Herceptin (trastuzumab) medical benefit coverage
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Defines medical benefit coverage, prior authorization, and administration coding for Herceptin (trastuzumab) for MVP Health Care Medicaid members, primarily for cancer indications; applies to providers submitting medical benefit claims.
No material clinical or coverage changes in this revision.
Coverage Criteria
Coverage criteria
Covered when ALL of the following are met
Such use is subject to retro-review per policy.
Providers must obtain prior authorization as required by the program.
Off-label requests are evaluated against MVP's experimental/investigational criteria.
The policy does not list any additional coverage notes beyond the program-level authorization requirements. Off-label uses of Herceptin are handled through the insurer's experimental/investigational review process and must meet MVP's clinical coverage criteria for Experimental or Investigational Procedures and related policies.
The document does not specify any conditions that are explicitly deemed not medically necessary. Instead, it states that off-label use requires prior authorization and must meet MVP's clinical coverage criteria for Experimental or Investigational Procedures; such review may render an off-label request non-covered if criteria are not met.
Coding
| J9355 | Injection, trastuzumab, excludes biosimilar; 10 mg |
Provider Actions & Authorization
Prior Authorization Required
Prior authorization is required for trastuzumab (Herceptin) when used to treat cancer diagnoses. Authorization is handled through the MVP Cancer Guidance Program.
- Herceptin (trastuzumab) used for cancer indications: prior authorization required via the MVP Cancer Guidance Program.
- Off-label use of Herceptin: prior authorization required and must meet MVP clinical coverage criteria for Experimental or Investigational Procedures, Drugs and Treatments.
Providers must request prior authorization through the MVP Cancer Guidance Program for Herceptin when used for cancer diagnoses. For off‑label uses, submit a prior authorization request demonstrating that the request meets MVP's clinical coverage criteria for investigational or experimental therapies.
Coverage and Review Notes
On‑label (FDA‑approved) use of Herceptin is covered under the member's medical benefit. Coverage is subject to retroactive review. Cancer indications require prior authorization through the MVP Cancer Guidance Program; off‑label indications require prior authorization and must meet MVP's clinical coverage criteria.
Prior Authorization
Use of Herceptin for cancer diagnoses is subject to authorization per the MVP Cancer Guidance Program. Off‑label uses are also subject to prior authorization and clinical review under MVP's Experimental or Investigational Procedures policy.
Initial Therapy Requirements
Initial therapy requirements
Initial coverage rules
Subject to retro-review.
Site of Care / Administration
Infusion administration coding and site guidance
Administer Herceptin under the medical benefit using standard chemotherapy infusion administration coding (CPT 96413 for up to 1 hour; 96415 for each additional hour). No additional site‑of‑care restrictions are specified beyond standard medical benefit administration coding.
Biosimilar Information
Definitions
Background
Herceptin (trastuzumab) is a recombinant humanized IgG1 kappa monoclonal antibody that targets the HER2 protein. It is indicated for certain HER2-positive breast and gastric cancers. The policy clarifies that on‑label cancer indications for Herceptin are covered under the member's medical benefit and are subject to retro‑review, and that use for a cancer diagnosis requires authorization through the MVP Cancer Guidance Program. Off-label uses require prior authorization and must meet the insurer's experimental/investigational criteria.
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