| Coverage Policy Manual | |
| Policy #: | 2024070 |
| Category: | Pharmacy |
| Initiated: | October 2024 |
| Last Review: | October 2024 |
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| Tarlatamab-dlle (e.g., Imdelltra) | |
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| Description: |
Tarlatamab (e.g., Imdelltra) is a bispecific T-cell engaging (BiTE) monoclonal antibody. BiTE molecules consist of 2 single-chain variable fragment (scFv) binding domains joined by a flexible peptide linker, one which always targets CD3 on T-cells, and the other can be modified to target any surface antigen. For tarlatamab, the modifiable scFv binding domain targets delta-like protein 3 (DLL3) which is expressed on the surface of small cell lung cancer (SCLC) cells, but not on normal lung tissue. The linking of DLL3 on SCLC cells with the CD3 receptor on T-cells via the BiTE molecule causes T-cell activation, release of inflammatory cytokines, and cell lysis independent of normal CD3/major histocompatibility complex (MHC) recognition. Tarlatamab (e.g., Imdelltra) is indicated for the treatment of extensive stage SCLC with disease progression on or after platinum-based chemotherapy. Tarlatamab has a black box warning for cytokine release syndrome and neurotoxicity, both of which can be life-threatening.
Regulatory Status
Tarlatamab-dlle (e.g., Imdelltra) was approved by the U.S. Food and Drug Administration (FDA) on May 16, 2024, for the treatment of adult individuals with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. This accelerated approval may be contingent upon verification of clinical benefit in a confirmatory trial.
Coding
See CPT/HCPCS Code section below.
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Policy/ Coverage: |
For members of plans that utilize an oncology benefits management program, Prior Approval is required for this service when rendered for oncologic indications and is managed through the oncology benefits management program.
The Step Therapy Medication Act is applicable to fully insured (Arkansas Blue Cross, Health Advantage, and Exchange) and specified governmental (ASE/PSE and ASP) health plans. The law is not applicable to FEP or self-insured ERISA groups (including but not limited to Walmart or other Blue Advantage groups). Initial approval for exigent request is 28 days. Otherwise, initial approval for standard review is up to 1 year.
Effective February 12, 2025
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Tarlatamab-dlle (e.g., Imdelltra) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes when ALL the following criteria are met:
INITIAL APPROVAL STANDARD REVIEW for up to 6 months:
CONTINUED APPROVAL for up to 12 months:
Off-label
The use of this drug is covered if an FDA-approved oncologic indication exists (not listed as an indication above) with the member meeting all the additional requirements of the prescribing information (package insert listed in the “Indications and Usage”) AND/OR a NCCN category 1 or 2A recommendation is recognized in the NCCN Drugs and Biologics Compendium with the member meeting specified criteria (See policy #2000030).
Policy Guidelines
The ECOG or Eastern Cooperative Oncology Group Performance Status is based on the following scale:
Dosage and Administration
Dosing per FDA Guidelines where applicable.
For off-label indications, authorizations will not exceed 10 mg every 28 days OR maximum recommended doses as outlined below unless medical literature supports a higher dose.
The recommended dose of tarlatamab-dlle (e.g., Imdelltra) is loading dose regimen of 1 mg on day 1 of first cycle, followed by 10 mg on days 8 and 15 of the first cycle. Starting at cycle 2, tarlatamab-dlle (e.g., Imdelltra) is given at dose 10 mg on days 1 and 15, every 28 days until disease progression or unacceptable toxicity.
Tarlatamab-dlle (e.g., Imdelltra) is available as a 1 mg powder for solution vial and 10 mg powder for solution vial.
Tarlatamab-dlle (e.g., Imdelltra) should be administered as an intravenous infusion by a healthcare professional.
