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    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsKansas DH&E Prior Auth — Tecelra Coverage | OpenPa…
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    CurrentKansas Department of Health and EnvironmentPolicy N/A

    Criteria for Prior Authorization — T-Cell Receptor (TCR) Immunotherapy Agents (afamitresgene autoleucel/Tecelra)

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    Defines prior authorization requirements for TCR immunotherapy agents (specifically afamitresgene autoleucel/Tecelra) for payers and providers; governs coverage criteria, required diagnostics, dosing limits, and approval duration.

    Policy Summary
    PayerKansas Department of Health and Environment
    PolicyPrior authorization criteria for TCR immunotherapy agents (afamitresgene autoleucel/Tecelra)
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionObtain prior authorization and document FDA‑approved indication, age, MAGE‑A4 tumor expression, HLA‑A*02:01/02:02/02:03/02:06 positivity, prior systemic therapy for synovial sarcoma, and dosing within Table 1 limits.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    1agent detailed
    3 monthsinitial approval
    1infusions allowed
    ≥18

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    min age
    10 x10^9dose

    Coverage Criteria

    Initial Prior Authorization (afamitresgene autoleucel)

    Covered when ALL of the following are met

    General and agent-specific criteria: Must be approved for the indication, age, weight (if applicable), and not exceed dosing limits listed in Table 1; preferred PDL drug required if applicable unless the patient meets non-preferred PDL prior authorization criteria; for afamitresgene autoleucel specifically, patient has received prior systemic therapy for treatment of synovial sarcoma; patient is HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive; tumor expresses MAGE-A4 as determined by an FDA-approved or cleared companion diagnostic; follow package insert for indications/doses not explicitly in PA criteria.

    Length of initial approval: 3 months; approval limited to 1 infusion per lifetime; reauthorization is not permitted.

    Reauthorization is not permitted for afamitresgene autoleucel (Tecelra). Coverage is limited to 1 infusion per lifetime; initial approval duration is 3 months and no subsequent reauthorizations will be approved.

    Coding and Dosage

    Covered/Referenced Codesmixed
    No codes listed
    inv-04: Dose per infusion — 10 x 10^9 MAGE-A4 T cells
    Dose per infusion10 x 10^9 MAGE-A4 T cells (single IV infusion)
    Administration routeIntravenous (single IV infusion)
    Per-infusion dose formAutologous MAGE-A4 T cell product
    inv-05: Minimum age — >= 18 years
    Minimum age>= 18 years
    PopulationAdults with unresectable or metastatic synovial sarcoma
    Age sourceTable 1 — FDA‑approved age and dosing limits

    Provider Actions and Requirements

    Prior Authorization

    Prior authorization required

    Prior authorization is required for all current and future dose forms of TCR immunotherapy agents; afamitresgene autoleucel (Tecelra) requires meeting the agent-specific criteria in Table 1 plus the general PA criteria.

    • All medication-specific criteria including drug-specific indication, age, and dose in Table 1 must be met.
    • Package insert information will be used to review requests for indications/doses not explicitly listed in the PA criteria.
    Step Therapy

    Preferred PDL drug required when applicable

    When a preferred PDL drug exists that treats the PA indication, the preferred PDL agent is required unless the patient meets the non-preferred PDL prior authorization criteria.

    Background

    Afamitresgene autoleucel (Tecelra) is a MAGE‑A4–directed T‑cell receptor (TCR) autologous cell therapy indicated under accelerated approval for adults with unresectable or metastatic synovial sarcoma. The FDA‑approved indication is based on overall response rate and durability of response; confirmatory trials are ongoing. Coverage requires that the tumor expresses MAGE‑A4 as determined by an FDA‑approved or cleared companion diagnostic and that the patient is positive for an eligible HLA‑A*02 allele (HLA‑A*02:01P, A*02:02P, A*02:03P, or A*02:06P).

