Lymphoma and Leukemia Agents (Arzerra, Gazyva, Zynlonta) - Medical-Benefit Prior Authorization
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Medical-benefit prior authorization policy for specified lymphoma and leukemia agents (Arzerra/ofatumumab vial, Gazyva/obinutuzumab, Zynlonta/loncastuximab) describing indications, authorization criteria, continuation and limitation rules for Mass General Brigham Health Plan members (MassHealth UPPL).
Expanded indication for Gazyva was added, effective 7/1/26.
Arzerra (ofatumumab vial) and Gazyva (obinutuzumab) were added to the criteria.
Venclexta criteria for AML were updated to be consistent with NCCN guidelines and brand/generic language added under Limitations.
Aliqopa was removed due to FDA withdrawal.
Coverage Criteria and Indications
COVERAGE CRITERIA
Authorization may be granted when ALL of the following criteria for the specific agent and indication are met.
Review history summary
Summary of review history documenting additions, removals, and revisions to coverage criteria.
ALL of the following
- 07/20/22 — Policy reviewed and created for July P&T; initial additions included multiple agents and separation of benefit settings; effective 9/01/22.
- 01/11/23 — Reviewed and administrative updates; off‑label indications added for Venclexta (MM) and Imbruvica (CNS lymphoma); effective 3/1/23.
- 04/12/23 — Added Arzerra (ofatumumab vial), Gazyva (obinutuzumab), Leukeran (chlorambucil), and Zynlonta (loncastuximab); effective 5/1/23.
- 09/13/23 — Multiple updates including Imbruvica suspension, MCL/MZL appendix changes, Brukinsa expansion, and Calquence updates.
- 10/02/23 — Venclexta criteria for AML updated to align with NCCN; brand/generic language added under Limitations; formatting updates.
- 12/13/23 — Added Jaypirca requiring PA and QL; effective 1/2/24.
- 05/15/25 — Formatting and reference updates; Aliqopa removed due to FDA withdrawal; lupus nephritis indication added; effective 6/1/25.
- 06/10/26 — Reviewed and updated for P&T; expanded indication for Gazyva added, effective 7/1/26.
Covered Regimens and Labeled Indications
| Regimen | Indication / Key elements | Coverage status |
|---|---|---|
| Obinutuzumab (Gazyva) monotherapy or as specified in label | ||
| Includes labeled uses for CLL/SLL and follicular lymphoma per prescribing information; specific criteria (e.g., del(17p)/TP53 considerations for CLL) apply | ||
| Covered with criteria |
| Regimen | Indication / Key elements | Coverage status |
|---|---|---|
| Ofatumumab (Arzerra) extended treatment | ||
| Extended treatment of patients in complete or partial response after at least two lines of therapy for recurrent or progressive CLL (per label); requires documentation of prior therapies and response | ||
| Covered with criteria |
| Regimen | Indication / Key elements | Coverage status |
|---|---|---|
| Loncastuximab tesirine (Zynlonta) monotherapy | ||
| Relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy (includes DLBCL NOS, DLBCL arising from low-grade lymphoma, high-grade B-cell lymphoma); member ≥18, oncologist/hematologist, appropriate dosing | ||
| Covered with criteria |
| Regimen / Study | Population / Key elements | Coverage status |
|---|---|---|
| Venetoclax + obinutuzumab (Fischer et al., NEJM 2019) | ||
| Patients with CLL and coexisting conditions; cited trial: Fischer K et al., N Engl J Med. 2019;380(23):2225-2236 | ||
| Referenced as supportive regimen (covered per trial reference) |
| Agent | Notes in policy / inclusion | Coverage status |
|---|---|---|
| Obinutuzumab (Gazyva) | ||
| Gazyva added to criteria (04/12/23 review); FDA-labeled regimens and indications (CLL combinations, follicular lymphoma regimens, lupus nephritis) are reflected in policy criteria | ||
| Included in criteria (covered with criteria) |
Provider Actions, Prior Authorization and Reauthorization
Medical-Benefit Prior Authorization Required
Prior authorization is required for the listed agents when billed under the medical benefit (MassHealth UPPL).
