CurrentmhnPolicy CP.PHAR.227

Pertuzumab (Perjeta), Pertuzumab-dpzb (Poherdy)

Defines medical necessity criteria, approved indications (FDA and selected NCCN off-label uses), initial and continuation approval rules, dosing, duration limits, age and prescriber requirements, contraindications/boxed warnings, and coding implications for pertuzumab and its biosimilar across Commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyPertuzumab (Perjeta), Pertuzumab-dpzb (Poherdy)

Policy CodePolicy CP.PHAR.227

Change TypeMaterial revisions and additions (2021–2025)

Effective DateJun 1, 2016

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) supporting that member meets all approval criteria; prior authorization may be required.

POLICY UPDATE CHANGES

2Q 2021: Added requirement for BRAF wild-type disease for off-label colorectal cancer and added salivary gland tumor indication per NCCN; references updated.

2Q 2022: Clarified pertuzumab must be prescribed with trastuzumab and docetaxel or chemotherapy; template changes applied.

2Q 2023: Added option for Perjeta without taxanes for patients previously treated with chemotherapy and trastuzumab; changed docetaxel to taxane-containing chemotherapy; removed requirement for no prior HER2 inhibitor in colorectal cancer; added unresectable/metastatic gallbladder cancer and cholangiocarcinoma to NCCN uses.

2Q 2024: For gallbladder cancer and cholangiocarcinoma, added option for treatment with resected gross residual (R2) disease and added residual tumor classification to Appendix D.

2Q 2025: Continued therapy: added maximum duration for neoadjuvant/adjuvant breast cancer (1 year up to 18 cycles); updated commercial approval duration language; added biosimilar Poherdy to policy.

3FDA Approved Indications (listed)

3NCCN Off-label Indications Supported

Coverage Summary & Indications

Pertuzumab (Perjeta) and its biosimilar pertuzumab-dpzb (Poherdy) are HER2 receptor antagonists used in combination with trastuzumab and chemotherapy for HER2-positive breast cancers and selected NCCN-recommended off-label indications. Dosing follows the prescribing information and NCCN guidance with an initial dose of 840 mg followed by 420 mg every 3 weeks, and neoadjuvant/adjuvant courses continued to complete 1 year (up to 18 cycles) as indicated. Product is supplied as a 420 mg/14 mL single-dose vial. Coverage stance: covered_with_criteria.

Prior Authorization, Documentation & Billing Requirements

Prior Authorization

Prior authorization required / documentation submission

Providers must submit documentation such as office chart notes, laboratory results, or other clinical information demonstrating the member meets all approval criteria. Prior authorization may be required for use in combination with trastuzumab and for certain lines of business.

J9306

Documentation Required

Genomic testing requirement for colorectal cancer indication

For advanced/metastatic colorectal cancer indication, documentation must demonstrate HER2-positive status, wild-type RAS defined as KRAS and NRAS mutation-negative (as determined by an FDA‑approved test for this use), and BRAF mutation‑negative status.

Billing Rule

Dose and regimen compliance

The prescribed regimen must be FDA‑approved or recommended by NCCN. Dose increases must not exceed 420 mg every 3 weeks unless the new dose is supported by practice guidelines or peer‑reviewed literature and the prescriber submits supporting evidence.

J9306

Prior Authorization

Approval duration limits

Initial approval duration is 6 months. Continued therapy approval duration differs by line of business: Medicaid and HIM approvals are for 12 months; Commercial approvals are for 6 months or to the member's renewal date, whichever is longer.

Scope applies to Commercial, HIM, and Medicaid lines of business. The policy defines medical necessity criteria and approved indications (FDA-approved and selected NCCN off-label uses), initial and continuation approval rules, dosing and duration limits, age and prescriber requirements, contraindications/boxed warnings, and coding implications for pertuzumab and its biosimilar.

Applicable Codes

HCPCS - Drug J-codeHCPCSCovered

J9306

Injection, pertuzumab, 1 mg

Evidence & References

Evidence referenced includes: Perjeta Prescribing Information (Genentech PI February 2021; accessed January 13, 2025), Poherdy Prescribing Information (Organon November 2025; accessed November 19, 2025), and NCCN Guidelines (Breast Cancer Version 6.2024). Dosing and duration follow the PI and NCCN guidance.

Background & Definitions

Pertuzumab and biosimilar pertuzumab-dpzb are HER2 receptor antagonists indicated with trastuzumab and chemotherapy for HER2-positive breast cancers and selected NCCN off-label uses. The product is available as a 420 mg/14 mL single-dose vial.

Term	Definition
{"text":"R2","status":""},{"text":"Resected gross residual disease (macroscopic residual tumor).","status":""}
{"text":"HER2-positive","status":""},{"text":"Human epidermal growth factor receptor 2 protein overexpression or gene amplification.","status":""}
{"text":"Wild-type RAS","status":""},{"text":"KRAS and NRAS mutation-negative.","status":""}

Key thresholds

Age minimum>= 18 years

Initial dosingInitial dose: 840 mg IV, then maintenance 420 mg IV every 3 weeks

Neoadjuvant/adjuvant maximum durationTotal of 1 year treatment (up to 18 cycles)

Revision Timeline

02.05.212Q2021 annual review

Added requirement for BRAF wild-type disease for off-label colorectal cancer per NCCN; added NCCN compendium-supported indication of salivary gland tumors and combined with colorectal cancer criteria; references reviewed and updated.

09.06.222Q2022 annual review

Revised criteria to clarify pertuzumab must be prescribed with trastuzumab and docetaxel or chemotherapy; template changes applied to other diagnoses/indications; references updated.

01.05.232Q2023 annual review

For breast cancer, added option for Perjeta without taxanes for members previously treated with chemotherapy and trastuzumab without pertuzumab and revised docetaxel to taxane-containing chemotherapy per NCCN; removed requirement for no prior HER2 inhibitor in colorectal cancer; added unresectable or metastatic HER2-positive gallbladder cancer and cholangiocarcinoma to NCCN recommended uses (off-label); references reviewed and updated.