HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 

Medical Policy:
I-65-004
Topic:
Paclitaxel, albumin-bound (Abraxane)
Section:
Injections
Effective Date:
October 1, 2018
Issued Date:
October 1, 2018
Last Revision Date:
September 2018
Annual Review:
May 2017
 
 

Paclitaxel, albumin-bound (Abraxane®) is an antimicrotubule agent that promotes the assembly of microtubules from tubulin dimers and stabilizes microtubules by preventing depolymerization. This stability results in the inhibition of the normal dynamic reorganization of the microtubule network that is essential for vital interphase and mitotic cellular functions. Paclitaxel (Abraxane) is an albumin-bound form of paclitaxel, a natural product with antitumor activity. In contrast to solvent-based paclitaxel, which requires premedication to decrease the risks of hypersensitivity reactions (eg, difficulty breathing, hives, swollen eyes and lips), paclitaxel (Abraxane) requires no premedication.

Policy Position Coverage is subject to the specific terms of the member's benefit plan.

Paclitaxel, albumin-bound (Abraxane) may be considered medically necessary when used in the treatment of ANY ONE the following condition(s):


Bladder Cancer

  • As a single agent for ureothelial cancers clinical stage T4b or T2-T4a, N1-3 disease; or
    • For recurrence post cystectomy; or
    • For metastatic disease as a second-line alternate regimen for bladder cancer.

 

Bladder Cancer – Primary Carcinoma of the Urethra

  • Single agent for recurrent or metastatic disease as a second-line alternate regimen for primary carcinoma of the urethra, upper GU tract tumors, or urothelial carcinoma of the prostate.

Breast Cancer - Invasive

  • As a single agent for recurrent or metastatic  human epidermal growth factor receptor  2 (HER2)-negative disease that has ANY ONE of the following indications:
    • With symptomatic visceral disease or visceral crisis; or
    • Disease that is hormone receptor-negative or hormone receptor-positive and endocrine therapy refractory; or
  • Therapy in combination with trastuzumab for human epidermal growth factor receptor 2 (HER2)-positive recurrent or metastatic trastuzumab-exposed disease that has ANY ONE of the following indications:
    • With symptomatic visceral disease or visceral crisis; or
    • Disease that is hormone receptor-negative or hormone receptor-positive and endocrine therapy refractory; or
    • For treatment after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior chemotherapy must have included an anthracycline unless clinically contraindicated.

Cervical Cancer

  • Second-line therapy as a single agent for ANY ONE of the following indications:
    • Local/regional recurrence; or
    • Distant metastases.

Melanoma

  • As single agent therapy for individuals with metastatic or unresectable disease as second-line or subsequent therapy for disease progression; or
  • As subsequent therapy after maximum clinical benefit from BRAF targeted therapy for individuals with an Eastern Cooperative Oncology Group [ECOG], performance status (PS) of 0-2.

Non-Small Cell Lung Cancer (NSCLC)

  • First-line treatment of locally advanced or metastatic NSCLC in combination with carboplatin in individuals who are not candidates for curative surgery or radiation therapy; or
  • As single agent therapy for recurrence or metastasis as a single agent for individuals with an ECOG PS 2, or in combination with carboplatin for ECOG, PS 0-2, for any of the following:
    • First-line therapy in cases of ALK, EGFR, ROS1, and PD-L1 negative or unknown; or
    • As subsequent therapy for sensitizing epidermal growth factor receptor (EGFR) mutation-positive tumors and prior erlotinib, afatinib, or gefitinib, or osimertinib therapy; or
    • As subsequent therapy for anaplastic lymphoma kinase (ALK)-positive tumors and prior crizotinib, ceritinib, or alectinib therapy; or
    • As subsequent therapy for ROS1-positive tumors and prior crizotinib therapy; or
    • As subsequent therapy for PD-L1-positive tumors (greater than or equal to 50%) and ALK, EGFR, and ROS1 negative tumors and prior pembrolizumab therapy; or
  • Therapy in place of either paclitaxel or docetaxel in individuals with a history of hypersensitivity reactions to either of these agents despite premedication for same; or
  • As an alternative therapy for individuals with contraindications to standard hypersensitivity premedications.

Ovarian Cancer – Epithelial Ovarian Cancer/Fallopian Tube Cancer/Primary Peritoneal Cancer

  • Single agent therapy for epithelial ovarian cancer (persistent disease or recurrence); or
  • Single agent therapy for fallopian tube cancer (persistent disease or recurrence); or
  • Single agent therapy for primary peritoneal cancer (persistent disease or recurrence).

