Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Colon cancer.
Treatment: Erbitux 200 MG/100 ML VIAL.
The insurer denied the Erbitux 200 MG/100 ML VIAL.
The denial is upheld.

The patient is a male with metastatic adenocarcinoma of the rectosigmoid junction.

The patient was initially diagnosed with localized disease. The exact stage was not indicated. He underwent resection and adjuvant chemotherapy of FOLFOX (fluoruracil/oxaliplatin). This treatment was completed several years ago.

The patient developed recurrent diseases in the liver and was treated with cetuximab/FOlFIRI (fluorouracil/irinotecan). There was no documentation of KRAS (Kirsten rat sarcoma viral oncogene homolog), NRAS (neuroblastoma Rat sarcoma virus viral oncogene homolog) and BRAF (v-Rapidly Accelerated Fibrosarcoma murine sarcoma viral oncogene homolog B) mutation status at this time or subsequently. He had a good response to this treatment and went on to have partial liver resection.

After this, the patient had "multiple" liver recurrences treated with RFA (radiofrequency ablation) and SBRT (stereotactic body radiation therapy), but it was not indicated that he had any additional chemotherapy.

This year, the patient developed a spinal metastasis with tumor infiltration of the L4 (fourth lumbar spine vertebra) vertebral body.

The plan is to treat the patient with Erbitux (cetuximab)/FOLFOX (fluorouracil/oxaliplatin).

No, the requested Erbitux (cetuximab) is not medically necessary.
The issue with the requested treatment with cetuximab is that the medical records do not document the results of KRAS (Kirsten rat sarcoma viral oncogene homolog), NRAS (neuroblastoma Rat sarcoma virus viral oncogene homolog) and BRAF (v-Rapidly Accelerated Fibrosarcoma murine sarcoma viral oncogene homolog B) mutation testing. The NCCN (National Comprehensive Cancer Network) Guidelines only support the use of cetuximab or panitumumab if the tumor is KRAS (Kirsten rat sarcoma viral oncogene homolog), NRAS (neuroblastoma Rat sarcoma virus viral oncogene homolog) and BRAF (v-Rapidly Accelerated Fibrosarcoma murine sarcoma viral oncogene homolog B) mutation negative (1).

The reason for this is because tumors that have KRAS (kirsten rat sarcoma viral oncogene homolog) or NRAS (neuroblastoma Rat sarcoma virus viral oncogene homolog) mutations (2, 3, 4). Similarly, tumors with BRAF (v-Rapidly Accelerated Fibrosarcoma murine sarcoma viral oncogene homolog B) mutations also do not respond well to treatment with cetuximab (5, 6, 7).

As the records did not document that the tumor was KRAS (Kirsten rat sarcoma viral oncogene homolog), NRAS (neuroblastoma Rat sarcoma virus viral oncogene homolog), and BRAF (v-Rapidly Accelerated Fibrosarcoma murine sarcoma viral oncogene homolog B) mutation negative, the treatment would not be medically necessary. That the patient had responded earlier to treatment with cetuximab/FOLFIRI ((fluorouracil/irinotecan) does not alter this determination. It cannot be determined from the history of response to treatment that the cetuximab component made any positive contribution to the observed response.

A faxed note of appeal wrote, "AS NOTED IN CHART, PATIENT CONFIRMED RAS (Rat sarcoma virus) WILD TYPE." The note references the provided medical records; the chart records provided make no mention of KRAS mutation testing and the accuracy of this statement of appeal cannot be assumed. In addition, there is no mention of NRAS (neuroblastoma Rat sarcoma virus viral oncogene homolog) or BRAF (v-Rapidly Accelerated Fibrosarcoma murine sarcoma viral oncogene homolog B) mutation testing in this faxed appeal note.

Without mutation testing, medical necessity for Erbitux cannot be confirmed.