Prior Authorization Criteria for Imdelltra Effective November 1, 2024

Date: October 16, 2024

Attention: All Providers

Prior authorization effective date: November 1, 2024

Call to action: The purpose of this communication is to inform providers that on October 1, 2024, Imdelltra became a benefit of Medicaid and CHIP. Health and Human Services commission (HHSC) will require prior authorization for Imdelltra (procedure code C9170) for Medicaid and CHIP, effective November 1, 2024.

Imdelltra (Tarlatamab-dlle) is a bispecific delta-like ligand 3 (DLL3)-directed CD3 T-cell engager indicated for the treatment of adult clients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.
Imdelltra (Tarlatamab-dlle) infusion MUST be administered by a qualified healthcare professional in a health care setting with appropriate medical support.

Criteria for Initial Approval:

• Patient is at least 18 years of age or older; AND
• Patient has a confirmed diagnosis of ES-SCLC (diagnosis code C3400, C3401, C3402, C3410, C3411, C3412, C342, C3430, C3431, C3432, C3480, C3481, C3482, C3490, C3491, or C3492); AND
• Patient has previously received platinum-based chemotherapy with either Cisplatin or Carboplatin; AND
• Patient does not have a clinically significant active systemic infection

Monitoring parameters:

• Providers should monitor the following
  • Cytokine release syndrome (CRS); AND
  • Neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS); AND
  • Cytopenia, including neutropenia, thrombocytopenia, and anemia; AND
  • Hepatoxicity. Providers should monitor liver enzymes and bilirubin before each Imdelltra treatment

Provider Attestation requirements:

• Providers should attest to counseling female clients of childbearing age regarding the risk of embryo-fetal toxicity and counseling to prevent pregnancy during the treatment period and two months after the last infusion of tarlatamab-dlle (Imdelltra) by using an effective method of contraception.

Criteria for Continuation of therapy:

• Patient has met all initial requirements for initial approval and is currently being treated with Imdelltra with no adverse reactions; AND
• Patient has experienced positive clinical response to the treatment as documented by ANY of the following
  • Stabilization of the disease; OR
  • Decrease in tumor size; OR
  • Decrease in tumor spread; AND
• Patient has not experienced any unacceptable clinically significant adverse events defined by ANY of the following
  • Severe cytopenia; OR
  • Hepatotoxicity; OR
  • Neurotoxicity

Next step for providers: Providers should refer to the Texas Medicaid Provider Procedures Manual (TMPPM), Outpatient Drug Services Handbook for more details on the clinical policy and prior authorization requirements.

Note: If request is for a non-FDA approved dose, indication, or age medical rational must be submitted in support of therapy (such as high-quality peer reviewed literature, acceptable compendia or evidence based practice guidelines) and exceptions will be considered on a case-by-case basis.

If and when there any updates or changes related to the coverage for Imdelltra, we will promptly communicate those changes to you.

If you have any questions, please email Provider Relations at:providerrelations@texaschildrens.org

For access to all provider alerts, log into: www.texaschildrenshealthplan.org/provideralerts