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Date Printed: October 23, 2017: 07:29 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-J2000-34

Original Effective Date: 04/01/15

Reviewed: 03/08/17

Revised: 04/15/17

Subject: Palbociclib (Ibrance®)

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 234,000 new cases of breast cancer are predicted to be diagnosed in the United States in 2015. It is estimated that 20 to 50% of those diagnosed with early stage breast cancer will eventually progress to metastatic breast cancer.

Palbociclib (Ibrance), a cyclin-dependent kinase inhibitor, was approved by the U.S. Food and Drug Administration (FDA) in February 2015 for use in combination with letrozole for the treatment of postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer as initial endocrine-based therapy for their metastatic disease. This indication is approved under accelerated approval based on progression-free survival (PFS) [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 palbociclib were evaluated in a randomized, open-label phase 2 trial (PALOMA-1) of postmenopausal women with ER-positive, HER2-negative advanced breast cancer who had not received previous systemic treatment for their advanced disease. A total of 165 patients were randomized to receive with palbociclib plus letrozole (n=84) or letrozole alone (n=81). The primary endpoint was progression free survival (PFS).

Palbociclib plus letrozole treatment resulted in a median PFS of 20.2 months compared with 10.2 month for letrozole alone. An objective response occurred in 43% versus 33%, with 1% in each group achieving a complete response. The median overall survival was 37.5 months with palbociclib plus letrozole compared with 33.3 months with letrozole alone. In a cohort of patients with cancer with amplification of cyclin D1, loss of p16, or both, the median PFS was 18.1 months versus 11.1 months.

National Comprehensive Cancer Network (NCCN) Guidelines for Breast Cancer (Version 2.2016) recommend palbociclib in combination with letrozole or fulvestrant.

POSITION STATEMENT:

Initiation of palbociclib (Ibrance) meets the definition of medical necessity for ANY of the following indications when ALL associated criteria are met:

1. Breast Cancer

a. Member is diagnosed with recurrent or metastatic breast cancer

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

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

d. Palbociclib will be used in combination with letrozole (Femara) or fulvestrant (Faslodex)

e. Member meets ONE of the following:

i. Postmenopausal

ii. Premenopausal AND receiving ovarian ablation/suppression

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

f. Dose does not exceed ALL of the following

i. 125 mg/day – dosage will be achieved using the fewest number of capsules per day

ii. 21 capsules/28 days

2. Soft Tissue Sarcoma

a. Member is diagnosed with a retroperitoneal sarcoma

b. Member's disease is characterized as a well-differentiated/dedifferentiated liposarcoma (WD-DDLS) with CDK4 amplification – laboratory documentation must be provided

c. Dose does not exceed ALL of the following

i. 125 mg/day – dosage will be achieved using the fewest number of capsules per day

ii. 21 capsules/28 days

Approval duration: 6 months

Continuation of palbociclib (Ibrance) meets the definition of medical necessity for members meeting the following criteria:

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 soft tissue sarcoma, OR the member has previously met all indication-specific initiation criteria

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

3. Dose does not exceed ALL of the following

a. 125 mg/day – dosage will be achieved using the fewest number of capsules per day

b. 21 capsules/28 days

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

• 125 mg once daily taken with food for 21 days followed by 7 days off treatment

Dose Adjustments

• Refer to prescribing information

Drug Availability

• 125 mg, 100 mg, and 75 mg capsules

PRECAUTIONS:

Boxed Warning

None

Contraindications

None

Precautions/Warnings

• Hematologic: Neutropenia may occur

• Infections

• Embryo-Fetal Toxicity

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding

C9399

Unclassified drugs or biologicals

J8999

Prescription drug, oral, chemotherapeutic, Not Otherwise Specified

ICD-10 Diagnoses Codes That Support Medical Necessity

C49.0

Malignant neoplasm of connective and soft tissue of head, face and neck

C49.10-C49.12

Malignant neoplasm of connective and soft tissue of upper limb, including shoulder

C49.20-C49.22

Malignant neoplasm of connective and soft tissue of lower limb, including hip

C49.3

Malignant neoplasm of connective and soft tissue of thorax

C49.4

Malignant neoplasm of connective and soft tissue of abdomen

C49.5

Malignant neoplasm of connective and soft tissue of pelvis

C49.6

Malignant neoplasm of connective and soft tissue of trunk, unspecified

C49.8

Malignant neoplasm of overlapping sites of connective and soft tissue

C49.9

Malignant neoplasm of connective and soft tissue, unspecified

C49.A0 – C49.A9

Gastrointestinal stromal tumor

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 revised 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

Pertuzumab (Perjeta) IV, 09-J1000-75

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

OTHER:

None

REFERENCES:

  1. AHFS Drug Information. Bethesda (MD): American Society of Health-System Pharmacists, Inc; 2016 [cited 2016-02-12]. In: STAT!Ref Online Electronic Medical Library [Internet]. Available from: http://online.statref.com/.
  2. Clinical Pharmacology [Internet]. Tampa (FL): Gold Standard, Inc.; 2017 [cited 2017-02-12]. Available from: http://www.clinicalpharmacology.com/.
  3. ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine; 2000 Feb 29 - [cited 2017-02-12]. Available from: http://clinicaltrials.gov/.
  4. DRUGDEX® System [Internet]. Greenwood Village (CO): Thomson Micromedex; Updated periodically [cited 2017-02-12]. Available from: http://www.thomsonhc.com/.
  5. National Comprehensive Cancer Network®. NCCN clinical practice guidelines in oncology (NCCN Guidelines®). Breast Cancer, v. 1.2016 [cited 2017-02-21]. 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 2017-02-12]. 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 2017-02-12]. Available from: http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm/.
  8. Pfizer. Ibrance (palbociclib) capsule. 2015 [cited 2017-02-12]. In: DailyMed [Internet]. Bethesda (MD): National Library of Medicine. Available from: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e0e6412f-50b4-4fd4-9364-62818d121a07/.
  9. Turner NC, Ro J, Loi S, et al. Palbociclib in Hormone-Receptor-Positive Advanced Breast Cancer. N Engl J Med. 2015 Jul 16;373(3):209-19.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 03/08/17.

GUIDELINE UPDATE INFORMATION:

04/15/15

New Medical Coverage Guideline.

09/15/15

Revision to guideline; consisting of position statement, description, references.

11/01/15

Revision: ICD-9 Codes deleted.

04/15/16

Review and revision; description, position statement, references.

10/01/16

Revision to guideline; consisting of ICD10 codes

04/15/17

Review and revision; description, position statement, references.

Date Printed: October 23, 2017: 07:29 AM