Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Metastatic colon cancer
Treatment: Lapatinib
The insurer denied the Lapatinib.
The denial is overturned. 

The patient is a female with metastatic colon cancer. Other medical problems include asthma and obesity. Her tumor was human epidermal growth factor receptor II (HER-2) amplified on FoundationOneCDx testing. Microsatellite instability testing was negative. V-raf murine sarcoma viral oncogene homolog B1 (BRAF), kirsten rat sarcoma viral oncogene homolog (KRAS) and neuroblastoma ras viral oncogene homolog (NRAS) mutation testing was negative. Tumor mutation burden was ten mutations/megabase. 

The patient was diagnosed with colon cancer metastatic to multiple sites within the abdominal cavity including fallopian tubes, ovaries, and appendix. She was treated with panitumumab/FOLFOX with response. She developed progression of disease while on a break from chemotherapy and was started on treatment with fluorouracil/leucovorin/panitumumab. She developed progression of disease. She was then treated with panitumumab/FOFLRI. The interval history from this date reads: "She reports occasional rectal bleeding when she is constipated. Recently had an abnormal Pap smear and underwent endometrial biopsy which was positive for metastatic colon cancer." She has progression of disease on imaging, and plan is for treatment with lapatinib/trastuzumab. 

The request was denied by the Plan as the testing results for human epidermal growth factor receptor II (HER2) were not provided. A letter of appeal (undated) was submitted. This letter explained that the patient was young, needed the medication, and referenced the provided records.

Yes, the proposed treatment is medically necessary.

The patient was treated with panitumumab/FOLFOX, but cannot tolerate more oxaliplatin due to peripheral sensory neuropathy. She has been treated with panitumumab/FOLFIRI, but has progressed.

The National Comprehensive Cancer Network (NCCN) Guidelines support as next line therapy (1):
"Regorafenibx
or
Trifluridine + tipiracil  bevacizumab
or
([Nivolumab  ipilimumab] or pembrolizumab [preferred]) (dMMR/MSI-H only)
or
(Trastuzumab + [pertuzumab or lapatinib]) or fam-trastuzumab deruxtecan-nxkio HER2-amplified and RAS and BRAF WT".

The FoundationOneCDx test performed was positive for human epidermal growth factor receptor II (HER-2) amplification and kirsten rat sarcoma viral oncogene homolog (KRAS)/neuroblastoma ras viral oncogene homolog (NRAS) and V-raf murine sarcoma viral oncogene homolog B1 (BRAF) were all wild type. The National Comprehensive Cancer Network (NCCN) supports the use of lapatinib plus trastuzumab to treat this patient. 

This treatment is also supported by the phase II HERACLES trial (2).

The treatment is supported by expert guidelines and the medical literature. It would be considered medically necessary.

This was previously denied due to lack of supporting testing. In order for this treatment to be appropriate, the tumor must be positive for human epidermal growth factor receptor II (HER2) amplification and not contain neuroblastoma ras viral oncogene homolog (NRAS), kirsten rat sarcoma viral oncogene homolog (KRAS) or v-raf murine sarcoma viral oncogene homolog B1 (BRAF) mutations. The request for coverage was previously denied as this information had not been provided. 

This information was provided in the information submitted for the appeal and this additional information supports the medical necessity of the treatment. The reversal of the denial decision is based solely on the new information provided.