CurrentAloha CarePolicy RXMP-26

Perjeta (pertuzumab) — Medical Benefit Coverage Criteria

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Defines medical-benefit coverage, authorization, and clinical criteria for pertuzumab (Perjeta) for AlohaCare Medicaid & Medicare members. Applies to Medical Benefit administration of Perjeta (HCPCS J9306).

Policy Summary

PayerAloha Care

PolicyPerjeta (pertuzumab) — Medical Benefit Coverage Criteria

Policy CodePolicy RXMP-26

Change TypeNo material clinical or coverage changes

Effective DateOct 20, 2023

Last ReviewOct 20, 2025

Next Review DateOct 20, 2025

Key ActionSubmit prior authorization for Perjeta (J9306); initial approvals are for 3 months with reauthorization available for 12 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J9306HCPCS code

3 moInitial approval

12 mo

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CurrentAloha CarePolicy RXMP-26

Perjeta (pertuzumab) — Medical Benefit Coverage Criteria

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Policy Summary

PayerAloha Care

PolicyPerjeta (pertuzumab) — Medical Benefit Coverage Criteria

Policy CodePolicy RXMP-26

Change TypeNo material clinical or coverage changes

Effective DateOct 20, 2023

Last ReviewOct 20, 2025

Next Review DateOct 20, 2025

Key ActionSubmit prior authorization for Perjeta (J9306); initial approvals are for 3 months with reauthorization available for 12 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J9306HCPCS code

3 moInitial approval

12 mo

Coverage Criteria for pertuzumab (Perjeta)

Initial therapy — early/locally advanced/inflammatory

Covered when ALL of the following are met for early/locally advanced/inflammatory HER2+ breast cancer:

Early/locally advanced/inflammatory criteria: Member has HER2-positive breast cancer AND ECOG performance status 0-2 AND will use pertuzumab in one of: (1) neoadjuvant therapy with primary tumor >2 cm or clinically evident lymph node positive OR (2) adjuvant systemic therapy for high risk of recurrence; AND member will use pertuzumab in combination with trastuzumab and either paclitaxel (J9267) or docetaxel (J9171) ± carboplatin (J9045); AND pertuzumab is limited to a maximum of 18 cycles (12 months).ECOG 0-2; tumor >2 cm or node positive; max 18 cycles

Also requires ADRC referral for QUEST non-ABD non‑Medicaid cancer members per internal instruction.

Initial therapy — metastatic disease

Covered when ALL of the following are met for metastatic HER2+ breast cancer:

Metastatic criteria: Member has metastatic HER2-positive breast cancer AND is using pertuzumab in combination with trastuzumab and either docetaxel (J9171) or paclitaxel (J9267); AND this combination will be used as the only chemotherapy until disease progression; AND pertuzumab and trastuzumab may continue if docetaxel or paclitaxel is stopped for toxicity or other side effects.use until progression

Continuation therapy — adjuvant after TCHP

Covered when ALL of the following are met for continuation after TCHP:

Post‑TCHP adjuvant continuation: Member requests pertuzumab in combination with trastuzumab for 12 months after completing 6 cycles (18 weeks) of TCHP (docetaxel, carboplatin, trastuzumab, pertuzumab) for early stage, locally advanced, or inflammatory breast cancer.12 months after 6 cycles

Metastatic disease with brain metastases

Covered when ALL of the following are met for brain metastases:

Brain metastases: Member has metastatic HER2-positive breast cancer with brain metastases AND either: (1) asymptomatic brain metastases as primary/initial therapy OR (2) recurrent or stable brain metastasis disease; AND pertuzumab is used in combination with trastuzumab.

Colorectal cancer (HER2‑amplified)

Covered when ALL of the following are met for colorectal adenocarcinoma (including appendiceal and anal):

Colorectal HER2‑amplified: Member has colorectal (including appendiceal and anal) adenocarcinoma that is HER2‑amplified AND RAS and BRAF wild type AND has not been previously treated with a HER2 inhibitor in combination with trastuzumab AND is not a candidate for intensive therapy or pertuzumab is being used as subsequent therapy for progression of advanced/metastatic disease.RAS and BRAF wild type

Requests for pertuzumab will be excluded when it is administered after trastuzumab is discontinued or when it is given as part of a regimen that does not include concurrent trastuzumab. The policy explicitly lists this scenario as an exclusion and such requests may be denied.

Use of pertuzumab in combination with other targeted biologic agents that are not allowed by the criteria is an exclusion. Examples called out in the policy include, but are not limited to, erlotinib, cetuximab (J9055), panitumumab (J9303), bevacizumab (J9035/Q5107/Q5118), lapatinib, and ziv‑aflibercept (J9400). Concurrent use with these excluded agents is considered not covered and may be denied.

