SCHEDULE 2 THE SERVICES

SCHEDULE 2 THE SERVICES A. Service Specificatins Service Specificatin N. Service Cmmissiner Lead Prvider Lead Prtn Beam Therapy Prgramme Fina Marley, Head f Highly Specialised Cmmissining Perid 1 st April 2016 31 st March 2019 Date f Review Octber 2017. 1. Ppulatin Needs 1.1 Natinal/lcal cntext and evidence base 1.1.1 Prtn Beam Therapy (PBT) prvides radiatin by delivering a beam f prtn particles, rather than by external beam raditherapy (EBRT) using X-Rays. PBT facilitates the safe use f cntrlled dses f inising radiatin t treat peple wh have cancer with the aim f delivering as high a dse f radiatin as pssible t the cancer whilst sparing the surrunding nrmal tissues. A phenmenn knwn as the Bragg Peak means that almst n radiatin dse is depsited in the nrmal tissue beynd the tumur. This is in cntrast t X-rays where there is dse extensin beynd the tumur, reducing as the beam diverges and attenuates 1.1.2 PBT can be used alne r as part f a multi-mdality treatment regime with surgery and /r chemtherapy. PBT is cmplex and requires an understanding f the principles f medical physics, radibilgy, radiatin safety, dsimetry, radiatin treatment planning, simulatin and interactin f radiatin with ther treatment mdalities. 1.1.3 PBT is a treatment that is given with curative intent. Its use can reduce sme acute txicity and mre significantly can reduce the lng term permanent side effects f treatment and imprve the chances f maintaining quality f life. PBT can als be used as part f a dse escalatin strategy t increase tumur cntrl, by sparing critical structures. It is typically delivered t patients every weekday, ver a number f weeks, depending n the tumur site. Mst patients are treated n an utpatient basis. 1.2 Prtn Overseas Prgramme 1.2.1. Prtn beam therapy has been ffered t all clinically apprpriate patients in England since 2008 thrugh the NHS Prtn Beam Prgramme. NHS England will cntinue t d s in line with agreed clinical plicies fr the duratin specified. 1

1.3 NHS Prtn Beam Therapy Service 1.3.1 In 2009, planning began n the develpment f an NHS Prtn Beam Therapy service. Tw PBT centres have been cmmissined by the Department f Health and NHS England at The Christie NHS Fundatin Trust in Manchester and University Cllege Lndn Hspitals NHS Fundatin Trust in Lndn. 1.3.2 It is anticipated that when the NHS service starts it will still be necessary fr sme patients requiring PBT t cntinue t be sent fr treatment abrad. This is t allw the NHS service t increase its clinical expertise and capacity in a safe and cntrlled manner. 2. Outcmes 2.1 NHS Outcmes Framewrk Dmains & Indicatrs Dmain 1 Preventing peple frm dying prematurely X Dmain 2 Enhancing quality f life fr peple with lng-term X cnditins Dmain 3 Helping peple t recver frm episdes f ill-health r X fllwing injury Dmain 4 Ensuring peple have a psitive experience f care X Dmain 5 Treating and caring fr peple in safe envirnment and prtecting them frm avidable harm X 2.2 Lcal defined utcmes Imprve cancer survival and cure rates Deliver higher, accurately targeted therapeutic dses f radiatin t tumurs Minimise and reduce the shrt and lng-term side effects f treatment Imprve the patient experience f treatment Develp clear clinical utcme infrmatin t supprt further clinical and service develpment T supprt develpment f the UK based service, infrastructure, clinical prtcls and pathways f care. 3. Scpe 3.1 Aims and bjectives f service Aims 3.1.1 The aim f the service is t prvide high energy prtn beam therapy services fr adult, teenage and yung adult (age 16 24 years), and paediatric patients (age < 16 years), verseas t imprve cancer utcmes, reduce mrbidity arising frm treatment and supprt the patient and family thrughut their cancer jurney and beynd. Objectives 3.1.2 The bjective f the Prtn Overseas Prgramme service is that: All eligible patients that are able and willing t d s receive PBT at the recgnised high quality treatment prviders verseas cmmissined by NHS England. 2

