Perjeta (pertuzumab) medical benefit coverage
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Defines MVP Health Care Medicaid medical benefit coverage and prior authorization requirements for Perjeta (pertuzumab) for cancer diagnoses, including on-label and off-label use, and applicable administration and billing codes.
No material clinical or coverage changes in this revision.
Coverage Criteria for Perjeta (pertuzumab)
On-label cancer use
Covered when ALL of the following are met
On-label use is subject to retro-review and prior authorization per MVP Cancer Guidance Program
Failure to obtain authorization may result in denial
Off-label use
Covered when ALL of the following are met
Also subject to related MVP policies (e.g., Behavioral Health Services, Drugs and Treatments; Clinical Trials Policy)
Perjeta used for indications outside the FDA‑approved labeling is considered off‑label. Off‑label use is eligible for coverage only when it meets MVP’s requirements for prior authorization and also satisfies MVP’s clinical coverage criteria for Experimental or Investigational Procedures and the policy on Off‑Label use of FDA Approved Drugs. Off‑label requests that do not meet those related clinical coverage policies are not authorized.
Billing and Coding
Provider Actions and Authorization Requirements
Perjeta prior authorization required
Perjeta (pertuzumab) used for a cancer diagnosis requires prior authorization through the MVP Cancer Guidance Program. For off‑label indications, prior authorization is also required and those uses must meet MVP's clinical coverage criteria for Experimental or Investigational Procedures and related MVP policies.
- Covered HCPCS code: J9306 must be included on authorization requests when applicable.
- Off-label uses must meet MVP policies for Experimental or Investigational Procedures and Off-Label use of FDA Approved Drugs.
Obtain MVP Cancer Guidance Program authorization
Obtain authorization through the MVP Cancer Guidance Program before initiating Perjeta for any cancer diagnosis; there are no specific step agents or failure requirements listed in this policy, but authorization is required as a condition of coverage.
- Authorization expectation applies both to on‑label and off‑label cancer uses per the MVP Cancer Guidance Program.
- Failure to obtain authorization may lead to claim denial (see denial risk block).
Documentation and retro‑review requirements
On‑label use of Perjeta is covered under the member's medical benefit but is subject to retro‑review; off‑label use requires prior authorization and must meet MVP's clinical coverage criteria and related policies.
- Document indication (on‑label vs off‑label) and supporting clinical information in the medical record to support retrospective review or prior authorization requests.
- Off‑label requests must reference applicable MVP policies (Experimental or Investigational Procedures; Off‑Label use of FDA Approved Drugs; Behavioral Health Services, Drugs and Treatments; Clinical Trials Policy).
Denial risk if authorization not obtained
Failure to obtain the required prior authorization through the MVP Cancer Guidance Program for Perjeta when used for a cancer diagnosis may result in denial of coverage.
- Prior authorization is a condition of coverage for cancer indications; verify approval before administration.
- For off‑label uses, ensure authorization and compliance with MVP off‑label/experimental criteria to avoid denial.
Background
Perjeta (pertuzumab) is a HER2‑targeted monoclonal antibody included in this policy as an agent requiring authorization when used for cancer diagnoses. Per MVP, use of Perjeta for a cancer diagnosis is subject to the MVP Cancer Guidance Program prior authorization process; off‑label cancer indications additionally must meet MVP’s experimental/investigational and off‑label drug coverage criteria.
Definitions
Initial Therapy Criteria
Initial therapy
On-label initial indication
On-label use is covered under the medical benefit and is subject to retro-review and prior authorization per MVP Cancer Guidance Program
Step Therapy and Prior Requirements
| Step | Requirement |
|---|---|
| 1 | Authorization per MVP Cancer Guidance Program is required before use for any cancer diagnosis; no specific step agents or prior failures are listed in the policy. |
Site of Care and Administration
Infusion administration billing
When Perjeta is administered in an infusion setting, bill chemotherapy infusion administration using CPT 96413 (IV infusion, up to 1 hour) for the single or initial substance/drug.
- Code: 96413 — Chemotherapy administration, intravenous infusion technique; up to 1 hour; single or initial substance/drug.
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