Table 75: T-Cell Immunotherapies
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
Drug Category: Immunotherapies
Medication Class/Individual Agents: T-Cell Immunotherapies
I. Prior-Authorization Requirements
T-Cell Immunotherapies - Autologous T-cell Immunotherapy |
Clinical Notes |
|||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.
Autologous T-cell Immunotherapies are treatments that use a patient’s own T cells to attack cancer cells. The T cells are genetically modified ex vivo to activate the patient’s immune response and then reinfused back into the patient. Recognition of a specific tumor/cell surface antigen activates T cell response independently of major histocompatibility complex. Some examples of these include Chimeric Antigen Receptor (CAR)-T cell therapy and Tumor-infiltrating lymphocyte (TIL) therapy and miscellaneous therapy, such as autologous T cells transduced with melanoma-associated antigen A4 (MAGE-A4). Currently available CAR-T cell therapies include those directed against CD19-positive B-cell malignancies (axicabtagene ciloleucel, brexucabtagene autoleucel, lisocabtagene maraleucel, tisagenlecleucel) and B cell maturation antigen (BCMA) (ciltacabtagene autoleucel, idecabtagene vicleucel). Given the risk of serious adverse reactions, such as cytokine release syndrome (CRS) and neurological toxicities, these agents are only available through a restricted program under a Risk Evaluation and Mitigation (REMS) and administered by certified treatment centers. Lifileucel is currently the only TIL therapy on the market. It is approved for the treatment of adults with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. To manufacture this therapy, a portion of the patient’s tumor tissue is removed during a surgical procedure prior to treatment. The patient’s TIL cells are separated from the tumor tissue, activated and multiplied into billions of cells at a manufacturing center and then returned to the patient as a single dose for intravenous infusion following lymphodepletion. This agent must be administered in an inpatient hospital setting where specialists skilled in cardiopulmonary or intensive care medicine are available. Afamitresgene autoleucel is the first gene therapy to treat adults with metastatic synovial sarcoma and is also the first FDA-approved T cell receptor gene therapy. This product is manufactured by modifying the patient’s own T cells to express a T cell receptor that targets MAGE-A4, an antigen expressed by cancer cells in synovial sarcoma. It is administered as a single intravenous dose. Due to the boxed warning for CRS, it must be given in an authorized treatment center. For additional information regarding these T-cell immunotherapies, please see the Acute Hospital Carve-Out Drugs List found at www.mass.gov/druglist. Another form of T-cell immunotherapies is the Bispecific T Cell Engagers (BiTE). These are monoclonal antibodies that act as linkers between T cells and specific target antigens. They contain two distinct variable regions, one of which engages T cells, typically at the CD3 receptor, and a second which engages the target antigen, effectively activating the T cell against that target. Because BiTE agents are ready for use “off the shelf” without patient specific processing, they can be deployed in a wider range of health care settings. |
|||||||||||||||||||||||||||||||
T-Cell Immunotherapies - Bispecific Antibodies |
||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||
T-Cell Immunotherapies - Chimeric Antigen Receptor (CAR)-T Immunotherapies |
||||||||||||||||||||||||||||||||
|
CO | Carve-Out. This agent is listed on the Acute Hospital Carve-Out Drugs List and is subject to additional monitoring and billing requirements. |
MB | This drug is available through the health care professional who administers the drug or in an outpatient or inpatient hospital setting. MassHealth does not pay for this drug to be dispensed through the retail pharmacy. If listed, PA does not apply through the hospital outpatient and inpatient settings. Please refer to 130 CMR 433.408 for PA requirements for other health care professionals. Notwithstanding the above, this drug may be an exception to the unified pharmacy policy; please refer to respective MassHealth Accountable Care Partnership Plans (ACPPs) and Managed Care Organizations (MCOs) for PA status and criteria, if applicable. |
II. Therapeutic Uses
FDA-approved, for example:
- B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse (Kymriah)
- Extensive stage small cell lung cancer (ES-SCLC) (Imdelltra)
- Relapsed or refractory B-cell precursor ALL (Tecartus)
- relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (Breyanzi)
- Relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy (Epkinly, Kymriah, Lunsumio, Yescarta)
- Relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) or large B-cell lymphoma (LBCL) arising from FL, after two or more lines of systemic therapy (Columvi)
- Relapsed or refractory LBCL after two or more lines of systemic therapy, including DLBCL, NOS, high grade B-cell lymphoma, and DLBCL arising from FL (Kymriah)
- Relapsed or refractory LBCL after two or more lines of systemic therapy, including DLBCL, NOS, primary mediastinal LBCL, high grade B-cell lymphoma, and DLBCL arising from FL (Yescarta)
- Relapsed or refractory mantle cell lymphoma (Breyanzi)
- LBCL refractory to first line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy (Yescarta)
- LBCL refractory to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy, or refractory to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age (Breyanzi)
- Relapsed or refractory LBCL after two or more lines of systemic therapy, including DLBCL, NOS (including DLBCL arising from indolent lymphoma), and high grade B-cell lymphoma (Epkinly)
- Relapsed or refractory LBCL or FL after two or more lines of systemic therapy, including DLBCL, NOS (including DLBCL arising from indolent lymphoma), high grade B-cell lymphoma, primary mediastinal LBCL, and FL grade 3B (Breyanzi)
- Relapsed or refractory mantle cell lymphoma (Tecartus)
- Relapsed or refractory multiple myeloma after at least one prior line of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody (Carvykti)
- Relapsed or refractory multiple myeloma after two or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody (Abecma)
- Relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody (Elrexfio, Talvey, Tecvayli)
- Unresectable or metastatic melanoma (Amtagvi)
- Unresectable or metastatic synovial sarcoma (Tecelra)
Note: The above list may not include all FDA-approved indications.