Transition-of-Care: Current Therapy Review
Authorization may be reviewed on a case-by-case basis for members who are new to the plan and currently receiving the requested medication; this does not apply when the product was obtained as samples or through a manufacturer's patient assistance program.
- Provider should document current therapy and source of medication (exclude samples or manufacturer assistance supplies).
- Case-by-case review may permit continuation of existing, stable therapy consistent with FDA-approved indications.
Reauthorization and Continuation Requirements
Initial approvals and reauthorizations are for 6 months; reauthorization requires physician attestation of a positive response for all agents except Arzerra. For Arzerra, clinical rationale is required to continue therapy beyond the FDA‑approved duration.
- Include physician attestation documenting positive clinical response for reauthorization requests (non-Arzerra agents).
- For Arzerra, submit clinical rationale supporting treatment beyond the FDA‑approved duration when requesting continuation.
Policy Updates and Prior Authorization Note
Policy changes, additions, or new-agent criteria are subject to prior review by the Pharmacy & Therapeutics (P&T) committee and any applicable prior authorization requirements will be reflected in the review history.
- Providers should follow the most recent criteria as reflected in the policy review history when submitting prior authorization requests.
- New agents or criteria added after P&T review will require applicable prior authorization consistent with the updated policy.
Coding, Approval Duration, and Prescribing References
| N/A | Prescribing information references for specific agents (Zynlonta, Arzerra, Gazyva) cited |
Definitions and Policy Terminology
Line of Therapy Designations
salvage
first-line
first-line
second-line
Biomarker and Diagnostic Requirements
References, Citations and Revision History
The policy cites peer-reviewed clinical trials and prescribing information to support regimen-specific recommendations. Key trial evidence includes Fischer et al., "Venetoclax and obinutuzumab in patients with CLL and coexisting conditions" (N Engl J Med. 2019) which specifically evaluates the venetoclax + obinutuzumab combination in CLL and informs coverage of that regimen. Additional clinical references include phase III and real‑world studies of venetoclax and related BCL‑2–targeting strategies (e.g., MURANO trial long‑term results and other venetoclax reports) that underpin use in relapsed/refractory disease, as well as iwCLL and other guideline literature cited for diagnostic and treatment standards. The document also references prescribing information for the included agents: Zynlonta® (loncastuximab), Arzerra® (ofatumumab), and Gazyva® (obinutuzumab), which are used to align dosing, labeled indications, and continuation rules with regulatory labeling.
Policy reviewed and created for July P&T; matched MassHealth UPPL and expanded criteria list (added Aliqopa, Calquence, Copiktra, Imbruvica, Venclexta, Zydelig); renamed to 'Lymphoma and Leukemia agents'; effective 2022-09-01.
Administrative update noting Aliqopa available through medical benefit only; guideline added two off-label indications (Venclexta for multiple myeloma, Imbruvica for CNS lymphoma); appendix updated; effective 2023-03-01.
Added Arzerra (ofatumumab vial), Gazyva (obinutuzumab), Leukeran (chlorambucil), and Zynlonta (loncastuximab) to criteria; added appendix for members stable on Copiktra or Zydelig; effective 2023-05-01.
Multiple updates: Imbruvica suspension added; MCL and MZL Imbruvica criteria moved to appendix after voluntary withdrawal; added Calquence MZL off-label criteria per NCCN; Brukinsa criteria added for expanded FDA approval; other CLL/SLL criteria updates.
Venclexta criteria for AML updated to align with NCCN guidelines and brand/generic language added under Limitations; formatting updates throughout.
Added Jaypirca to criteria requiring prior authorization and quantity limits; effective 2024-01-02.
Aliqopa was removed from the policy due to FDA withdrawal; formatting and references updated and remaining medical-benefit drugs clarified (effective 2025-06-01 for lupus nephritis addition).
Reviewed and updated for P&T to expand the indication for Gazyva; expansion effective 2026-07-01.
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