Medical Policy

Effective Date:01/01/2023 Title:Velcade
Revision Date: Document:BI710:00
CPT Code(s):J9041
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)    Velcade (bortezomib) requires prior authorization.

2)    Velcade is used to treat multiple myeloma and mantle cell lymphoma (MCL).

3)    Velcade is a specialty drug covered under the medical benefit.

Medical Statement

Initial Approval Criteria

A.   Multiple Myeloma and Mantle Cell Lymphoma (must meet all):
1. Diagnosis of one of the following (a or b):

a.    Multiple Myeloma

b.    Mantle Cell Lymphoma (B-cell lymphoma subtype);

2. Prescribed by or in consultation with an oncologist or hematologist;

3. Age > 18 years;

4. Request meets the following:

            a. Dose does not exceed 1.3mg/m2;

5. Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

 

Initial Approval Duration: 6 months.

 

B.   NCCN Recommended Uses (off-label) (must meet all):

 

1.    Diagnosis of one of the following (a-h):

a.    AIDS-related Kaposi sarcoma (advanced cutaneous, oral, visceral, or nodal disease) – after 2 or more prior lines of systemic therapy

b.    Multicentric Castleman’s disease (B-cell lymphoma subtype) – as subsequent therapy

c.    Systemic light chain amyloidosis;

d.    Adult T-cell leukemia/lymphoma – as subsequent therapy;

e.    Waldenstrom macroglobulinemia/lymphoplasmacytic lymphoma;

f.     T-cell acute lymphoblastic leukemia (T-ALL) – for relapsed or refractory disease;

g.    Pediatric acute lymphoblastic leukemia (ALL) – as subsequent therapy

h.    Pediatric Hodgkin lymphoma (HL) – as subsequent therapy in combination with ifosafamide and vinorelbine;

2.    Prescribed by or in consultation with an oncologist or hematologist;

3.    Age > 18 years (all indications except pediatric ALL and HL);

4.    Dose is within FDA maximum limit for any FDA-approved indication or is supported by practice guidelines or peer-reviewed literature for the relevant off-label use

 

Initial Approval Duration: 6 months

 

For Continued Therapy request, member must be responding positively to therapy and dose must be consistent with initial approval dosing requirements.

 

Continuation of therapy approval duration: 12 months

 

Codes Used In This BI:

 

1)    J9041 – Injection, bortezomib (Velcade) 0.1mg

Limits
Intentially left empty
Reference

1)    Velcade Prescribing Information. Cambridge, MA: Millennium Phasrmaceuticals, Inc.; October 2021.

2)    Bortezomib Prescribing Information. Durham, NC: Accord Healthcare; July 2022.

3)    NCCN Drugs and Biologics Compendium. Accessed online May 27, 2022.

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.