CurrentAetnaPolicy N/A

Imdelltra (tarlatamab-dlle) Medication Precertification Request / Coverage Criteria

Precertification request form and required clinical information for coverage consideration of Imdelltra (tarlatamab-dlle) for patients (including Aetna members) being considered for initiation or continuation of therapy, primarily for extensive-stage small cell lung cancer.

Policy Summary

PayerAetna

PolicyImdelltra (tarlatamab-dlle) precertification request / coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionComplete and submit the precertification form with documentation of prior platinum‑based chemotherapy progression for initiation or evidence of treatment tolerance/no progression for continuation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1page(s) in form

ES-SCLCprimary indication

precert requiredprocess

Aetnapayer

Coverage Criteria for Imdelltra (tarlatamab-dlle)

Initial and Continuation Therapy

Covered when ALL of the following are met (information required on form):

Initiation criteria: Patient has extensive-stage small cell lung cancer (ES-SCLC).

Document ES-SCLC on the precertification form (clinical information section).

Initiation criteria: Patient has experienced disease progression on or after platinum-based chemotherapy.

Form requires answering whether disease progression occurred on or after platinum-based chemotherapy (Yes/No).

Continuation criteria: For continuation requests, there is no evidence of unacceptable toxicity while on the current regimen.

Form contains checkbox to indicate unacceptable toxicity; clinical documentation required if present.

Policy Summary

PayerAetna

PolicyImdelltra (tarlatamab-dlle) precertification request / coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

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Continuation criteria: For continuation requests, there is no evidence of disease progression while on the current regimen.

Form contains checkbox to indicate disease progression; clinical documentation required if present.

The precertification form is specific to treatment of extensive-stage small cell lung cancer (ES-SCLC). The form lists ES-SCLC as the diagnosis for which Imdelltra (tarlatamab-dlle) is being requested and does not include any other indications or explicit exclusions on the form itself.

The form requires documentation relevant to prior therapy when submitting a request. For initiation requests the requester must indicate whether the patient has experienced disease progression on or after platinum-based chemotherapy (checkbox for Yes/No). For continuation requests the form requires documentation addressing whether there is evidence of unacceptable toxicity or disease progression while on the current regimen (checkbox for Yes/No).

Initial Therapy

Initiation requests require prior therapy information.

Initiation: Diagnosis of extensive-stage small cell lung cancer (ES-SCLC) documented on the form.

Clinical information section requests ES-SCLC diagnosis for initiation requests.

Initiation: Documentation that the patient experienced disease progression on or after platinum-based chemotherapy.

Form asks: 'Has the patient experienced disease progression on or after platinum-based chemotherapy?' with Yes/No checkbox; selection and supporting documentation required.

Continuation Therapy

Continuation requests must document current treatment tolerance and disease status.

Continuation: Documentation that there is no evidence of unacceptable toxicity while on the current regimen.

Form asks: 'Is there evidence of unacceptable toxicity or disease progression while on the current regimen?' with Yes/No checkbox; clinical documentation of toxicity (or its absence) required.

Continuation: Documentation that there is no evidence of disease progression while on the current regimen.

Form requires the responder to indicate presence or absence of disease progression; supporting clinical notes/imaging required if progression is indicated.

Coding — Procedure and Diagnosis Codes

Administration CPT codes (form placeholder)CPT

Administration code(s) (CPT):

Place to list administration CPT codes as applicable on the form

Diagnosis ICD codes (form fields)ICD-10

Primary ICD Code:	Primary diagnosis ICD code (to be provided by requester)
Secondary ICD Code:	Secondary diagnosis ICD code (to be provided)
Other ICD Code:	Other applicable ICD codes

Provider Actions & Submission Requirements

Prior Authorization

Prior Authorization Required

Precertification is required for Imdelltra (tarlatamab-dlle). The precertification form must clearly indicate whether the request is for the start of treatment (include planned start date) or for continuation of therapy (include date of last treatment).

Mark request type: Start of treatment or Continuation of therapy
Include start date for initiation requests; include date of last treatment for continuation requests

Documentation Required

Prior Chemotherapy Documentation

For initiation requests, the form must document whether the patient has experienced disease progression on or after platinum-based chemotherapy. The precertification request should include prior-line chemotherapy details to demonstrate that progression occurred on/after platinum-based therapy.

Question on form: "Has the patient experienced disease progression on or after platinum-based chemotherapy?" — must be answered
Provide prior chemotherapy regimen(s), dates, and response/progression information

Documentation Required

Required Documentation to Submit

Submit a complete and legible precertification request including patient demographics, insurance information (Aetna member ID, group number, other coverage IDs), prescriber details (name, specialty, NPI, license), dispensing/provider administration details (place of administration, pharmacy or infusion center, NPI/TIN), and product information (Imdelltra dose and frequency). For initiation requests include diagnosis (ICD code) and required clinical documentation; for continuation requests include evidence regarding toxicity or disease progression while on current regimen.

Patient demographics: name, DOB, contact, weight/height, allergies
Insurance: Aetna Member ID, group #, other coverage and IDs, Medicare/Medicaid if applicable
Prescriber: name, license, NPI, specialty, contact info
Dispensing/administration: site of care, pharmacy/center name, NPI/TIN, administration CPT codes if applicable
Product: Imdelltra dose and frequency; primary ICD code and other codes as applicable
Clinical: for initiation — diagnosis ES-SCLC and prior chemotherapy/progression documentation; for continuation — date of last treatment and evidence of toxicity or progression

Denial Risk

Potential Denial or Fraud Risk

Aetna may request additional information or clarification to evaluate precertification requests. Knowingly filing materially false or incomplete information to obtain coverage is fraudulent and may result in denial and civil or criminal penalties.

Aetna may request supporting records if needed
False statements or concealment of material information is a fraudulent insurance act

Background

Background: This precertification request targets use of Imdelltra (tarlatamab-dlle) in patients with ES-SCLC. Initiation requests must document prior-line therapy status specifically indicating progression on or after platinum-based chemotherapy. Continuation requests must document current treatment tolerance and disease status, confirming absence of unacceptable toxicity or disease progression to support ongoing coverage consideration.

Definitions

ES-SCLC — definition/key term

TermExtensive-stage small cell lung cancer (ES-SCLC)

Context in formListed as the primary indication for Imdelltra (tarlatamab-dlle) precertification requests.

Initiation requirementFor initiation requests, documentation that the patient has experienced disease progression on or after platinum-based chemotherapy is required.

Continuation requirementFor continuation requests, documentation that there is no evidence of unacceptable toxicity or disease progression while on the current regimen is required.

Form actionClinical information section must be completed in its entirety for all precertification requests referencing ES-SCLC.

Step Therapy / Prior Treatment Requirements

Step	Requirement	Notes
1	Documentation that the patient has experienced disease progression on or after platinum-based chemotherapy	Form asks: 'Has the patient experienced disease progression on or after platinum-based chemotherapy?' with Yes/No checkbox; required for initiation requests

Place of Administration

Note

Specify place of administration (site of care)

Specify the place of administration on the form; available options include self-administered, physician's office, outpatient infusion center, or home infusion center.

Check the appropriate place of administration box on the form.
Provide facility/center name and phone as requested when selecting outpatient or home infusion options.