CurrentCareSourcePolicy N/A

UTILIZATION MANAGEMENT MEDICAL POLICY

Defines prior authorization and medical-benefit coverage criteria, dosing, and limitations for Phesgo (pertuzumab, trastuzumab, hyaluronidase-zzxf) for early (neoadjuvant/adjuvant) and metastatic HER2-positive breast cancer in adults.

Policy Summary

PayerCareSource

PolicyUTILIZATION MANAGEMENT MEDICAL POLICY

Policy CodePolicy N/A

Change TypeClarified; Revised (historical deletion)

Effective DateAug 7, 2024

Next Review Date

Key ActionPrior authorization is recommended for medical benefit coverage of Phesgo and approval is recommended for those who meet the stated criteria and dosing.

SourceLink

POLICY UPDATE CHANGES

Prior deleted metastatic criteria from 07/12/2023: removed requirement that patient not previously treated with anti-HER2 therapy or chemotherapy for metastatic disease and removal of requirement that medication be used in combination with chemotherapy in metastatic setting.

Annual Revision, Summary of Changes = No criteria changes.

2Covered Indications (early, metastatic)

1Prior Authorization Required

18Max cycles (adjuvant)

Coverage Summary

Defines prior authorization and medical-benefit coverage criteria for Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf) subcutaneous injection for adults with HER2-positive breast cancer. Coverage stance: covered with criteria for both early (neoadjuvant/adjuvant) and metastatic indications when the policy criteria are met. Status: CURRENT. Effective date: 2024-08-07 (last review 2024-08-07).

Dosing & Duration Summary

Dosing intervalMaintenance dose every 3 weeks (not more frequently than once every 3 weeks)

Initial dose (neoadjuvant/adjuvant)One-time 1,200 mg pertuzumab, 600 mg trastuzumab, 30,000 units hyaluronidase in 15 mL administered subcutaneously

Maintenance dose (neoadjuvant/adjuvant and metastatic)600 mg pertuzumab, 600 mg trastuzumab, 20,000 units hyaluronidase in 10 mL every 3 weeks administered subcutaneously

Initial dose (metastatic) — documentation noteSource lists an initial one-time 600 mg trastuzumab and 30,000 units hyaluronidase in 15 mL (inconsistent with neoadjuvant/adjuvant initial dosing)

Duration (adjuvant/neoadjuvant)Complete 1 year of treatment (up to 18 cycles)

Duration (metastatic)Continue until disease progression or unmanageable toxicity

Missed dose ruleIf time between two sequential injections is ≥ 6 weeks, re-administer the initial dose then resume maintenance dosing

Initial Therapy Criteria (Early / Adjuvant-Neoadjuvant)

FDA-Approved Indications - Early (Neoadjuvant/Adjuvant) Breast Cancer

Covered when ALL of the following are met:

ALL of the following

Patient is ≥ 18 years of age
Patient has human epidermal growth factor receptor 2 (HER2)-positive disease
Patients should be selected based on an FDA-approved companion diagnostic
Patient must meet ONE of the following
- Medication will be used in combination with chemotherapy (examples: doxorubicin, cyclophosphamide, docetaxel, paclitaxel, carboplatin)
- Medication is continued after chemotherapy to complete 1 year of neoadjuvant or adjuvant therapyComplete 1 year of treatment (up to 18 cycles)

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Prior Authorization

Prior authorization required

Prior authorization is recommended for medical-benefit coverage of Phesgo. Approval is recommended for patients who meet the stated criteria and dosing. Requests for doses outside the established dosing in this policy will be considered case-by-case by a clinician; approvals should be granted when the Recommended Authorization Criteria and the dosing thresholds are met. Exceptions for out-of-schedule dosing may be considered on a case-by-case basis.

Billing Rule

Administration route and setting

Phesgo is for subcutaneous use only and must be administered by a healthcare professional. It should not be given intravenously and is not substitutable for the specified IV agents (e.g., ado-trastuzumab emtansine or fam-trastuzumab deruxtecan).

Continuation / Metastatic Therapy Criteria

FDA-Approved Indications - Metastatic Breast Cancer

Approve for 1 year when ALL of the following are met:

ALL of the following

Patient is ≥ 18 years of age
Patient has human epidermal growth factor receptor 2 (HER2)-positive disease
Patients should be selected based on an FDA-approved companion diagnostic
Medication is prescribed by or in consultation with an oncologist
Specialist prescribing requirement

Dosing (metastatic): Initial and maintenance dosing per policyMaintenance dose every 3 weeks; continue until disease progression or unmanageable toxicity

Documentation Required

Specialist prescribing requirement

Approval requires that Phesgo be prescribed by or in consultation with a physician who specializes in the condition treated (oncologist).

Denial Risk

Not recommended outside criteria

Coverage is not recommended for circumstances that are not listed in the Recommended Authorization Criteria.

Provider Actions & Documentation Requirements

Documentation Required

Companion diagnostic

Patients should be selected for therapy based on an FDA‑approved companion diagnostic test for HER2.

Note

Operational guidance

Summary operational guidance: Prior authorization is recommended for Phesgo (see prior authorization requirement). Requests meeting the Recommended Authorization Criteria and the dosing thresholds should be approved; requests for doses outside the established dosing will be considered case-by-case by a clinician. Phesgo is administered subcutaneously and must be given by a healthcare professional.

If the interval between sequential injections is ≥ 6 weeks, re-administer the initial dose before resuming maintenance dosing.

Maintenance dosing is given every 3 weeks (not more frequently than once every 3 weeks).

Maximum adjuvant/neoadjuvant duration: complete 1 year of treatment (up to 18 cycles).

Clinical Evidence & References

NCCN guideline: NCCN Breast Cancer Clinical Practice Guidelines v4.2024 (accessed July 3, 2024) support substitution of Phesgo where pertuzumab IV plus trastuzumab IV are used and note use of HER2-targeted therapy for up to 1 year in the neoadjuvant/adjuvant setting.

Prescribing information: Phesgo prescribing information: Genentech; June 2020.

Definitions

Phesgo (definition)Combination subcutaneous injection of pertuzumab, trastuzumab, and hyaluronidase-zzxf administered by a healthcare professional

HER2-positive (definition)Human epidermal growth factor receptor 2 positive breast cancer as determined by an FDA-approved companion diagnostic

Background

Phesgo is a fixed-dose subcutaneous combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf indicated for HER2-positive early (neoadjuvant/adjuvant) and metastatic breast cancer in adults. Its dosing and administration differ from intravenous pertuzumab and trastuzumab products, it is for subcutaneous use only, and it must be administered by a healthcare professional.

Caution: the metastatic dosing section in the document lists an initial dose of 600 mg trastuzumab and 30,000 units hyaluronidase in 15 mL, which appears inconsistent with the stated initial dosing elsewhere and may be a documentation error.

Revision History

2024-08-07annual_revisionLatest

Annual Revision, No criteria changes

2023-07-12material_change

Deleted two metastatic criteria: removal of requirement that patient not previously treated with anti-HER2 therapy or chemotherapy for metastatic disease, and removal of requirement that medication be used in combination with chemotherapy in the metastatic setting