Last Review Date: 09/03/2019

Date of Origin: 07/01/2019

Dates Reviewed: 07/2019, 09/2019

1. Length of Authorization

Coverage will be provided for six months (up to 6 cycles of therapy) and may NOT be renewed.

2. Dosing Limits

          A.  Quantity Limit (max daily dose) [NDC Unit]:

• Polivy 140 mg SDV vial: 1 vial per 21 days*

          B.  Max Units (per dose and over time) [HCPCS Unit]:

• 140 billable units every 21 days*

3. Initial Approval Criteria

Coverage is provided in the following conditions:

• Patient is 18 years or older; AND
• Patient will receive prophylaxis for Pneumocystis jiroveci pneumonia and herpesvirus; AND
• Patient does not currently have Grade ≥ 2 peripheral neuropathy; AND
• Patient has not had a prior allogeneic stem-cell transplant; AND
• Patient has not had an autologous stem-cell transplant within 100 days prior to start of therapy, or is not a candidate; AND
• Patient has not had chimeric antigen receptor T-cell (CAR-T) therapy within 100 days prior to start of therapy; AND
• Patient does not have CNS lymphoma; AND
• Patient does not have a history of transformation of indolent disease to DLBCL; AND

      Diffuse Large B-cell Lymphoma (DLBCL) †

• • Patient has relapsed or refractory disease; AND
  • Used in combination with bendamustine and rituximab; AND
  • Used as subsequent treatment after at least two prior therapies (Note: For patients with relapsed disease who received prior bendamustine, response duration must have been >1 year)

      † FDA Approved Indication(s), ‡ Compendia Recommended Indication(s)

4. Renewal Criteria

Coverage cannot be renewed.

5. Dosage/Administration

6. Billing Code/Availability Information

HCPCS code:

• J9999 – Not otherwise classified, antineoplastic drugs
• J9309 – Injection, polatuzumab vedotin-piiq 1 mg; 1 mg = 1 billable unit (effective 1/1/2020)

NDC:

• Polivy 140 mg lyophilized powder for injection, single-use vial: 50242-0105-xx

7. References

          1.  Polivy [package insert]. South San Francisco, CA; Genentech, Inc; June 2019. Accessed June 2019.

          2.  Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for polatuzumab vedotin.  National Comprehensive Cancer Network, 2019.  The NCCN                                 Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National                     Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed June 2019.

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD) and Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. They can be found at: http://www.cms.gov/medicare-coverage-database/search/advanced-search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD): N/A