English: Thank you, Presiding Officer. Last July, I announced the establishment of an independent review of the IPFR process - the individual patient funding request process. The purpose of the review was to look afresh at the clinical criteria - usually referred to as 'clinical exceptionality' - used to make IPFR decisions and the potential to reduce the number of IPFR panels in Wales. My approach to this review has been to try to be open, inclusive and transparent from the outset. That involved all political parties, the public and the NHS in Wales. For example, health opposition spokespeople have been fully involved in the whole process, including briefing sessions with the chair of the review group at the outset and conclusion of the review. The patient perspective featured strongly. Two patients were members of the review group and discussion sessions were held across Wales for patients, their families and carers and patient organisations. The pharmaceutical industry, health boards and clinicians participated fully, giving their views on how the process could be improved. I published the report of the review in January this year, as soon as it was available, to provide everyone with the earliest opportunity to consider the findings and the recommendations. In parallel, my officials have been discussing the report with health boards, the Association of the British Pharmaceutical Industry Cymru Wales and our medicines experts at the All-Wales Therapeutics and Toxicology Centre, which I hope you'll forgive me for referring to, from now on, as the AWTTC. The consensus is that this is a helpful report that makes thoughtful and pragmatic recommendations that will help health boards to deal with what are sensitive and very often complex decisions. I am particularly pleased that the patient voice has centre stage in the report. I will now deal with the review group's recommendations on the issues that they were asked to consider. Clinical exceptionality has been the underpinning principle upon which IPFR decisions have been made across the UK. It is not a well understood concept, and is open to varying interpretation. This is discussed fully in the report with practical recommendations to reform the IPFR decision criteria, which have been broadly welcomed. The proposed changes cover situations where there is a recommendation from the National Institute for Health and Care Excellence or the All-Wales Medicines Strategy Group, which I'll now refer to as NICE and the AWMSG respectively. They also refer to cases where a recommendation from NICE or the AWMSG has not been made. The review group recommends a new two-part test covering, as a first point, a significant clinical benefit to the patient and, secondly, value for money. This means assessing the degree of clinical benefit expected by the treatment, and whether the cost of the treatment is in balance with the expected benefits. In relation to whether the number of IPFR panels should be reduced, the review group concluded that the risks inherent in moving to a single national panel or reducing the number of panels negated any compelling argument for change. The review group has, however, made other helpful recommendations to support health boards in making further improvements to the process. This includes clarifying commissioning policies and embedding IPFR policy within those frameworks, and strengthening the central expert support, quality assurance and governance function of the AWTTC. Health boards, supported by the AWTTC, have already begun the initial work to reform the clinical decision criteria with the aim of making this change to the guidance by May. Today, I've written to health board chairs to confirm the arrangements for implementing all of the recommendations by September of this year. Health boards will always have to make difficult choices about the relative clinical benefits versus the cost and the value for money at an individual patient level, balanced against the