HIGHMARK COMMERCIAL MEDICAL POLICY - DELAWARE

 
 
Medical Policy:
I-137-006
Topic:
Obinutuzumab (Gazyva)
Section:
Injections
Effective Date:
February 26, 2018
Issued Date:
October 1, 2018
Last Revision Date:
September 2018
Annual Review:
January 2018
 
 

Obinutuzumab (Gazyva®) is a monoclonal antibody that targets the CD20 antigen expressed on the surface of pre B- and mature B-lymphocytes.

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

Delaware Mandate

Effective September 1, 2017, 18 Delaware Code §§3338B and 3555B, require that no individual policy or contract of health insurance, or certificate issued thereunder, which is delivered, issued for delivery, renewed, modified, altered, or amended in this State by any health insurer, health service corporation or health maintenance organization that directly or indirectly covers the treatment of cancer shall limit or exclude coverage for a drug approved by the United States Food and Drug Administration by mandating that the insured shall first be required to fail to successfully respond to a different drug or drugs or prove a history of failure of such drug or drugs; provided, however that the use of such drug or drugs is consistent with best practices for the treatment of stage 4 advanced, metastatic cancer or, in the case of other cancers, the use of the drug is supported by national clinical guidelines, national standards of care, or peer reviewed medical literature for the treatment of the cancer, or in the case of targeted therapy, the target at issue.

 

Obinutuzumab (Gazyva) may be considered medically necessary for ANY of the following indications:

Chronic Lymphoid Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL)

  • Previously untreated CLL in combination with chlorambucil (Leukeran); or 
  • First-line therapy for CLL/ SLL when:
    • In combination with chlorambucil (Leukeran) for disease without del(17p)/TP53 mutation in individuals age greater than or equal to 65 years, younger individuals with significant comorbidities, or frail individuals unable to tolerate purine analogs (preferred regimen); or
    • In combination with bendamustine (Treanda, Bendeka) for disease without del(17p)/TP53 mutation in individuals age greater than or equal to 65 years or for younger individuals with or without significant comorbidities who have indications for treatment (preferred regimen): or
    • As a single agent for disease without del(17p)/TP53 mutation in individuals age greater than or equal to 65 years, younger individuals with significant comorbidities, or frail individuals unable to tolerate purine analogs; or
    • As a single agent for disease with del(17p)/TP53 mutation; or
  • CLL/SLL single agent therapy for relapsed or refractory disease without del (17p)/TP53 mutation in individuals with indications for treatment.

Follicular lymphoma

  • Follicular lymphoma, after relapse, or those who are refractory to a rituximab (Rituxan)-containing regimen, in combination with bendamustine (Treanda, Bendeka) followed by obinutuzumab (Gazyva) monotherapy; or
  • Follicular lymphoma, in combination with chemotherapy followed by obinutuzumab (Gazyva) monotherapy, in previously untreated stage II bulky, III, or IV disease in those with at least a partial response to combination therapy; or
  • Follicular lymphoma (grade 1-2) first-line therapy for stage I (bulky), contiguous stage II (bulky), non-contiguous stage II disease, or for individuals with indications for treatment with stage III or IV disease in combination with:
    • CHOP (cyclophosphamide doxorubicin, vincristine, and prednisone) regimen; or
    • CVP (cyclophosphamide, vincristine, and prednisone) regimen; or
    • Bendamustine(Treanda, Bendeka); or
  • Follicular lymphoma (grade 1-2) second-line or subsequent therapy for refractory or progressive disease in combination with bendamustine in individuals with indications for treatment; or
  • Follicular lymphoma (grade 1-2) maintenance therapy in individuals with indications for treatment:
    • As first-line consolidation or extended dosing; or
    • As second-line consolidation or extended dosing if refractory to rituximab (Rituxan).

