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)    Polivy (polatuzumab vedotin-piiq) requires prior authorization.

2)    Polivy is used to treat a type of relapsed or refractory lymphoma.

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

I. Initial Approval Criteria

A. Diffuse Large B-Cell Lymphoma (must meet all):

1. Diagnosis of DLBCL (see subtypes at Appendix D);

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

3. Age ≥ 18 years;

4. Member is not a candidate for allogeneic or autologous stem cell transplant;

5. Member has received ≥ 1 prior therapy;

6. Polivy is prescribed as a single agent or in combination with bendamustine* and/or a rituximab product* ;

*Prior authorization may be required for bendamustine and rituximab products

7. Request meets one of the following (a or b):*

a. Dose does not exceed 1.8 mg/kg on Day 1 of a 21-day cycle, for a maximum of 6 cycles;

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

*Prescribed regimen must be FDA-approved or recommended by NCCN.

Approval duration: 6 months (medical justification supports requests for cycles beyond 6)

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

1. Diagnosis of one of the following (a, b, c, d, or e):

a. Follicular lymphoma (FL) (grade 1-2);

b. Mantle cell lymphoma;

c. Monomorphic post-transplant lymphoproliferative disorder (B-cell type);

d. One of the following AIDS-related B-cell lymphoma subtypes (i, ii, iii, or iv):

i. AIDS-related DLBCL;

ii. Primary effusion lymphoma;

iii. HHV8-positive diffuse large B-cell lymphoma, NOS;

iv. AIDS-related plasmablastic lymphoma;

e. Histologic transformation of nodal marginal zone lymphoma to diffuse large B-cell lymphoma;

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

3. Age ≥ 18 years;

4. For requests other than FL grade 1-2, member is not a candidate for allogeneic or autologous stem cell transplant;

5. Member has received ≥ 1 prior therapy;

6. Polivy is prescribed as a single agent or in combination with bendamustine* and/or a rituximab product* ;

*Prior authorization may be required for bendamustine and rituximab products

7. 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 (prescriber must submit supporting evidence).*

*Prescribed regimen must be FDA-approved or recommended by NCCN

Approval duration: 6 months (medical justification is required for requests for more than 6 cycles)

II. Continued Therapy

A. All Indications in Section I (must meet all):

1. Currently receiving medication via QualChoice benefit, or documentation supports that member is currently receiving Polivy for a covered indication and has received this medication for at least 30 days;

2. Member is responding positively to therapy;

3. Member meets one of the following (a or b):

a. Member has received < 6 cycles of Polivy;

b. Member has received less than the number of cycles recommended by NCCN for the covered indication;

4. If request is for a dose increase, request meets one of the following (a or b):*

a. New dose does not exceed 1.8 mg/kg on Day 1 of a 21-day cycle, for a maximum of 6 cycles;

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

*Prescribed regimen must be FDA-approved or recommended by NCCN.

Approval duration: 12 months (medical justification supports requests for cycles beyond 6)

Codes Used In This BI:

1)    J9309 Injection, polatuzumab vedotin-piiq

1. Polivy Prescribing Information. South San Francisco, CA: Genentech, Inc.; September 2020. Available at: https://www.gene.com/download/pdf/polivy_prescribing.pdf. Accessed May 2, 2022.

2. National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at: http://www.nccn.org/professionals/drug_compendium. Accessed May 2, 2022.

3. National Comprehensive Cancer Network. B-Cell Lymphomas Version 3.2022. Available at: https://www.nccn.org/professionals/physician_gls/pdf/b-cell.pdf. Accessed May 2, 2022.

Addendum:

1)    Effective 11-01-2023: Updated criteria set for DLBCL and added NCCN recommended off-label uses.