In October 2015, NICE recommended that Tolvaptan (JINARC®) therapy should be made available for selected patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) in England and Wales In January 2016, the Scottish Medicines Consortium (SMC) also approved Tolvaptan for use in Scotland. Currently Tolvaptan is being used in Canada, Japan, Korea and Switzerland for ADPKD and has been approved for use in Europe by the European Medicines Agency (EMA).
NICE recommended that patients with ADPKD who may be eligible for treatment must have Stage 2 or 3 chronic kidney disease (CKD) and ‘evidence of rapidly progressing disease’. SMC have approved its use for Stages 1-3 CKD, similar to that recommended by the EMA. The definition and evaluation of ‘rapid progression’ are however not established and have not been stipulated by NICE, SMC or the EMA. The main purpose of this commentary is to address the issue of how to identify patients with evidence of or who are at risk of rapid disease progression.
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