CurrentViva HealthPolicy IC-0096

Perjeta® (pertuzumab) (Intravenous) — Coverage Criteria

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Defines prior authorization, dosing limits, indications, and renewal criteria for intravenous pertuzumab (Perjeta) for Viva Health members; applies to providers requesting coverage for this drug.

Policy Summary

PayerViva Health

PolicyPerjeta (pertuzumab) (Intravenous) — Coverage Criteria

Policy CodePolicy IC-0096

Change TypeNo material changes

Effective DateJun 2, 2026

Last ReviewJun 2, 2026

Next Review DateJun 2, 2026

Key ActionObtain prior authorization (initially valid for 180 days; renewals may be granted every 6 months with neoadjuvant/adjuvant limited to 1 year).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J9306HCPCS billing code

50242-0145-xxNDC (420 mg vial)

420 mgMaintenance dose

840 mgLoading dose

18 cycles

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CurrentViva HealthPolicy IC-0096

Perjeta® (pertuzumab) (Intravenous) — Coverage Criteria

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Defines prior authorization, dosing limits, indications, and renewal criteria for intravenous pertuzumab (Perjeta) for Viva Health members; applies to providers requesting coverage for this drug.

Policy Summary

PayerViva Health

PolicyPerjeta (pertuzumab) (Intravenous) — Coverage Criteria

Policy CodePolicy IC-0096

Change TypeNo material changes

Effective DateJun 2, 2026

Last ReviewJun 2, 2026

Next Review DateJun 2, 2026

Key ActionObtain prior authorization (initially valid for 180 days; renewals may be granted every 6 months with neoadjuvant/adjuvant limited to 1 year).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J9306HCPCS billing code

50242-0145-xxNDC (420 mg vial)

420 mgMaintenance dose

840 mgLoading dose

18 cycles

Max adjuvant duration

6 monthsInitial PA validity

Coverage Criteria for Perjeta (pertuzumab)

Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Initial eligibility

Breast cancer indications
- Neoadjuvant/preoperative: Used as neoadjuvant/preoperative therapy; member has ≥ T1c disease, node-positive disease, or inflammatory disease; used in combination with trastuzumab and chemotherapy.
- Adjuvant: Used as adjuvant therapy; member has ≥ T1 disease, node-positive disease, or inflammatory disease (unless otherwise specified); used in combination with trastuzumab and chemotherapy for pT2-3 and pN0 or pN+ OR used in combination with trastuzumab alone as specified; or used after completion of planned chemotherapy following surgery in members with ≥ ypT0N0 or pCR by axillary staging and used with trastuzumab.
- Recurrent/metastatic: Used for recurrent unresectable (local/regional) or metastatic disease or inflammatory breast cancer with no response to preoperative systemic therapy; used in combination with one of the specified regimens (e.g., trastuzumab + aromatase inhibitor ± palbociclib for select maintenance, trastuzumab + taxane as first-line, trastuzumab ± cytotoxic therapy as subsequent therapy, or fam-trastuzumab deruxtecan as first-line) and meeting hormone receptor, menopausal, or other regimen-specific requirements.
Central nervous system (CNS): Member has brain metastases from breast cancer and therapy is used in combination with trastuzumab.
Colorectal and related gastrointestinal tumors: Member has RAS and BRAF wild-type disease (CRC, appendiceal, small bowel) and therapy is used in combination with trastuzumab per indication-specific prior therapy and disease-stage criteria (initial or subsequent treatment for unresectable/metastatic disease as specified).
Head and neck (salivary gland) tumors: Member has salivary gland tumors, therapy is used with trastuzumab, and member has recurrent disease with distant metastases or unresectable locoregional recurrence/second primary following prior radiation.
Biliary tract: Used as subsequent treatment after progression on systemic therapy for unresectable or metastatic biliary tract disease and used in combination with trastuzumab.

Initial dosing — Dose and administration for initial therapy

Dose and administration for initial therapy

Dose schedule: Administer an initial loading dose of 840 mg intravenous (IV) x1, followed by maintenance dosing of 420 mg IV every 21 days; continue until disease progression or unacceptable toxicity. For neoadjuvant/preoperative therapy, administer 3–9 cycles prior to surgery. Neoadjuvant/adjuvant use is limited to a total of 1 year (maximum 18 cycles).

Continuation Therapy / Renewal — Authorization may be renewed when ALL of the following are met

Authorization may be renewed when ALL of the following are met

Renewal eligibility: Member continues to meet the universal and indication-specific criteria (including concomitant therapy requirements and performance status); duration of authorization has not been exceeded; disease response demonstrated as stabilization of disease or decrease in tumor size or spread; absence of unacceptable toxicity (examples include left ventricular dysfunction, severe infusion-related reactions, hypersensitivity/anaphylaxis); and recent LVEF obtained within the previous 3 months meeting indication-specific thresholds.

