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Date Printed: April 22, 2018: 05:40 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-J2000-93

Original Effective Date: 3/15/18

Reviewed: 2/14/18

Revised: 00/00/00

Next Review: 3/13/19

Subject: Abemaciclib (Verzenio)

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    
           

DESCRIPTION:

Approximately 255,000 new cases of breast cancer are predicted to be diagnosed in the United States in 2017. It is estimated that 20 to 50% of those diagnosed with early stage breast cancer will eventually progress to metastatic breast cancer.

Abemaciclib (Verzenio™), an inhibitor of cyclin-dependent kinases 4 and 6 (CDK4, CDK6), was approved by the U.S. Food and Drug Administration (FDA) in 2017 for use as monotherapy or in combination with fulvestrant for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.

The safety and efficacy of abemaciclib monotherapy were evaluated in subjects with refractory HR-positive, HER2-negative metastatic breast cancer in a phase II single-arm open-label study (MONARCH-1). Subjects (n=132) had progressed on or after prior endocrine therapy and had one or two chemotherapy regimens in the metastatic setting. Abemaciclib 200 mg was administered orally on a continuous schedule every 12 hours until disease progression or unacceptable toxicity.

At the 12-month final analysis, the primary objective of confirmed objective response rate (ORR) was 19.7% (95% CI, 13.3-27.5; all partial response). The median progression-free survival (PFS) was 6.0 months and median overall survival was 17.7 months. The most common adverse events were diarrhea, fatigue, and nausea with discontinuation due to any adverse events occurring in 7.6% of subjects.

The safety and efficacy of abemaciclib in combination with fulvestrant were evaluated in subjects with refractory HR-positive, HER2-negative metastatic breast cancer in a double-blind, phase III study (MONARCH-2). Subjects (n=669) had progressed on or after prior endocrine therapy and were randomly assigned 2:1 to receive abemaciclib (150 mg twice daily) plus fulvestrant (n=446) or placebo plus fulvestrant (n=223).

Abemaciclib plus fulvestrant significantly extended PFS versus fulvestrant alone (median, 16.4 v 9.3 months; hazard ratio, 0.553; 95% CI, 0.449 to 0.681; P < .001). In patients with measurable disease, abemaciclib plus fulvestrant achieved an ORR of 48.1% (95% CI, 42.6% to 53.6%) compared with 21.3% (95% CI, 15.1% to 27.6%) in the control arm. The most common adverse events in the abemaciclib arm were diarrhea, neutropenia, nausea, and fatigue with discontinuation due to any adverse events occurring in 15.9% of subjects.

National Comprehensive Cancer Network (NCCN) Guidelines for Breast Cancer (Version 3.2017) recommend abemaciclib for treatment of treatment of recurrent or stage IV HR-positive/HER2-negative disease.

POSITION STATEMENT:

Comparative Effectiveness

The FDA 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 abemaciclib (Verzenio) meets the definition of medical necessity when ALL of the following criteria are met:

1. Member is diagnosed with either of the following:

a. Recurrent breast cancer

b. Metastatic breast cancer

2. Member has hormone receptor (HR)-positive disease – laboratory documentation must be provided

3. Member has human epidermal growth factor receptor 2 (HER2)-negative disease – laboratory documentation must be provided

4. Member meets one of the following:

a. Abemaciclib will be used as monotherapy AND member has progressed on prior endocrine therapy and prior chemotherapy in the metastatic setting

b. Abemaciclib will be used in combination with fulvestrant (Faslodex) AND member has progressed on prior endocrine therapy

5. Member meets one of the following:

a. Postmenopausal

b. Use will be in combination with an agent that suppress testicular steroidogenesis (e.g., leuprolide, goserelin)

6. Member has not previously had disease progression while on a CDK4/6 inhibitor (e.g., palbociclib)

7. Dose does not exceed:

a. Monotherapy: 200 mg twice daily – dosage will be achieved using the fewest number of tablets per day

b. Combination with fulvestrant: 150 mg twice daily – dosage will be achieved using the fewest number of tablets per day

Approval duration: 6 months

Continuation of abemaciclib (Verzenio) 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 breast cancer, OR the member has previously met all indication-specific initiation criteria

2. Member’s disease has not progressed during treatment with abemaciclib

3. Dose does not exceed:

a. Monotherapy: 200 mg twice daily – dosage will be achieved using the fewest number of tablets per day

b. Combination with fulvestrant: 150 mg twice daily – dosage will be achieved using the fewest number of tablets per day

Approval duration: 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

• Recommended starting dose in combination with fulvestrant: 150 mg twice daily.

