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Date Printed: December 16, 2017: 09:17 PM

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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-J2000-56

Original Effective Date: 03/15/16

Reviewed: 09/13/17

Revised: 10/15/17

Next Review: 09/12/18

Subject: Alectinib (Alecensa®)

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.

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

DESCRIPTION:

Alectinib (Alecensa), a kinase inhibitor that targets anaplastic lymphoma kinase (ALK) and RET, was approved by the U.S. Food and Drug Administration (FDA) in December 2015 treatment of patients with ALK-positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. This indication is approved under accelerated approval based on tumor response rate and duration of response [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

The safety and efficacy of alectinib were established in two single-arm, multicenter clinical trials conducted in patients with locally advanced metastatic ALK-positive NSCLC, who have progressed on crizotinib. The objective response rate (ORR) was 38% (95% CI: 28%, 49%) by IRC and 46% (95% CI: 35%, 57%) by Investigator for patients in study 1 after a median follow-up of 4.8 months and 44% (95% CI: 36%, 53%) by IRC and 48% (95% CI: 39%, 57%) by Investigator for patients in study 2 after a median follow-up of 10.9 months. The median duration of response was 7.5 months for study 1 and was 11.2 months for study 2.

An assessment of the ORR and duration of response for central nervous system (CNS) metastases was completed in 51 patients with measurable lesions in the CNS at baseline enrolled into these studies. The ORR in the central nervous system was 61% (95% CI: 46%, 74%) with a median duration of response of 9.1 months (95% CI: 5.8, NE). The most common adverse reactions (incidence ≥ 20%) were fatigue, constipation, edema and myalgia.

National Comprehensive Cancer Network (NCCN) Guidelines for Non-Small Cell Lung Cancer (Version 8.2017) recommend alectinib as preferred first line therapy for ALK-positive recurrent or metastatic disease.

POSITION STATEMENT:

Comparative Effectiveness

The Food and Drug Administration has deemed the drug(s) or biological product(s) in this coverage policy to be appropriate for self-administration or administration by a caregiver (i.e., not a healthcare professional). Therefore, coverage (i.e., administration) in a provider-administered setting such as an outpatient hospital, ambulatory surgical suite, physician office, or emergency facility is not considered medically necessary.

Initiation of alectinib (Alecensa) meets the definition of medical necessity when ALL of the following criteria are met:

1. Member is diagnosed with non-small cell lung cancer (NSCLC)

2. Member’s disease is recurrent or metastatic

3. Member’s disease is anaplastic lymphoma kinase (ALK)-positive – laboratory documentation must be provided

4. Alectinib will be used as monotherapy

5. Alectinib dose does not exceed 1200 mg daily – dosage will be achieved using the fewest number of capsules per day

Duration of approval: 6 months

Continuation of alectinib (Alecensa) 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 the treatment of ALK-positive NSCLC, OR the member has previously met all indication-specific initiation criteria

2. Alectinib is used as monotherapy

3. Alectinib dose does not exceed 1200 mg once daily – dosage will be achieved using the fewest number of capsules per day

Duration of approval: 1 year

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

• 600 mg orally twice daily

Dose Adjustments

• Recommendations for dose modifications due to adverse reactions are provided in FDA-approved Prescribing Information

Drug Availability

• Capsules: 150 mg

PRECAUTIONS:

Boxed Warning

• None

Contraindications

• None

Precautions/Warnings

• Hepatotoxicity

• Interstitial Lung Disease (ILD)/Pneumonitis

• Bradycardia

• Severe Myalgia and Creatine Phosphokinase (CPK) Elevation

• Embryo-Fetal Toxicity

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding

J8999

Prescription drug, oral, chemotherapeutic, Not Otherwise Specified

C9399

Unclassified drugs or biologicals (Hospital Outpatient Use ONLY)

ICD-10 Diagnosis Codes That Support Medical Necessity

C33

Malignant neoplasm of trachea

C34.00 – C34.92

Malignant neoplasm of bronchus and lung

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

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

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

Crizotinib (Xalkori®) Capsules, 09-J1000-57

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. Genentech, Inc. Alecensa (alectinib hydrochlorid) capsule. 2017 [cited 8/28/17]. In: DailyMed [Internet]. Bethesda (MD): National Library of Medicine. Available from: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=42c49deb-713b-427a-9670-08af08adcffb/.
  5. 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.
  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; 2017 [cited 8/28/17]. Available from: http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm/.

COMMITTEE APPROVAL:

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

GUIDELINE UPDATE INFORMATION:

03/15/16

New Medical Coverage Guideline.

10/15/17

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

Date Printed: December 16, 2017: 09:17 PM