Translate the text from Welsh to English.



 
Cais Cyllido Claf Unigol (IPFR) yw’r broses y mae byrddau iechyd a Phwyllgor Gwasanaethau Iechyd Arbenigol Cymru (WHSSC) yn ei defnyddio i ystyried darparu claf â thriniaeth nad yw ar gael fel rheol yn GIG Cymru.  
  
Ym mis Gorffennaf 2016, cyhoeddais adolygiad annibynnol o’r broses IPFR, i ystyried y maen prawf a ddefnyddiwyd wrth wneud penderfyniadau IPFR – eithriadoldeb clinigol – a’r posibiliad o leihau nifer y paneli IPFR.  
  
Ym mis Ionawr y llynedd, cyhoeddais yr adroddiad a gofyn am adborth amdano.  Ym mis Mawrth cyhoeddais fy mod yn derbyn yr argymhellion yn yr adroddiad ac y byddwn yn eu gweithredu.  
  
Daeth yr adroddiad i’r casgliad y dylai clinigwr brofi yr enillai claf fudd clinigol arwyddocaol o’r driniaeth y gofynnwyd amdani a bod y driniaeth yn cynnig gwerth rhesymol am arian i GIG Cymru, yn hytrach na cheisio profi bod claf yn eithriadol yn glinigol (argymhelliad 11\).  Ym mis Mai 2017, cyhoeddodd GIG Cymru ganllawiau cenedlaethol newydd, Polisi GIG Cymru: Gwneud Penderfyniadau ynghylch Ceisiadau Cyllido Cleifion Unigol, sy’n ymgorffori’r meini prawf newydd hyn.  Mae pob bwrdd iechyd yng Nghymru yn cadw at y canllawiau newydd.  
  
Argymhellodd yr adroddiad y dylai pob bwrdd iechyd barhau i gael ei banel IPFR ei hun, yn hytrach na sefydlu un panel cenedlaethol, felly mae’r arfer hwn wedi parhau (argymhelliad 20\).  Ystyriwyd un panel yn anymarferol, oherwydd nifer y ceisiadau a logisteg rheoli un panel.  Ailddyluniwyd y ffurflen gais i adlewyrchu’r meini prawf newydd (argymhelliad 27\) a lansiwyd y fersiwn electronig ym mis Rhagfyr.  Datblygwyd templed safonol i gofnodion cyfarfod y panel IPFR er mwyn cofnodi brasamcan budd a gwerth yr IPFR (argymhelliad 15\) erbyn mis Medi.  
  
Cymeradwywyd deg argymhelliad (9, 12\-14, 16\-18 a 20\-22\) arferion cyfredol yn y GIG fel diystyru argaeledd triniaeth, fforddiadwyedd, neu ffactorau anghlinigol pan fo’r panel IPFR yn gwneud ei benderfyniad; ceisio cyngor arbenigol i’r panel IPFR pan fo angen; monitro deilliannau’r IPFRs a nodi’r rhesymau dros benderfyniad y panel.  Fe’u gweithredwyd ar unwaith, drwy barhau â’r arferion presennol.  
  
Aeth saith argymhelliad (2\-8\) i’r afael â materion comisiynu, a all effeithio ar IPFRs.  Cynhyrchodd GIG Cymru ganllawiau cymeradwyo ymlaen llaw Cymru gyfan a ffurflen gais (2 a 5\).  Cynhaliodd comisiynwyr byrddau iechyd gyfarfodydd i rannu arferion da a chydlynu gwasanaethau a gomisiynir (3\).  Ar wefan Canolfan Therapiwteg a Thocsicoleg Cymru Gyfan y mae gwybodaeth wedi’i diweddaru am sut mae’r broses IPFR yn gweithio a’r llwybrau comisiynu eraill ar gyfer mynediad i feddyginiaethau a thriniaethau eraill (4 a 6\).  Mae byrddau iechyd yn defnyddio testun safonol a gytunwyd i esbonio pam na chaiff cleifion yng Nghymru ddewis lle y’u trinnir (7\), er y caiff eu bwrdd iechyd eu hanfon at ddarparwr iechyd arall am driniaeth.  Adolygwyd gwefan WHSSC i roi gwybodaeth gliriach am y gwasanaethau y mae’n eu comisiynu a’r rhai nad yw (8\).  Gweithredwyd yr argymhellion hyn erbyn mis Hydref.  
  
Sefydlwyd grŵp gweithio gan staff y GIG i lunio fframwaith comisiynu newydd (argymhelliad 1\), sy’n adlewyrchu’r newidiadau a gafwyd drwy weithredu’r argymhellion eraill.  Mae’r fframwaith yn cael ei ddatblygu o hyd.  
  
Un argymhelliad (10\) oedd sefydlu polisi cenedlaethol cyson o ran defnyddio ymyriadau rhad y gofynnwyd amdanynt drwy IPFR.  Mae gan fyrddau iechyd a WHSSC drefniadau yn barod i wneud y mwyaf o ymyriadau sydd yr un mor effeithiol ond sy’n costio llai; er enghraifft, mae byrddau iechyd yn defnyddio meddyginiaethau generig a biodebyg yn barod yn lle meddyginiaethau brand drutach heb fod eisiau trefniadau cymeradwyo biwrocrataidd.  Ar adegau bydd yn briodol defnyddio’r broses IPFR hyd yn oed pan fo’r ymyriad yn rhad; nid yw’n briodol gwyro oddi ar y llwybr trin arferol dim ond am fod meddyginiaeth yn llai drud.    
  
