Costimulation Blockade: America First, Canada Second … What About Norway?

To the Editor: We read with interest the letter by Gill et al, “Commenting on Costimulation Blockade in Large Markets Only” (1Gill AJS Halloran P Jevnikar T Cole E Rush D Knoll G Costimulation blockade holds emerging hope for patients in large markets only.Am J Transplant. 2017; 17: 1147Abstract Full Text Full Text PDF PubMed Scopus (1) Google Scholar). They pinpoint the fact that for a long time, the United States has been the testing ground for the development and commercialization of new therapeutics. This is a problem for therapeutics with small target patient populations such as immunosuppressant drugs. The authors anticipate that this will be a bigger issue in the future, arguing that establishing a market foothold for new transplant therapeutics in the U.S. market likely will be even more difficult with the availability of generic immunosuppressant drugs. What about us — Norway — a country with only 5.2 million inhabitants, small compared with the population of 35 million in Canada and virtually nothing compared with the 321 million inhabitants of the United States? Where do our patients stand? In 2015, the United States performed 17 878 kidney transplantations, Canada performed 1513, and Norway performed only 254. However, there is only one transplant center in Norway, so when assessed on a center-to-center basis, we are among the largest worldwide and active in clinical research. Some of our patients would definitely profit from the use of belatacept. We have tried to get BMS Norway interested in developing further knowledge on which transplant populations would benefit the most from belatacept. There has been no-nil-zero response. In the interest of our patients, we have drafted several clinical trials in which costimulation blockade is one of the treatment arms but there is a struggle in financing the study drug. In Norway, Social Security reimburses all oral immunosuppressive medication for all patients. Once the drug is given intravenously, the hospital has to cover the entire cost. We contacted the Norwegian Directorate of Health, the Norwegian Medicines Agency, Parliament members, and even the press to try to get access to and funding for use of the drug. There was no response nor at any time support or interest from BMS Norway. This year, we finally got the cost of belatacept accepted in the hospital budget, which would allow us to start studies. What happens then? Belatacept is not available for new patients—worldwide. We applaud and strongly support the invitation from Canada to get BMS engaged with clinicians in smaller markets. BMS will, however, probably still have “America first and now Canada second …” but please do not forget smaller markets like Norway! The authors of this manuscript have no conflicts of interest to disclose as described by the American Journal of Transplantation.

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