CurrentCignaPolicy v020126

Perjeta (pertuzumab) patient information and prior authorization form

This document is a Cigna patient information and prior authorization request form for Perjeta (pertuzumab) intravenous solution. It governs information collection and authorization submission details for providers requesting coverage for Perjeta across specified cancer indications.

Policy Summary

PayerCigna

PolicyPerjeta (pertuzumab) patient information and prior authorization form

Policy CodePolicy v020126

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionComplete the indication-specific clinical questions and required provider/facility identifiers and submit the completed form (fax: 855-840-1678 or via CoverMyMeds/SureScripts) to request prior authorization for Perjeta.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5 business daysstandard response time

30 MG/1 MLvial concentration

855-840-1678submission fax

Accredopreferred specialty pharmacy

Coverage Criteria for Perjeta (pertuzumab)

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Indication-specific clinical criteria

Coverage assessment is based on indication-specific criteria documented by the provider. The form collects the following conditional elements used to determine medical necessity:

Breast cancer (HER2+): For breast cancer, confirm human epidermal growth factor receptor 2 (HER2)-positive disease; specify whether use is neoadjuvant/adjuvant for >= T2 or >= N1 early stage or locally advanced disease or for recurrent/stage IV disease; if neoadjuvant/adjuvant, confirm Perjeta will be given in combination with trastuzumab AND either docetaxel or paclitaxel; document whether the patient has been previously treated for this diagnosis and if previously treated, indicate whether Perjeta will be used in combination with trastuzumab when prior therapy included chemotherapy and trastuzumab in the absence of prior Perjeta.

Form contains checkboxes for each conditional item.

Colorectal cancer (CRC): For CRC, document unresectable advanced or metastatic disease and HER2-amplified disease; indicate whether Perjeta will be given as subsequent therapy in combination with trastuzumab; confirm tumor is RAS wild-type and document prior HER2 inhibitor exposure and prior chemotherapy history including whether patient received oxaliplatin-based or irinotecan-based regimens as queried on the form.

Multiple conditional questions capture prior regimen exposures (oxaliplatin, irinotecan, FOLFOXIRI, fluoropyrimidines).

Appendiceal cancer: For appendiceal cancer, document HER2-amplified disease and that tumor is RAS and BRAF wild-type as requested; indicate whether Perjeta will be given as subsequent therapy in combination with trastuzumab and whether patient previously received a HER2 inhibitor.

Form contains specific yes/no items for appendiceal cancer.

Biliary tract cancer: For biliary tract cancer, indicate whether Perjeta will be given as subsequent therapy in combination with trastuzumab and confirm progression on or after systemic treatment for unresectable or gross residual (R2) disease or metastatic HER2-positive disease (IHC3+/ISH+/NGS amplification) as queried on the form.

Specific progression and HER2-status questions are on the form.

Salivary gland / head and neck cancer: For salivary gland or head and neck cancer, document planned combination with trastuzumab when applicable, confirm use as systemic therapy for HER2-positive recurrent disease with distant metastases when indicated, and document performance status (PS 0-3) per form items.

Form asks performance status and combination therapy questions.

Brain metastases in HER2-positive breast cancer: For brain metastases in HER2-positive breast cancer, indicate whether Perjeta will be given in combination with high-dose trastuzumab as treatment per the form.

Form includes a specific question about combination with high-dose trastuzumab.

Other indications: For all other indications, document the requested indication and provide HER2 status, prior therapies, and any other condition-specific information requested on the form to support medical necessity.

Form includes a checkbox for ‘All other indications or diagnoses’ and space for additional pertinent information.

Some Cigna plans require that infusion therapy be provided in the least intensive medically appropriate setting. The prior authorization form therefore asks whether the patient is a candidate for redirection to an alternate, less intensive site (for example, physician office or home infusion) and whether home infusion or an in‑office infusion site is available. Providers should document clinical rationale if redirection is not appropriate, because failure to consider alternate settings may affect authorization decisions.

