CurrentAetnaPolicy N/A

Trodelvy (sacituzumab govitecan-hziy) Medication Precertification Request - Coverage Criteria

Precertification/notification form used by Aetna for requests to initiate or continue treatment with Trodelvy for oncology indications; completed by providers seeking coverage authorization.

Policy Summary

PayerAetna

PolicyTrodelvy precertification request form (coverage criteria)

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit a completed precertification form with required patient, prescriber, diagnosis, product, prior therapy, and signatures to Aetna (phone/fax provided) to request authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2 pagesform length

Aetna Precertification Notificationcontact phone

1-888-267-3277fax number

breast, urothelial, otherindications on form

Coverage Criteria

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Indication and disease documentation: Provider documents the cancer type (e.g., breast cancer, urothelial carcinoma, other) and clinical setting (locally advanced, recurrent, metastatic, unresectable).

Form includes checkboxes for breast cancer subtypes, urothelial carcinoma, and free-text 'Other'

Triple-negative breast cancer confirmation: For triple-negative breast cancer, provider confirms tumor testing negative for ALL of the following receptors: A) HER2, B) estrogen receptor, and C) progesterone receptor.

Checkboxes provided for Yes/No/Unknown confirmation

Prior therapy documentation for TNBC: Has the patient received at least two prior therapies, with at least one line for metastatic disease?

Checkboxes for Yes/No; form collects specific prior agents/classes elsewhere

Prior therapy documentation for hormone receptor positive disease: Provider documents prior endocrine therapy and prior CDK4/6 inhibitor use and prior chemotherapy (at least two lines including a taxane with at least one in the metastatic setting) as applicable.

Checkboxes provided for each prior therapy class (endocrine therapy, CDK4/6 inhibitor, chemotherapy) and candidate status for fam-trastuzumab deruxtecan-nxki

Prior therapy documentation for urothelial and genitourinary cancers: Provider documents prior platinum-containing chemotherapy and prior PD-1 or PD-L1 inhibitor use as applicable.

Form lists examples of platinum agents and PD-1/PD-L1 agents with checkboxes

Single agent use: Provider indicates whether the requested drug will be used as a single agent (Yes/No).

Checkbox for single agent Yes/No appears on multiple indication sections

Clinical setting selection: Provider selects the clinical setting in which the drug will be used (first-line vs subsequent; locally advanced, recurrent, metastatic, unresectable, or other).

Form includes explicit checkboxes for place in therapy and clinical setting

Continuation criteria: For continuation requests, provider documents whether there is evidence of unacceptable toxicity or disease progression while on the current regimen.

Continuation section asks 'Is there evidence of unacceptable toxicity or disease progression?' with Yes/No checkboxes

Regimen choice	Dose (provider to supply)	Frequency (provider to supply)
Single agent (check if yes)
Combination regimen (specify agents)
Product requested: Trodelvy (sacituzumab govitecan-hziy)

Provider Actions & Submission Requirements

Prior Authorization

Precertification required

Precertification/notification to Aetna must be submitted using the Trodelvy Medication Precertification Request form; call Aetna Precertification Notification at 1-866-752-7021 (TTY: 711) or fax the form to 1-888-267-3277. For Medicare Advantage Part B patients, use the separate Medicare request form.

Call: 1-866-752-7021 (TTY: 711)
Fax: 1-888-267-3277
Medicare Advantage Part B: use Medicare request form

Step Therapy

Document prior therapies and place in therapy

Document prior lines of therapy on the form by checking the appropriate boxes and listing prior treatments — examples collected include prior chemotherapy (including taxane), endocrine therapy (e.g., anastrozole, letrozole, fulvestrant), CDK4/6 inhibitors (e.g., abemaciclib, palbociclib, ribociclib), platinum-containing chemotherapy (e.g., cisplatin, carboplatin), and PD-1/PD-L1 inhibitors (e.g., pembrolizumab, nivolumab, avelumab, atezolizumab).

Indicate number of prior lines (e.g., at least two prior therapies with ≥1 for metastatic disease for TNBC)
Check prior use of endocrine therapy and CDK4/6 inhibitors for HR+ disease
Check prior platinum and PD-1/PD-L1 inhibitor use for urothelial cancers

Documentation Required

Required documentation for precertification

Submit a fully completed and legible form including patient information, insurance information, prescriber information (including signature and date), dispensing provider and product details (dose and frequency), primary/secondary ICD codes, and all required clinical information for initiation or continuation requests.

Patient demographics and contact information
Insurance and member ID details
Prescriber name, credentials, NPI, phone/fax and signature/date
Product request: Trodelvy dose and frequency
Primary and secondary ICD diagnosis codes
Required clinical items (disease type, biomarkers, prior therapies, place in therapy, continuation details)

Denial Risk

Incomplete or inaccurate submission may lead to denial

Failure to provide complete and legible information or knowingly submitting materially false or concealed information may result in denial, requests for additional information, or fraud investigation.

Form must be complete and legible for precertification review
Materially false or concealed information may lead to denial and civil/criminal penalties

Biomarker Requirements

HER2, estrogen receptor, progesterone receptor — tumor testing negative for all three receptors

DefinitionTriple-negative breast cancer: breast cancer subtype defined by tumor testing negative for HER2, estrogen receptor, and progesterone receptor

Confirmation question on formForm asks: 'Does the patient have a diagnosis of triple-negative breast cancer confirmed by the breast cancer cells testing negative for ALL of the following receptors: A) HER2, B) estrogen, and C) progesterone?' with checkboxes Yes/No/Unknown

Related disease options on formForm lists other disease subtype options including 'The cancer cells are hormone receptor positive' and 'Other'

Use in clinical settingForm requests the clinical setting for use (Recurrent, Metastatic, Unresectable, Other)

Definitions

Breast cancer subtype defined by tumor testing negative for HER2, estrogen receptor, and progesterone receptor

TermTriple-negative breast cancer

Form selectionForm includes a checkbox item: 'Triple negative breast cancer' under tumor type

Diagnostic confirmation requiredForm requires confirmation that tumor tested negative for HER2, estrogen, and progesterone receptors with response options Yes/No/Unknown

Prior therapy promptForm asks if patient has received at least two prior therapies, with at least one line for metastatic disease

Single-agent questionForm asks whether the requested drug will be used as a single agent (Yes/No)

Background

Trodelvy (sacituzumab govitecan-hziy) is an antibodydrug conjugate for use in selected breast and urothelial cancers; this precertification form collects the clinical details needed to assess appropriateness for initiation or continuation. The form requires completion of disease type and setting (for example, recurrent, metastatic, or unresectable), tumor subtype (including confirmation that breast cancer is triple-negative by testing negative for HER2, estrogen, and progesterone receptors), documentation of prior therapies (for instance, whether the patient has received at least two prior therapies with at least one line for metastatic disease for TNBC or prior endocrine therapy/CDK4/6/chemotherapy where applicable), and whether Trodelvy will be used as a single agent. The acknowledgement section reminds providers that the plan may request additional information and that fraudulent submissions are prohibited.