    Definitions

    inv-11: MAGE-A4 — Melanoma-associated antigen A4; tumor expression must be determined by an FDA-approved or cleared companion diagnostic.
    TermMAGE-A4 (melanoma-associated antigen A4)
    Diagnostic requirementTumor expression must be determined by an FDA‑approved or cleared companion diagnostic device
    Reference for testsInformation on FDA‑approved tests available at http://www.fda.gov/CompanionDiagnostics
    inv-12: Afamitresgene autoleucel (Tecelra) — A MAGE-A4 directed T-cell receptor (TCR) autologous cell therapy administered as a single IV infusion containing 10 x 10^9 MAGE-A4 T cell...
    AgentAfamitresgene autoleucel (Tecelra)
    DescriptionA MAGE-A4–directed T‑cell receptor (TCR) autologous cell therapy administered as a single IV infusion containing 10 x 10^9 MAGE-A4 T cells

    Initial Therapy Criteria

    Initial therapy (Tecelra)

    Initial dosing and eligibility

    Initial therapy for Tecelra: Single IV infusion of 10 x 10^9 MAGE-A4 T cells for patients ≥ 18 years with unresectable or metastatic synovial sarcoma who are MAGE-A4 positive and HLA-A*02:01, -A*02:02, -A*02:03, or -A*02:06 positive and have received prior systemic therapy; must not exceed dosing limits in Table 1.10 x 10^9 cells; >= 18 years

    Dose and age per Table 1; tumor MAGE-A4 expression must be determined by an FDA-approved/cleared companion diagnostic.

    Continuation / Reauthorization Criteria

    Reauthorization

    Reauthorization rules

    Reauthorization is not permitted for afamitresgene autoleucel; approval is limited to one infusion per lifetime with an initial approval duration of 3 months.1 infusion per lifetime; initial approval: 3 months

    Step Therapy

    StepRequirement
    1Preferred PDL drug treating the prior authorization indication is required when applicable unless the patient meets the non-preferred PDL prior authorization criteria.

    Quantity Limits

    inv-16: afamitresgene autoleucel (Tecelra) — 1
    Quantity limit1 infusion per lifetime
    Initial approval durationInitial length of approval: 3 months
    ReauthorizationReauthorization is not permitted
    Policy Summary
    PayerKansas Department of Health and Environment
    PolicyPrior authorization criteria for TCR immunotherapy agents (afamitresgene autoleucel/Tecelra)
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionObtain prior authorization and document FDA‑approved indication, age, MAGE‑A4 tumor expression, HLA‑A*02:01/02:02/02:03/02:06 positivity, prior systemic therapy for synovial sarcoma, and dosing within Table 1 limits.
    SourceLink
    On This Page
    Coverage CriteriaCoding and DosageProvider Actions and RequirementsBackgroundDefinitionsInitial Therapy CriteriaContinuation / Reauthorization CriteriaStep TherapyQuantity Limits
    Documentation Required

    Document indication, age, dosing, prior therapy, HLA and MAGE‑A4 results

    Provider must document the FDA‑approved indication, patient age, and that the dose does not exceed the limits listed in Table 1; for afamitresgene autoleucel specifically, document prior systemic therapy for synovial sarcoma, HLA-A*02:01, -A*02:02, -A*02:03, or -A*02:06 positive result, and tumor MAGE-A4 expression as determined by an FDA‑approved or cleared companion diagnostic.

    • Dose per infusion: 10 x 10^9 MAGE-A4 T cells (single IV infusion).
    • Minimum age: ≥ 18 years.
    • Initial approval length: 3 months; reauthorization is not permitted; approval limited to 1 infusion per lifetime.
    Denial Risk

    Denial will be issued if listed criteria are not met

    Failure to meet any required general or agent-specific criteria will trigger denial — including indication, minimum age, dosing limits in Table 1, required use of a preferred PDL agent (unless non-preferred PA criteria are met), prior systemic therapy for synovial sarcoma (for Tecelra), HLA-A*02:01/02:02/02:03/02:06 positivity, or tumor MAGE‑A4 expression determined by an FDA‑approved/cleared companion diagnostic.

    • Reauthorization is not permitted; requests for additional infusions beyond the single approved infusion per lifetime will be denied.
    • Requests that exceed Table 1 dosing limits or do not meet minimum age will be denied.
    Indication (table)Unresectable or metastatic synovial sarcoma (adults)