Gastric Mucosa-associated Lymphoid Ttissue (MALT) Lymphoma

  • For the treatment of gastric MALT lymphoma when used as:
    • Second-line or subsequent therapy for recurrent or progressive disease in combination with bendamustine (Treanda, Bendeka) in individuals with indications for treatment; or
    • Maintenance therapy as second-line consolidation or extended dosing in rituximab (Rituxan) refractory individuals treated with obinutuzumab (Gazyva) and bendamustine (Treanda, Bendeka) regimen for recurrent disease.

Nodal Marginal Zone Lymphoma

  • For the treatment of Nodal Marginal Zone Lymphoma when used as:
    • Second-line or subsequent therapy for refractory or progressive disease in combination with bendamustine (Treanda, Bendeka)  in individuals with indications for treatment; or
    • Maintenance therapy as second-line consolidation or extended dosing in rituximab (Rituxan) refractory individuals treated with obinutuzumab (Gazyva) and bendamustine (Treanda, Bendeka) regimen for recurrent disease.

Nongastric MALT Lymphoma

  • For the treatment of nongastric MALT lymphoma when used as:
    • Second-line or subsequent therapy for refractory or progressive disease in combination with bendamustine (Treanda, Bendeka) in individuals with indications for treatment; or
    • Maintenance therapy as second-line consolidation or extended dosing in rituximab (Rituxan) refractory individuals treated with obinutuzumab (Gazyva) and bendamustine (Treanda, Bendeka) regimen for recurrent disease.

Splenic Marginal Zone Lymphoma

  • For the treatment of splenic marginal zone lymphoma when used as:
    • Second-line or subsequent therapy for refractory or progressive disease in combination with bendamustine (Treanda, Bendeka) in individuals with indications for treatment; or
    • Maintenance therapy as second-line consolidation or extended dosing in rituximab (Rituxan) refractory individuals treated with obinutuzumab (Gazyva) and bendamustine (Treanda, Bendeka) regimen for recurrent disease.

Obinutuzumab (Gazyva) is considered experimental/investigational for all other indications and therefore non-covered.  Scientific evidence does not support its use for any other indications.

J9301

 

 

 

 

 

 


NOTE: Dosage recommendations per the FDA label.

Covered Diagnosis Codes

C82.00

C82.01

C82.02

C82.03

C82.04

C82.05

C82.06

C82.07

C82.08

C82.09

C82.10

C82.11

C82.12

C82.13

C82.14

C82.15

C82.16

C82.17

C82.18

C82.19

C82.20

C82.21

C82.22

C82.23

C82.24

C82.25

C82.26

C82.27

C82.28

C82.29

C82.30

C82.31

C82.32

C82.33

C82.34

C82.35

C82.36

C82.37

C82.38

C82.39

C82.40

C82.41

C82.42

C82.43

C82.44

C82.45

C82.46

C82.47

C82.48

C82.49

C82.50

C82.51

C82.52

C82.53

C82.54

C82.55

C82.56

C82.57

C82.58

C82.59

C82.60

C82.61

C82.62

C82.63

C82.64

C82.65

C82.66

C82.67

C82.68

C82.69

C82.80

C82.81

C82.82

C82.83

C82.84

C82.85

C82.86

C82.87

C82.88

C82.89

C82.90

C82.91

C82.92

C82.93

C82.94

C82.95

C82.96

C82.97

C82.98

C82.99

C83.00

C83.01

C83.02

C83.03

C83.04

C83.05

C83.06

C83.07

C83.08

C83.09

C83.80

C83.81

C83.82

C83.83

C83.84

C83.85

C83.86

C83.87

C83.88

C83.89

C85.80

C85.81

C85.82

C85.83

C85.84

C85.85

C85.86

C85.87

C85.88

C85.89

C88.4

C91.10

C91.11

C91.12

Z85.72

 


Place of Service: Outpatient

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

The administration of Obinutuzumab (GAZYVA) 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 insured business and, if elected, ASO.



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.