BlueCross BlueShield of Tennessee Medical Policy Manual

Paclitaxel (Protein-Bound)

NDC CODE(S)

68817-0134-XX Abraxane 100 MG SUSR (CELGENE CORP)

DESCRIPTION

Paclitaxel is a natural product with antitumor activity.  Obtained from Taxus media or Taxus baccata, a variety of the Western yew tree, it is highly lipophilic and insoluble in water.  Paclitaxel is an anti-microtubule agent which induces abnormal arrays or “bundles” of microtubules during the cell cycle and inhibits vital interphase and mitotic cellular functions.

By reformulating paclitaxel as albumin-bound nanoparticles, the protein-bound paclitaxel has improved solubility over conventional paclitaxel which requires the use of toxic solvents such as polyoxyethylated castor oil and ethanol in its production.  This allows infusion of the agent to be made in a shorter time, reduces the risk of hypersensitivity reactions and eliminates the need for premedication with dexamethasone, diphenhydramine, and cimetidine.  It is important to note that protein-bound paclitaxel is not a substitute for conventional paclitaxel and should not be used with other paclitaxel formulations.  It has been proven that protein-bound paclitaxel does not have the identical biochemical systemic reaction as paclitaxel.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

All indications

260mg/m² every 21 days

All indications

100mg/m² days 1, 8, and 15 of a 21-day cycle

Pancreatic Cancer

125mg/m² days 1, 8, and 15 of a 28-day cycle

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

IMPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers.  This Medical Policy relates only to the services or supplies described in it.  The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy.  For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed.  If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.

ADDITIONAL INFORMATION 

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

GRADE

ECOG PERFORMANCE STATUS

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 selfcare but unable to carry out any work activities; up and about more than 50% of waking hours

3

Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours

4

Completely disabled; cannot carry on any selfcare; totally confined to bed or chair

5

Dead

No controlled studies were found in the published literature that validate the use of paclitaxel (protein-bound) for the treatment of other conditions or diseases.

SOURCES

Lexicomp Online. (2017, March). AHFS DI. Paclitaxel. Retrieved September April 19, 2017 from Lexicomp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2017, March). Paclitaxel protein-bound. Retrieved April 19, 2017 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2017). NCCN Drugs & Biologics Compendium™. Paclitaxel, albumin bound. Retrieved April 19, 2017 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2015 December). Center for Drug Evaluation and Research. Abraxane for injectable suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound). Retrieved April 19, 2017 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021660s041lbl.pdf.

ORIGINAL EFFECTIVE DATE:  8/10/2013

MOST RECENT REVIEW DATE:  7/11/2017

ID_MRx

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

Pharmaceutical Decision Support Tree

Paclitaxel (Protein-Bound) (Abraxane®)

  1. Is this the initial request for this agent?

If yes, go to question #2

If no, go to question #12

  1. Is the individual 18 years of age or older?

If yes, go to question #3

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have a diagnosis of bladder cancer with ALL of the following?

If yes, go to question #11

If no, go to question #4

  1. Does the individual have a diagnosis of breast cancer if ALL of the following?

If yes, go to question #5

If no, go to question #7

  1. Is the disease recurrent or metastatic and ANY ONE of the following?

If yes, go to question #11

If no, go to question #6

  1. Is the request for a diagnosis of breast cancer as a substitute for paclitaxel or docetaxel if patient has experienced hypersensitivity reactions despite premedication or the individual has contraindications to standard hypersensitivity premedications?

If yes, go to question #11

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have a diagnosis of melanoma that is ALL of the following?

If yes, go to question #11

If no, go to question #8

  1. Does the individual have a diagnosis of non-small cell lung cancer (NSCLC) and ANY ONE of the following?

If yes, go to question #11

If no, go to question #9

  1. Does the individual have a diagnosis of ovarian cancer with ALL of the following?

If yes, go to question #11

If no, go to question #10

  1. Does the individual have a diagnosis of pancreatic adenocarcinoma for treatment in combination with gemcitabine (Gemzar®) for ANY ONE of the following?

If yes, go to question #11

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for 900 billable units per 21 days for dosage of 260mg/m² every 21 days OR 100mg/m² days 1, 8, and 15 of a 21-day cycle OR, for pancreatic cancer, 125mg/m² days 1, 8, and 15 of a 28-day cycle for a six month authorization period?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual continue to meet the initial approval criteria in questions 3 through 11?

If yes, go to question #13

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is response to treatment indicated by stabilization of disease or decrease in size of tumor or tumor spread with absence of unacceptable toxicity from the agent?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

This document has been classified as public information.