CurrentMVP Health CarePolicy N/A

Perjeta (pertuzumab) — Medical Benefit Coverage Criteria

Defines coverage and prior authorization requirements for Perjeta (pertuzumab) administered under the medical benefit for MVP Health Care Medicaid members, including on-label and off-label use for cancer diagnoses.

Policy Summary

PayerMVP Health Care

PolicyPerjeta (pertuzumab) — Medical Benefit Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateApr 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization through the MVP Cancer Guidance Program for Perjeta when used to treat a cancer diagnosis.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J9306covered drug HCPCS code

96413administration CPT code listed

Prior Authorizationprior auth required

On-label coveredcoverage stance

Coverage Criteria

inv-01: Coverage conditions

Policy Summary

PayerMVP Health Care

PolicyPerjeta (pertuzumab) — Medical Benefit Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateApr 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization through the MVP Cancer Guidance Program for Perjeta when used to treat a cancer diagnosis.

SourceLink

On This Page

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Covered when the following apply

On-label metastatic HER2+ breast cancer: Perjeta is indicated for first-line treatment of HER2-positive metastatic breast cancer in combination with trastuzumab and docetaxel

Supported by prescribing information

Medical benefit coverage: On-label use of Perjeta is covered under the member's medical benefit and is subject to retro-review

Retro-review may occur

Prior authorization for cancer diagnoses: Perjeta when used for a cancer diagnosis requires prior authorization per the MVP Cancer Guidance Program

Off-label use also requires prior authorization and must meet MVP clinical coverage criteria

Perjeta (pertuzumab) prescribed for an indication not listed in the FDA-approved labeling is considered off-label and requires prior authorization. Off-label use must satisfy MVP Health Care's clinical coverage criteria for Experimental or Investigational Procedures and related policies governing off‑label use of FDA‑approved drugs; such uses are not automatically covered and will be reviewed against those criteria.

Coding

Covered HCPCS CodesHCPCSCovered

J9306

Injection, pertuzumab, 1 mg

Administration CPT CodesCPT

96413

Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug

Provider Actions & Billing Notes

Prior Authorization

Prior Authorization Required

Perjeta (pertuzumab) used for a cancer diagnosis requires prior authorization through the MVP Cancer Guidance Program. Providers must obtain authorization before administration to ensure coverage under the member's medical benefit. Failure to obtain prior authorization may result in denial or retroactive claim adjustments.

Prior authorization required for cancer diagnoses per MVP Cancer Guidance Program
Applies to all indications when billed under the medical benefit for cancer treatment

Note

On‑Label Coverage Subject to Retro‑Review

On-label use of Perjeta is covered under the member's medical benefit but is subject to retro-review. Coverage of on-label administrations may be retrospectively reviewed to confirm medical necessity and documentation; maintain complete clinical records to support the claim.

On‑label coverage is subject to retrospective review
Ensure clinical documentation supports diagnosis and on‑label indication

Step Therapy

There are no additional step therapy requirements specified for Perjeta in this policy. Prior authorization requirements for cancer indications still apply.

No explicit step therapy requirements in policy
Prior authorization per the Cancer Guidance Program remains applicable

Documentation Required

Supporting Documentation

Providers must submit supporting clinical documentation with prior authorization requests and with claims as requested for retro-review. Acceptable documentation includes relevant prescribing information, pathology reports, staging and biomarker results, treatment plan, and progress notes. Documentation should align with MVP submission requirements to facilitate timely review.

Submit prescribing information, pathology reports, staging/biomarker results, treatment plan, and progress notes
Follow MVP documentation requirements and Cancer Guidance Program submission instructions

Denial Risk

Prior Authorization Reminder

Use of Perjeta for a cancer diagnosis is subject to prior authorization through the MVP Cancer Guidance Program; lack of prior authorization may affect payment and coverage determination.

Prior authorization required for cancer diagnosis — verify approval before administration
Noncompliance with prior authorization process may result in claim denial or member liability

Initial Therapy Criteria

inv-12: Initial therapy

Initial coverage considerations

FDA-indicated regimen: Use as first-line treatment in combination with trastuzumab and docetaxel for HER2-positive metastatic breast cancer

Per prescribing information

Prior authorization required per MVP Cancer Guidance Program for cancer diagnoses

On-label use is subject to retro-review

Step Therapy

Step	Requirement	Notes
1	No explicit step therapy requirement specified — Prior authorization required per the MVP Cancer Guidance Program	Applies to Perjeta when used for a cancer diagnosis; off‑label use also requires prior authorization and must meet MVP clinical coverage criteria for Experimental or Investigational Procedures.

Site of Care & Administration

Billing Rule

Administer and bill under medical benefit (infusion center)

Perjeta is administered and billed under the medical benefit; use appropriate administration CPT/HCPCS codes when billing infusion services.

Drug HCPCS: J9306 Injection, pertuzumab, 1 mg
Administration CPT: 96413 Chemotherapy infusion, up to 1 hour

Definitions

Perjeta (pertuzumab) — definition and mechanism

Generic namePertuzumab

Brand namePerjeta

Drug class / mechanismHumanized recombinant monoclonal antibody that blocks ligand-dependent heterodimerization of HER2 (human epidermal growth factor receptor-2), inhibiting downstream intracellular signaling leading to growth arrest and apoptosis.

Primary indication (as stated)First-line treatment of HER2‑positive metastatic breast cancer in combination with trastuzumab and docetaxel.

Route of administrationIntravenous injection (administered under the medical benefit).

Background

Perjeta (pertuzumab) is a humanized recombinant monoclonal antibody that blocks ligand‑dependent heterodimerization of the human epidermal growth factor receptor 2 (HER2), disrupting downstream signaling pathways that promote tumor cell growth. It is indicated for use in HER2‑positive metastatic breast cancer as part of first‑line combination regimens and, when used for any cancer diagnosis, requires prior authorization through the MVP Cancer Guidance Program.