Renewal — Renewal requirements for ongoing therapy

Renewal requirements for ongoing therapy

Renewal monitoring and LVEF requirements: LVEF obtained within the previous 3 months as follows: for neoadjuvant and adjuvant breast cancer, LVEF ≥ 50% OR absolute decrease < 10% from baseline; for all other indications, LVEF > 45% OR LVEF 40%–45% with an absolute decrease < 10% from baseline. Continue only if absence of unacceptable toxicity and evidence of disease response or stability; duration limits not exceeded.

The following combination is excluded from coverage: pertuzumab when administered together with trastuzumab and hyaluronidase-zzxf (Phesgo). Requests for pertuzumab that involve concurrent use with Phesgo will not meet the universal criteria for authorization.

Billing, Codes, and Dosing Limits

HCPCS CodesHCPCSCovered

J9306

Injection, pertuzumab, 1 mg; 1 billable unit = 1 mg

Covered HCPCS CodesHCPCSCovered

J9306

Injection, pertuzumab, 1 mg; 1 billable unit = 1 mg

NDCNDCCovered

50242-0145-xx

Perjeta 420 mg/14 mL single-dose vial for injection

Covered ICD-10 Diagnosis CodesICD-10Covered

C06.9	Malignant neoplasm of mouth, unspecified
C07	Malignant neoplasm of parotid gland
C08.0	Malignant neoplasm of submandibular gland
C08.1	Malignant neoplasm of sublingual gland
C08.9	Malignant neoplasm of major salivary gland, unspecified
C17.0	Malignant neoplasm of duodenum
C17.1	Malignant neoplasm of jejunum
C17.2	Malignant neoplasm of ileum
C17.3	Meckel's diverticulum, malignant
C17.8	Malignant neoplasm of overlapping sites of small intestine

1–10 of 98

1/10

Maintenance dosing interval

Maintenance dosing intervalEvery 21 days (maintenance dose administered IV q21 days)

Loading dose timingSingle loading dose given prior to maintenance dosing schedule

Use untilContinue maintenance dosing every 21 days until disease progression or unacceptable toxicity (per dosing guidance)

Pertuzumab dosing (per dose units)

Loading dose840 mg (840 billable units) — single dose

Maintenance dose420 mg (420 billable units) per dose

Provider Requirements, Documentation, and Authorization

Prior Authorization

Prior authorization required — initial and renewal validity

Prior authorization is required for pertuzumab and will be issued initially for 180 days (6 months). Renewals may be granted every 6 months (180 days); neoadjuvant and adjuvant breast cancer treatment may be renewed up to a maximum total of 1 year (18 cycles).

Initial PA period: 180 days (6 months).
Renewal interval: may be renewed every 180 days.
Neoadjuvant/adjuvant breast cancer cap: maximum 1 year (18 cycles).

Note

Utilization management factors considered for PA

Utilization management (prior authorization) is applied considering the drug indication, safety and efficacy data, and drug cost; these factors are used to determine whether prior authorization is required and to guide review decisions.

NQTL factors considered: indication, safety/efficacy, and drug cost.

Step Therapy and Regimen Requirements

Step	Requirement
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Administration Setting

Note

Infusion administration and continuation criteria

Administer pertuzumab intravenously and continue therapy until disease progression or unacceptable toxicity.

Note

Medicare Part B and local coverage considerations

For hospital outpatient administration, consult Medicare Part B guidance; local NCDs, LCDs, or LCAs may apply and must be followed where applicable.

Key Definitions

HER2-positive (definition)

DefinitionTumor HER2 overexpression or amplification as determined by FDA-approved or CLIA-compliant testing

IHC criterionImmunohistochemistry (IHC) assay 3+

ISH/FISH criteriaDual-probe ISH: HER2/CEP17 ratio ≥2.0 AND average HER2 copy number ≥4.0 signals/cell (other specified combinations of ratio, copy number, and concurrent IHC detailed in testing algorithms)

NGS considerationNGS-detected HER2 amplification per indication-specific testing algorithms may be accepted (as specified in policy references)

Perjeta (pertuzumab)

Agent descriptionPerjeta (pertuzumab) — a HER2-directed monoclonal antibody administered intravenously

Background

Pertuzumab is a HER2-directed monoclonal antibody administered intravenously for the treatment of HER2-positive malignancies, most commonly in breast cancer. Prior to initiation and periodically during therapy, left ventricular ejection fraction (LVEF) must be within normal limits and monitored (for example, approximately every 3 months) because of potential cardiotoxicity. Use is restricted to patients with HER2-positive disease confirmed by an FDA-approved or CLIA-compliant test.