Cafwyd tri argymhelliad (24\-26\) i wella’r hyfforddiant i glinigwyr.  Erbyn mis Medi, roedd clinigwyr wedi derbyn sesiynau hyfforddi fel rhan o’u datblygiad proffesiynol parhaus (24\); cafwyd nodiadau canllaw i glinigwyr am esbonio’r broses IPFR i gleifion (25\); datblygwyd canllaw gwneud penderfyniadau i helpu clinigwyr â’r broses ceisio am IPFR ac roedd gan bob bwrdd iechyd un man cyswllt i helpu â’r cais (26\).    
  
Sefydlwyd Grŵp Cynghorol Sicrhau Ansawdd a chafodd ei gyfarfod cyntaf ym mis Ionawr i adolygu IPFRs a ddewiswyd ar hap oddi wrth bob bwrdd iechyd (argymhelliad 19\).  Mae’r Grŵp yn adrodd i gyfarwyddwyr meddygol a Phrif Swyddog Meddygol Llywodraeth Cymru.  Mae’r aelodau wedi cyfrannu at ddatblygu deunyddiau hyfforddi newydd i gleifion a chlinigwyr (argymhelliad 23\).    
  
Hoffwn ailadrodd fy niolch i aelodau’r grŵp adolygu, am wneud tasg mor feichus ymhlith eu holl ymrwymiadau eraill; i’r cleifion a’r cyrff a ddarparodd dystiolaeth, ac i bawb sy wedi gweithio mor ddiwyd i wneud y broses IPFR yn symlach ac yn haws ei deall.  






Translation:


 
An Individual Patient Funding Request (IPFR) is the process health boards and the Welsh Health Specialised Services Committee (WHSSC) use to consider providing a patient with a treatment which is not routinely available in NHS Wales.  

  

In July 2016, I announced an independent review of the IPFR process, to consider the criterion used to make IPFR decisions \- clinical exceptionality \- and the potential to reduce the number of IPFR panels.    

  

In January last year I published the report and sought feedback on it.  In March I announced that I accepted and would implement the recommendations contained in the report.    

  

The report concluded that, rather than attempting to prove a patient was clinically exceptional, a clinician should prove the patient would gain significant clinical benefit from the treatment requested and that the treatment offered reasonable value for money for NHS Wales (recommendation 11\).  In May 2017, NHS Wales issued new national guidance NHS Wales Policy: Making Decisions on Individual Patient Funding Requests, which incorporates these new criteria.  All health board IPFR panels are adhering to the new guidance.  

  

The report recommended that each health board should continue to have its own IPFR panel, rather than establishing a single national panel, so this practice has continued (recommendation 20\).  A single panel was considered impracticable, due to the number of IPFRs and the logistics of managing a single panel.  The application form was re\-designed to reflect the new criteria (recommendation 27\) and the electronic version launched in December.  A standard template for the IPFR panel meeting minutes was developed to record a broad estimate of the IPFR’s benefit and value (recommendation 15\) by September.  

  

Ten recommendations (9, 12\-14, 16\-18 and 20\-22\) endorsed current practice in the NHS such as disregarding the availability of a treatment, affordability or non\-clinical factors when the IPFR panel makes its decision; seeking expert advice for the IPFR panel when  

necessary; monitoring the outcomes of IPFRs and documenting the reasons for the IPFR panel’s decision.  They were implemented immediately by continuing current practice.  

  

Seven recommendations (2\-8\) addressed commissioning issues, which can impact on IPFRs.  NHS Wales produced all\-Wales prior approval process guidance and an application form (2 and 5\).  Health board commissioners held meetings to share good practice and co\-ordinate commissioned services (3\).  The All\-Wales Therapeutics and Toxicology Centre website has updated information on how the IPFR process works and the alternative commissioning routes for access to medicines and non\-medicines (4 and 6\).  Health boards are using agreed standard text to explain why patients in Wales may not choose their place of treatment (7\), even though their health board may send them to another healthcare provider for treatment.  The WHSSC website has been revised to give clearer information about which services it does or does not commission (8\).  These recommendations were implemented by October.  

  

An NHS staff working group has been established to draft the new commissioning framework (recommendation 1\), reflecting the changes brought about by implementing the other recommendations.  The framework is still in development.  

  

One recommendation (10\) was to set a consistent national policy on the use of inexpensive interventions requested via IPFR.  Health boards and WHSSC already have arrangements in place to maximise the use of interventions of equal effectiveness but lower cost; for example, health boards already routinely use generic and biosimilar medicines over more expensive branded medicines without the need for bureaucratic approval arrangements.  There will be occasions where it is appropriate to use the IPFR process even where an intervention is inexpensive; simply because a medicine is less expensive does not mean it is appropriate to deviate from the usual treatment pathway.    

  

There were three recommendations (24\-26\) to improve the training for clinicians.  By September, clinicians had received training sessions as part of their continuing professional development (24\); there were guidance notes for clinicians about explaining the IPFR process to patients (25\); a decision\-making guide had been developed to help clinicians with the IPFR application process and each health board had a single point of contact for help with the application (26\).  

  

A Quality Assurance Advisory Group was established, and held its first meeting in January, to review randomly selected IPFRs from each health board (recommendation 19\).  The Group reports to medical directors and to the Welsh Government’s Chief Medical Officer.  Members have been involved in developing new training materials for patients and clinicians (recommendation 23\).  

  

I would like to reiterate my thanks to the members of the review group, for carrying out such a demanding task amongst all their other commitments; to the patients and organisations who provided evidence, and to everyone who has worked so diligently to make the IPFR process simpler and better understood.