CurrentCignaPolicy v031526

Patient information and prior authorization form for Enhertu (fam-trastuzumab deruxtecan-nxki)

This document is a patient information / prior authorization intake form used by Cigna to collect clinical and administrative information for requests of Enhertu; it affects prescribers, office staff, specialty pharmacies, and Cigna review teams processing authorization for this medication.

Policy Summary

PayerCigna

PolicyPatient information and prior authorization form for Enhertu

Policy CodePolicy v031526

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit the completed patient information form with all required fields, indication-specific clinical details, HER2 status, prior therapies, and preferred dispensing site (Accredo preferred) to initiate prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

20+document chunks/questions

7distinct indication sections

Accredopreferred specialty pharmacy

Fax & phonesubmission methods

Indication-specific Coverage Criteria

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Indication-specific data collection for coverage determination

Coverage assessment will require indication-specific clinical criteria; the form collects the following per-indication items which will be used to determine medical necessity:

Indication selection: Patient's diagnosis must be one of the listed tumor types (e.g., appendiceal adenocarcinoma, biliary tract cancer, bladder cancer, brain metastases in breast cancer, breast cancer, cervical carcinoma, colon cancer, endometrial carcinoma, gastric/GEJ adenocarcinoma, NSCLC, ovarian cancer, pancreatic adenocarcinoma, rectal cancer, salivary gland tumors, small bowel adenocarcinoma, solid tumors, vaginal cancer, vulvar cancer, other).

Form lists tumor types to select

HER2/HER2-mutation status: Documentation of HER2 status or HER2-mutation is required where indicated (e.g., HER2-positive IHC3+, HER2-amplified, HER2-low, or HER2-mutation depending on tumor type).

See per-indication sections for exact required test/result

Disease stage or setting: Form asks whether disease is unresectable, locally advanced, recurrent, or metastatic as applicable to the tumor type (e.g., unresectable/metastatic for solid tumors, metastatic/resected gross residual/unresectable for biliary tract).

Disease stage required for coverage decision

Prior therapy and step-therapy considerations: Prior systemic treatments or specific prior regimens are requested when relevant (examples: prior trastuzumab-based regimen for gastric/GEJ; prior fluoropyrimidine/oxaliplatin/irinotecan for appendiceal/colon; prior platinum and checkpoint inhibitor for bladder; prior anti-HER2 regimens in breast).

Prior therapy details influence line of therapy determination

Therapy intent and exclusivity: Sections ask whether the requested medication will be the only agent used for the diagnosis at this time and whether it is first-line, second-line, or subsequent therapy.

Indicates combination or single-agent use

Alternative options and eligibility: Form queries whether satisfactory alternative treatment options exist and whether the patient is eligible for or ineligible for certain therapies (e.g., checkpoint inhibitors for dMMR/MSI-H appendiceal disease, platinum/checkpoint for bladder).

Used to support medical necessity

Solid tumors

Solid tumors checklist: Patient has unresectable or metastatic disease; HER2-positive (IHC3+) solid tumor; documentation of prior systemic treatment status and whether satisfactory alternative treatment options exist.

Form asks these items for solid tumors

Biliary tract cancer

Biliary tract checklist: Requested medication will be the only agent used for this diagnosis at this time; intended as subsequent therapy; disease described (metastatic, resected gross residual R2, or unresectable); documented progression on or after systemic treatment; HER2-positive (IHC3+) status.

Form requires all items to be answered for biliary tract cancer

Bladder cancer

Bladder checklist: Requested medication will be the only agent used for this diagnosis at this time; HER2-positive (IHC3+) status; intended as second-line systemic therapy (if yes, prior first-line therapy containing both platinum chemotherapy and an immune checkpoint inhibitor including maintenance is required to be documented); if used as subsequent-line therapy, prior receipt of platinum and a checkpoint inhibitor or documented ineligibility for those agents must be provided.

Prior platinum and checkpoint inhibitor use or ineligibility is queried

Pancreatic adenocarcinoma

Pancreatic checklist: Requested medication will be the only agent used for this diagnosis at this time; HER2-positive (IHC3+) status; patient's performance status provided (PS 0–4); documentation of local recurrence in the pancreatic operative bed after resection or recurrent metastatic disease.

