Herceptin denials in California external review
In the California DMHC record, independent physician reviewers decided 12 published external-review cases involving Herceptinand overturned the plan’s denial in 41.7%. That is a historical result among cases that reached this program, not a forecast for an individual appeal.
What the insurer actually argued
| Reason given | Decisions | Overturned |
|---|---|---|
Experimental/Investigational The plan called the treatment unproven. These turn on published evidence, so the appeal is a literature argument. | 7 | 42.9% |
Medical Necessity The plan said the care wasn’t medically necessary. The most common fight, and the most winnable. | 5 | 40% |
What the reviewers wrote
Where the denial was overturned
Physician 1: The patient is a 59-year-old woman diagnosed with breast cancer in January 2005. She was found to have a 1.1 cm high-grade invasive ductal carcinoma. Estrogen receptor was positive, progesterone receptor was borderline, and HER2 was overexpresed. Axillary nodes were negative. Apparently, the tumor was sent for Oncotype genomic analysis; the results indicated the patient’s recurrence score was 54, which places her predicted rate of recurrence by 10 years at 34%. The patient was then treated with adjuvant chemotherapy including cycles of Adriamycin/Cytoxan and then Taxol. It has now been proposed that the patient also be treated with Herceptin.
Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Verzenio, Herceptin, and Faslodex. The records provided for review document that this patient’s diagnoses include secondary malignant neoplasm of liver and intrahepatic bile duct, malignant neoplasm of central portion of right female breast, and malignant neoplasm of breast, unspecified site. The patient’s provider has recommended treatment with a regimen consisting of Verzenio, Herceptin, and Faslodex. The recently published results of the monarcHER trials showed a significant progression free survival in patients that were ER positive and HER2 positive treated with abemaciclib plus Herceptin with Faslodex versus Herceptin plus standard of care chemotherapy.
Where the denial was upheld
Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Brand name Herceptin. Per the National Comprehensive Cancer Network (NCCN) guidelines, biosimilar agents for trastuzumab (Herceptin) are endorsed as standard substitutions. In addition, U.S. Food and Drug Administration (FDA) approved biosimilar agents, such as Kanjinti, are appropriate substitutes for brand name Herceptin. Oftentimes, patients with HER2 positive metastatic breast cancer can develop progression of disease and need to be changed to different medications. Based on current recommendations, brand name Herceptin is not supported for treatment of this patient when biosimilar agents are available to provide control over this patient’s disease. Therefore, the requested brand name Herceptin is not medically necessary for treatment of this patient.
The patient is a 48-year-old woman who was first diagnosed with breast cancer in June 2004. At that time she was found to have a poorly differentiated invasive ductal adenocarcinoma, 2cm in size. Estrogen and progesterone receptors were negative. HER2-neu assay was also negative. Surgical options and chemotherapy were recommended to the patient but she declined, preferring instead to pursue holistic therapies.In October 2004, the patient was found to have diffuse bone metastases, as well as liver metastases. She elected to pursue non-conventional treatment in Germany. Currently, the patient has requested therapy with Herceptin, which has been denied by the Health Plan on the basis it is not medically necessary for treatment of the patient’s condition.Herceptin is an antibody with real usefulness in the treatment of metastatic breast cancer and has very low toxicity.
Figures and quotations on this page come from 42,749 published decisions in the California DMHC Independent Medical Review dataset. These are California external-review outcomes. Other state and federal programs have different eligibility rules, processes, and current availability; the rates here do not transfer to those programs or predict an individual result. Excerpts are quoted verbatim from the public record and describe this treatment generally, not any individual case.
These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Herceptin, then check the rights and deadlines that apply to your plan.
SOURCE: CALIFORNIA DMHC INDEPENDENT MEDICAL REVIEW OUTCOMES (CHHS OPEN DATA) · AGGREGATES + DEIDENTIFIED DECISION EXCERPTS/REFERENCE IDS · METHODOLOGY