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What's New


                                               Kidney/Pancreas and Islet Transplantation: Version 7.0

What’s New?

1. Updated first year billed charges from Milliman:


See tables at the end of this Quick Reference Guide.

2. Allocation Policy Changes

Prior to October 30, 2014, pancreas as one component of SPK transplant was the only organ without a consistent national allocation scheme. Local variations and old policy peculiarities led to underutilization of pancreata, with large numbers of perfectly good organs being discarded. As a result of long efforts by the OPTN/UNOS Pancreas Committee, pancreas and SPK candidates now appear on a single match run list for organ offers, kidneys no longer go first before potential recipients for SPK and pancreas, and local candidates allocated a pancreas can receive a kidney if qualified. There was also a change in how diabetic uremic patient accrue SPK waiting time.

SPK adult candidates must be registered for an SPK transplant, are qualified to accrue kidney waiting time, and must be on insulin with a c-peptide ≤ 2 ng/mL, or if c-peptide is > 2 ng/mL, must have a BMI ≤ 30 kg/m2. The BMI was increased from 28 to 30 in July, 2015 because too few patients qualified as candidates for SPK.

The outcomes of these changes as related to the pancreas are being followed. Early results as seen in the transplant volumes in the Summary above, suggest that factors other than the allocation system changes are holding down the transplant rates.

3. Islet Transplantation:

Completed results from this trial, which began enrolling patients in 2004, were published in Diabetes Care on April 18, 2016. Of the 15 centers originally in the Clinical Islet Transplantation Consortium, 8 remained involved through the conclusion of this NIH-funded study, and in total enrolled 48 patients with Type 1 diabetes and hypoglycemic unawareness, the two primary inclusion criteria. After one year, 42 of the patients were free of severe hypoglycemic events, had established near-normal glucose control, and had regained hypoglycemic awareness. This met the study’s, and the FDA’s criteria for success. After two years, 34 of the patients still met those criteria. FDA approval is expected, with the next step being development of the licensing process for the cellular product as a “biologic” with its strict standards for production facilities. [1]
 
Success does not necessarily mean patients will be free of exogenous insulin requirements, although 25 of the patients no longer needed insulin therapy after one year. Patients are also not free of life-long immunosuppression, so the procedure should be limited to those already on immunosuppressants, often from a prior kidney transplant, or to those with frequent severe episodes of hypoglycemia in spite of optimal medical therapy. Data collection will continue to determine if the long term benefits outweigh the risks of infection, secondary malignancies, and other significant side effects of immunosuppression.

CMS through its National Coverage Decision for Islet Cell Transplantation continues to support this form of treatment within the context of this Clinical Trial (260.3.1), awaiting the FDA process for licensure. Medicare had paid for the routine costs and the transplantation for those participating in the trial.

4. Cellular therapy beyond islets is a topic of great interest. One company, ViaCyte, has produced a thin perforated strip of plastic that is inserted under the skin. The strip is perforated and filled with hundreds of thousand Beta cells grown from pancreatic stem cells. The University of California San Diego is following the first patient to have this encapsulated “box” inserted to see if it works to maintain tight control of blood sugar. Other research efforts are focused on transforming patients’ own liver cells in the lab into pancreatic cells that can be infused. Much of the thinking behind these efforts is to broaden the use of cellular preparations containing beta cells to treat both Types 1 and 2, plus those that have characteristics of both (the “thin” Type 2 population).

 

1 BJ Hering et al. Phase 3 trial of transplantation of human islets in type 1 diabetes complicated by severe hypoglycemia. Diabetes Care DOI: 10.2337/dc15-1988 (2016).