Transplantation and Expanded Criteria Donors: Hepatitis C

It is a well-known fact that there is a shortage of organs for those who desperately need them. It has been called a burgeoning crisis in organ supply that challenges the transplant community to reassess the thresholds for acceptable risk and to maximize and optimize the use of organs from all consenting donors.

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In 2018 there were more transplants than ever: 36,500. Depending on the region, the average wait time for a deceased donor organ can be a few months to as long as 5 years. Mortality rates are increasing while people are waiting for an organ. This shortage of available organs has led to the increased use of Expanded Criteria Donors in transplant centers for many different organs. This article discusses liver transplant recipients who are hepatitis C negative and receive a liver from an expanded criteria liver donor who is Hepatitis C positive. As of 7/24/19, there were 13,117 people in the U.S. waiting for a liver transplant.

What is an Expanded Criteria Donor (ECD)?

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Essentially, an Expanded Criteria Donor is a donor who is older than 60 and who may have a significant medical history or chronic disease (such as obesity, hypertension, diabetes). They may not have perfect labs in relation to the organ they are donating. Each organ has its own specific set of criteria for transplant eligibility. From an organ point of view, the donor, graft survival, and function of the organ are not considered ideal or standard but use of the ECD organ can significantly shorten the waiting time to transplant. The ideal deceased donor organ has historically come from a young donor, who has suffered a trauma or anoxic event resulting in brain death and who has had a short period of time between said event, brain death and organ harvest.

Why is this important?

Due to an aging population along with the rising incidence of obesity, diabetes, non-alcoholic fatty liver disease, and the opioid epidemic, the quality of donor organs is expected to decrease, which in turn results in decreased use of those organs.

Also important to note is that as the field of transplantation has evolved and medicine has improved, e.g. introducing immunosuppression for treatment of organ rejection, transplant outcomes have therefore improved. Better outcomes mean more patients are referred for transplant, and thus while supply is limited, demand is rising. Studies have shown that using ECDs has increased the organ pool for liver, lung, and kidney transplant with positive outcomes.

It is important to note that these organs must be matched to the best recipient, not necessarily the sickest; that is, a patient who can tolerate the less-than-ideal organ in order to maintain an acceptable outcome. It is also vitally important that the patient be advised of what an expanded criteria organ means in relationship to his health and long-term prognosis. The patient must be in agreement to accept this type of organ vs. continuing on the wait list.

Up until a few years ago, the treatment of Hepatitis C was difficult and prolonged, with many patients never completing the full course of treatment. Historically transplantation of an organ that was Hepatitis C antibody-positive would only be transplanted into a patient who was also Hepatitis C antibody-positive. If there was not a Hepatitis C-positive recipient, those organs were discarded. 

With the advent of direct acting anti-viral drugs such as Harvoni and Solvaldi for the treatment and eradication of Hepatitis C, donor livers that are Hepatitis C-positive are now being used in Hepatitis C-negative patients. These drugs have a high success rate, greater than 90%, and are well tolerated by the patient. Why is this significant? Because those patients receiving such an organ will now be infected with Hepatitis C thru the transplantation of that organ and will need subsequent treatment for it. Treatment costs are not insignificant, and it is important that the patient understand that s/he will need to be treated for the disease in order to maintain the new organ.

The literature suggests that treatment for Hepatitis C post-transplant be authorized up front, before the actual transplant. However, in discussions with transplant networks and in our experience as an MGU, it is not always known that the member will be receiving a Hepatitis C-positive organ, nor do we always know if the patient is Hepatitis C positive or negative. In the past, patients have been treated for the Epstein-Barr Virus (EBV) and Cytomegalovirus (CMV) prophylactically, as it is known that the virus can possibly be transferred to the recipient. In the case of Hepatitis C-positive donors, it is known up front that the patient will intentionally be infected with a disease and will require treatment. Treatment costs can range from approximately $24,000 to $185,000, depending upon which drug is prescribed and the duration.                                  

According to Milliman’s research report 2017 US Organ and Tissue Transplant Cost Estimates and Discussion, the entire episode of treatment from pre-transplant to 180 days post-transplant discharge, including Rx (immunosuppressants), had an estimated average billed cost of $812,500. The liver transplant itself can range from approximately $350,000 to $850,000 as a general range for the commercial population (without complications), depending upon where in the United States it occurs. Costs for Hepatitis C treatment after transplant will be in addition to these estimated costs.

Reinsurance Coverage

It is important to review your plan document and benefit coverage to ensure your plan covers such treatment. Does your plan language address such items as Expanded Criteria Donor and any resulting need for treatment? Are you seeing requests for prior authorization of drugs for treatment of Hepatitis C that was or will be transmitted during a liver transplant? For many plans, the cost of Hepatitis C treatment in addition to the liver transplant may push claims beyond their excess loss retention or deductible.

We have reviewed this issue and reached out to our reinsurance partner, Zurich American Insurance Company. After review, Zurich will cover Hepatitis C-positive livers being transplanted in Hepatitis C-negative recipients, assuming the transplant has been reviewed and approved for medical necessity and there are no exclusions or limitations in the plan document. Subsequent Hepatitis C treatment with direct acting antiviral medications will also be covered under excess loss assuming treatment has been determined to be medically necessary and there are no limitations or exclusions in the plan document regarding such treatment.

Article written by Ginny Fisher, RN, BSN, Managed Care Specialist for Summit Reinsurance Services, Inc. For more information about how this may affect your plan, please contact your Summit ReSources care specialist. The following sources were used as reference material for this article:                                        Clin Liver Dis 2017May;21 (2): 289-301