CurrentMass General Brigham Health PlanPolicy N/A

Zynlonta (loncastuximab tesirine-lpyl) and related lymphoma/leukemia agents prior authorization

Medical-benefit prior authorization criteria for Zynlonta and other specified lymphoma and leukemia agents for MassHealth members, governing oncologist/hematologist prescribing and documentation requirements.

Policy Summary

PayerMass General Brigham Health Plan

PolicyZynlonta (loncastuximab tesirine-lpyl) and related lymphoma/leukemia agents prior authorization

Policy CodePolicy N/A

Change TypeAdded agentsadministrative updates

Effective Date06/01/2025

Next Review DateN/A

Key ActionObtain prior authorization and provide documentation of diagnosis, prior therapies, prescriber specialty, dosing, and evidence of response or contraindication.

SourceLink

POLICY UPDATE CHANGES

Updated formatting and references; only applicable medical benefit drugs remain while other Rx drugs should be available on the MHDL; Aliqopa removed due to FDA withdrawal.

Added Zynlonta (loncastuximab tesirine-lpyl) to criteria.

Added Arzerra (ofatumumab vial) and Gazyva (obinutuzumab) to criteria.

6 monthsInitial and reauthorization approval duration

≥18Minimum age requirement

≥2 regimensZynlonta prior therapy requirement

Medical

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Coverage Criteria for Listed Indications

Follicular Lymphoma

Authorization may be granted when ALL of the following are met:

FL criteria: 1. Diagnosis of follicular lymphoma (FL); 2. Member is ≥ 18 years of age; 3. Prescriber is an oncologist or hematologist; 4. Appropriate dosing; 5. ONE of the following: (a) Paid claims or physician attestation of relapsed or refractory FL after treatment with a rituximab-containing regimen; OR (b) Concurrent therapy with a first-line chemotherapy agent

Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Authorization may be granted when ALL of the following are met:

CLL/SLL criteria: 1. Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL); 2. Member is ≥ 18 years of age; 3. Prescriber is an oncologist or hematologist; 4. Appropriate dosing; 5. ONE of the following: (a) CLL/SLL without del(17p)/TP53 mutation; OR (b) CLL/SLL with del(17p)/TP53 mutation AND is treatment naive

Arzerra (ofatumumab) - Relapsed/Refractory CLL

Authorization may be granted when ALL of the following are met:

Arzerra relapsed CLL: 1. Diagnosis of CLL (relapsed or refractory); 2. Member is ≥ 18 years of age; 3. Prescriber is an oncologist or hematologist; 4. Appropriate dosing; 5. Paid claims or physician attestation of inadequate response, adverse reaction, or contraindication to BOTH fludarabine AND alemtuzumab (Campath).

Alemtuzumab (Campath) may be available through the Campath Distribution Program.

Zynlonta (loncastuximab tesirine-lpyl) - Large B-Cell Lymphoma (Relapsed or Refractory)

Authorization may be granted when ALL of the following are met:

Zynlonta relapsed/refractory LBCL: 1. Diagnosis of relapsed or refractory large B-cell lymphoma (includes DLBCL NOS, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma); 2. Member is ≥ 18 years of age; 3. Prescriber is an oncologist or hematologist; 4. Appropriate dosing; 5. Prior therapy with at least TWO prior chemotherapy regimens, or contraindication to ALL recommended chemotherapy regimens.

The policy does not impose any specialty limitations. No explicit restrictions by prescriber specialty are listed in the coverage table; prescribers are expected to be oncologists or hematologists where specified in individual criteria, but there is no separate specialty exclusion for these agents in the plan-level specialty limitations.

For continuation (reauthorization) requests, the policy requires documentation of ongoing benefit. Specifically, for Arzerra (ofatumumab vial) a clinical rationale is required if use is requested beyond the FDA‑approved duration. For all other listed agents, reauthorization requests must include a physician attestation indicating a positive response to therapy to support continuation.