Quantity Limits and Dosing

Pertuzumab dosing (quantity limits)

Loading dose (repeat)840 mg (840 billable units) — single initial loading dose

Maintenance dose (repeat)420 mg (420 billable units) every 21 days for maintenance

Billing unitsHCPCS billing expressed in mg (1 billable unit = 1 mg) per policy dosing limits

Policy Summary

PayerViva Health

PolicyPerjeta (pertuzumab) (Intravenous) — Coverage Criteria

Policy CodePolicy IC-0096

Change TypeNo material changes

Effective DateJun 2, 2026

Last ReviewJun 2, 2026

Next Review DateJun 2, 2026

Key ActionObtain prior authorization (initially valid for 180 days; renewals may be granted every 6 months with neoadjuvant/adjuvant limited to 1 year).

SourceLink

On This Page

Maintenance frequencyAdminister maintenance 420 mg every 21 days

Step Therapy

Use pertuzumab only in required combination regimens

Pertuzumab must be administered in specified combination regimens for breast and other indications — for breast cancer settings it is used in combination with trastuzumab and chemotherapy, and other indication-specific combinations (e.g., trastuzumab with aromatase inhibitor ± palbociclib for maintenance, trastuzumab + taxane, or trastuzumab ± cytotoxic therapy) per the indication-specific criteria.

Neoadjuvant/adjuvant and many metastatic breast cancer pathways require pertuzumab + trastuzumab + chemotherapy.
Maintenance or subsequent regimens list trastuzumab combinations (aromatase inhibitor ± palbociclib, taxane, or cytotoxic therapy) as specified.

Step Therapy

No defined step therapy sequence in this policy section

This policy’s NQTL checklist indicates utilization review and prior authorization are considerations for managing access, but no specific step therapy sequence or mandatory prior-line agents are defined in this section.

NQTL notes PA consideration but does not specify a defined stepwise therapy sequence.

Documentation Required

Document HER2-positive status and baseline/serial LVEF

Provide documentation confirming HER2-positive status using FDA‑approved or CLIA‑compliant testing methods (examples include IHC, ISH/FISH, or NGS amplification per indication-specific algorithms) and baseline LVEF within normal limits with periodic LVEF monitoring (e.g., about every 3 months) as available.

HER2 testing options: IHC 3+, ISH/FISH criteria, or NGS amplification per indication.
Baseline LVEF must be within normal limits prior to initiating therapy and LVEF should be assessed regularly (e.g., every ~3 months).

Billing Rule

Required billing and diagnosis documentation (J9306, NDC, ICD-10)

When requesting coverage or submitting claims, document the HCPCS billing code and units for pertuzumab (J9306 — 1 billable unit = 1 mg), the NDC for Perjeta 420 mg vial (50242-0145-xx), and the applicable ICD-10 diagnosis code from the covered diagnosis list.

HCPCS: J9306 — Injection, pertuzumab, 1 mg (1 billable unit = 1 mg).
NDC: 50242-0145-xx for Perjeta 420 mg/14 mL vial.
Include appropriate ICD-10 diagnosis code from Appendix 1 when submitting claims or PA requests.

Denial Risk

Triggers for denial — missing HER2, LVEF, or unacceptable toxicity

Failure to document HER2‑positive status by an FDA‑approved or CLIA‑compliant test, failure to provide acceptable LVEF assessment (abnormal or not within required timeframes), or evidence of unacceptable toxicity (e.g., left ventricular dysfunction, severe infusion reactions) may trigger denial of authorization.

Lack of required HER2 testing documentation can lead to denial.
Abnormal LVEF or missing/insufficient LVEF data may result in denial.
Unacceptable toxicities (left ventricular dysfunction, severe infusion-related or hypersensitivity reactions) are grounds for denial.

Prior Authorization

PA and utilization management considerations — denial risk if criteria not met

Prior authorization and utilization management may be applied taking into account indication, clinical safety and efficacy, and drug cost; absence of an appropriate prior authorization or failure to meet PA criteria may result in denial of coverage.

PA may be required based on indication, safety/efficacy, and drug cost.
Lack of PA or failure to meet PA criteria is a basis for denial.

Primary manufacturer referencePerjeta package insert (Genentech, April 2026) cited as the manufacturer source

Guideline referencesNCCN Drugs & Biologics Compendium and NCCN Guidelines cited as referenced clinical sources