CurrentCignaPolicy v061623

Trodelvy (sacituzumab govitecan-hziy) prior authorization

Prior authorization form and requirements for coverage of Trodelvy (sacituzumab govitecan-hziy) for oncology indications (breast cancer, urothelial cancer, other) for Cigna members. Affects prescribing clinicians and facilities submitting authorization requests.

Policy Summary

PayerCigna

PolicyTrodelvy (sacituzumab govitecan-hziy) prior authorization

Policy CodePolicy v061623

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit a completed prior authorization form (including patient/provider identifiers, diagnosis, disease stage, prior therapies, and dosing) by fax to (855) 840-1678 or online for review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5 business daysstandard response time for prescription drug coverage requests

Trodelvy 180mgmedication listed on form

(855) 840-1678fax number to submit completed form

(800) 882-4462phone number for urgent requests

Coverage Criteria

Authorization criteria

Coverage assessed based on all applicable clinical questions completed on form

General requirements: Form must include patient and provider identifiers, diagnosis, requested drug, dose/frequency/duration, and supporting clinical information (disease stage, prior therapy, performance status, concurrent agents)

Documented via form fields

Indication-specific pathways: For breast cancer: either metastatic triple-negative breast cancer (mTNBC) OR HR+, HER2- disease with unresectable locally advanced or metastatic disease and prior therapies as specified; For urothelial cancer: locally advanced or metastatic disease with prior platinum-containing chemotherapy and prior PD-1/PD-L1 inhibitor

Answered in checkbox questions

Breast cancer — HR+, HER2- pathway: Patient has HR+, HER2- breast cancer; disease is unresectable locally advanced or metastatic; patient has received endocrine-based therapy AND two or more additional systemic therapies in the metastatic setting

Policy Summary

PayerCigna

PolicyTrodelvy (sacituzumab govitecan-hziy) prior authorization

Policy CodePolicy v061623

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit a completed prior authorization form (including patient/provider identifiers, diagnosis, disease stage, prior therapies, and dosing) by fax to (855) 840-1678 or online for review.

SourceLink

On This Page

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Form asks these specific items

Breast cancer — mTNBC pathway: Patient has metastatic triple-negative breast cancer (mTNBC); patient has received two or more prior therapies for this metastatic disease

Form asks these specific items

Urothelial cancer pathway: Patient has locally advanced or metastatic urothelial cancer; patient previously received a platinum-containing chemotherapy (eg, carboplatin or cisplatin); patient previously received a PD-1 or PD-L1 inhibitor

Form asks these specific items

The form does not list specific, standalone exclusions; however, several questions are used to establish eligibility and may functionally exclude patients who do not meet them. For example, the form requires documentation of disease subtype and extent (e.g., metastatic triple-negative breast cancer, HR+, HER2- with unresectable locally advanced or metastatic disease, or locally advanced/metastatic urothelial cancer) and prior therapy history (e.g., two or more prior therapies for mTNBC; endocrine-based therapy plus TWO or more additional systemic therapies for HR+, HER2- disease; prior platinum and prior PD-1/PD-L1 therapy for urothelial cancer). Absence of these required disease stage or prior-therapy elements on the submitted form may effectively result in a determination that treatment is not authorized.

The form indicates that treatment may be considered not medically necessary when the patient does not meet the prescribed prior-therapy or disease-extent criteria captured on the form. Examples include lack of documentation that an mTNBC patient has received TWO or more prior therapies for metastatic disease, or that an HR+, HER2- patient has received endocrine-based therapy plus TWO or more additional systemic therapies in the metastatic setting, or missing prior platinum and PD-1/PD-L1 exposure for urothelial cancer.

Requested Drug / Coding

Requested drugmixedCovered

Trodelvy 180mg

Trodelvy 180mg powder for injection (sacituzumab govitecan)

Provider Actions & Submission Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Trodelvy (sacituzumab govitecan-hziy). Submit the completed prior authorization form by fax to the number on the form or online via CoverMyMeds (www.covermymeds.com) or through SureScripts in your EHR. Include all required patient and provider identifiers and contact details to avoid delays.

Submit online: www.covermymeds.com/main/prior-authorization-forms/cigna/
Submit via SureScripts in EHR
Office fax: (use fax number on form)
Standard response time: 5 business days; call to expedite urgent requests

Step Therapy

Prior Therapy Requirements

The prior authorization form must include documentation of prior systemic therapies as applicable to the indication. For metastatic triple-negative breast cancer (mTNBC) and other metastatic indications, indicate the number and names of prior therapies; for HR+, HER2- breast cancer document endocrine-based therapy plus TWO or more additional systemic therapies in the metastatic setting where applicable.

mTNBC: documentation that the patient has received TWO or more prior therapies for metastatic disease
HR+, HER2- breast cancer: prior endocrine-based therapy AND TWO or more additional systemic therapies in the metastatic setting
Urothelial cancer: prior platinum-containing chemotherapy (e.g., carboplatin or cisplatin) and prior PD-1/PD-L1 inhibitor when applicable

Documentation Required

Required Documentation on Form

Ensure the PA form contains all required documentation fields. Missing or incomplete items may result in denial or delayed review. Complete all starred (*) items and provide diagnosis, disease stage, prior therapies, performance status, dosing, and provider/patient identifiers.

