Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Cancer
Treatment: Surgical Services
The insurer denied the liver transplant. 
The denial is overturned.

The patient is a male who underwent a sigmoid resection and left hepatectomy for sigmoid cancer (T-laNlb) metastatic to the liver. His other medical issues include hypertension, diabetes and a myocardial infarction. His positron emission tomography (PET) scan is negative for extrahepatic malignancy. He has undergone chemotherapy and is maintained on Gemzar. His oncologic situation has been stable for one year. He meets Oslo criteria. He passed his transplant evaluation in terms of cardiology (stress test was negative for ischemia and his ejection fraction was 73%), social work and frailty assessments. There are no other contraindications for liver transplantation.

All of the documentation has been reviewed. The question under review is whether liver transplantation is more beneficial than standard of care. The answer is yes. Although the experience is small and mostly in Europe, it would appear that the five year survival is approximately 70% compared to roughly 10% with standard of care. This also represents competitive overall survival compared to other transplant necessitating diagnoses. Hence, it does not lead to organ wastage.

This indication is appropriate as it (and the patient's candidacy) have been approved by the Institutional review Board which is multi-disciplinary and has a high threshold for safety and equity. Liver transplantation has been performed for this indication in the United States and abroad. It is this reviewer's opinion that it will become standard of care and is only stymied by the organ donor shortage.

The contraindication of extrahepatic metastasis from primary liver tumors does not apply. In this scenario, these metastases are to the liver and the primary has been controlled. Similar accepted indications are metastatic (to the liver) gastrointestinal stromal tumors (GIST), neuroendocrine tumors and ocular melanomas.

The Oslo group (as reported herein) reported excellent survival albeit with very high recurrence rates. Toso, et al, in a "letter from the frontline," indicated that planned liver transplantation in appropriately selected patients can lead to excellent outcomes. Dr. Mazzaferro, who developed the Milan Criteria for liver transplantation for hepatocellular cancer has written "the arguments for loosened criteria are more valid" because of improved management compared to the past. There is now better understanding of tumor biology, better imaging technology and better chemotherapy.

As of June 2020, there were 7 prospective studies registered at Clinical Trials.gov. The working group from the International Liver Transplant Society wrote that "liver transplant can be a viable option in highly selected patients with unresectable colorectal liver metastasis." Last, it must be noted that liver transplantation is very heavily oversighted and transparent. Hence, this aggressive posture must be well thought out in order to ensure patient safety, hospital and program security and respect to the precious resource that is a donor liver. This reviewer feels this indication is appropriate.