health needs for their local population. IPFR decisions will therefore always be sensitive. However, taken together, all of the recommendations, when implemented, will have a positive impact on the IPFR process, making it more easily understandable and less prone to being misused. The IPFR process has a place within the policy framework for access to treatment for a relatively small number of individuals. For the majority of the population, we will continue to place the appraisal process at the centre of our evidence-based approach, ensuring people have access to clinically and cost-effective treatment. The new £80 million treatment fund I announced in January supports this approach by providing earlier access to new medicines recommended by NICE or the AWMSG. The review group endorses our policy position of placing appraisal at the heart of decisions on the routine availability of treatment. They also highlight the importance of appraisal as the best way to evaluate clinical effectiveness and value for money. In particular, I welcome their recommendation that the pharmaceutical industry should submit their medicines for appraisal as soon as possible after licensing to ensure a timely and transparent appraisal of the clinical benefits. We have a good relationship with the industry and the Association of the British Pharmaceutical Industry Cymru Wales. The ABPI and individual companies engage with us and the AWMSG on the appraisal agenda and the wider new medicines work. The ABPI contributed to the review group's work and are supportive of implementing the report's recommendations. I will, of course, continue to support and encourage industry to work with us and NHS Wales to ensure the earliest possible access to innovative treatments. I would like to finish by thanking the review group in their entirety for their effort and commitment in tackling what is a highly complex area, and in doing so compassionately and intelligently, and delivering their recommendations within a challenging timeframe.
Welsh: Diolch, Lywydd. Fis Gorffennaf diwethaf, cyhoeddais sefydlu adolygiad annibynnol o'r broses IPFR - y broses ceisiadau cyllido cleifion unigol. Pwrpas yr adolygiad oedd edrych o'r newydd ar y meini prawf clinigol - y cyfeirir atynt fel rheol fel 'eithriadoldeb clinigol' - a ddefnyddir i wneud penderfyniadau IPFR a'r potensial i leihau nifer y paneli IPFR yng Nghymru. Rwyf wedi ceisio cadw agwedd agored, gynhwysol a thryloyw tuag at yr adolygiad hwn ers y dechrau. Roedd hynny'n cynnwys yr holl bleidiau gwleidyddol, y cyhoedd a'r GIG yng Nghymru. Er enghraifft, mae llefarwyr iechyd y gwrthbleidiau wedi chwarae rhan lawn yn y broses gyfan, gan gynnwys sesiynau briffio gyda chadeirydd y grŵp adolygu ar ddechrau a diwedd yr adolygiad. Roedd safbwynt y claf yn elfen gref. Roedd dau o gleifion yn aelodau o'r grŵp adolygu a chynhaliwyd sesiynau trafod ledled Cymru i gleifion, eu teuluoedd a'u gofalwyr a sefydliadau cleifion. Cymerodd y diwydiant fferyllol, byrddau iechyd a chlinigwyr ran lawn, gan roi eu barn am sut y gellid gwella'r broses. Cyhoeddais adroddiad yr adolygiad ym mis Ionawr eleni, cyn gynted ag yr oedd ar gael, er mwyn i bawb gael cyfle cyn gynted â phosibl i ystyried y canfyddiadau a'r argymhellion. Ochr yn ochr â hynny, mae fy swyddogion wedi bod yn trafod yr adroddiad â'r byrddau iechyd, Cymdeithas Diwydiant Fferyllol Prydain Cymru Wales a'n harbenigwyr ar feddyginiaethau yng Nghanolfan Therapiwteg a Thocsicoleg Cymru Gyfan, a gobeithiaf y gwnewch faddau imi am gyfeirio at honno, o hyn ymlaen, fel yr AWTTC. Y consensws yw bod hwn yn adroddiad defnyddiol sy'n gwneud argymhellion meddylgar ac ymarferol a fydd yn helpu byrddau iechyd i ymdrin â'r penderfyniadau sensitif hyn sy'n aml iawn yn rhai cymhleth. Rwy'n arbennig o falch mai llais y claf sydd bwysicaf yn yr adroddiad. Rwyf nawr yn mynd i ymdrin ag argymhellion y grŵp adolygu am y materion y gofynnwyd iddynt eu hystyried. Mae eithriadoldeb clinigol wedi bod yn egwyddor sylfaenol