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Date Printed: October 23, 2017: 07:28 AM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

09-J1000-57

Original Effective Date: 01/01/12

Reviewed: 09/13/17

Revised: 10/15/17

Subject: Crizotinib (Xalkori®) Capsules

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Dosage/ Administration Billing/Coding Reimbursement Program Exceptions Definitions
           
Related Guidelines Other References Updates  
           

DESCRIPTION:

Crizotinib (Xalkori) is a small molecule inhibitor of tyrosine kinases including anaplastic lymphoma kinase (ALK), hepatocyte growth factor (HGFR, c-MET) and Receteur d’Origine Nantais (RON). It was granted orphan drug status in September 2010 and approval under accelerated approval regulations on August 26, 2011. Currently, crizotinib is indicated for treatment of persons with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is ALK-positive as detected by an approved test. This approval was based on response rate and data demonstrating improvement in patient reported outcomes or survival with crizotinib are not available. The effect of crizotinib on other tumor types where chromosomal rearrangements of ALK (i.e., anaplastic large cell lymphoma, inflammatory myofibroblastic tumor, pediatric neuroblastoma) occur is under investigation. Current National Comprehensive Cancer Network (NCCN) guidelines support the use of crizotinib in the treatment of NSCLC (Version 8.2017) and inflammatory myofibroblastic tumor (Version 2.2017).

POSITION STATEMENT:

Initiation of crizotinib (Xalkori) meets the definition of medical necessity when used for treatment of ANY of the following indications and ALL associated criteria are met:

1. Non-small cell lung cancer (NSCLC)

a. Member’s disease is recurrent or metastatic

b. Member’s disease is documented as having one of the following genetic alterations:

i. Anaplastic lymphoma kinase (ALK) (i.e., ALK positive) – laboratory documentation must be provided

ii. High level MET amplification – laboratory documentation must be provided

iii. MET exon 14 skipping mutation – laboratory documentation must be provided

iv. ROS1 rearrangement – laboratory documentation must be provided

c. Crizotinib will be used as monotherapy

d. Crizotinib dose does not exceed 500 mg daily – dosage will be achieved using the fewest number of capsules per day

2. Inflammatory myofibroblastic tumor (IMT)

a. Member has documented anaplastic lymphoma kinase (ALK)-positive disease – laboratory documentation must be provided

b. Crizotinib will be used as monotherapy

c. Crizotinib dose does not exceed 500 mg daily – dosage will be achieved using the fewest number of capsules per day

Duration of approval: 6 months

Continuation of crizotinib (Xalkori) meets the definition of medical necessity when ALL of the following criteria are met:

  1. Authorization/reauthorization has been previously approved by Florida Blue or another health plan in the past two years for treatment of NSCLC that has a genetic alteration (i.e., ALK-positive, high MET amplification, MET exon 14 skipping mutation, ROS1 rearrangement) or ALK-positive IMT, OR the member has previously met all indication-specific initiation criteria
  2. Crizotinib is used as monotherapy
  3. Crizotinib dose does not exceed 500 mg daily – dosage will be achieved using the fewest number of capsules per day

Duration of approval: 1 year

Crizotinib meets the definition of medical necessity when used for treatment of the following designated Orphan Drug indication when the maximum FDA-approved dose is not exceeded:

1. Anaplastic large cell lymphoma

2. Neuroblastoma

Duration of approval: 6 months

DOSAGE/ADMINISTRATION:

THIS INFORMATION IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND SHOULD NOT BE USED AS A SOURCE FOR MAKING PRESCRIBING OR OTHER MEDICAL DETERMINATIONS. PROVIDERS SHOULD REFER TO THE MANUFACTURER’S FULL PRESCRIBING INFORMATION FOR DOSAGE GUIDELINES AND OTHER INFORMATION RELATED TO THIS MEDICATION BEFORE MAKING ANY CLINICAL DECISIONS REGARDING ITS USAGE.

FDA-approved:

250 mg orally, twice daily

Dose Adjustments:

Drug Availability:

PRECAUTIONS:

Hepatotoxicity: Drug-induced hepatotoxicity with fatal outcome has occurred. Monitor monthly and as clinically indicated with more frequent testing in persons with Grade 2–4 elevations. Temporarily suspend, dose reduce, or permanently discontinue crizotinib as indicated.

Pneumonitis: Severe, including fatal, treatment-related pneumonitis has been observed. Monitor members for pulmonary symptoms indicative of pneumonitis. Permanently discontinue in members diagnosed with treatment-related pneumonitis.

