CurrentCommunity Health ChoicePolicy N/A

Prior Authorization Criteria for Imdelltra (tarlatamab-dlle)

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This policy governs Medicaid and CHIP prior authorization for Imdelltra (tarlatamab-dlle) in adults with extensive-stage small cell lung cancer whose disease progressed after platinum-based chemotherapy. It applies to covered dates of service on or after November 1, 2024, in Texas Medicaid managed care and fee-for-service programs.

Policy Summary

PayerCommunity Health Choice

PolicyPrior Authorization Criteria for Imdelltra (tarlatamab-dlle)

Policy CodePolicy N/A

Change TypeInitial issuance

Effective DateNovember 1, 2024

Next Review DateN/A

Key ActionObtain prior authorization before administering Imdelltra for Medicaid and CHIP dates of service on or after November 1, 2024.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+Minimum client age

C9170Prior authorization procedure code

2 monthsPregnancy prevention after infusion

3Safety monitoring domains

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CurrentCommunity Health ChoicePolicy N/A

Prior Authorization Criteria for Imdelltra (tarlatamab-dlle)

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Sign up for all communityhealthchoice policy alerts

Know when communityhealthchoice releases new policies or updates existing guidance.

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Policy Summary

PayerCommunity Health Choice

PolicyPrior Authorization Criteria for Imdelltra (tarlatamab-dlle)

Policy CodePolicy N/A

Change TypeInitial issuance

Effective DateNovember 1, 2024

Next Review DateN/A

Key ActionObtain prior authorization before administering Imdelltra for Medicaid and CHIP dates of service on or after November 1, 2024.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+Minimum client age

C9170Prior authorization procedure code

2 monthsPregnancy prevention after infusion

3Safety monitoring domains

Coverage Criteria

Initial Therapy Criteria

Covered when ALL of the following are met:

Initial therapy

The client is 18 years or older.Age >= 18 years
The client has a confirmed diagnosis of extensive-stage small cell lung cancer using one of the listed diagnosis codes.
The client has previously received platinum-based chemotherapy with cisplatin or carboplatin.
The client does not have a clinically significant active systemic infection.
The prescriber attests that female clients of childbearing age were counseled about the risk of embryo-fetal toxicity and pregnancy prevention during treatment and for two months after the last infusion, using an effective method of contraception.

Renewal or Continuation Therapy Criteria

Covered for renewal or continuation when ALL of the following are met:

Renewal or continuation therapy

The client continues to meet the initial-therapy requirements and has been treated with Imdelltra previously.
The client has experienced a positive clinical response to treatment, documented by stabilization of the disease and a decrease in tumor size or spread.
The client has not experienced unacceptable, clinically significant adverse reactions or toxicity, including severe cytopenia, hepatotoxicity, or neurotoxicity.No unacceptable clinically significant toxicity

Authorization is excluded when the client has a clinically significant active systemic infection.

Renewal or continuation is excluded when the client has experienced unacceptable clinically significant adverse reactions or toxicity, including severe cytopenia, hepatotoxicity, or neurotoxicity, during Imdelltra therapy.

Coding and Eligibility Details

Prior authorization procedure codeHCPCSCovered

C9170

Imdelltra procedure code

Diagnosis codes for confirmed ES-SCLCICD-10Covered

C3400	Confirmed extensive-stage small cell lung cancer diagnosis
C3401	Confirmed extensive-stage small cell lung cancer diagnosis
C3402	Confirmed extensive-stage small cell lung cancer diagnosis
C3410	Confirmed extensive-stage small cell lung cancer diagnosis
C3411	Confirmed extensive-stage small cell lung cancer diagnosis
C3412	Confirmed extensive-stage small cell lung cancer diagnosis
C342	Confirmed extensive-stage small cell lung cancer diagnosis
C3430	Confirmed extensive-stage small cell lung cancer diagnosis
C3431	Confirmed extensive-stage small cell lung cancer diagnosis
C3432	Confirmed extensive-stage small cell lung cancer diagnosis

1–10 of 16

1/2

Eligibility threshold

Minimum age18 years or older

Applies toClients seeking prior authorization for Imdelltra (tarlatamab-dlle)

Covered conditionExtensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy

Pregnancy prevention

Required prevention periodDuring treatment and for two months after the last infusion

Counseling requirementThe prescriber must attest that female clients of childbearing age were counseled about the risk of embryo-fetal toxicity

Authorization and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Imdelltra (tarlatamab-dlle; procedure code C9170) for Medicaid and CHIP clients for dates of service on or after November 1, 2024.

Imdelltra became a Medicaid and CHIP benefit on October 1, 2024.
Infusions must be administered by a qualified healthcare professional in a healthcare setting with appropriate medical support.

Documentation Required

Initial Authorization Documentation

For initial authorization, submit documentation confirming the client meets all applicable clinical requirements for Imdelltra treatment.