The form also collects the intended administration site (home, physician office, hospital outpatient, or other) and asks whether the medication is for a chronic or long‑term condition. Include the site selection and any supporting medical necessity rationale when submitting the completed form to help the reviewer determine whether the requested setting meets plan requirements.

Provider Submission and Prior Authorization Requirements

Prior Authorization

Prior Authorization Required — Perjeta

Perjeta (pertuzumab) prior authorization is required. Completion of the indication-specific clinical questions on the Perjeta Prior Authorization form is required for prior authorization submission; include all requested clinical details to avoid processing delays.

Medication: Perjeta IV solution details and dosing/frequency/duration must be provided.
Answer indication-specific questions (breast, CRC, appendiceal, biliary, salivary gland/head & neck, brain metastases) and combination therapy fields (trastuzumab + taxane) as applicable.
Document whether therapy is first-line or previously treated; if previously treated, indicate prior therapies and whether Perjeta will be used in combination with trastuzumab without pertuzumab.

Documentation Required

Form Requires Line-of-Therapy and Combination Therapy Details

The form asks whether the requested therapy is first-line or for previously treated disease and asks specifically whether Perjeta will be used in combination with trastuzumab AND a taxane (docetaxel or paclitaxel) where applicable. Be sure to indicate prior treatments, line of therapy, and all combination agents.

Select first-line vs previously treated and provide prior treatment details when applicable.
For breast cancer, indicate neoadjuvant/adjuvant vs recurrent/stage IV and whether used with trastuzumab + docetaxel or paclitaxel.

Documentation Required

Provider and Patient Identification Required

Provide complete provider and patient identification on the form. Include physician/practice identifiers (DEA, NPI or TIN), office contact, phone and fax, facility dispensing/administration details (facility name, tax ID, address), patient demographics, and Cigna ID. Incomplete asterisked (*) items will prevent faxed communication of the review outcome.

Physician Name, Specialty, DEA/NPI/TIN, Office Contact, Phone, Fax, Office Address.
Patient Name, Cigna ID, DOB, Address, Phone.
Facility/administrator details: facility name, Tax ID, state, full address.

Denial Risk

Site-of-Care Rule — Use Least Intensive Appropriate Setting

Per some Cigna plans, infusion of medication must occur in the least intensive, medically appropriate setting. Consider site-of-care (home, physician office, outpatient) and document whether patient is a candidate for redirection or home infusion. Failure to consider or document site-of-care options may affect coverage.

Select intended administration site and indicate if patient is candidate for redirection to alternate setting.
Document whether physician has an in-office infusion site and whether patient is eligible for home infusion.
Note: Specialty Care Options Case Manager may assist with redirection to alternate infusion sites.

Initial Therapy Combination Requirements

Initial therapy combination requirements

Form asks whether therapy is first-line or beyond first-line and whether it will be used in combination with trastuzumab and a taxane.

First-line / Neoadjuvant–Adjuvant combination: If requested medication is first-line or is being used for neoadjuvant/adjuvant therapy for qualifying early-stage (>=T2 or >=N1) or locally advanced HER2-positive breast cancer, document Perjeta will be given in combination with trastuzumab AND either docetaxel or paclitaxel.

Checkboxes on form confirm combination regimen.

Previously treated / Subsequent-line combination: If requested medication is being used beyond first-line (previously treated for this diagnosis), indicate whether Perjeta will be used in combination with trastuzumab when prior therapy included chemotherapy and trastuzumab in the absence of prior Perjeta; for CRC, appendiceal, biliary tract and other non-breast indications, document whether Perjeta will be given as subsequent therapy in combination with trastuzumab and provide prior regimen history as requested.

Form documents prior exposure to trastuzumab and other HER2 inhibitors and specific chemotherapy regimens to support sequencing decisions.