ac yn sail i benderfyniadau am IPFR ledled y DU. Nid oes dealltwriaeth dda o'r cysyniad, ac mae'n agored i amrywiol ddehongliadau. Mae'r adroddiad yn trafod hyn yn llawn ac yn gwneud argymhellion ymarferol i ddiwygio meini prawf penderfyniadau IPFR, sydd wedi cael croeso cyffredinol. Mae'r newidiadau arfaethedig yn cynnwys sefyllfaoedd lle ceir argymhelliad gan y Sefydliad Cenedlaethol dros Ragoriaeth mewn Iechyd a Gofal neu Grŵp Strategaeth Feddyginiaethau Cymru, y byddaf nawr yn cyfeirio atynt fel NICE ac AWMSG yn y drefn honno. Maent hefyd yn cyfeirio at achosion lle nad yw NICE nac AWMSG wedi gwneud argymhelliad. Mae'r grŵp adolygu'n argymell prawf dwy ran newydd i gynnwys, fel pwynt cyntaf, budd clinigol sylweddol i'r claf ac, yn ail, gwerth am arian. Mae hyn yn golygu asesu faint o fudd clinigol a ddisgwylir gan y driniaeth, ac a yw cost y driniaeth yn gymesur â'r buddion disgwyliedig. O ran a ddylid bod wedi lleihau nifer y paneli IPFR, casgliad y grŵp adolygu oedd bod y risgiau cynhenid wrth symud at un panel cenedlaethol neu leihau nifer y paneli yn negyddu unrhyw ddadl rymus dros newid. Mae'r grŵp adolygu, fodd bynnag, wedi gwneud argymhellion defnyddiol eraill i gefnogi byrddau iechyd i wneud gwelliannau pellach i'r broses. Mae hyn yn cynnwys egluro polisïau comisiynu ac ymgorffori polisi IPFR o fewn y fframweithiau hynny, a chryfhau swyddogaethau cefnogaeth arbenigol ganolog, sicrwydd ansawdd a swyddogaeth llywodraethu yr AWTTC. Mae byrddau iechyd, gyda chymorth yr AWTTC, eisoes wedi dechrau'r gwaith cychwynnol i ddiwygio'r meini prawf ar gyfer penderfyniadau clinigol gyda'r nod o wneud y newid hwn i'r canllawiau erbyn mis Mai. Heddiw, rwyf wedi ysgrifennu at gadeiryddion byrddau iechyd i gadarnhau'r trefniadau i roi pob un o'r argymhellion ar waith erbyn mis Medi eleni. Bydd yn rhaid i fyrddau iechyd wneud dewisiadau anodd bob amser am y manteision clinigol cymharol yn erbyn y gost a'r gwerth am arian ar lefel cleifion unigol, gan gydbwyso hyn ag anghenion iechyd eu poblogaeth leol. Felly, bydd penderfyniadau IPFR bob amser yn sensitif. Fodd bynnag, gyda'i gilydd, bydd yr holl argymhellion, ar ôl eu rhoi ar waith, yn cael effaith gadarnhaol ar y broses IPFR, gan ei gwneud yn haws ei deall ac yn llai tueddol o gael ei chamddefnyddio. Mae gan y broses IPFR le o fewn y fframwaith polisi ar gyfer mynediad at driniaeth ar gyfer nifer cymharol fach o unigolion. Ar gyfer y rhan fwyaf o'r boblogaeth, byddwn yn parhau i sicrhau bod y broses werthuso yn ganolog i'n dull seiliedig ar dystiolaeth, gan sicrhau bod triniaeth glinigol effeithiol a chost-effeithiol ar gael i bobl. Mae'r gronfa driniaeth newydd gwerth £80 miliwn a gyhoeddais ym mis Ionawr yn cefnogi'r ymagwedd hon drwy ddarparu mynediad cynharach at feddyginiaethau newydd a argymhellir gan NICE neu'r AWMSG. Mae'r grŵp adolygu yn cefnogi ein safbwynt polisi o sicrhau bod gwerthuso yn ganolog i benderfyniadau am argaeledd arferol triniaeth. Maent hefyd yn amlygu pwysigrwydd gwerthuso fel y ffordd orau o werthuso effeithiolrwydd clinigol a gwerth am arian. Yn benodol, ryw'n croesawu eu hargymhelliad y dylai'r diwydiant fferyllol gyflwyno eu meddyginiaethau i'w gwerthuso cyn gynted â phosibl ar ôl eu trwyddedu i sicrhau gwerthusiad amserol a thryloyw o'r buddion clinigol. Mae gennym berthynas dda â'r diwydiant ac â Chymdeithas Diwydiant Fferyllol Prydain Cymru Wales. Mae'r ABPI a'r cwmnïau unigol yn ymgysylltu â ni a'r AWMSG am yr agenda werthuso a'r gwaith ehangach ar feddyginiaethau newydd. Cyfrannodd yr ABPI at waith y grŵp adolygu ac maent yn gefnogol i roi argymhellion yr adroddiad ar waith. Byddaf, wrth gwrs, yn parhau i gefnogi ac annog diwydiant i weithio gyda ni a GIG Cymru i sicrhau'r mynediad cynharaf posibl at driniaethau arloesol. Hoffwn orffen drwy ddiolch i'r grŵp adolygu yn eu cyfanrwydd am eu hymdrech a'u hymroddiad wrth ymdrin â'r maes cymhleth iawn hwn, gan wneud hynny mewn modd tosturiol a deallus, ac am ddarparu eu hargymhellion o fewn amserlen heriol.