III. Evaluation Criteria for Approval
Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.
- All PA requests must include clinical diagnosis, drug name, dose, and frequency.
- Dispensing in a 90-day supply of medication may be mandated or allowable for agents in this therapeutic class (designated by M90 or A90, respectively, in the Drug Notes section above). Applicable quantity limits are described below as units per day, per month, per 28 days, or as clinically appropriate, and may be extrapolated for fills of longer day supply.
- A preferred drug may be designated for this therapeutic class. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class. Additional information about these agents, including PA requirements and preferred products, can be found within the MassHealth Drug List at www.mass.gov/druglist.
- For recertification requests, approval may require submission of additional documentation including, but not limited to, documentation of: some or all criteria for the original approval; response to therapy; clinical rationale for continuation of use; status of member’s condition; appropriate diagnosis; appropriate age; appropriate dose, frequency, and duration of use for requested medication; complete treatment plan; current laboratory values; and member’s current weight.
- Additional criteria may apply depending upon diagnosis and/or requested medication (see below). Other factors, including rebate and FDA-approval status, may change independently of scheduled MassHealth updates, which may result in additional restrictions.
Abecma
- Documentation of the following is required:
- diagnosis of relapsed or refractory multiple myeloma; and
- prescriber is a hematologist or oncologist; and
- appropriate dosing (member's weight must be provided); and
- member is ≥ 18 years of age on treatment date; and
- inadequate response or adverse reaction to two or more lines of systemic therapies or contraindication to all other lines of systemic therapies; and
- member’s disease is refractory to at least one proteasome inhibitor or has a contraindication to all proteasome inhibitors; and
- member’s disease is refractory to at least one immunomodulatory agent or has a contraindication to all immunomodulatory agents; and
- member’s disease is refractory to at least one anti-CD38 monoclonal antibody or has a contraindication to all anti-CD38 monoclonal antibodies; and
- administration will take place in a health care facility that has been certified pursuant to the REMS program specific to the treatment being provided.
Amtagvi
- Documentation of the following is required:
- appropriate diagnosis; and
- member is ≥ 18 years of age; and
- prescriber is an oncologist; and
- inadequate response or adverse reaction to one or contraindication to all appropriate PD-1 blocking antibodies; and
- for BRAF V600 mutation positive, inadequate response or adverse reaction to one or contraindication to all BRAF inhibitors; and
- appropriate dosing and treatment dates; and
- infusion will take place in a qualified treatment facility.
Breyanzi
- Documentation of the following is required for large B-cell lymphoma refractory to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy, or refractory to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age:
- appropriate diagnosis; and
- prescriber is a hematologist or oncologist; and
- appropriate dosing (member's weight must be provided); and
- member is ≥ 18 years of age on treatment date; and
- inadequate response or adverse reaction to one line of systemic therapy; and
- one of the following:
- member has refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or
- member has refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and is not eligible for HSCT (e.g., due to comorbidities or age); and
- infusion will take place in a health care facility that has been certified pursuant to the REMS program specific to the treatment being provided.
- Documentation of the following is required for a diagnosis of relapsed or refractory large B-cell lymphoma or follicular lymphoma after two or more lines of systemic therapy, including DLBCL, NOS (including DLBCL arising from indolent lymphoma), high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and FL grade 3B:
- appropriate diagnosis; and
- prescriber is a hematologist or oncologist; and
- appropriate dosing (member's weight must be provided); and
- member is ≥ 18 years of age on treatment date; and
- inadequate response or adverse reaction to two lines of systemic therapies; and
- infusion will take place in a health care facility that has been certified pursuant to the REMS program specific to the treatment being provided.
