Translate the text from Welsh to English.



 
Mae mynediad i feddyginiaethau i gleifion â ffeibrosis systig (CF) yn fater yr wyf i ac Aelodau’r Cynulliad wedi mynegi pryder dwfn yn gyson yn ei gylch.  Ym mis Chwefror, rhyddheais ddatganiad ysgrifenedig am fynediad i feddyginiaethau CF a wneir gan Vertex Pharmaceuticals.  Heddiw, yn sgil y cyhoeddiad gan Gonsortiwm Meddyginiaethau’r Alban 


(SMC) na all argymell defnyddio Orkambi® neu Symkevi®, dymunaf yn awr ddarparu diweddariad am y sefyllfa yng Nghymru.


Cyflwr difrifol a etifeddir yw ffeibrosis systig sy’n effeithio ar oddeutu 400 o bobl yng Nghymru, gan effeithio ar yr ysgyfaint a’r system dreulio yn bennaf.  Mae’n rhaid wrth driniaeth ddyddiol â ffisiotherapi, gwrthfiotigau, a chymryd tabledi ensymau gyda bwyd, ac mae’n lleihau ansawdd a hyd bywydau pobl yn arwyddocaol.  Ar hyn o bryd, nid oes dim modd gwella ac mae triniaethau yn anelu at reoli’r symptomau unigol.  


Mae CF yn cael effaith ddinistriol ar gleifion a’u teuluoedd ac wrth reswm rwy’n rhannu eu dymuniad am fynediad i driniaethau newydd effeithiol i’r clefyd cronig hwn.  


Gadewch imi fod yn glir, fy man cychwyn yw dymuno gweld meddyginiaethau newydd ac arloesol ar gael yn amserol ac yn gyson i gleifion yng Nghymru.  Mae buddsoddiad £80m y mae’r Llywodraeth hon yn ei wneud yn ein Cronfa Triniaethau Newydd yn sicrhau mai dyna’r sefyllfa i bob meddyginiaeth a werthusir ac a argymhellir gan y Sefydliad Cenedlaethol dros Ragoriaeth mewn Iechyd a Gofal (NICE) a’r Grŵp Strategaeth Feddyginiaethau Cymru (AWMSG), dau gorff gwerthuso technolegau iechyd a gydnabyddir yn rhyngwladol.   


Bu ivacaftor (Kalydeco®),y driniaeth addasu clefyd gyntaf i gleifion ag CF, ar gael i gleifion yng Nghymru ers 2012\.  Ers hynny, mae ei wneuthurwr, Vertex Pharmaceuticals, wedi dod â dau feddyginiaeth CF arall i’r farchnad, lumacaftor/ivacaftor (Orkambi®) a tezacaftor/ivacaftor (Symkevi®)   


Ystyriwyd argaeledd Orkambi® gan NICE a’r SMC yn 2016\.  Nid oedd yr un ohonynt yn gallu argymell ei defnyddio bryd hynny, ac yn 2017 ailgyhoeddodd NICE ei argymhelliad yn ganllaw “Peidiwch â’i Wneud,” gan bwysleisio na ddylai’r driniaeth hon fod ar gael fel rheol.  


Mae cyhoeddiad heddiw gan yr SMC yn glir na all argymell defnyddio Orkambi®, er gwaethaf tystiolaeth newydd a’r gytundeb am bris gostyngedig newydd.  Ni all yr SMC argymell defnyddio Symkevi® ychwaith.  Yn achos y ddwy feddyginiaeth, mae penderfyniadau’r SMC yn cadarnhau nad oedd yr achosion clinigol nac economaidd yn ddigon cadarn i gael ystyried y naill feddyginiaeth neu’r llall yn gost\-effeithiol, hyd yn oed ar y pris gostyngedig a gynigiwyd gan Vertex.  


Ers 2016, rydym wedi estyn gwahoddiadau lu i Vertex ymgysylltu â phroses werthuso AWMSG.  Yn y pen draw, ysgrifennodd Vertex ataf ym mis Mehefin i gadarnhau eu bwriad i wneud cyflwyniad i AWMSG o ran Orkambi® a Symkevi® ill dau.  Fodd bynnag, hyd yn hyn nid yw Vertex wedi anfon cyflwyniad at AWMSG am y naill feddyginiaeth neu’r llall.  


