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Getting Vertex Pharmaceuticals’ Orphan Drug Kalydeco (Ivacaftor) To The UK (September 25, 2012 Update)

September 26, 2012

       Getting Vertex Pharmaceuticals’ orphan drug Kalydeco (Ivacaftor) to the UK is a lengthy process.  This is an update to the Orphan Druganaut September 13, 2012, Blog Post. As described in that Blog Post, the steps to be taken are :

1)  Kalydeco is approved at the end of July 2012 by the European Medicines Agency (EMA)

2)  The process first starts in England, where the Clinical Reference Group (CRG) for CF is set up

3)  Then the CRG makes a Health Technology Appraisal (HTA), which will be reviewed.  A recommendation is then made on the supply of Kalydeco to CF patients in England

4)  The CF Trust is involved with other jurisdictions in the UK – Wales and Northern Ireland.  Wales and Norther Ireland have different arrangements for assessing issues related to the potential NHS funding of Kalydeco

5)   In Scotland, the Scottish Medicines Consortium (SMC) decides what drugs are to be funded by the NHS.

       Per The Cystic Fibrosis Trust in the UK, the Clinical Priorities Advisory Group (CPAG) met on September 25, 2012, and :

 “ …. we are awaiting a full read-out of what was discussed regarding Kalydeco. We expect to receive a statement tomorrow, (September 26, 2012) from the CPAG & we will publish it together with our response as soon as we get it. This will not be a final decision but we expect to hear the next steps….”

Copyright  © 2012-2013, Ann-Teresa Cusenza and Orphan Druganaut Blog.  All rights reserved.

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