- Documentation of the following is required for a diagnosis of relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma:
- appropriate diagnosis; and
- prescriber is a hematologist or oncologist; and
- appropriate dosing (member's weight must be provided); and
- member is ≥ 18 years of age on treatment date; and
- inadequate response or adverse reaction to one, or contraindication to all of the following: Brukinsa, Calquence, Imbruvica; and
- inadequate response, adverse reaction, or contraindication to Venclexta; and
- infusion will take place in a health care facility that has been certified pursuant to the REMS program specific to the treatment being provided.
- Documentation of the following is required for a diagnosis of relapsed or refractory mantle cell lymphoma:
- appropriate diagnosis; and
- prescriber is a hematologist or oncologist; and
- appropriate dosing (member's weight must be provided); and
- member is ≥ 18 years of age on treatment date; and
- inadequate response or adverse reaction to one, or contraindication to all of the following: Brukinsa, Calquence, Imbruvica; and
- inadequate response or adverse reaction to one other line of systemic therapy; and
- infusion will take place in a health care facility that has been certified pursuant to the REMS program specific to the treatment being provided.
Carvykti
- Documentation of the following is required:
- diagnosis of relapsed or refractory multiple myeloma; and
- prescriber is a hematologist or oncologist; and
- appropriate dosing (member's weight must be provided); and
- member is ≥ 18 years of age on treatment date; and
- inadequate response or adverse reaction to one prior line of systemic therapy or contraindication to all other lines of systemic therapies; and
- member’s disease is refractory to at least one proteasome inhibitor or has a contraindication to all proteasome inhibitors; and
- member’s disease is refractory to at least one immunomodulatory agent or has a contraindication to all immunomodulatory agents; and
- member’s disease is refractory to lenalidomide; and
- administration will take place in a health care facility that has been certified pursuant to the REMS program specific to the treatment being provided.
Columvi
- Documentation of the following is required:
- diagnosis of relapsed or refractory DLBCL, NOS or LBCL arising from FL; and
- prescriber is a hematologist or oncologist; and
- appropriate dosing; and
- member is ≥ 18 years of age; and
- member has received at least two lines of systemic therapies, including at least one anti-CD20 monoclonal antibody.
Elrexfio, Talvey, and Tecvayli
- Documentation of the following is required:
- diagnosis of relapsed or refractory multiple myeloma; and
- prescriber is a hematologist or oncologist; and
- appropriate dosing (member's weight must be provided); and
- member is ≥ 18 years of age on treatment date; and
- inadequate response or adverse reaction to four lines of systemic therapies or contraindication to all other lines of systemic therapies; and
- member’s disease is refractory to at least one proteasome inhibitor or has a contraindication to all proteasome inhibitors; and
- member’s disease is refractory to at least one immunomodulatory agent or has a contraindication to all immunomodulatory agents; and
- member’s disease is refractory to at least one anti-CD38 monoclonal antibody or has a contraindication to all anti-CD38 monoclonal antibodies; and
- administration will take place in a health care facility that has been certified pursuant to the REMS program specific to the treatment being provided.
Epkinly
- Documentation of the following is required for the diagnosis of DLBCL:
- diagnosis of one of the following:
- relapsed or refractory DLBCL, NOS; or
- relapsed or refractory DLBCL arising from indolent lymphoma; or
- relapsed or refractory DLBCL arising from high-grade B-cell lymphoma; and
- prescriber is a hematologist or oncologist; and
- appropriate dosing; and
- member is ≥ 18 years of age; and
- member has received at least two lines of systemic therapies, including at least one anti-CD20 monoclonal antibody; and
- inadequate response, adverse reaction, or contraindication to Columvi.
- diagnosis of one of the following:
- Documentation of the following is required for a diagnosis of relapsed or refractory FL:
- appropriate diagnosis; and
- prescriber is a hematologist or oncologist; and appropriate dosing; and
- member is ≥ 18 years of age on treatment date; and
- inadequate response or adverse reaction to two lines of systemic therapies, including at least one anti-CD20 monoclonal antibody; and
- inadequate response, adverse reaction, or contraindication to Lunsumio.
Imdelltra
- Documentation of the following is required:
- diagnosis of extensive stage small cell lung cancer; and
- prescriber is an oncologist; and
- appropriate dosing; and
- inadequate response, adverse reaction, or contraindication to one platinum-based chemotherapy.
