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Table 75: T-Cell Immunotherapies


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Drug Category: Immunotherapies

Medication Class/Individual Agents: T-Cell Immunotherapies

I. Prior-Authorization Requirements

 T-Cell Immunotherapies - Bispecific Antibodies

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

elranatamab-bcmm Elrexfio PA   MB
epcoritamab-bysp Epkinly PA   MB
glofitamab-gxbm Columvi PA   MB
mosunetuzumab-axgb Lunsumio PA   MB
talquetamab-tgvs Talvey PA   MB
teclistamab-cqyv Tecvayli PA   MB

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.

CAR-T immunotherapy is unique; a patient’s own T cells are genetically modified ex vivo to activate the patient’s immune response and then reinfused back into the patient. These therapies have produced promising results in clinical trials, and thus far, the long-term durability of response is not known.

Given the risk of serious adverse reactions such as cytokine release syndrome (CRS) and neurological toxicities, these agents are administered by certified treatment centers.

MassHealth Drug Utilization Review will be reaching out to prescribers after infusion date to verify clinical effectiveness and for long-term monitoring of sustained response. For additional information regarding CAR-T immunotherapies, please see the Acute Hospital Carve-Out Drugs List found at www.mass.gov/druglist.

Epcoritamab-bysp is a T-cell engaging bispecific antibody indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS), including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy. This agent also has a black box warning for potential CRS and immune effector cell-associated neurotoxicity syndrome (ICANS). It should only be administered by a healthcare professional with immediate access to appropriate medical support, including supportive medications to manage these possible side effects.

Glofitamab-gxbm is a bispecific antibody that binds to CD20 expressed on the surface of B-cells, and to CD3 receptor expressed on the surface of T-cells. It is indicated for the treatment of adult patients with relapsed or refractory DLBCL, NOS or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy. Glofitamab-gxbm has a black box warning for potential CRS and thus should only be administered by a healthcare professional with immediate access to appropriate medical support, including supportive medications to manage severe CRS.

Teclistamab-cqyv is a subcutaneous “off-the-shelf” T-cell-redirecting, bispecific antibody that targets both B-cell maturation antigen (BCMA) and CD3. It is indicated for the treatment of adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory (IMiD) agent, and an anti-CD38 monoclonal antibody. It is approved with a REMS requiring that healthcare facilities that dispense the therapy must be specially certified to recognize and manage CRS and neurologic toxicities.

 

 T-Cell Immunotherapies - Chimeric Antigen Receptor (CAR)-T Immunotherapies

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

axicabtagene ciloleucel Yescarta PA   CO, MB
brexucabtagene autoleucel Tecartus PA   CO, MB
ciltacabtagene autoleucel Carvykti PA   CO, MB
idecabtagene vicleucel Abecma PA   CO, MB
lisocabtagene maraleucel Breyanzi PA   CO, MB
tisagenlecleucel Kymriah PA   CO, MB
Table Footnotes
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)
  • Relapsed or refractory B-cell precursor ALL (Tecartus)
  • Relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy (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)
  • 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 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 four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody (Abecma, Carvykti,  Elrexfio, Talvey, Tecvayli)

Note: The above list may not include all FDA-approved indications.

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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, Carvykti, 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.

 

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 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.

 

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.

    

Epkinly

  • Documentation of the following is required:
    • 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.

   

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.

 

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: ibrutinib, acalabrutinib, zanubrutinib; 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.

  

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: 05/2024


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Last updated 05/16/24

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