Performance status is captured on the form

Small bowel adenocarcinoma

Small bowel checklist: Requested medication will be the only agent used for this diagnosis at this time; intended as second-line or subsequent therapy; patient has advanced or metastatic disease; HER2-positive (IHC3+) status.

Form captures line of therapy and disease extent

Vulvar cancer

Vulvar checklist: Patient has advanced or recurrent/metastatic disease; requested medication will be the only agent used for this diagnosis at this time; intended as second-line or subsequent therapy; HER2-positive (IHC 3+ or 2+) status.

Form accepts IHC 2+ or 3+ for vulvar cancer

Vaginal cancer

Vaginal checklist: Requested medication will be the only agent used for this diagnosis at this time; intended as second-line or subsequent therapy; HER2-positive (IHC 3+ or 2+) status.

Form accepts IHC 2+ or 3+ for vaginal cancer

There are no explicit absolute exclusions listed on the intake form. Instead, authorization is determined by completion of the indication-specific clinical checklist items. Failure to document required clinical details—for example, the HER2 status specified for a given tumor type—would preclude approval even though the form does not present a separate exclusion list.

The coverage sections are organized around affirmative clinical criteria for each listed indication rather than enumerating negative exclusions. For each tumor type the form asks whether the disease meets required attributes (for example: unresectable or metastatic status, HER2 IHC or mutation status, prior systemic therapies, and whether Enhertu will be the sole agent used). These per-indication confirmations serve as the basis for medical necessity determinations.

Initial Therapy — Breast Cancer

Breast cancer initial therapy information

Breast cancer-specific initial therapy considerations captured on the form.

Line of therapy: Form asks whether Enhertu is being given as first-line or second-line therapy for stage IV breast cancer and whether rapid progression occurred within 6 months of neoadjuvant/adjuvant therapy.

Used to determine appropriateness for initial use

Prior anti-HER2 exposure: If not first-line or for certain breast settings the form asks if the patient has received two or more prior anti-HER2-based regimens and the setting of those prior regimens (metastatic vs neoadjuvant/adjuvant).

Guides eligibility for later-line use

HER2 classification details: Form records HER2 classification (HER2-positive IHC3+ or IHC2+ with ISH+, HER2-low, HER2-ultralow, HER2-negative) and asks additional questions based on HER2 subgroup (e.g., hormone receptor status for HER2-low/ultralow).

Specific HER2 categories are defined on the form

Documented Prior Therapy / Step Requirements

Requirement	Details / Form Questions
Prior specific systemic therapies
Form asks whether patient previously received fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy for appendiceal adenocarcinoma; asks if patient received two or more prior anti‑HER2–based regimens for breast cancer and requests the setting (metastatic vs neoadjuvant/adjuvant).

Requirement	Details / Form Questions
Prior platinum and checkpoint inhibitor exposure (or documented ineligibility)
For bladder cancer the form queries whether first‑line therapy included both platinum chemotherapy and an immune checkpoint inhibitor (including maintenance) when requested as second‑line; for subsequent‑line use the form asks whether the patient already received both agents or is ineligible for them.

Submission, Documentation, and Denial Risks

Prior Authorization

Prior authorization submission — requirements

Submit a completed patient information form including all required (asterisked) fields, medication dosing, and facility/dispensing information. Incomplete required patient or prescriber information may prevent authorization and delay processing.

Complete all asterisked (*) fields on the form
Include medication requested, dose, frequency, and duration
Provide facility/dispensing and specialty pharmacy selection

Prior Authorization

Indication-specific prior authorization questions

Indication-specific prior authorization questions must be completed to confirm diagnosis details, HER2 status (including IHC/ISH details where applicable), disease stage (unresectable or metastatic where required), and prior lines of systemic therapy. Requests missing these indication-specific details risk delay or denial.

Complete the question set specific to the patient's diagnosis (e.g., breast, biliary tract, bladder, pancreatic, small bowel, vulvar, vaginal, appendiceal, solid tumors)
Document HER2 testing results (IHC score and ISH if performed) and indicate HER2-positive vs HER2-low/ultralow/negative when asked
Confirm unresectable or metastatic disease status when applicable

Documentation Required

Required documentation — HER2 and prior therapies

Documentation should include HER2 IHC status (specify score: 3+, 2+, 1+, 0) and ISH results if performed, plus prior systemic treatments including agents, lines of therapy, and treatment setting (metastatic vs neoadjuvant/adjuvant).