Patient identifiers: Cigna ID, name, date of birth, address, phone
Provider identifiers: Physician name, specialty, DEA/NPI/TIN, office contact, phone, fax
Clinical data: diagnosis (ICD-10), disease subtype (mTNBC, HR+/HER2-, urothelial), metastatic or unresectable status, disease stage
Therapy details: names, dates, doses, frequency, duration, and concurrent agents
Performance status and other pertinent clinical information

Denial Risk

Missing or Unmet Clinical Criteria — Denial Risk

Missing answers to key clinical questions or failure to meet clinical criteria (disease subtype, metastatic/unresectable status, required number/type of prior therapies, prior platinum or PD-1/PD-L1 therapy where applicable) creates a denial risk. Verify all indication-specific questions are answered and supporting notes are included.

If indication-specific questions (e.g., mTNBC, HR+/HER2-, urothelial) are incomplete, the request may be denied
If prior therapy requirements are not met or not documented, the request may be denied
If metastatic or unresectable status is not documented where required, the request may be denied

Definitions

mTNBC definition and form question

DefinitionMetastatic triple-negative breast cancer (mTNBC) — breast cancer that is metastatic and lacks hormone receptors (ER/PR) and HER2 overexpression; the form asks whether the patient has mTNBC (Yes/No).

mTNBC prior therapy requirementHas the patient received TWO or more therapies previously for this metastatic disease? (Yes/No) — affirmative required for authorization pathway for mTNBC.

Related breast cancer branchIf not mTNBC, form asks if patient has HR-positive, HER2-negative disease and, if so, whether disease is unresectable locally advanced or metastatic and if the patient received endocrine-based therapy plus TWO or more additional systemic therapies in the metastatic setting.

Use on formQuestion appears under Clinical Information: checkbox for mTNBC (Yes/No) and follow-up questions about prior therapies for metastatic disease.

Implication for coverageResponses inform indication-specific authorization: meeting the mTNBC prior-line requirement is necessary for the mTNBC pathway; failure to meet or document this may result in denial or determination of not medically necessary.

Initial Therapy Criteria

Initial therapy requirements

Initial authorization depends on the selected indication and documentation of prior lines of therapy as specified on the form

Initial authorization: Submit indication (breast cancer subtype or urothelial cancer), confirm disease extent (unresectable locally advanced or metastatic where applicable), and document prior lines of therapy as specified on the form

Form fields collect these data

Breast cancer options: Determine which breast cancer pathway applies (mTNBC OR HR+, HER2-); then confirm corresponding prior therapy requirements

Checked on form

If HR+, HER2-: Patient has HR+, HER2- breast cancer AND disease is unresectable locally advanced or metastatic AND patient has received endocrine-based therapy AND two or more additional systemic therapies in the metastatic setting

Form question: unresectable/metastatic and prior therapies

If mTNBC: Patient has metastatic triple-negative breast cancer AND patient has received two or more prior therapies for this metastatic disease

Form question: mTNBC and prior therapies

If urothelial cancer: Patient has locally advanced or metastatic urothelial cancer AND patient has previously received a platinum-containing chemotherapy AND patient has previously received a PD-1 or PD-L1 inhibitor

Form questions: disease extent, prior platinum, prior PD-1/PD-L1

Step Therapy / Prior Lines Requirements

Prior therapy requirement	Details
Breast cancer — HR+, HER2-	Patient must have unresectable locally advanced or metastatic disease and have received endocrine-based therapy plus TWO or more additional systemic therapies in the metastatic setting (checkbox on form).
Breast cancer — metastatic triple‑negative (mTNBC)	Patient must have received TWO or more prior therapies for this metastatic disease (checkbox on form).
Urothelial cancer	Patient must have locally advanced or metastatic disease and prior receipt of a platinum‑containing chemotherapy and a PD‑1 or PD‑L1 inhibitor (each captured by checkboxes on form).

Site of Care

Note

Specify site of care and facility/dispensing details

Indicate where the medication will be obtained and provide facility and/or prescriber dispensing details: select from biologics, prescriber's office stock, retail pharmacy, home health/home infusion, or other, and include facility name, tax ID, address and whether the medication is for chronic/long-term use.

Site options: Biologics; Prescriber's office stock (medical claim); Retail pharmacy; Home Health/Home Infusion; Other
Provide facility name, state, tax ID#, full address, and specify if medication is for chronic/long-term use

Background

Trodelvy (sacituzumab govitecan-hziy) is captured on the form for use in selected advanced cancers. The form collects the indication (breast cancer, urothelial cancer, or other), disease subtype (including metastatic triple-negative breast cancer (mTNBC) and HR+, HER2- breast cancer), and disease extent (unresectable locally advanced or metastatic disease where applicable). It also requires prior-therapy history relevant to each indication — for example, confirmation of TWO or more prior therapies for mTNBC and specific prior therapies for urothelial cancer — to assess appropriateness for Trodelvy.