Translate the text from Welsh to English.



 
Mae ivacaftor (Kalydeco) yn feddyginiaeth newydd ar gyfer trin cleifion â ffibrosis systig a’r mwtaniad G551D yn y genyn CFTR. Mae ar gael i gleifion yn Lloegr ond nid yw’r Sefydliad Cenedlaethol dros Ragoriaeth mewn Iechyd a Gofal (NICE) wedi’i arfarnu. Cafodd ei arfarnu gan Gonsortiwm Meddyginiaethau’r Alban (SMC) ac ni argymhellwyd ei ddefnyddio. Ers hynny mae’r feddyginiaeth wedi’i hariannu drwy system newydd a sefydlwyd gan Lywodraeth yr Alban mewn ymateb i feddyginiaethau amddifad.

Yng Nghymru, arfarnwyd Kalydeco gan Grŵp Strategaeth Feddyginiaethau Cymru Gyfan (AWMSG) ar 8 Mai 2013\. Roedd hyn yn cwblhau proses a ddechreuwyd adeg y cysylltiad cyntaf â Vertex, gweithgynhyrchydd Kalydeco, ym mis Gorffennaf 2011 pan ofynnwyd iddynt gymryd rhan ym mhroses arfarnu AWMSG. Ar ôl arfarnu Kalydeco ar 8 Mai, ac mewn cyfarfod cyhoeddus, cyhoeddodd AWMSG mai’r cyngor oedd na ddylwn argymell defnyddio Kalydeco yn GIG Cymru. Er y bydd oddeutu 10 diwrnod arall fel arfer nes i mi gael cyngor ysgrifenedig gan AWMSG, gan fod rhaid caniatáu amser ar gyfer cyflwyno apeliadau, rwyf wedi penderfynu cyhoeddi’r datganiad hwn er mwyn egluro’r ffordd ymlaen.

Mae cyngor AWMSG mewn perthynas â Kalydeco wedi ystyried materion effeithiolrwydd cost a’r data sydd ar gael o dreialon clinigol. O ystyried mai cyfyngedig yw’r data, a bod y costau’n uchel – tua £180,000 y claf y flwyddyn – mae’r rhain yn ystyriaethau priodol iawn. Fodd bynnag, mae materion cydraddoldeb yn yr achos hwn yn fy arwain i’r casgliad bod yn rhaid canfod ffordd o ddarparu Kalydeco drwy GIG Cymru i’r cleifion cymwys hynny â ffibrosis systig. Rwy’n cael ar ddeall bod 13 o gleifion cymwys yng Nghymru ar hyn o bryd ac rwy’n cadarnhau y bydd Kalydeco ar gael i’r unigolion hyn. Mae gwaith bellach wedi cychwyn ar y manylion ar gyfer cyflwyno’r feddyginiaeth.

Yn y dyfodol, bydd meddyginiaethau eraill sydd yn y categori amddifad ac amddifad iawn, ac mae angen i mi sicrhau y gall ein proses arfarnu yng Nghymru eu gwerthuso’n effeithiol.  Rwyf felly wedi gofyn i’r Prif Swyddog Fferyllol drefnu adolygiad \[gyda phawb perthnasol sydd â buddiant] o’n proses arfarnu i ymdrin â’r meddyginiaethau newydd ac arloesol hyn ar gyfer clefydau prin. Byddaf yn adrodd i’r Cynulliad Cenedlaethol ar hynt y gwaith maes o law.

Yn olaf, hoffwn ganmol gwaith AWMSG, ei is\-grwpiau a’r staff sy’n parhau i roi cyngor i Weinidogion Cymru mewn ffordd effeithiol, effeithlon a thryloyw ar feddyginiaethau newydd rheoli meddyginiaethau yn strategol a phresgripsiynu. Caiff proses arfarnu technoleg iechyd AWMSG ei chydnabod yn rhyngwladol am fod yn drylwyr a thryloyw o ran rheoli’n effeithiol y mynediad i feddyginiaethau newydd, effeithiol a diogel ar gyfer cleifion yng Nghymru.







Translation:


 
Ivacaftor (Kalydeco) is a new medicine for the treatment of patients with cystic fibrosis and the G551D  mutation in the CFTR gene.   It has been made available to patients in England although it has not been appraised by the National Institute for Health and Care Excellence (NICE).  In Scotland it was appraised by the Scottish Medicines Consortium (SMC) and  was not recommended for use. It has been subsequently funded by a new mechanism set up by the Scottish Government to respond to orphan medicines.


In Wales, Kalydeco was appraised by the All Wales Medicines Strategy Group (AWMSG) on 8 May 2013, concluding a process which commenced when they first made contact with Vertex, the manufacturer of Kalydeco, in July 2011 and requested their engagement in the AWMSG appraisal process.  Following the appraisal of Kalydeco on  8 May, and at a meeting  held in public, AWMSG announced their advice to me  was  to not recommend Kalydeco for use in NHS Wales. Although it will normally be  a further 10 days or so before I receive the written advice from AWMSG, as they must now allow time for appeals to be lodged, I have decided to issue this statement to clarify the way forward.   

   

AWMSG’s advice in relation to Kalydeco will have taken into account issues of cost effectiveness and available clinical trial data.  Given that data is limited, and costs are high – at some £180,000 per patient per year, these are very proper considerations.  Issues of equity in this case, however, lead me to conclude that a way must be found to provide Kalydeco within NHS Wales for those eligible patients with cystic fibrosis.  I am currently advised that there are in the region of 13 eligible patients in Wales and I confirm Kalydeco will be available for these individuals.   Work on the detail of its introduction  is now underway.


In the future there will be other medicines which fall into the category of orphan and ultra orphan status and I need to ensure our appraisal process in Wales can effectively evaluate them.  I have therefore  asked the Chief Pharmaceutical Officer to set up a review  \[involving all relevant interests] of our appraisal process to deal with these new, innovative medicines for rare diseases. I will report back to the National Assembly on progress as it becomes available.


Lastly, I would like commend the work of the AWMSG, its subgroups and staff who continue to provide advice in an effective, efficient and transparent manner to  Welsh Ministers on new medicines, strategic medicines management and prescribing.  The AWMSG health technology appraisal process has an international recognition for operating a robust and transparent appraisal process to effectively manage  access to new, effective and safe medicines for patients in Wales.