A wnaiff Ysgrifennydd y Cabinet roi'r wybodaeth ddiweddaraf am y trafodaethau a gafodd Llywodraeth Cymru gyda Vertex Pharmaceuticals ynghylch y cyffur ffibrosis systig Orkambi?
There have been no formal discussions between the Welsh Government and Vertex about Orkambi® (lumacaftor/ivacaftor). However, I wrote to Vertex in September this year to remind it that a medicine must be appraised and recommended by National Institute for Health and Care Excellence (NICE) or the All-Wales Medicines Strategy Group (AWMSG) before it can be routinely provided by the NHS. It is Vertex’s responsibility to comply with the appraisal process.
To date, the company has only proposed a commercial agreement that covers Orkambi®, several other licensed Cystic Fibrosis medicines, and as many as 18 medicines which have not yet been licensed or appraised. This portfolio approach has been rejected in all parts of the UK.
It is for Vertex to decide whether it wishes to enter into a specific commercial arrangement for Orkambi® with the NHS in Wales, taking account of the uncertainties and anomalies identified by NICE. Any arrangement would require a clear and binding commitment to engage in a future health technology appraisal by NICE or AWMSG within a specified time (normally 12 months). As it stands, I have yet to see any tangible evidence that Vertex is willing to move on these important issues.