However, long term oral maintenance immunosuppression and other prescription medications can cost patients upwards of $2,500.00 per month depending on various factors including the number of prescription medications, insurance coverage, with the average annual cost of medications in the United States reported between $10,000 and $14,000 per patient ( 3). There is a clear cost savings to transplantation in support of kidney failure in place of hemodialysis ( 2). The average reported cost of a solid organ transplant ranges from $260,000.00 for a single kidney transplant to over $1.2 million dollars for combined heart and lung transplants ( 1). The advent of these biologics, often adapted from the use in autoimmune disease, has further complicated the cost of therapy. To date, there are no FDA approved medications for antibody mediated rejection (AMR), and so off label use of biologics and other small molecules becomes commonplace. When antibody mediated injury occurs, therapy to mitigate B cell responses and plasma cells are engaged. These agents are specific to mitigating T cell responses against the allograft. Therapy is needed indefinitely, for the duration of the allograft. These typically consist of corticosteroids, a calcineurin inhibitor (CNI), and an anti-metabolite, often mycophenolic acid. Long term suppression of the immune response requires a combination of agents taken orally. These biologics are potent and only used for specific total doses and in the short time period post-operatively. Historically this consisted of high dose intravenous corticosteroids, but now entails the use of biological therapies that suppress T cell function or cause T cell depletion. Therapy begins at the time of transplant using induction therapy. Immunosuppression is required for the lifetime of a solid organ transplant to prevent rejection. These new therapies are of high value to the community but will contribute additional burden to current drug costs. Finally the pipeline of new therapies is limited due to the cost of development of a drug, the inherent cost of clinical studies, and lack of defined endpoints for newer therapies in high risk patients. The impact of the Affordable Care Act remains uncertain at this time. While in kidney transplantation, Medicare part B covers three years of medication, there is frequent non-adherence due to cost after that time-point. Moreover, transplant Centers are managing higher risk transplant recipients that require more complex induction regimens and longer term use of such biologic agents in the context of desensitization or abrogation of de novo antibody mediated injury. For those lacking long term insurance coverage, this may be a significant out of pocket expense that is not affordable. The cost of these medications is a constant concern and the advent of generics has brought this cost down modestly.
Conventional therapy includes both induction therapy (a biologic that is infused peri-operatively) followed by maintenance therapy. A solid organ transplant is life-saving therapy that engenders the use of immunosuppressive medications for the lifetime of the transplanted organ and its recipient.
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