Table 75: Chimeric Antigen Receptor (CAR)-T 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: Chimeric Antigen Receptor (CAR)-T Immunotherapies
I. Prior-Authorization Requirements
Chimeric Antigen Receptor (CAR)-T Immunotherapies |
Clinical Notes |
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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 and neurological toxicities, these agents are administered by certified treatment centers. MassHealth Drug Utilization Review will be reaching out to prescribers approximately 30 days after the CAR-T infusion date to verify clinical effectiveness and at ongoing intervals 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. |
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, prior authorization does not apply through the hospital outpatient and inpatient settings. Please refer to 130 CMR 433.408 for prior authorization 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 prior authorization 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, Yescarta)
- 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 (Kymriah)
- 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 (Yescarta)
- Large B-cell lymphoma refractory to first line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy (Yescarta)
- 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 (Breyanzi)
- 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 (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)
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 and Carvykti
- Documentation of the following is required:
- diagnosis of 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; 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
- member has failed ≥ four 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
- infusion 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
- member has failed ≥ 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
- member has failed ≥ 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.
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
- member has failed ≥ 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
- member failed two 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:
Tecartus
- Documentation of the following is required for relapsed or refractory MCL:
- 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, adverse reaction, or contraindication to anthracycline- or bendamustine-containing chemotherapy; and
- inadequate response, adverse reaction, or contraindication to ibrutinib, acalabrutinib or 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:
- 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
- member has failed ≥ 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
- member has failed ≥ 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: 04/2023
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Last updated 04/13/23