Client is 18 years or older.
Confirmed diagnosis of extensive-stage small cell lung cancer (ES-SCLC); applicable diagnosis codes: C3400, C3401, C3402, C3410, C3411, C3412, C342, C3430, C3431, C3432, C3480, C3481, C3482, C3490, C3491, or C3492.

Drug and Indication Background

Imdelltra (tarlatamab-dlle) is a bispecific delta-like ligand 3 (DLL3)-directed CD3 T-cell engager indicated for adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease has progressed on or after platinum-based chemotherapy. Infusion must be administered by a qualified healthcare professional in a healthcare setting with appropriate medical support.

Clinical Safety Definitions

Cytokine release syndrome (CRS)

TermCytokine release syndrome (CRS)

DefinitionA severe systemic inflammatory reaction

Monitoring relevanceProviders should monitor clients for signs and symptoms during Imdelltra treatment

Immune effector cell-associated neurotoxicity syndrome (ICANS)

TermImmune effector cell-associated neurotoxicity syndrome (ICANS)

DefinitionNeurologic toxicity associated with immune effector cell therapies

Monitoring relevance

Initial Therapy

Initial therapy is covered when ALL of the following requirements are met:

Initial therapy

The client is at least 18 years old.Age >= 18 years
The client has confirmed extensive-stage small cell lung cancer.
The client previously received platinum-based chemotherapy with cisplatin or carboplatin.
The client does not have a clinically significant active systemic infection.

Continuation Therapy

Renewal or continuation is covered when ALL of the following requirements are met:

Continuation therapy

The client continues to meet the initial requirements and has previously been treated with Imdelltra.
The client has a positive clinical response documented by disease stabilization and decreased tumor size or spread.
The client has no unacceptable, clinically significant adverse reactions or toxicity, including severe cytopenia, hepatotoxicity, or neurotoxicity.No unacceptable toxicity

Site of Care Requirement

Note

Administer the infusion in a supported setting

Imdelltra infusion must be administered by a qualified healthcare professional in a healthcare setting with appropriate medical support.

Use a qualified healthcare professional to administer the infusion.
Provide the infusion in a setting with appropriate medical support.

Policy Summary

PayerCommunity Health Choice

PolicyPrior Authorization Criteria for Imdelltra (tarlatamab-dlle)

Policy CodePolicy N/A

Change TypeInitial issuance

Effective DateNovember 1, 2024

Next Review DateN/A

Key ActionObtain prior authorization before administering Imdelltra for Medicaid and CHIP dates of service on or after November 1, 2024.

SourceLink

On This Page

Prevention methodAn effective method of contraception must be used to prevent pregnancy

Disease progression occurred on or after platinum-based chemotherapy, with prior treatment using cisplatin or carboplatin.

Client does not have a clinically significant active systemic infection.

Prescriber attests that female clients of childbearing age were counseled about embryo-fetal toxicity and the need to prevent pregnancy during treatment and for two months after the last infusion using effective contraception.

Documentation Required

Continuation Documentation

Requests to renew or continue Imdelltra require documentation that the client remains eligible and has received and benefited from prior treatment without unacceptable toxicity.

Client continues to meet the initial-therapy requirements and has been treated with Imdelltra in the past.
Positive clinical response is documented, including disease stabilization and a decrease in tumor size or spread.
Client has not experienced unacceptable, clinically significant adverse reactions or toxicity, including severe cytopenia, hepatotoxicity, or neurotoxicity.

Note

Required Treatment Monitoring

Monitor every client for serious treatment-related toxicity throughout therapy and complete required laboratory monitoring before each Imdelltra treatment.

Monitor for severe reactions, including cytokine release syndrome (CRS).
Monitor for neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS).
Monitor for cytopenias, including neutropenia, thrombocytopenia, and anemia; perform a complete blood count before each treatment.
Monitor for hepatotoxicity; assess liver enzymes and bilirubin before each treatment.

Denial Risk

Initial-Therapy Denial Conditions

Initial authorization may be denied when the client does not satisfy all required initial-therapy criteria or when the request lacks the required supporting documentation.

Client is younger than 18 years.
Diagnosis is not confirmed ES-SCLC or is not supported by an applicable diagnosis code.
Client has not previously received platinum-based chemotherapy with cisplatin or carboplatin.
Client has a clinically significant active systemic infection.
Required reproductive-risk counseling and contraception attestation are absent or incomplete.

Denial Risk

Continuation Denial Conditions

Renewal or continuation may be denied when ongoing eligibility, prior Imdelltra treatment, clinical benefit, or safety requirements are not demonstrated.

Client no longer meets the initial-therapy requirements or has not previously been treated with Imdelltra.
Documentation does not show positive clinical response, disease stabilization, or a decrease in tumor size or spread.
Client has experienced unacceptable, clinically significant adverse reactions or toxicity, including severe cytopenia, hepatotoxicity, or neurotoxicity.

Providers should monitor clients for neurologic toxicity during Imdelltra treatment

The prescriber attests that female clients of childbearing age received counseling regarding embryo-fetal toxicity and effective contraception during treatment and for two months after the last infusion.