CurrentCignaPolicy N/A

Herceptin Hylecta (trastuzumab; hyaluronidase) prior authorization

Cigna prior authorization form and requirements for coverage of Herceptin Hylecta (trastuzumab; hyaluronidase) for patients with HER2-positive breast cancer, detailing clinical questions, site-of-care and dispensing options. Affects prescribers and facilities requesting coverage from Cigna.

Policy Summary

PayerCigna

PolicyHerceptin Hylecta (trastuzumab; hyaluronidase) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed prior authorization form including patient and prescriber identifiers, diagnosis and HER2 status, dosing and duration, and documentation of prior trial/contraindication/intolerance to listed IV trastuzumab biosimilars when subcutaneous use is requested due to inability to obtain or maintain IV access.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2-4 daysstandard response time for prescription drug coverage requests

(800) 882-4462phone for URGENT prior authorization requests

Accredopreferred specialty pharmacy

(855) 840-1678fax to submit completed form

Coverage Criteria

Policy Summary

PayerCigna

PolicyHerceptin Hylecta (trastuzumab; hyaluronidase) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

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Authorization criteria

Coverage is considered when requested for HER2-overexpressing breast cancer with supporting clinical details; provider must attest to required items.

Core authorization requirements: Provider submits completed form with required identifiers, diagnosis (ICD-10), confirmation of HER2-overexpressing disease, treatment intent (metastatic vs adjuvant), planned dose/quantity/duration, and prior therapy history.

See form fields under 'Medication Requested' and 'Clinical Information' for required items.

If subcutaneous route requested because IV access cannot be obtained/maintained: Provider documents trial, contraindication, or intolerance to at least one listed IV trastuzumab biosimilar (Kanjinti, Ogivri, or Trazimera).

Field on form asks for documentation when IV access is the issue.

Metastatic-use specifics: If metastatic disease, indicate whether used in combination with paclitaxel (Abraxane) for first-line treatment, whether the requested medication will be the only agent used at this time, and document prior chemotherapy regimens for metastatic disease.

Form includes metastatic-specific questions.

Adjuvant-use specifics: If adjuvant use, document node status (positive/negative/unknown), ER/PR status and tumor size/grade when applicable, and whether the medication will be used as part of specified regimens (anthracycline → taxane or docetaxel+carboplatin).

Form contains detailed adjuvant pathway questions.

The PA form does not list specific clinical exclusions for Herceptin Hylecta. However, providers should be aware that some Cigna plans permit site-of-care redirection: the form states that, for certain plans, infusion "MUST occur in the lowest cost, medically appropriate setting." Facilities and prescribers should document setting details on the form and be prepared to justify the chosen site or provide a medical necessity rationale if redirection is queried or recommended.

The form does not enumerate explicit not medically necessary (NMN) conditions. It does, however, note that infusion services may be subject to plan-level site-of-care rules requiring administration in the lowest cost, medically appropriate setting. Providers should expect review for setting appropriateness and potential redirection; indicate on the form whether the infusion is in a hospital outpatient–affiliated facility and, if so, whether the patient is a candidate for redirection or a medical necessity rationale is provided.

Initial Therapy

Initial therapy

Initial authorization requires documentation of diagnosis, HER2 status, treatment intent, and prior therapies where applicable.

Initial therapy requirements: For new starts, provide diagnosis (including ICD-10), confirm HER2-overexpressing disease, specify metastatic vs adjuvant intent, and supply planned dosing/quantity/duration and start date.

Form fields under 'Medication Requested' and 'Clinical Information' capture these elements.

When subcutaneous administration is requested due to inability to obtain/maintain IV access: Document a trial, contraindication, or intolerance to at least one IV trastuzumab biosimilar (Kanjinti, Ogivri, or Trazimera).

Question appears on the form for new starts with IV access issues.

Regimen and disease-specific documentation: If metastatic: indicate combination with paclitaxel (Abraxane) for first-line or single-agent use and prior metastatic chemotherapy exposure. If adjuvant: provide node status, ER/PR details, tumor size/grade where prompted, and select applicable adjuvant regimen option.

See metastatic- and adjuvant-specific items in Clinical Information.

Provider Actions & Submission Requirements

Documentation Required

Required clinical and administrative information

Prior authorization is required for Herceptin Hylecta. The completed prior authorization (PA) form must include required patient and prescriber identifiers, diagnosis (ICD-10), medication name/dose/quantity, duration of therapy, start date, and site-of-care information. Provide documentation of relevant clinical details (disease stage, prior therapies, performance status) and prescriber attestation/signature.

Required patient identifiers: Cigna ID, patient name, date of birth, patient address, patient phone.
Required prescriber identifiers: Physician name, specialty, DEA/NPI/TIN, office contact, office phone and fax, office address.
Medication details: medication requested (Herceptin Hylecta), directions for use, ICD-10 diagnosis code, dose, quantity, duration of therapy, start date, new start vs continuation.
Clinical details: disease stage, prior therapy (including names/doses/schedules), performance status, HER2 status and metastatic/adjuvant use when applicable.
Administrative: site where medication will be obtained and administered, facility name/address/tax ID if applicable, and whether infusion is in a hospital outpatient setting.