QT Interval Prolongation: In members who have a history of or predisposition for QTc prolongation, or who are taking medications that are known to prolong the QT interval, consider periodic monitoring with electrocardiograms and electrolytes.

Bradycardia: Avoid using crizotinib in combination with bradycardic agents. Monthly monitoring of pulse rate and blood pressure is recommended. In cases of symptomatic bradycardia, hold crizotinib and re-evaluate the use of concomitant medications.

ALK Testing: Detection of ALK-positive NSCLC using an FDA-approved test, indicated for this use, is necessary for selection of patients for treatment with crizotinib.

Pregnancy: crizotinib can cause fetal harm when administered to a pregnant woman.

Renal Impairment: In members with severe renal impairment not requiring peritoneal dialysis or hemodialysis, adjust the crizotinib dose.

BILLING/CODING INFORMATION:

HCPCS Coding

C9399

Unclassified drugs or biologicals (Hospital Outpatient Use ONLY)

J8499

Prescription drug, oral, nonchemotherapeutic, NOS

ICD-10 Diagnosis Codes That Support Medical Necessity

C33

Malignant neoplasm of trachea

C34.00 – C34.92

Malignant neoplasm of bronchus and lung

C49.4 – C49.5

Malignant neoplasm of connective and soft tissue of abdomen or pelvis

C79.31

Secondary malignant neoplasm of brain

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products: No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline revised date.

Medicare Part D: Florida Blue has delegated to Prime Therapeutics authority to make coverage determinations for the Medicare Part D services referenced in this guideline.

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

Carboplatin (Paraplatin®) IV, 09-J0000-93

Denosumab (Prolia™; Xgeva™) Injection, 09-J1000-25

Gemcitabine (Gemzar®), 09-J0000-96

Paclitaxel and Paclitaxel (protein-bound) IV, 09-J1000-05

Pemetrexed Disodium (Alimta®) IV, 09-J1000-01

Topotecan HCl (Hycamtin®) IV, 09-J1000-02

Vinorelbine Tartrate (Navelbine®) IV, 09-J1000-03

OTHER:

None.

REFERENCES:

  1. Clinical Pharmacology [Internet]. Tampa (FL): Gold Standard, Inc.; 2017 [cited 8/28/17]. Available from: http://www.clinicalpharmacology.com/.
  2. ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine; 2000 Feb 29 - [cited 8/28/17]. Available from: http://clinicaltrials.gov/.
  3. DRUGDEX® System [Internet]. Greenwood Village (CO): Thomson Micromedex; Updated periodically [cited 8/28/17]. Available from: http://www.thomsonhc.com/.
  4. National Comprehensive Cancer Network®. NCCN clinical practice guidelines in oncology (NCCN Guidelines®). Non-small cell lung cancer, v. 8.2017 [cited 8/28/17]. Available from: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp.
  5. National Comprehensive Cancer Network®. NCCN clinical practice guidelines in oncology (NCCN Guidelines®). Soft tissue sarcoma, v. 2.2017 [cited 8/28/17]. Available from: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp.
  6. NCCN Drugs & Biologics Compendium [Internet]. Fort Washington (PA): National Comprehensive Cancer Network; 2017 [cited 8/28/17]. Available from: http://www.nccn.org/professionals/drug_compendium/content/contents.asp/.
  7. Orphan Drug Designations and Approval [Internet]. Silver Spring (MD): US Food and Drug Administration; 2015 [cited 8/28/17]. Available from: http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm/.
  8. Pfizer. Xalkori (crizotinib) capsule. 2017 [cited 8/28/17]. In: DailyMed [Internet]. Bethesda (MD): National Library of Medicine. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2a51b0de-47d6-455e-a94c-d2c737b04ff7/.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 09/13/17.

GUIDELINE UPDATE INFORMATION:

01/01/12

New Medical Coverage Guideline.

01/15/14

Review and revision to guideline; consisting of revising position statement, updating dosage/administration, precautions, references, coding, and program exceptions.

01/15/15

Review and revision to guideline; consisting of position statement, references.

11/01/15

Revision: ICD-9 Codes deleted.

01/15/16

Review and revision to guideline; consisting of updating position statement, coding, references

09/15/16

Review and revision to guideline, consisting of updating position statement, coding, references

10/01/16

Revision to guideline; consisting of updating ICD10 codes

10/15/17

Review and revision to guideline, consisting of updating position statement, coding, references.

Date Printed: October 23, 2017: 07:28 AM