New perspectives for the organ transplantation market
Organ transplantation helps to save overall costs. Of all organ transplantations, kidney transplantation is the most frequent by a wide margin (66% of total transplanted organs in 2016).1 Despite the high cost, various health economics studies found that the procedure is cost-saving. To mention one of the studies: “In conclusion, kidney transplantation is cost-effective across all donor types despite higher costs for marginal organs and innovative living donor practices.”2
The number of worldwide organ transplantations is rising
Between 2000 and 2016, worldwide organ transplantations have increased from around 40'000 per year to around 135'000 per year (total of kidney, heart, lung, liver, pancreas, and small bowel).3 Still, there would be many more organ transplantations if there were no severe bottlenecks present which lead to long waiting lists to receive an organ transplant. For example, the number of patients added to US transplant waiting lists each year—roughly 50,000—is dwarfed by the ~730,000 annual US deaths attributable to end-stage organ disease.4
The bottlenecks to increase the number of transplants further
There are three bottlenecks that need to be addressed: Donor/recipient mapping, the shortage of available organs, and the lifespan a transplanted organ keeps working. For each of these challenges, digital health companies provide solutions. This Thematic Insight will mainly focus on how to address the shortage of available organs, and how to keep the transplanted organ working for longer.
The problem of organ allocation is complicated, as there is a wide variety of factors that have to be combined. One of the limitations has been the time it takes to keep an organ outside of the donor fresh enough to bridge the distance to the recipient. This hurdle kept transplantation centers from sharing the characteristics of the patients on their waiting lists hospitals far away. However, if transportation of the organ is enhanced, there should be more matches possible on a geographically wider area.
Every year, tens of thousands of Americans receive new organs. However, an average of about 8,000 people die every year waiting for the organs they need.
Addressing the shortage of available organs
The global shortage of organs for transplantation has long been recognized as a major public health challenge, and the World Health Organization (Geneva) estimates that only 10% of the worldwide need for organ transplantation is being met.6
There are two primary reasons behind the shortage of available organs: First, not enough potential donors carry a document to allow using their viable organs in the event of brain death. Various governments have begun to raise awareness within their population towards this matter. Spain for example had great success in increasing organ donation, albeit with a somewhat controversial legislation change: When attempting to explain Spain’s success, it’s the ‘opt-out’ (or presumed consent) system for deceased organ donation that is perhaps cited more often than anything else. Opt-out means that a patient is presumed to consent to organ donation even if they have never registered as a donor.7
Second, current transportation methods where the organs are put on ice often cause damage to the organ, which gets worse the longer it takes before it can be implanted. Recent approaches offer promising solutions to this issue: By keeping the harvested organ alive in a healthier condition, many more organs are eligible for transplantation – thus the radius of organ supply can be greatly enhanced. An interesting and innovative technological solution towards this goal is a “Organ-in-a-Box” solution: The OCS acts as a miniature intensive care unit that keeps organs alive and healthy by preserving them in a natural state that mimics the human body so that organs can remain viable for transplant along the way to recipients.8
Keep the transplanted organ working for longer
A transplanted kidney's lifespan is 15 to 20 years on average. If the kidney stops working, the patient is back on the waiting list for a new one. However, a second or even a third transplant is more complex, as finding a new good match between donor and recipient becomes increasingly difficult. In practice, this often results in patients having to undergo dialysis treatment for a long time, or even for the rest of their lives. To avoid this, extending the lifespan of transplant kidneys should be prioritized.9
Tests have recently been introduced to transplantation centers to monitor patients after transplantation. These tests are able to measure organ stress and help to take measures against organ failure. In many cases, an adjustment to the dose of immunosuppressing medication can keep the organ successfully engrafted and properly working. CareDX’s test, AlloSure, “is the first and only non-invasive test that assesses organ health by directly measuring allograft injury. AlloSure can accurately determine active rejection, enabling better management of […] kidney transplant patients. AlloSure is a clinically and analytically validated, non-invasive blood test that measures donor-derived cell-free DNA (dd-cfDNA), an indicator of kidney injury.”10
Cell-free DNA (cfDNA) is a clear biomarker: It is fragmented DNA in the bloodstream indicating cell injury and death. When graft injury occurs, donor-derived cell-free DNA increases in the blood. Measuring cfDNA is an accurate, non-invasive tool for kidney transplant surveillance – notably, it will enable the physician to adjust medication or to gauge whether the organ stress is due to any other factor, like poor medical compliance. Correcting before it’s too late enhances the long term success of the organ transplant, data that any transplantation hospital has to publicize.
Why it matters
For end stage renal disease patients as an example, a kidney transplant is generally a lot more appealing than chronic dialysis. Even when dialysis can be done at home instead of having to go to a dialysis center (home dialysis), the process still requires time and comes at a high cost and several medical risks. However, waiting lists are long and could grow even further. Despite the high cost of a transplantation, even the payors are generally favoring transplantations as the health economics look quite positive because of lower chronic care costs. Long waiting lists are not satisfactory to anybody and also raise difficult questions on how to best allocate available organs to candidates. With better donor/recipient matching databases, progress in organ transportation which will in turn increase the number of useable organs, and tests to predict the health of the implanted organ, it should be possible to transform the organ transplantation market in a way that will enable more patients to profit from a transplanted organ.
Organ transplantation has been growing, but is still constrained by donor/recipient mapping, not sufficient availability of donor organs, and transplanted organs failing too soon. For all these challenges, digital health companies offer solutions to mitigate the constraints, thereby increasing the number of transplants and shortening the waiting list. It is difficult to overcome the hurdles for more widespread transplantation without taking into account these fundamentally new approaches. Only through the combination of these new approaches the whole transplantation segment can be revolutionized, and many more patients, but also the payer, can profit from transplanted organs.
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