Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Polatuzumab Vedotin-Piiq (Polivy™)

Policy #:08.01.59b

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract. The Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition.

MEDICALLY NECESSARY

Polatuzumab vedotin-piiq (Polivy™) is considered medically necessary and, therefore, covered for a maximum of six cycles in adult individuals who are not eligible for autologous stem cell rescue, for any of the following indications:

DIFFUSE LARGE B-CELL LYMPHOMA
Used in combination with bendamustine and rituximab as second-line or subsequent therapy for partial response, no response, relapsed, progressive, or refractory disease after at least 2 prior therapies.*

HIGH-GRADE B-CELL LYMPHOMAS
Used in combination with bendamustine and rituximab as second-line or subsequent therapy for partial response, no response, relapsed, progressive, or refractory high-grade B-cell lymphomas with translocations of MYC and BCL2 and/or BCL6 after at least 2 prior therapies.*

*Examples of prior therapies may include the following (this is not an all-inclusive list):
  • R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone)
  • ICE (ifosfamide, carboplatin, etoposide) with or without rituximab
  • DHAP (dexamethasone, cytarabine, cisplatin) with or without rituximab
  • GemOx (gemcitabine and oxaliplatin) with or without rituximab
  • CAR-T therapies (e.g., axicabtagene ciloleucel [Yescarta™], tisagenlecleucel [Kymriah™])

EXPERIMENTAL/INVESTIGATIONAL

All other uses for polatuzumab vedotin-piiq (Polivy) are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the Company medical policy on off-label coverage for prescription drugs and biologics.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
Guidelines

DRUG INFORMATION

The following information was taken directly from the prescribing information at the time of this policy's publication: The recommended dose of polatuzumab vedotin-piiq (Polivy) is 1.8 mg/kg as an intravenous infusion over 30-90 minutes every 21 days for 6 cycles in combination with bendamustine and a rituximab product. Premedicate with an antihistamine and antipyretic, and administer prophylaxis for Pneumocystis jiroveci pneumonia and herpesvirus.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, polatuzumab vedotin-piiq (Polivy) is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

Polatuzumab vedotin-piiq (Polivy) was approved by the FDA on June 10, 2019 in combination with bendamustine and a rituximab product for the treatment of adult individuals with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, after at least two prior therapies.

The safety and effectiveness of polatuzumab vedotin-piiq (Polivy) have not been established in pediatric individuals.

Description

Diffuse large B cell lymphoma (DLBCL) is the most common aggressive subtype of non-Hodgkin lymphoma (NHL), accounting for approximately one-third of individuals with NHL. Initial treatment typically consists of a chemotherapy regimen (e.g., R-CHOP [rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone]), followed by a stem cell transplant, if possible. For relapsed or refractory disease in those who are not candidates for transplant, the following regimens are examples of options that could slow the disease progression or obtain remission:
  • Polatuzumab vedotin-piiq (Polivy) + BR (rituximab + bendamustine)
  • ICE (ifosfamide, carboplatin, etoposide) with or without rituximab
  • DHAP (dexamethasone, cytarabine, cisplatin) with or without rituximab
  • GemOx (gemcitabine and oxaliplatin) with or without rituximab
  • CAR-T therapies (e.g., axicabtagene ciloleucel [Yescarta™], tisagenlecleucel [Kymriah™])

Polatuzumab vedotin-piiq (Polivy) is a delivery system for the chemotherapy agent. It is an antibody-drug conjugate (ADC) that consists of a monoclonal antibody, a cytotoxic agent (small molecule anti-mitotic agent [MMAE]), and a linker system that attaches MMAE to the antibody. Once polatuzumab vedotin-piiq (Polivy) attaches to CD79b protein found on the B-cells, the MMAE binds to microtubules and kills dividing cells by inhibiting cell division and inducing apoptosis.

Polatuzumab vedotin-piiq (Polivy™) was approved by the FDA on June 10, 2019, in combination with bendamustine and a rituximab product, for the treatment of adult individuals with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, after at least two prior therapies.

PEER-REVIEWED LITERATURE
Summary

A study by Sehn et al, GO29365 (NCT02257567), evaluated the efficacy of polatuzumab vedotin-piiq (Polivy™) in an open-label, phase Ib/II, multicenter trial of 80 individuals with relapsed or refractory DLBCL after least one prior regimen. Individuals were randomized 1:1 to receive either polatuzumab vedotin-piiq (Polivy™) 1.8 mg/kg IV on Day 2 of Cycle 1 and on Day 1 of Cycles 2–6 in combination with bendamustine and a rituximab product (P+BR) or BR alone for six 21-day cycles.

Eligible individuals were not candidates for autologous HSCT at study entry. The study excluded individuals with Grade 2 or higher peripheral neuropathy, prior allogeneic HSCT, active central nervous system lymphoma, or transformed lymphoma. Ninety-eight percent of individuals had DLBCL not otherwise specified. The median number of prior therapies was 2 (range: 1–7), with 29% receiving one prior therapy, 25% receiving 2 prior therapies, and 46% receiving 3 or more prior therapies. Eighty percent of patients had refractory disease to last therapy.

The primary efficacy endpoints were complete response (CR) rate and duration of response (DOR). At the end of treatment, CR was 40% in P+BR group compared to 18% in BR group. In the P+BR group, of the 25 individuals who achieved a partial or complete response, 16 (64%) had a DOR of at least 6 months, and 12 (48%) had a DOR of at least 12 months. In the BR group, of the 10 individuals who achieved a partial or complete response, 3 (30%) had a DOR lasting at least 6 months, and 2 (20%) had a DOR lasting at least 12 months.

