CLINICAL MEDICAL POLICY

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1 Policy Name: Policy Number: Approved By: Provider Notice Date: CLINICAL MEDICAL POLICY Portrazza (Necitumumab) MP-021-MD-WV Medical Management Original Effective Date: 06/02/2016 Annual Approval Date: Revision Date: Products: Application: Page Number(s): WVFH Medicaid All participating hospitals and providers 1 of Disclaimer West Virginia Family Health 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: West Virginia Family Health 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. DEFINITIONS: 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.). 1

2 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. 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. 4. Post-payment Audit Statement The medical record must include documentation that reflects the medical necessity criteria and is subject to audit by West Virginia Family Health at any time pursuant to the terms of your provider agreement. 2

3 5. Place of Service The place of service for the administration of Portrazza is outpatient. CODING REQUIREMENTS: Procedure Codes CPT Code Description J3490 Unclassified drugs J3590 Unclassified biologics J9999 Not otherwise classified, antineoplastic drugs C9475 Injection, Necitumumab, 1 mg Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour Diagnosis Codes ICD 10 Codes Description C34.0 Malignant neoplasm of main bronchus 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 C34.3 Malignant neoplasm of lower 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 C34.8 Malignant neoplasm of overlapping sites of bronchus and 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 REIMBURSEMENT Participating facilities will be reimbursed per their West Virginia Family Health contract. 3

4 POLICY SOURCE(S) Portrazza (Necitumumab) [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; 03/2011. Available at: Accessed on May 12, NCCN Guidelines Version : Non-Small Cell Lung Cancer Thatcher H, Hirsch FR, Luft AV, et al. 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, Randomized, Controlled Phase 3 Trial. Lancet Oncol Jul;16(7): Available at: Accessed on May 12, US Food and Drug Administration (FDA). Center for Biologics Evaluation and Research. Available at: Accessed on May 12, Portrazza web site. Portrazza dosing and administration guide. Available at: Accessed on May 12, Eastern Cooperative Oncology Group (ECOG) Performance Status Grade Description 0 Fully active, able to carry on all pre-disease performance without restriction 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work 2 Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours 3 Capable of only limited self-care, confined to bed or chair more than 50% of waking hours 4 Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair 5 Dead 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 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. 4

5 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. 5