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

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

axicabtagene ciloleucel Yescarta CO ^ PA  
tisagenlecleucel Kymriah CO ^ PA  

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.

 
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.
 
^ This drug is available through the health care professional who administers the drug. MassHealth does not pay for this drug to be dispensed through a retail pharmacy.
 

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 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 follicular lymphoma (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)

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

Back to top


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.
  • 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 the member’s condition and requested medication (see below).

 

Kymriah

  • 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 diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), high grade B-cell lymphoma and DLBCL arising from follicular lymphoma (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 had ≥ two lines of systemic therapies; and
    • infusion will take place in a health care facility that has been certified pursuant to the Risk Evaluation and Mitigation Strategy (REMS) program specific to the treatment being provided; and
    • infusion will take place in an inpatient setting.
  • 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
    • a letter from the prescriber’s hospital financial department addressing participation status in the manufacturer’s outcomes-based contract; 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
    • infusion will take place in an inpatient setting; 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.

 

Yescarta

  • Documentation of the following is required:
    • 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; 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 had ≥ 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; and
    • infusion will take place in an inpatient setting.


Original Effective Date: 02/2018

Last Revised Date: 08/2019


Clinical Criteria Main Page | Back to topPrevious  |  Next

Last updated 08/29/19