HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 
Medical Policy:
I-133-004
Topic:
Ixabepilone (Ixempra)
Section:
Injections
Effective Date:
February 11, 2019
Issued Date:
February 11, 2019
Last Revision Date:
January 2019
Annual Review:
January 2019
 
 

The principal pharmacologic action of Ixabepilone (Ixempra®) in cancer patients is halting cell division by inhibiting microtubules in the mitotic phase, leading to cell death. Ixabepilone (Ixempra) also demonstrates synergistic antitumor activity in combination with capecitabine in vivo.

Policy Position

Food and Drug Administration (FDA) Indications

Ixabepilone (Ixempra) may be considered medically necessary when ANY ONE of the following criteria is met:

  • Breast cancer, locally advanced or metastatic, as monotherapy in individuals whose tumors are resistant or refractory to anthracyclines, taxanes, and capecitabine; or
  • Breast cancer, locally advanced or metastatic, in combination with capecitabine in individuals who are taxane- or anthracycline-resistant, or taxane-resistant with a contraindication to anthracyclines.

 

Ixabepilone (Ixempra) is considered experimental/investigational for all other indications and therefore, non-covered. Scientific evidence does not support the use for any other indications than those listed above.

J9207

 

 

 

 

 

 


National Comprehensive Cancer Network (NCCN) Recommendations

 

Ixabepilone (Ixempra) may be considered medically necessary when ANY ONE of the following criteria is met:

  •  As a single agent for recurrent or metastatic breast cancer human epidermal growth factor receptor 2 (HER2)-negative disease:

o    With symptomatic visceral disease or visceral crisis; or

o    That is hormone receptor-negative or hormone receptor-positive and endocrine therapy refractory; or

  • Therapy in combination with trastuzumab (Herceptin®) for HER2-positive recurrent or metastatic trastuzumab (Herceptin)-exposed disease

o    With symptomatic visceral disease or visceral crisis; or

o    That is hormone receptor-negative or hormone receptor-positive and endocrine therapy refractory.

Ixabepilone (Ixempra) is considered experimental/investigational for all other indications and therefore, non-covered.  Scientific evidence does not support the use for any other indications than those listed above.

 

J9207

 

 

 

 

 

 


Other Medically Accepted Non-FDA Approved Indications, Class IIb or Higher Grade Recommendation

Ixabepilone (Ixempra) may be considered medically necessary when used in the treatment of metastatic hormone refractory prostate cancer.

 

 

Ixabepilone (Ixempra) is considered experimental/investigational for all other indications and therefore, non-covered. Scientific evidence does not support the use for any other indications than those listed above.

J9207

 

 

 

 

 

 


NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Highmark may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

Covered Diagnosis Codes for Procedure Code J9207:

 

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

C61

Z85.3


Place of Service: Outpatient

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

An ixabepilone (Ixempra) 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



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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.