Step Therapy

Step/switch considerations for IV biosimilars

If the patient is unable to obtain or maintain IV access and subcutaneous trastuzumab (Herceptin Hylecta) is being requested, the PA form asks whether the patient has had a trial of, contraindication to, or intolerance of IV trastuzumab biosimilars. Document whether a trial, contraindication, or intolerance exists to one of the IV trastuzumab biosimilars (e.g., Kanjinti, Ogivri, Trazimera) when applicable.

Document response to: "Is the patient unable to obtain or maintain intravenous (IV) access?"
If yes, provide documentation of trial, contraindication, or intolerance to IV trastuzumab/biosimilars (Kanjinti, Ogivri, Trazimera) as indicated on the form.

Prior Authorization

Prior Authorization Required

Prior authorization is required for Herceptin Hylecta; include prior trial, contraindication, or intolerance details for IV products when applicable. Ensure the PA includes the completed attestation and prescriber signature. Submit requests online at https://cigna.promptpa.com or fax to (855) 840-1678; urgent requests may be called to (800) 244-6224.

PA submission methods: online (Cigna PromptPA), fax, or phone for urgent requests.
Include attestation: prescriber signature and date.
Form completion: answer whether medication will be obtained from Accredo Specialty Pharmacy, prescriber's office stock, retail pharmacy, or home infusion vendor.

Denial Risk

Site-of-care redirection risk

Infusion may be redirected to the lowest cost medically appropriate setting per plan terms. If infusion is occurring in a hospital outpatient setting, indicate whether the patient is a candidate for redirection (e.g., ambulatory infusion site, home) and provide medical necessity rationale if redirection is not appropriate.

Document whether infusion is in a facility affiliated with a hospital outpatient setting.
If yes, document whether candidate for re-direction to an alternate setting (AIS, MDO, home) and provide rationale if not a candidate.
Failure to consider site-of-care redirection may affect coverage or payment.

Required documentation	Notes
Attestation that patient is unable to obtain or maintain intravenous (IV) access
If subcutaneous (SC) route requested because IV access is unavailable: documentation of trial, contraindication, or intolerance to at least one listed IV trastuzumab biosimilar (Kanjinti, Ogivri, or Trazimera)

Biosimilar / Formulation Considerations

Note

Document inability to maintain IV access and prior IV biosimilar trial

When subcutaneous Herceptin Hylecta is requested because IV access cannot be obtained/maintained, the form requires documentation of a trial, contraindication, or intolerance to an IV trastuzumab biosimilar to support the SC route.

Note

Provide biosimilar trial/contraindication/intolerance details for SC use

Document trial, contraindication, or intolerance to at least one listed IV trastuzumab biosimilar (Kanjinti, Ogivri, or Trazimera) when requesting subcutaneous Herceptin Hylecta due to inability to obtain/maintain IV access; the form includes a specific field for this information.

Documentation Required

Attach supporting documentation for SC administration rationale

If requesting subcutaneous administration for Herceptin Hylecta because IV access is not possible, include the specific documentation on the PA form showing trial, contraindication, or intolerance to listed IV trastuzumab biosimilars as justification for SC route.

Definitions

Herceptin Hylecta — key definition

Drug nameHerceptin Hylecta (trastuzumab; hyaluronidase)

Formulation / routeTrastuzumab combined with hyaluronidase for subcutaneous administration

Typical presentation on formHerceptin Hylecta 600 mg-10,000 unit/5 mL vial (option listed on medication request)

Drug classHER2-targeted monoclonal antibody (trastuzumab) with hyaluronidase enabling subcutaneous delivery

Intent captured on formUsed for HER2-overexpressing breast cancer in metastatic or adjuvant settings (form collects regimen and prior therapy details)

HER2-overexpressing disease — definition & provider attestation

DefinitionBreast cancer that overexpresses HER2 (human epidermal growth factor receptor 2)

Provider confirmation requiredForm asks: 'Does the patient have HER2-overexpressing disease?' with Yes/No response required to confirm appropriateness of trastuzumab therapy

Clinical context requestedForm also queries metastatic vs adjuvant intent and related regimen details when breast cancer is indicated

Use in metastatic diseaseIf metastatic, form asks whether Herceptin Hylecta will be used with paclitaxel (Abraxane) or as sole agent and about prior chemotherapy regimens

OpenPayer

Herceptin Hylecta (trastuzumab; hyaluronidase) prior authorization

Coverage Criteria

Initial Therapy

Continuation Therapy

Provider Actions & Submission Requirements

Site of Care & Dispensing Options

Coding & Specialty Pharmacy Identifiers

Step Therapy / Supporting Documentation

Biosimilar / Formulation Considerations

Definitions

Background