound paclitaxel AND
Portrazza™ is being added to cisplatin and gemcitabine; AND
h. The patient will have routine monitoring of serum electrolytes prior to each dose of Portrazza™ during
treatment and for at least eight weeks following completion of treatment; AND
i. The prescriber is aware that the National Comprehensive Cancer Network does not agree with the
addition of a third agent to cisplatin and gemcitabine for the treatment of Non-Small Cell Lung Cancer;
AND
j. The medication dosing is within the following prescribing-supported parameter:
i. The dose does not exceed 800mg per dose as an intravenous infusion over 60 minutes; AND
ii. The dose does not exceed 2 doses every 3 weeks
2. Contraindications
There are no contraindications noted.
3. When the Portrazza™ is not covered
Portrazza™ is not indicated for the treatment of non-squamous non-small cell lung cancer.
All other conditions other than those listed above are considered experimental/investigational and therefore,
not medically necessary.
The scientific evidence does not support the use of this medication for any other condition.
4. Post-payment Audit Statement
The medical record must include documentation that reflects the medical necessity criteria and is subject to audit
by Gateway at any time pursuant to the terms of your provider agreement.
5. Place of Service
The place of service for the administration of Portrazza™ is outpatient.
Proprietary and Confidential Information of Gateway Health Plan ® © Copyright 2016 Gateway HealthSM
3
6. Length of Coverage
Coverage for Portrazza™ will be approved for a 12 month duration.
When non-formulary prior authorization criteria are not met, the request will be forwarded to a Medical
Director for review. The physician reviewer must override criteria when, in their professional judgement, the
requested medication is medically necessary.
7. Operational Guidelines
a) Professional
This policy is applied on a post-service prepayment basis for professional claims.
b) Facility
This policy is applied on a post-service prepayment basis for facility claims.
CODING REQUIREMENTS:
Diagnosis Codes
ICD 10 Codes
C34.0
C34.00
C34.01
C34.02
C34.10
C34.11
C34.12
C34.3
C34.30
C34.31
C34.32
C34.8
C34.80
C34.81
C34.82
C34.90
C34.91
C34.92
Description
Malignant neoplasm of main bronchus
Malignant neoplasm of unspecified main bronchus
Malignant neoplasm of right main bronchus
Malignant neoplasm of left main bronchus
Malignant neoplasm of upper lobe, unspecified bronchus or lung
Malignant neoplasm of upper lobe, right bronchus or lung
Malignant neoplasm of upper lobe, left bronchus or lung
Malignant neoplasm of lower lobe, bronchus or lung
Malignant neoplasm of lower lobe, unspecified bronchus or lung
Malignant neoplasm of lower lobe, right bronchus or lung
Malignant neoplasm of lower lobe, left bronchus or lung
Malignant neoplasm of overlapping sites of bronchus and lung
Malignant neoplasm of overlapping sites of unspecified bronchus and lung
Malignant neoplasm of overlapping sites of right bronchus and lung
Malignant neoplasm of overlapping sites of left bronchus and lung
Malignant neoplasm of unspecified part of unspecified bronchus or lung
Malignant neoplasm of unspecified part of right bronchus or lung
Malignant neoplasm of unspecified part of left bronchus or lung
Procedure Codes
CPT Code
J3490
J3590
J9999
C9475
96413
Description
Unclassified drugs
Unclassified biologics
Not otherwise classified, antineoplastic drugs
Injection, Necitumumab, 1 mg
Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial
substance/drug
Proprietary and Confidential Information of Gateway Health Plan ® © Copyright 2016 Gateway HealthSM
4
96365
Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial,
up to 1 hour
SUMMARY OF LITERATURE:
Lung cancer is the leading cause of death in the United States. It is estimated that 221,200 new case will be diagnosed
with lung cancer and that there will be 158,040 associated deaths in 2015. The most common form of lung cancer is
non-small cell lung cancer which can be further divided into two main types named for the kinds of cells found in the
cancer: squamous cell and non-squamous cell.
Treatment of NSCLC includes the use of monoclonal antibodies that block activity of epidermal factor receptor (EGRF), a
protein commonly found on squamous non-small cell lung cancer.
Thatcher et al (2015) compared treatment with Portrazza™ plus gemcitabine and cisplatin versus gemcitabine and
cisplatin alone in patients with previously untreated stage IV squamous NSCLC, in an open-label, phase III multi-center
randomized control trial. In this trial patients 18 years of age an older with histologically or cytologically confirmed
stage IV squamous NSCLC, with an 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.
Between January 7, 2010 and February 22, 2102 there were 1,093 patients enrolled and randomly assigned to receive
Portrazza™ plus gemcitabine and cisplatin (n=545) or gemcitabine and cisplatin (n=548). Overall survival was
significantly longer in the Portrazza™ plus gemcitabine and cisplatin group (median of 11.5 months versus 9.9 months in
the non-Portrazza™ group. These researchers found that the safety profile of Portrazza™ plus gemcitabine and cisplatin
were acceptable and in line with expectations. The authors concluded that these finding showed that the addition of
Portrazza™ to gemcitabine and cisplatin chemotherapy improved overall survival in patients with advanced squamous
NSCLC and represented a new first-line treatment option for patients with this disease.
Policy Source(s)
Portrazza® (Necitumumab) [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; 03/2011. Available at:
http://druginserts.com/lib/rx/meds/portrazza/. Accessed on May 12, 2016.
NCCN Guidelines Version 4.2016: Non-Small Cell Lung Cancer
Thatcher H, Hirsch FR, Luft AV, et al. Necitumumab Plus Gemcitabine and Cisplatin Versus Gemcitabine and Cisplatin Alone as FirstLine Therapy in Patients with Stage IV Squamous Non-Small Cell Lung Cancer (SQUIRE): An Open-Label, Randomized, Controlled
Phase 3 Trial. Lancet Oncol. 2015 Jul;16(7):763-74. Available at:
http://www.thelancet.com/pdfs/journals/lanonc/PIIS1470-2045(15)00021-2.pdf. Accessed on May 12, 2016.
US Food and Drug Administration (FDA). Center for Biologics Evaluation and Research.
Available at:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125547s000lbl.pdf. Accessed on May 12, 2016.
Portrazza ™web site. Portrazza™ dosing and administration guide. Available at:
http://www.portrazza.com/assets/img/_pdfs/PORTRAZZA-Nurse-Pharmacist-Dosing-Guide.pdf. Accessed on May 12, 2016.
Proprietary and Confidential Information of Gateway Health Plan ® © Copyright 2016 Gateway HealthSM