Please refer to separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Tarlatamab-dlle (e.g., Imdelltra), for any indication or circumstance not described above, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, tarlatamab-dlle (e.g., Imdelltra), for any indication or circumstance not described above, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective October 23, 2024 through February 11, 2025
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Tarlatamab-dlle (e.g., Imdelltra) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes when ALL the following criteria are met:
INITIAL APPROVAL STANDARD REVIEW for up to 6 months:
CONTINUED APPROVAL for up to 12 months:
Off-label
The use of this drug is covered if an FDA-approved oncologic indication exists (not listed as an indication above) with the member meeting all the additional requirements of the prescribing information (package insert listed in the “Indications and Usage”) AND/OR a NCCN category 1 or 2A recommendation is recognized in the NCCN Drugs and Biologics Compendium with the member meeting specified criteria (See policy #2000030).
Policy Guidelines
The ECOG or Eastern Cooperative Oncology Group Performance Status is based on the following scale:
Dosage and Administration
Dosing per FDA Guidelines where applicable.
For off-label indications, authorizations will not exceed 10 mg every 28 days OR maximum recommended doses as outlined below unless medical literature supports a higher dose.
The recommended dose of tarlatamab-dlle (e.g., Imdelltra) is loading dose regimen of 1 mg on day 1 of first cycle, followed by 10 mg on days 8 and 15 of the first cycle. Starting at cycle 2, tarlatamab-dlle (e.g., Imdelltra) is given every 28 days until disease progression or unacceptable toxicity.
Tarlatamab-dlle (e.g., Imdelltra) is available as a 1 mg powder for solution vial and 10 mg powder for solution vial.
Tarlatamab-dlle (e.g., Imdelltra) should be administered as an intravenous infusion by a healthcare professional.
Please refer to separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Tarlatamab-dlle (e.g., Imdelltra), for any indication or circumstance not described above, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, tarlatamab-dlle (e.g., Imdelltra), for any indication or circumstance not described above, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
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| Rationale: |
The efficacy of tarlatamab was evaluated in Study DeLLphi-301 [NCT05060016], an open-label, multicenter, multi-cohort clinical trial. Eligible individuals were required to have relapsed/refractory SCLC with disease progression after receiving previous treatment with platinum-based chemotherapy and at least one other line of prior therapy, an ECOG Performance Status of 0 or 1, and at least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) The trial excluded individuals with symptomatic brain metastases, evidence of interstitial lung disease or noninfectious pneumonitis, and active immunodeficiency.
A total of 99 individuals received IMDELLTRA intravenously at an initial dose of 1 mg on Cycle 1 Day 1 followed by 10 mg on Days 8, 15, and every 2 weeks thereafter until disease progression or unacceptable toxicity. The study population characteristics were median age 64 years (range: 35 to 82); 48% of individuals ≥65 years and 10% of individuals ≥75 years; 72% male; 58% White, 41% Asian; 1% Hispanic or Latino; and 74% have ECOG 1. Ninety-seven percent of individuals had metastatic disease at baseline; 22% had brain metastases at baseline; and 92% were former/current smokers. All individuals received prior platinum-based chemotherapy (median two lines); 74% received prior anti-PD-(L)1 therapy (including 59% who received anti-PD[L]1 therapy in combination with platinum-based chemotherapy in the frontline setting); 51% received prior topoisomerase I inhibitor (including 20% who received topotecan). Platinum sensitivity status, defined by time to progression after first line platinum therapy, was known for 69/99 individuals. Twenty-seven individuals (27%) had platinum-resistant SCLC, defined as time to progression < 90 days after first line platinum therapy, while 42 individuals (42%) had platinum-sensitive SCLC. Tumor assessments were performed every 6 weeks for the first 48 weeks and every 12 weeks thereafter. The major efficacy outcome measures were overall response rate (ORR) and duration of response (DOR) as evaluated by Blinded Independent Central Review (BICR) according to RECIST v1.1. Of the 69 individuals with available data regarding platinum sensitivity status, the ORR was 52% (95% CI 32, 71) in 27 individuals with platinum-resistant SCLC and 31% (95% CI 18, 47) in 42 individuals with platinum-sensitive SCLC.
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| CPT/HCPCS: | |
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Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
CPT Codes Copyright © 2025 American Medical Association. |
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