OFF-LABEL INDICATION

There may be additional indications contained in the Policy section of this document due to evaluation of criteria highlighted in the Company’s off-label policy, and/or review of clinical guidelines issued by leading professional organizations and government entities.
References

American Hospital Formulary Service (AHFS). Drug Information 2019. Polatuzumab vedotin-piiq (Polivy). [Lexicomp Online Web site]. 07/01/2019. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed November 7, 2019.

Elsevier’s Clinical Pharmacology Compendium. Polatuzumab vedotin-piiq (Polivy). 06/12/2019. [Clinical Key Web site]. Available at: https://www.clinicalkey.com/pharmacology/ [via subscription only]. Accessed November 7, 2019.

Freedman AS, Friedberg JW. Treatment of relapsed or refractory diffuse large B cell lymphoma. [UpToDate Web Site]. Updated 10/08/2019. Available at: http://www.uptodate.com/home [via subscription only]. Accessed November 7, 2019.

Lexi-Drugs Compendium. Polatuzumab vedotin-piiq (Polivy). 10/28/2019. [Lexicomp Online Web site]. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed November 7, 2019.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology - B-Cell Lymphomas. V.5.2019. 09/23/2019. [NCCN Web site]. Available at: https://www.nccn.org/professionals/physician_gls/pdf/b-cell.pdf [via free subscription]. Accessed November 7, 2019.

National Comprehensive Cancer Network (NCCN). NCCN Drugs & Biologics Compendium. Polatuzumab vedotin-piiq (Polivy). [NCCN Web site]. 2019. Available at: http://www.nccn.org/professionals/drug_compendium/content/contents.asp [via subscription only]. Accessed November 5, 2019.

Polivy (polatuzumab vedotin-piiq). [prescribing information]. South San Francisco, CA: Genetech Inc.; 06/2019. Available at: https://www.polivy.com/?c=pol-16ad19d516a&gclid=COSyx8-_6eICFdDzswod3kwCjQ . Accessed November 7, 2019.

Sehn LH, Herrera AF, Matasar MJ, et al. Polatuzumab Vedotin (Pola) Plus Bendamustine (B) with Rituximab (R) or Obinutuzumab (G) in Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL): Updated Results of a Phase (Ph) Ib/II Study. Blood 2018 132:Abstract 1683.

Study of Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab or Obinutuzumab Plus Bendamustine in Participants With Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma. 2019. Available at: https://clinicaltrials.gov/ct2/show/NCT02257567 . Accessed November 7, 2019.

Truven Health Analytics. Micromedex® DrugDex® Compendium. Polatuzumab vedotin-piiq (Polivy). 10/08/2019. Greenwood Village, CO. [Micromedex® Solutions Web site]. Available at: http://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed November 7, 2019.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Polatuzumab vedotin-piiq (Polivy) prescribing information and approval letter [FDA Web site]. 06/2019. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/ . Accessed November 7, 2019.




Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

C83.30 Diffuse large B-cell lymphoma, unspecified site

C83.31 Diffuse large B-cell lymphoma, lymph nodes of head, face, and neck

C83.32 Diffuse large B-cell lymphoma, intrathoracic lymph nodes

C83.33 Diffuse large B-cell lymphoma, intra-abdominal lymph nodes

C83.34 Diffuse large B-cell lymphoma, lymph nodes of axilla and upper limb

C83.35 Diffuse large B-cell lymphoma, lymph nodes of inguinal region and lower limb

C83.36 Diffuse large B-cell lymphoma, intrapelvic lymph nodes

C83.37 Diffuse large B-cell lymphoma, spleen

C83.38 Diffuse large B-cell lymphoma, lymph nodes of multiple sites

C83.39 Diffuse large B-cell lymphoma, extranodal and solid organ sites

C85.10 Unspecified B-cell lymphoma, unspecified site

C85.11 Unspecified B-cell lymphoma, lymph nodes of head, face, and neck

C85.12 Unspecified B-cell lymphoma, intrathoracic lymph nodes

C85.13 Unspecified B-cell lymphoma, intra-abdominal lymph nodes

C85.14 Unspecified B-cell lymphoma, lymph nodes of axilla and upper limb

C85.15 Unspecified B-cell lymphoma, lymph nodes of inguinal region and lower limb

C85.16 Unspecified B-cell lymphoma, intrapelvic lymph nodes

C85.17 Unspecified B-cell lymphoma, spleen

C85.18 Unspecified B-cell lymphoma, lymph nodes of multiple sites

C85.19 Unspecified B-cell lymphoma, extranodal and solid organ sites




HCPCS Level II Code Number(s)



J9309 Injection, polatuzumab vedotin-piiq, 1 mg



Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References


Policy History

08.01.59b
02/10/2020This policy has been reviewed in accordance with National Comprehensive Cancer Network (NCCN) and US Food and Drug Administration (FDA). Clarification was made regarding therapies administered prior to polatuzumab vedotin-piiq (Polivy™).

08.01.59a
01/01/2020This policy has been identified for the HCPCS code update, effective 01/01/2020.

The following NOC codes have been removed from this policy and replaced by the following HCPCS code:

REMOVED:
C9399 Unclassified drugs or biologicals
J3590 Unclassified biologics

ADDED: J9309 Injection, polatuzumab vedotin-piiq, 1 mg

08.01.59
08/26/2019The following new policy has been developed to communicate the Company's coverage criteria for polatuzumab vedotin-piiq (Polivy™).

Version Effective Date: 02/10/2020
Version Issued Date: 02/10/2020
Version Reissued Date: N/A

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