Prior Therapies and Sequencing

Clinical item	Provider response
Breast cancer: HER2-positive disease confirmed	Yes / No (checkbox)
Breast cancer: Neoadjuvant/adjuvant use for ≥T2 or ≥N1 early-stage or locally advanced disease	Yes / No (checkbox)
If neoadjuvant/adjuvant: Will Perjeta be used with trastuzumab AND either docetaxel or paclitaxel	Yes / No (checkbox)
Breast cancer: Use for recurrent or stage IV disease	Yes / No (checkbox)
Breast cancer: Previously treated for this diagnosis (first-line vs beyond first-line)	Yes (beyond first-line) / No (first-line) (checkbox)
If previously treated: Will Perjeta be used with trastuzumab when previously treated with chemotherapy and trastuzumab in the absence of prior Perjeta	Yes / No (checkbox)
Colorectal cancer (CRC): Will Perjeta be given as subsequent therapy in combination with trastuzumab	Yes / No (checkbox)
CRC: Unresectable advanced or metastatic cancer	Yes / No (checkbox)
CRC: HER2-amplified disease	Yes / No (checkbox)
CRC: Tumor RAS wild-type status	Yes / No (checkbox)
CRC: Prior treatment with a HER2 inhibitor before starting requested medication	Yes / No (checkbox)
CRC: Prior oxaliplatin-based therapy without irinotecan	Yes / No (checkbox)
If no (to prior oxaliplatin without irinotecan): Prior irinotecan-based therapy without oxaliplatin	Yes / No (checkbox)
If no (to prior irinotecan-based without oxaliplatin): Prior FOLFOXIRI regimen	Yes / No (checkbox)
If no (to prior FOLFOXIRI): Prior fluoropyrimidine without irinotecan or oxaliplatin	Yes / No (checkbox)
Appendiceal cancer: HER2-amplified disease	Yes / No (checkbox)
Appendiceal cancer: Tumor RAS and BRAF wild-type	Yes / No (checkbox)
Appendiceal cancer: Will Perjeta be given as subsequent therapy in combination with trastuzumab	Yes / No (checkbox)
Appendiceal cancer: Prior treatment with a HER2 inhibitor before starting requested medication	Yes / No (checkbox)
Biliary tract cancer: Will Perjeta be given as subsequent therapy in combination with trastuzumab	Yes / No (checkbox)
Biliary tract cancer: Progression on or after systemic treatment for unresectable R2 or metastatic disease that is HER2-positive (IHC3+/ISH+/NGS amplification)	Yes / No (checkbox)
Brain metastases in HER2-positive breast cancer: Will Perjeta be given with high-dose trastuzumab as treatment	Yes / No (checkbox)
Salivary gland/head & neck cancer: Will Perjeta be used in combination with trastuzumab	Yes / No (checkbox)
Salivary gland/head & neck cancer: Use as systemic therapy for HER2-positive recurrent disease with distant metastases	Yes / No (checkbox)

Background on Perjeta

Perjeta (pertuzumab) is an anti‑HER2 monoclonal antibody used to target HER2‑positive tumors. On the prior authorization form, Perjeta is requested predominantly in combination with trastuzumab and a taxane (commonly docetaxel or paclitaxel) for HER2‑positive breast cancer across neoadjuvant, adjuvant, and metastatic settings. The form captures HER2 status, line of therapy (first‑line vs previously treated), intended combination regimen, and dosing/frequency to verify indication‑appropriate use.

The form also supports other HER2‑amplified indications (for example colorectal, biliary tract, appendiceal, salivary gland/head & neck cancers, and brain metastases from HER2‑positive breast cancer) by collecting tumor HER2 amplification/status, prior therapies, performance status where applicable, and whether Perjeta will be given in combination with trastuzumab. These clinical details are used to determine medical necessity and appropriate sequencing of Perjeta within systemic therapy.

OpenPayer

Perjeta (pertuzumab) patient information and prior authorization form

Coverage Criteria for Perjeta (pertuzumab)

Drug Presentation and Coding

Provider Submission and Prior Authorization Requirements

Initial Therapy Combination Requirements

Prior Therapies and Sequencing

Acquisition Source and Administration Site

Key Definitions

Background on Perjeta