Mae ein GIG yn dibynnu ar werthusiadau seiliedig ar dystiolaeth er mwyn sicrhau y defnydd gorau o’i adnoddau cyfyngedig.  Mae’r penderfyniad diweddaraf hwn gan gorff gwerthuso arbenigol yn ychwanegu at y dystiolaeth nad yw prisiau Vertex yn adlewyrchu effeithiolrwydd clinigol eu meddyginiaethau, a bod y GIG yn gywir i beidio â’u hystyried yn driniaethau arferol i CF.  Anogaf Vertex i fyfyrio ar eu mecanwaith prisio a chadernid eu data clinigol, cyn gwneud cyflwyniad brys i AWMSG.


Caiff y datganiad ei gyhoeddi yn ystod y toriad er mwyn rhoi'r wybodaeth ddiweddaraf i aelodau. Os bydd aelodau eisiau i mi wneud datganiad pellach neu ateb cwestiynau ynglŷn â hyn pan fydd y Cynulliad yn dychwelyd, byddwn yn hapus i wneud hynny.







Translation:


 
Access to medicines for patients with cystic fibrosis (CF) is a matter about which I and Assembly Members have regularly expressed deep concern. In February, I issued a written statement about access to the CF medicines manufactured by Vertex Pharmaceuticals. Today, in light of the announcement by the Scottish Medicines Consortium (SMC) that they cannot recommend the use of either Orkambi® or Symkevi®, I now wish to provide an update on the situation in Wales.


Cystic fibrosis is a serious inherited disease affecting around 400 people in Wales, mainly affecting the lungs and digestive system. It requires daily treatment including physiotherapy, antibiotics, and taking enzyme tablets with food, and it significantly reduces the quality and duration of people’s lives. At present, there is no cure and current treatments aim to manage the individual symptoms.


CF has a devastating effect on patients and their families and obviously I share in their wish for access to effective new treatments for this chronic disease.


Let me be clear, my starting position is that I want to see new and innovative medicines made available promptly and consistently for patients in Wales. The £80m investment this Government is making in our New Treatment Fund is ensuring that is the case for all medicines appraised and recommended by the National Institute for Health and Care Excellence (NICE) and All Wales Medicines Strategy Group (AWMSG), 2 internationally recognised health technology assessment bodies.


Ivacaftor (Kalydeco®), the first disease\-modifying treatment for patients with CF, has been available to patients in Wales since 2012\. Since that time, its manufacturer Vertex Pharmaceuticals has brought two further CF medicines, lumacaftor/ivacaftor (Orkambi®) and tezacaftor/ivacaftor (Symkevi®) to market.


The availability of Orkambi® was considered by NICE and the SMC in 2016\. Neither body was able to recommend its use then, and in 2017 NICE re\-issued its recommendation as “Do Not Do” guidance, emphasising this treatment should not be routinely available.


Today’s announcement by the SMC is clear that, despite new evidence and the agreement of a new discounted price, they remain unable to recommend the use of Orkambi®. Neither is SMC able to recommend the use of Symkevi®. In the case of both of these medicines, the SMC’s decisions confirm the clinical and economic cases presented were insufficiently robust to allow either medicine to be considered cost\-effective, even at the discounted price offered by Vertex.


Since 2016, we have repeatedly invited Vertex to engage in the AWMSG appraisal process. Eventually in June, Vertex wrote to me confirming their intention to make a submission to AWMSG in respect of both Orkambi® and Symkevi®. However, to date Vertex has still not sent AWMSG a submission for either medicine.


Our NHS relies on evidence\-based appraisals to ensure that its limited resources are used to best effect. This latest decision by an expert appraisal body adds to the evidence that Vertex’s pricing does not reflect the clinical effectiveness of their medicines, and that the NHS is right not to consider them as a routine treatment for CF. I urge Vertex to reflect on their pricing mechanism and the robustness of their clinical data, before making an urgent submission to AWMSG.


This statement is being issued during recess in order to keep members informed. Should members wish me to make a further statement or to answer questions on this when the Assembly returns I would be happy to do so.