Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Gazyva (Obinutuzumab) requires prior authorization.

2)    Gazyva is used to treat certain types of leukemia and lymphoma.

3)    Gazyva is considered a specialty drug and is covered under the medical benefit.

Gazyva (Obinutuzumab) is considered medically necessary for members meeting the following criteria:

1)    Diagnosis of chronic lymphocytic  leukemia (CLL) or small lymphocytic lymphoma (SLL) AND

2)    No active hepatitis B virus infection

Codes Used In This BI:

J9301 Injection, Obinutuzumab, 10mg

1)    Aetna Medical Policy. Obinutuzumab (Gazyva) at: http://www.aetna.com/cpb/medical/data/800_899/0877.html

2)    Gazyva Product Information.  Genentech.  South San Francisco, CA.  February 2016.

3)    National Cancer Comprehensive Network (NCCN). Obinutuzumab. NCCN Drugs & Biologics Compendium. Fort Washington, PA: NCCN; 2016.

This policy applies to all health plans and products administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet.  Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) or Certificate of Coverage (COC) for those plans or products insured by QualChoice.  In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC or COC, the SPD, EOC, or COC, as applicable, will prevail.  State and federal mandates will be followed as they apply.