Regimen	Indication	Key criteria	Coverage status
Loncastuximab tesirine-lpyl (Zynlonta) per prescribing information	Relapsed or refractory large B-cell lymphoma	1. Diagnosis of relapsed or refractory large B-cell lymphoma; 2. Member is ≥ 18 years of age; 3. Prescriber is an oncologist or hematologist; 4. Appropriate dosing per PI; 5. Prior therapy with at least TWO prior chemotherapy regimens, or contraindication to ALL recommended chemotherapy regimens	covered with criteria

Line of Therapy Specifications

third-line or later

third-line or later: Prior therapy with at least TWO prior chemotherapy regimens, or contraindication to ALL recommended chemotherapy regimens (applies to relapsed/refractory large B-cell lymphoma).

first-line concurrent

first-line concurrent: Concurrent therapy with a first-line chemotherapy agent is acceptable under the follicular lymphoma criteria.

Provider Actions, Documentation, and Prior Authorization

Prior Authorization

Prior Authorization and Documentation / Continuity Reviews

Prior authorization is required for Zynlonta and listed agents under the medical benefit. Authorization may be reviewed for members new to the plan who are currently receiving treatment. Lack of required documentation or failure to meet prior therapy/contraindication requirements may result in denial or trigger continuation-review requirements.

Prior authorization required for Zynlonta (medical benefit).
Authorization may be reviewed case-by-case for members new to plan who are currently receiving treatment.
Denial risk or continuation-review if documentation is incomplete or criteria not met.

Documentation Required

Required Documentation

Provide documentation to support the request; incomplete records may delay or result in denial. Documentation should include: diagnosis, member age, prescriber specialty, dosing, and evidence of prior treatments or contraindications (see below). Where applicable, include paid claims, physician attestation, or clinical rationale.

Covered Agents and Coding

Covered/managed agents (no claim codes listed)mixed

N/A	No explicit CPT/HCPCS/ICD-10 codes listed in document; medical benefit contact and claim handling information provided.

Biomarker and Genetic Test Requirements

del(17p)/TP53 — Biomarker requirement details

Biomarkerdel(17p)/TP53

Applies toChronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) branching in criteria

Role in criteriaDetermines eligibility pathway: without del(17p)/TP53 qualifies under standard branch; with del(17p)/TP53 requires treatment-naive status for authorization

Member age requirement≥ 18 years

Prescriber requirementPrescriber must be an oncologist or hematologist

Definitions and Diagnostic Scope

Relapsed or refractory large B-cell lymphoma — scope and Zynlonta indication

DefinitionIncludes diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B‑cell lymphoma for which Zynlonta is indicated.

Indication for ZynlontaRelapsed or refractory large B‑cell lymphoma after two or more lines of systemic therapy

Age requirementMembers must be ≥ 18 years of age

Prior therapy requirementPrior therapy with at least TWO prior chemotherapy regimens, or contraindication to ALL recommended chemotherapy regimens

Prescriber requirementPrescriber must be an oncologist or hematologist

Covered Regimens and Dosing References

Drug	Dose / Schedule (per prescribing information)	Notes
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Background

Zynlonta (loncastuximab tesirine‑lpyl) is included in this medical‑benefit prior authorization policy for adult patients with relapsed or refractory large B‑cell lymphoma after prior therapy. The plan lists Zynlonta as a medical‑benefit agent (it is also available on the MassHealth Drug List under the pharmacy benefit) and requires prior authorization consistent with the coverage criteria that specify age (≥ 18 years), prescriber specialty (oncologist or hematologist), appropriate dosing, and prior therapy with at least two prior chemotherapy regimens or documentation of contraindication to recommended regimens for the relapsed/refractory large B‑cell lymphoma indication.

Revision History

2025-06-01revision_effective_dateLatest

Administrative and substantive updates: formatting and references updated; policy limited to applicable medical benefit drugs; Aliqopa removed due to FDA withdrawal.

2025-05-15review

Reviewed and updated for P&T on 05/15/25 with formatting and reference updates ahead of the 06/01/25 effective changes.

2023-04-12addition