3.2 Service descriptin 3.2.1 In additin t the standards required within the NHS Standard Cntract, specific quality standards and measures will be expected. The prvider must: Facilities and equipment meet technical standards in accrdance with the equipment specificatin and equipment supplier s service delivery mdel ensure mdern equipment is used including image guidance (MRI, CT scanner), treatment planning system tls, Onclgy Infrmatin Systems. be fully integrated with a cnventinal raditherapy prgramme and department have a minimum f tw rms and tw full gantries have full patient immbilisatin systems available have cntingency plans and cntracts in place fr patient treatment t cntinue in the event f technical interruptins and/r breakdwn Desirable be able t deliver passive and active (spt scanning) IMPT Prtn mdalities have the PBT centre situated within a Hspital campus have in-patient and ut-patient care n the same campus/site available Staffing ensure all staff delivering PBT are adequately trained and have the apprpriate skills and cmpetencies t d s meet the natinal standards fr training and practice f the relevant prfessinal bdies (equivalent t fr example Ryal Cllege f Radilgists (RCR), Sciety and Cllege f Radigraphers (SCR) and Institute f Physics and Engineering in Medicine (IPEM)). demnstrate prcesses fr the management f risk t staff supprt the develpment f the UK PBT service by, fr example, making prvisin by agreement fr training placements fr UK PBT clinicians and technicians. Clinical standards and pathways prvide assurance that raditherapy is delivered accrding t natinal and internatinal standards where apprpriate and applicable prvide assurance that their services match standards fr Raditherapy, that are cnsistent with the Cancer Refrm Strategy Cmmitment t develp Wrld Class services and the NHS England Visin fr Raditherapy Services (2014); be accredited by natinal and/r state regulatry bard participate in natinal quality assurance prgramme have treatment capacity and administrative prcesses t be able t accept patients within a timescale t allw pathways that meet clinically relevant start t raditherapy target times (will vary accrding t tumur) ensure the safe treatment f patients in accrdance with agreed prtcls demnstrate prcesses fr the management f risk t patients have dedicated prgrammes fr children, teenagers & yung adults and adults e.g. base f skull deliver care in settings apprpriate t age take a lead in engagement with apprpriate multi-disciplinary diagnstic and treatment 3

teams prvide full interdisciplinary care (Paediatric Onclgy, Anaesthesia, Endcrine, Head & Neck Surgery, Neursurgery) prvide supprtive therapy including chemtherapy, emergency management and tumur multi-disciplinary teams make prvisin fr psychscial multi-disciplinary teams use effective cmmunicatin pathways between the referring treatment centre multidisciplinary team and the verseas prvider multi- disciplinary team prvide treatment summaries back t the referring centres n cmpletin f treatment within tw weeks f cmpletin f treatment. enter patients prspectively int lcal r natinal registry and utcme evaluatin prgrammes, cllabrate with UK data cllectin n treatment details, clinical utcmes and transfer f full RTDICOM data fr NHS England Overseas prgramme t be able t stre and analyse prvide treatment t patients in accrdance with the natinally agreed (NCRI, CCL, CSG and NHRC) clinical trial prtcls within the UKCRN Study Prtfli and guidelines (CCLG) where these exist have a recrd f presenting practice and utcmes in natinal and internatinal cnferences, specialist meetings and in peer reviewed publicatins Desirable have frmal links r frm part f an Academic/University centre Patients ensure prtectin f children and ther vulnerable peple in line with natinal standards (equivalent t Safeguarding Vulnerable Peple in the Refrmed NHS: Accuntability and Assurance Framewrk https://www.england.nhs.uk/wpcntent/uplads/2013/03/safeguarding-vulnerable-peple.pdf) have case/patient management/cncierge service t facilitate patient pathways and referrals including arranging accmmdatin and prviding day t day supprt t families and carers f PBT patients whilst receiving treatment. prvide patients with infrmatin apprpriate t their needs and treatment pathway Paediatric Specific have a thrughput f ver 70 paediatric cases per annum and ver 30 sedated paediatric cases per year ensure ut-patient specialist paediatric anaesthesia is available fr all patients if required, including deep i.v. sedatin (standard) r full narcsis with intubatin, inductin & recvery rms. ensure Play therapy access is available fr all patients be frmally cnnected t high-vlume Paediatric Onclgy department ideally n the same campus and within the same rganisatinal framewrk participate in multicentre, multidisciplinary clinical trials e.g. SIOP links ensure that the paediatric service has frmal specialist academic leadership and links ensure specialised Paediatric Onclgists supervising apprpriate children at least weekly and ideally within the PBT centre 4

Referral pathway Site specific referral centre MDT Referring Centre Clinical Onclgy Cnsultatin with patient Referral made t Prtn Clinical Reference Panel (t include full dataset and imaging) Specific Prtn Clinical Reference Panel makes recmmendatin Treat lcally NHSE cmmissining decisin n recmmendatin IFR Apprved Nt Apprved Letter sent t referring centre cnfirming apprval and/r any cnditins, e.g. further surgery Original referring centre makes referral t verseas prvider Letter sent t verseas PBT centre cnfirming apprval Overseas treatment prvider accepts/rejects referral Patient accepted fr treatment Patient nt accepted fr treatment Patient agrees t treatment verseas 5

