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
B-CELL LYMPHOMAS
Relapsed or Refractory Large B-cell Lymphoma
Loncastuximab tesirine (Zynlonta) is considered medically necessary and, therefore, covered as third-line and subsequent therapy as a single agent for the treatment of adult individuals with relapsed or refractory large B-cell lymphoma (including partial response, no response, or progressive disease) in individuals who have received two or more prior lines of systemic therapy including any of the following subtypes: - Diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS)
- High-grade B-cell lymphoma including NOS, translocations of MYC and BCL2 and/or BCL6 (double/triple hit lymphoma)
- Acquired immunodeficiency syndrome (AIDS)/human immunodeficiency virus (HIV)-related DLBCL, primary effusion
lymphoma, human herpesvirus (HHV) 8–positive DLBCL
- Monomorphic posttransplant lymphoproliferative disorders
*Note: Coverage does not apply to individuals with:
- Bulky disease (tumor ≥10 cm in longest dimension)
- Active central nervous system (CNS) lymphoma
Histologic Transformation to DLBCL from Indolent Lymphoma
Loncastuximab tesirine (Zynlonta) is considered medically necessary and, therefore, covered
for the treatment of adult individuals with histologic transformation of a low-grade or indolent lymphoma to DLBCL* and have no intention to proceed to transplant, who have been previously treated with an anthracycline-based regimen, for either of the following: - As additional therapy for
partial response, no response, or progressive disease following
chemoimmunotherapy for histologic transformation after minimal or no prior therapy
- For histologic transformation after multiple prior therapies including two or more chemoimmunotherapy regimens for indolent disease prior to histologic transformation
*Including follicular lymphoma (grade 1–2), extranodal
marginal zone lymphoma (MZL) of the stomach (formerly called gastric
mucosa-associated lymphoid tissue [MALT] lymphoma), extranodal MZL of
nongastric sites (noncutaneous) (formerly called nongastric MALT lymphoma [noncutaneous]),
splenic MZL, and nodal MZL.
EXPERIMENTAL/INVESTIGATIONAL
All other uses for loncastuximab tesirine (Zynlonta) 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.
MANDATES
PENNSYLVANIA MEMBERS
In accordance with the Commonwealth of Pennsylvania's Act 6 of 2020 or Fair Access to Cancer Treatment Act, for members who are enrolled in Pennsylvania commercial products who have Stage 4, advanced metastatic cancer, refer to the Medical Policy titled "Coverage of Anticancer Prescription Oral and Injectable Drugs and Biologics and Supportive Agents" (08.01.08) for additional information regarding the applicable coverage of 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 drug.
