Coverage Policies

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INDEX:
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Effective Date: 04/01/2014 Title: Imbruvica
Revision Date: 06/01/2020 Document: BI447:00
CPT Code(s): None
Public Statement

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)    Imbruvica (Ibrutinib) requires prior authorization.

2)    Imbruvica is used to treat certain types of lymphoma and leukemia when other treatments have failed and graft versus host disease.

3)    Imbruvica is a specialty medication and must be obtained through the contracted specialty pharmacy.


Medical Statement

Imbruvica is considered medically necessary for patients with mantle cell lymphoma who meet the following criteria:

1)    A diagnosis of refractory or relapsed mantle cell lymphoma  AND

2)    Age > 18 years AND

3)    One of the following (a or b):

a.    Prescribed in combination with rituximab as pretreatment for HyperCVAD;

b.    Received at least two prior therapies, one of which must be Brukinsa, unless contraindicated or clinically significant adverse effects are experienced to all;

4)    ECOG score must be < 2.

 

For patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who meet the following criteria:

1) A diagnosis of CLL or SLL

2) Age > 18 years AND

3) Prescribed as a single agent or in combination with one of the following (a, b, or c):

      a) Rituximab;

      b) Obinutuzumab;

      c) bendamustine and rituximab:

4) ECOG score must be < 2.

 

For patients with a diagnosis of Waldenstrom’s macroblobulinemia (lymphoplasmacytic lymphoma).

1)    Diagnosis of WM;

2)    Age > 18 years;

3)    Prescribed as a single agent or in combination with rituximab

 

For patients with Marginal Zone Lymphoma (must meet all):

1)    Diagnosis of MZL;

2)    Age > 18 years;

3)    Received at least one prior anti-CD20-based therapy (e.g.rituximab), unless contraindicated or clinically significant adverse effects are experienced to all;

 

For Chronic Graft-Versus-Host Disease (must meet all):

1)    Diagnosis of cGVHD;

2)    Age >18 years;

3)    Member has a history of bone marrow/stem cell transplant;

4)    Members meets one of the following (a or b):

a.    Failure of a systemic corticosteroid (e.g. prednisone) at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced;

b.    If intolerance or contraindication to systemic corticosteroids, failure of an immunosuppressant (e.g. mycophenolate mofetil, cyclosporine, tacrolimus, sirolimus) at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced.


Limits

As a specialty drug, Imbruvica is limited to a 30 day supply per fill.


Reference

1)    Imbruvica Package Insert. Pharmacyclics, Inc. April 2020

 

2)    National Comprehensive Cancer network (NCCN) Clinical Practice Guidelines in Oncology. Non-Hodgkin’s Lymphoma.  Version 1.104.  Available at http://www.nccn.org/professionals/physician_gls/pdf/nhl.pdf.  Accessed July 30, 2020

 

3)    NCCN Drugs & Biologics Compendium. Accessed online July 30, 2020, 2020.


Application to Products
This policy applies to all health plans 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) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
This policy has recently been updated. Please use the index above or enter policy title in search bar for the latest version.