Pancreatic Adenocarcinoma

  • Treatment for pancreatic adenocarcinoma in combination with gemcitabine for ANY ONE of the following indications:
    • As first-line chemotherapy, or as induction therapy followed by chemoradiation in selected individuals without systemic metastases, for individuals with locally advanced unresectable disease and good performance status; or
    • As preferred first-line treatment of individuals with metastatic disease with good performance status; or
    • Neoadjuvant treatment of biopsy positive borderline resectable disease or resectable disease with high risk features (e.g., large primary tumors, highly elevated CA 19-9, large regional lymph nodes, extreme pain, excessive loss of weight); or
    • As Second-line therapy for:
      • Locally advanced unresectable or metastatic disease for individuals with good performance status and disease progression who were previously treated with Fluoropyrimidine-based therapy; or
      • Local recurrence in the pancreatic bed; or
      • Metastatic disease with or without local recurrence.

 

The use of paclitaxel, albumin-bound (Abraxane) is considered experimental/investigational and therefore, non-covered for all other indications. Peer reviewed literature does not support the use of paclitaxel, albumin-bound (Abraxane) for any indications other than those listed on this medical policy.

J9264

 

 

 

 

 

 




NOTE: Dosage recommendations per the FDA label.

Related Policies


Covered Diagnosis Codes for Procedure Codes J9264

 

C25.0

C25.1

C25.2

C25.3

C25.4

C25.7

C25.8

C25.9

C33

C34.00

C34.01

C34.02

C34.10

C34.11

C34.12

C34.2

C34.30

C34.31

C34.32

C34.80

C34.81

C34.82

C34.90

C34.91

C34.92

C43.0

C43.10

C43.111

C43.122

C43.20

C43.21

C43.22

C43.30

C43.31

C43.39

C43.4

C43.51

C43.52

C43.59

C43.60

C43.61

C43.62

C43.70

C43.71

C43.72

C43.9

C45.1

C45.9

C48.00

C48.1

C48.2

C48.8

C50.011

C50.012

C50.019

C50.021

C50.022

C50.029

C50.111

C50.112

C50.119

C50.121

C50.122

C50.129

C50.211

C50.212

C50.219

C50.221

C50.222

C50.229

C50.311

C50.312

C50.319

C50.321

C50.322

C50.329

C50.411

C50.412

C50.419

C50.421

C50.422

C50.429

C50.511

C50.512

C50.519

C50.521

C50.522

C50.529

C50.611

C50.612

C50.619

C50.621

C50.622

C50.629

C50.811

C50.812

C50.819

C50.821

C50.822

C50.829

C50.911

C50.912

C50.919

C50.921

C50.922

C50.929

C51.8

C51.9

C53.0

C53.1

C53.8

C53.9

C56.1

C56.2

C56.9

C57.00

C57.01

C57.02

C57.10

C57.11

C57.12

C57.20

C57.21

C57.22

C57.3

C57.4

C57.7

C57.8

C57.9

C61

C63.2

C63.9

C65.1

C65.2

C65.9

C66.1

C66.2

C66.9

C67.0

C67.1

C67.2

C67.3

C67.4

C67.5

C67.6

C67.7

C67.8

C67.9

C68.0

C78.00

C78.01

C78.02

C78.89

C79.11

C79.19

C79.60

C79.61

C79.62

C79.81

C79.82

C80.0

C80.1

D06.0

D06.1

D06.7

D06.9

Z85.07

Z85.118

Z85.20

Z85.3

Z85.40

Z85.41

Z85.43

Z85.50

Z85.51

Z85.820

 

 

 

 

 

 



Place of Service: Outpatient

Experimental/Investigational (E/I) services are not covered regardless of place of service.

The administration of paclitaxel, albumin-bound (Abraxane) is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.


The policy position applies to all commercial lines of business


Denial Statements

Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.



Links






This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.

Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
  • Qualified sign language interpreters
  • Written information in other formats (large print, audio, accessible electronic formats, other formats)

  • Provides free language services to people whose primary language is not English, such as:
  • Qualified interpreters
  • Information written in other languages
  • If you need these services, contact the Civil Rights Coordinator.

    If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

    You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

    U.S. Department of Health and Human Services
    200 Independence Avenue, SW
    Room 509F, HHH Building
    Washington, D.C. 20201
    1-800-368-1019, 800-537-7697 (TDD)

    Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

    Insurance or benefit/claims administration may be provided by Highmark, Highmark Choice Company, Highmark Coverage Advantage, Highmark Health Insurance Company, First Priority Life Insurance Company, First Priority Health, Highmark Benefits Group, Highmark Select Resources, Highmark Senior Solutions Company or Highmark Senior Health Company, all of which are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans.





    Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

    Discrimination is Against the Law
    The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
  • Qualified sign language interpreters
  • Written information in other formats (large print, audio, accessible electronic formats, other formats)

  • Provides free language services to people whose primary language is not English, such as:
  • Qualified interpreters
  • Information written in other languages
  • If you need these services, contact the Civil Rights Coordinator.

    If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295 , TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

    You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

    U.S. Department of Health and Human Services
    200 Independence Avenue, SW
    Room 509F, HHH Building
    Washington, D.C. 20201
    1-800-368-1019, 800-537-7697 (TDD)

    Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.