HER2 IHC score and ISH result (if applicable)
List of prior systemic therapies with regimen names and setting (e.g., metastatic, adjuvant, neoadjuvant)
Performance status or other disease-specific performance details when requested

Documentation Required

Prior therapy documentation

Prior therapy documentation is required and the form asks about prior lines of therapy to support authorization — include prior trastuzumab or other anti-HER2 regimens, fluoropyrimidine/oxaliplatin/irinotecan where applicable, checkpoint inhibitors, and platinum-containing chemotherapy when relevant to the indication.

Specify prior anti-HER2 regimens and number of prior anti-HER2-based regimens
For gastrointestinal and appendiceal indications, document fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy history
Document prior systemic therapy dates and responses/progression

Prior Authorization

Bladder cancer prior therapy specifics

For bladder cancer, the form requires documentation that the requested medication will be used as second-line systemic therapy and confirmation that the patient received a first-line regimen containing both platinum chemotherapy and an immune checkpoint inhibitor (including maintenance), or documentation of ineligibility for platinum and a checkpoint inhibitor.

Confirm the medication is being used as second-line systemic therapy
Document prior first-line therapy that included both platinum and a checkpoint inhibitor (or document ineligibility)

Denial Risk

Denial risks — indication and documentation deficiencies

Requests may be denied if the patient does not have unresectable or metastatic disease where required, or if required HER2-positivity is not documented for indications that require it. For biliary tract cancer, denial may occur if the medication is being used in combination with other agents when not indicated, or if the disease is not metastatic/unresectable or lacks documented progression after systemic treatment.

Denial risk if patient lacks unresectable/metastatic disease when that is an indication requirement
Denial risk if HER2-positivity (IHC3+ or required ISH+) is not documented where required
Biliary tract cancer: denial risk if medication used with other agents contrary to directions, or if disease is not metastatic/unresectable or progression after systemic therapy is not documented

Note

Site of care and dispensing information

Where will the medication be obtained? Indicate Accredo specialty pharmacy (Cigna's nationally preferred specialty pharmacy), prescriber's office stock (medical claim), retail pharmacy, home infusion, or other source. Specialty pharmacy and dispensing details must be provided to complete prior authorization.

Select Accredo Specialty Pharmacy when applicable (contact details available on form)
Provide facility name, state, Tax ID, and address if provider will dispense
Indicate whether patient is a candidate for home infusion or if physician has in-office infusion

Key Definitions and Clinical Terms

inv-21: HER2-positive definition

DefinitionIHC score of 3+ OR IHC 2+ with ISH positive (as defined on the form).

Source contextUsed to classify breast cancer HER2-positive status on the form (IHC 3+ or IHC 2+ with ISH positive).

inv-22: HER2-low definition

DefinitionIHC score of 1+ OR IHC 2+ with ISH negative (as defined on the form).

Source contextListed on the breast cancer section to identify HER2-low expression (IHC 1+ or 2+ with ISH negative).

Clinical noteHER2-low is captured separately from HER2-positive and HER2-ultralow on the form for treatment classification.

inv-23: HER2-positive (alternate indications)

Primary definitionHER2 positivity indicated by IHC 3+.

Vulvar/vaginal noteVulvar and vaginal cancer sections accept HER2 2+ or 3+ as indicating HER2-positive status per the form.

Solid tumors contextSolid tumors section specifically queries HER2-positive (IHC3+) status for unresectable or metastatic disease.

inv-24: Performance Status (PS)

Performance status optionsPS 0, PS 1, PS 2, PS 3, PS 4 (patient selects one).

Use casePerformance status is requested for pancreatic adenocarcinoma determinations on the form.

Associated itemsForm also queries whether medication will be the only agent used and disease recurrence/metastatic status alongside PS.

Policy Background

Enhertu (fam-trastuzumab deruxtecan-nxki) is an anti-HER2 antibody-drug conjugate used across multiple HER2-expressing or HER2-mutant solid tumors. The intake form collects tumor type, HER2 expression or mutation status, prior systemic treatments, and disease stage to support authorization decisions.

Policy Summary

PayerCigna

PolicyPatient information and prior authorization form for Enhertu

Policy CodePolicy v031526

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

SourceLink

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