Kymriah
- Documentation of the following is required for a diagnosis of relapsed or refractory FL after two or more lines of systemic therapy, or diagnosis of relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), high grade B-cell lymphoma and DLBCL arising from FL:
- appropriate diagnosis; and
- prescriber is a hematologist or oncologist; and
- appropriate dosing (member's weight must be provided); and
- member is ≥ 18 years of age on treatment date; and
- inadequate response or adverse reaction to two lines of systemic therapies; and
- infusion will take place in a health care facility that has been certified pursuant to the REMS program specific to the treatment being provided.
- Documentation of the following is required for a diagnosis of B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse:
- appropriate diagnosis; and
- prescriber is a hematologist or oncologist; and
- appropriate dosing (member's weight must be provided); and
- member is < 26 years of age on treatment date; and
- infusion will take place in a health care facility that has been certified pursuant to the REMS program specific to the treatment being provided; and
- one of the following:
- all of the following:
- member has Philadelphia chromosome positive ALL; and
- member has refractory disease or ≥ two relapses; and
- inadequate response or adverse reaction to two tyrosine kinase inhibitors or contraindication to all tyrosine kinase inhibitors; or
- both of the following:
- member has Philadelphia chromosome negative ALL; and
- member has refractory disease or ≥ two relapses.
- all of the following:
Lunsumio
- Documentation of the following is required for relapsed or refractory FL:
- appropriate diagnosis; and
- prescriber is a hematologist or oncologist; and
- appropriate dosing; and
- member is ≥ 18 years of age on treatment date; and
- inadequate response or adverse reaction to two lines of systemic therapies including at least one anti-CD20 monoclonal antibody.
Tecartus
- Documentation of the following is required for relapsed or refractory MCL:
- appropriate diagnosis; and
- prescriber is a hematologist or oncologist; and
- appropriate dosing (member's weight must be provided); and
- member is ≥ 18 years of age on treatment date; and
- inadequate response or adverse reaction to one or contraindication to both of the following: anthracycline-containing chemotherapy, bendamustine-containing chemotherapy; and
- inadequate response or adverse reaction to one or contraindication to all of the following: Brukinsa, Calquence, Imbruvica; and
- infusion will take place in a health care facility that has been certified pursuant to the REMS program specific to the treatment being provided.
- Documentation of the following is required for relapsed or refractory B-cell precursor ALL:
- appropriate diagnosis; and
- prescriber is hematologist or oncologist; and
- appropriate dosing (member's weight must be provided); and
- member is ≥ 18 years of age on treatment date; and
- one of the following:
- member has primary refractory ALL; or
- member experienced a first relapse following a remission lasting ≤ 12 months; or
- member has relapsed or refractory ALL after second-line or higher therapy; or
- member has relapsed or refractory ALL at least 100 days after allogenic stem cell transplant; and
- infusion will take place in a health care facility that has been certified pursuant to the REMS program specific to the treatment being provided; and
- if the member has Philadelphia positive ALL, inadequate response, adverse reaction, or contraindication to one tyrosine kinase inhibitor.
Tecelra
- Documentation of the following is required for a diagnosis of unresectable or metastatic synovial sarcoma:
- appropriate diagnosis; and
- member is ≥ 18 years of age on treatment date; and
- prescriber is an oncologist; and
- documentation of HLA-A 02:01P, HLA-A 02:02P, HLA-A 02:03P, or HLA-A 02:06P positive tumor; and
- tumor expresses the MAGE-A4 antigen; and
- inadequate response or adverse reaction to one or contraindication to all prior chemotherapy; and
- appropriate dosing and treatment dates; and
- infusion will take place in a qualified treatment facility.
Yescarta
- Documentation of the following is required for a diagnosis of relapsed or refractory FL after two or more lines of systemic therapy, or a diagnosis of relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL, NOS, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from FL:
- appropriate diagnosis; and
- prescriber is a hematologist or oncologist; and
- appropriate dosing (member's weight must be provided); and
- member is ≥ 18 years of age on treatment date; and
- inadequate response or adverse reaction to two lines of systemic therapies; and
- infusion will take place in a health care facility that has been certified pursuant to the REMS program specific to the treatment being provided.
- Documentation of the following is required for a diagnosis of large B-cell lymphoma refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy:
- appropriate diagnosis; and
- prescriber is a hematologist or oncologist; and
- appropriate dosing (member's weight must be provided); and
- member is ≥ 18 years of age on treatment date; and
- inadequate response or adverse reaction to one line of systemic therapy; and
- one of the following:
- member has primary refractory disease; or
- member relapsed within 12 months of a completed first line chemoimmunotherapy regimen; and
- infusion will take place in a health care facility that has been certified pursuant to the REMS program specific to the treatment being provided.
Original Effective Date: 02/2018
Last Revised Date: 02/2025
Clinical Criteria Main Page | Back to top | Previous | Next
Last updated 03/24/25