Patient care pathway Referral pathway fr Prtn Overseas Prgramme. Patient referral apprved & accepted. Patient willing t be treated verseas Referring centre makes travel & supprt arrangements with verseas prvider Referring centre liaises with verseas prvider re treatment dates, current treatment plan, sends images etc Patient travels t verseas prvider Patient receives PBT at verseas prvider as per prtcl Patient returns t UK n cmpletin f treatment On cmpletin f treatment, the verseas prvider sends treatment summary and discharge infrmatin t referring centre Patient nging treatment cntinues in UK 3.3 Ppulatin cvered A clear indicatin fr raditherapy and defined as curable and with cancer survival expectatin f 40% 5 year survival and n cmrbidities likely t limit life expectancy t <5 years. Fr further infrmatin see clinical cmmissining plicies fr: Prtn Beam Raditherapy Paediatric Cancer Treatment Prtn Beam Raditherapy fr Teenagers and Yung Adult Cancer Treatment Prtn Beam Raditherapy fr Adult Cancer Treatment http://www.england.nhs.uk/cmmissining/spec-services/npc-crg/grup-b/b01/ 3.4 Any acceptance/exclusin criteria There shuld be NO evidence f distant metastasis with the exceptin f: Rhabdmysarcma and Ewing s Tumurs where limited and nly lung disease that has 6

a gd partial respnse t the initial radilgical reassessment after chemtherapy will be cnsidered fr referral and treatment. Fr further infrmatin see clinical cmmissining plicies fr: Prtn Beam Raditherapy Paediatric Cancer Treatment Prtn Beam Raditherapy fr Teenagers and Yung Adult Cancer Treatment Prtn Beam Raditherapy fr Adult Cancer Treatment http://www.england.nhs.uk/cmmissining/spec-services/npc-crg/grup-b/b01/ 3.5 Interdependence with ther services/prviders Onclgy paediatric and adult Anaesthesia paediatric nly Endcrinlgy Head & neck surgery Neursurgery Paediatric neursurgery Specialist skull-based neursurgical unit Specialist spinal surgical unit Chemtherapy Emergency Care Play therapy paediatric nly Accmmdatin fr patients and carers Supprt services fr patients and carers Established links (r part f) University/Academic centre 4. Applicable Service Standards Refer t sectin 3.2 service descriptin fr service standards Demnstrate prcesses fr the management f risk t patients and staff The prvider will ntify the Chair f the Prtn Overseas Panel f any never events r serius untward incidents (see main cntract bdy fr definitins) within 48 hurs f the event ccurring. 4.1 Applicable natinal standards (eg NICE) Equivalent natinal standards where applicable fr Radiatin Prtectin Services shuld match internatinal standards fr Raditherapy, that are cnsistent with the Cancer Refrm Strategy Cmmitment t develp Wrld Class services and the NHS England Visin fr Raditherapy Services (2014); Be accredited by natinal and/r state regulatry bard Prvide treatment t patients in accrdance with the natinally agreed (NCRI, CCL, CSG and NHRC) clinical trial prtcls within the UKCRN Study Prtfli and guidelines (CCLG) where these exist Ensure prtectin f children and ther vulnerable peple in line with natinal standards (equivalent t Safeguarding Vulnerable Peple in the Refrmed NHS: Accuntability and Assurance Framewrk https://www.england.nhs.uk/wpcntent/uplads/2013/03/safeguarding-vulnerable-peple.pdf) 7

4.2 Applicable standards set ut in Guidance and/r issued by a cmpetent bdy (eg Ryal Clleges) Meet the natinal standards f the relevant prfessinal bdies (equivalent t fr example Ryal Cllege f Radilgists (RCR), Sciety and Cllege f Radigraphers (SCR) and Institute f Physics and Engineering in Medicine (IPEM)). 4.3 Applicable lcal standards As abve, where apprpriate 5. Applicable quality requirements and CQUIN gals 5.1 Applicable Quality Requirements (See Schedule 4A-D) refer t sectin 3.2 service descriptin fr service standards recgnised UK clinical nclgy experts t visit and assess clinical quality including patterns f integrated care the prvider will have a recgnised system t demnstrate service quality and standards the service will have detailed clinical prtcls setting ut natinally (and lcal where apprpriate) recgnised gd practice fr each treatment site the quality system and its treatment prtcls will be subject t regular clinical and management audit the prvider is required t undertake regular patient surveys and develp and implement an actin plan based n findings 5.2 Applicable CQUIN gals (See Schedule 4E) Nt applicable 6. Lcatin f Prvider Premises The Prvider s Premises are lcated at: 7. Individual Service User Placement 8