Initial Therapy Indications

Initial therapy indications

Initial therapy coverage rules reflect FDA dosing and combinations with trastuzumab plus a taxane; specific situational criteria outlined below.

Initial covered settings: Neoadjuvant for primary tumor >2 cm or node positive; Adjuvant for high risk of recurrence; Metastatic disease in combination with trastuzumab and docetaxel or paclitaxel with use until progression; Brain metastases settings as defined; Colorectal HER2‑amplified with RAS/BRAF wild type in select patients.

FDA dosing: 840 mg initial then 420 mg every 3 weeks (J9306).

Continuation / Maintenance Criteria

Continuation if taxane stopped

Continuation/maintenance rules:

Continuation after taxane discontinuation: Treatment with pertuzumab and trastuzumab may continue if docetaxel or paclitaxel is stopped due to toxicity or other side effects in metastatic disease.

Coding and Related Clinical Fields

Covered HCPCSHCPCSCovered

J9306

Injection pertuzumab 1 mg [Perjeta]

Referenced chemotherapy/targeted agent HCPCSHCPCS

J9045	Carboplatin
J9171	Docetaxel
J9267	Paclitaxel
J9055	Cetuximab
J9303	Panitumumab
J9035	Bevacizumab
J9400	Ziv‑aflibercept

inv-10: ECOG performance status

ECOG performance status range0-2

Use context (early/locally advanced/inflammatory)Required for neoadjuvant or adjuvant pertuzumab in early/locally advanced/inflammatory HER2+ breast cancer

Documentation requirementECOG score must be documented in clinical records submitted for prior authorization

Provider Requirements and Actions

Prior Authorization

Prior authorization required for Perjeta (J9306)

Perjeta (pertuzumab) (HCPCS J9306) is a medical‑benefit drug that requires prior authorization. Initial approval duration for new requests is 3 months; continuation/reauthorization approvals are for 12 months.

HCPCS: J9306 (Injection pertuzumab 1 mg, Perjeta 420mg/14mL SDV)
Formulary status: Medical Benefit — Authorization Required
Initial request duration: 3 months; COC/Reauthorization: 12 months

Step Therapy

Medicare Part B step therapy requirement for new starts

For Medicare Part B members starting pertuzumab, Medicare Part B Step Therapy Criteria must be met in addition to the policy coverage criteria before a request may be approved; the policy currently states there is no specific step therapy agent listed.

Requirement applies to new starts under Medicare Part B

Background

Pertuzumab (Perjeta) is an anti‑HER2 monoclonal antibody used in HER2‑positive disease; typical policy guidance describes it as administered in combination with trastuzumab and chemotherapy. The policy exclusions and coverage criteria assume use together with trastuzumab and do not support pertuzumab monotherapy or regimens substituting other targeted biologics.

Key Definitions

inv-16: HER2+ breast cancer

DefinitionBreast cancer with overexpression or amplification of the human epidermal growth factor receptor 2 (HER2); pertuzumab is indicated for HER2-positive disease

Indication in policyCovered for early/locally advanced/inflammatory and metastatic HER2+ breast cancer when criteria are met

Required combinationPertuzumab must be used in combination with trastuzumab and a taxane (paclitaxel J9267 or docetaxel J9171) per coverage criteria

inv-17: Neoadjuvant

DefinitionNeoadjuvant = treatment given prior to surgery

Neoadjuvant eligibility criterionPrimary tumor > 2 cm OR clinically evident lymph node positivity

Step Therapy (Medicare Part B)

Requirement	Details
Medicare Part B step therapy requirement	For new starts, Medicare Part B Step Therapy Criteria must be met in addition to Coverage Criteria before a request may be approved. Policy states: 'No step therapy'.

Quantity Limits and Dosing

inv-21: Perjeta (pertuzumab) dosing per FDA and policy limits

FDA dosing schedule840 mg initial dose followed by 420 mg every 3 weeks

HCPCS code / supplyJ9306 — Injection pertuzumab 1 mg; supplied as Perjeta 420 mg/14 mL SDV

Policy quantity limit for early diseaseMaximum 18 cycles (12-month course) for early/locally advanced/inflammatory breast cancer

Site of Care / Benefit Assignment

Billing Rule

Infusion center — medical-benefit administration required

Perjeta is covered only as a medical-benefit infusion; the pharmacy benefit is excluded and administration must occur in the medical/infusion setting.

Formulary status: Pharmacy benefit excluded to Medical Benefit
Administer under Medical Benefit (infusion center/clinical infusion setting)