• Recommended starting dose as monotherapy: 200 mg twice daily.

Dose Adjustments

• Dosing interruption and/or dose reductions may be required based on individual safety and tolerability

Drug Availability

• Tablets: 50 mg, 100 mg, 150 mg, and 200 mg

PRECAUTIONS:

Boxed Warning

• None

Contraindications

• None

Precautions/Warnings

• Diarrhea: Instruct patients at the first sign of loose stools to initiate antidiarrheal therapy, increase oral fluids, and notify their healthcare provider

• Neutropenia: Monitor complete blood counts prior to the start of therapy, every 2 weeks for the first 2 months, monthly for the next 2 months, and as clinically indicated

• Hepatotoxicity: Increases in serum transaminase levels have been observed. Perform liver function tests (LFTs) before initiating treatment and monitor LFTs every two weeks for the first two months, monthly for the next 2 months, and as clinically indicated

• Venous Thromboembolism: Monitor patients for signs and symptoms of thrombosis and pulmonary embolism and treat as medically appropriate

• Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding

J8999

Prescription drug, oral, chemotherapeutic, Not Otherwise Specified

ICD-10 Diagnoses Codes That Support Medical Necessity

C50.011 – C50.929

Malignant neoplasm of breast

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) and/or Local Coverage Determination (LCD) were found at the time of the last guideline review date.

DEFINITIONS:

Adjuvant Treatment: Additional cancer treatment given after the primary treatment to lower the risk that the cancer will return. Adjuvant therapy may include chemotherapy, radiation therapy, hormone therapy, targeted therapy, or biologic therapy. Adjuvant therapy can be used after or in combination with another form of cancer therapy and is commonly used following removal of a cancerous tumor to further help in treatment.

DPD: deoxypyridinoline, also called D-Pyrilinks or Pyrilinks-D, is a crosslink of type I collagen present in bone which is excreted unmetabolized in urine and is a specific marker of bone resorption. It is measured in a urine tests in members when osteoporosis is suspected.

Metastatic cancer: when cancer spreads from the primary site (place where it started) to other places in the body.

Neoadjuvant treatment: Treatment given as a first step to shrink a tumor before the main treatment, which is usually surgery, is given. Examples of neoadjuvant therapy include chemotherapy, radiation therapy, and hormone therapy. It is a type of induction therapy

RELATED GUIDELINES:

Ado-trastuzumab emtansine (Kadcyla) Injection, 09-J1000-90

Docetaxel (Taxotere®) IV, 09-J0000-95

Palbociclib (Ibrance), 09-J2000-34

Pertuzumab (Perjeta) IV, 09-J1000-75

Ribociclib (Kisqali), 09-J2000-75

Trastuzumab (Herceptin®) Injection, 09-J0000-86

OTHER:

None

REFERENCES:

  1. Clinical Pharmacology [Internet]. Tampa (FL): Gold Standard, Inc.; 2018 [cited 1/30/18]. Available from: http://www.clinicalpharmacology.com/.
  2. ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine; 2000 Feb 29 - [cited 1/30/18]. Available from: http://clinicaltrials.gov/.
  3. DRUGDEX® System [Internet]. Greenwood Village (CO): Thomson Micromedex; Updated periodically [cited 1/30/18]. Available from: http://www.thomsonhc.com/.
  4. National Comprehensive Cancer Network®. NCCN clinical practice guidelines in oncology (NCCN Guidelines®). Breast Cancer, v. 3.2017 [cited 1/30/18]. Available from: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp.
  5. NCCN Drugs & Biologics Compendium [Internet]. Fort Washington (PA): National Comprehensive Cancer Network; 2018 [cited 1/30/18]. Available from: http://www.nccn.org/professionals/drug_compendium/content/contents.asp/.
  6. Eli Lilly. Verzenio (abemaciclib) tablet. 2017 [cited 1/30/18]. In: DailyMed [Internet]. Bethesda (MD): National Library of Medicine. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=be4bc0de-0fdc-4d46-8d25-be43c79e6a06/.
  7. Orphan Drug Designations and Approval [Internet]. Silver Spring (MD): US Food and Drug Administration; 2018 [cited 1/30/18]. 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 02/14/18.

GUIDELINE UPDATE INFORMATION:

03/15/18

New Medical Coverage Guideline.

Date Printed: April 22, 2018: 05:40 PM