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UKADC System Partners Meeting

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UK Antimicrobial Diagnostics Collaborative System Partners Meeting Slides from April 3rd Meeting

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UKADC System Partners Meeting

  1. 1. Mapping the Diagnostics Landscape A UKADC Workshop for System Partners Supported by
  2. 2. Where do you think you sit on the Diagnostics System? PRODUCT ADOPTION? ? PRODUCT EVALUATION 2 PRODUCT DEVELOPMENT
  3. 3. The system as its stands 1. Is it fit for purpose? 2. Who does what exactly & why? 3. Is your role as effective as it could be? 4. Do you believe the system works? 5. How do we make it work better? 6. How can I make it work better? 3
  4. 4. Keynote- Lord O`Neill of Gatley
  5. 5. Biological test should be mandatory, should’nt they? Phil Howard, Consultant Antimicrobial Pharmacist, Leeds Teaching Hospitals Mark Fielder, Professor of Medical Microbiology, Kingston University, London David Wells, Head of Pathology Services Consolidation, NHS Improvement Dr Elisabeth Adams, MD, Aquarius Population Health
  6. 6. QUESTIONS DO YOU BELIEVE THERE IS A ROLE FOR RAPID DIAGNOSTICS WITHIN COMMUNITY HEALTHCARE OR SHOULD ALL TESTING REMAIN IN THE LAB? DO YOU BELIEVE THE BARRIER TO USAGE OF RAPID DIAGNOSTICS IS THE COST? DO YOU THINK TACKLING ANTIMICROBIAL RESISTANCE CAN BE ACHIEVED THROUGH DIAGNOSTICS OR WOULD YOU INVEST INTO ALTERNATIVE METHODS? IS THE DECISION MAKING PROCESS FOR DIAGNOSTIC USAGE CONFUSING AND CONVOLUTED? IS IT FIT FOR PURPOSE? WHY HAVE THE O' NEIL REVIEW RECCOMENDATIONS FAILED TO BE IMPLEMENTED? WHO IS AT FAULT AND HOW DO WE CHANGE?
  7. 7. Mapping the current landscape and system for Diagnostics Session supported by Dr Sarah Byron,Associate Director,Diagnostics Assessment Programme, National Institute for Health and Care Excellence & Scott Buckler, Founder, 4 All of Us
  8. 8. INDUSTRY VIEWS
  9. 9. CLINICIANS VIEWS
  10. 10. Mike Wakemen, Pharmacist Consultant How a diagnostic pathway can be achieved
  11. 11. Michael Wakeman BSc, MSc MRPharmS How a diagnostic pathway can be achieved Mapping the Diagnostics Landscape A UKADC Workshop for System Partners
  12. 12. Initial Pilot Intervention O A pilot study to investigate the use of Point of Care C-reactive protein (POC CRP) testing in community pharmacy to deliver appropriate interventions in Respiratory Tract Infections (RTIs)
  13. 13. Cough (acute): antimicrobial prescribing NICE guideline Published: 7 February 2019 nice.org.uk/guidance/ng120 ©
  14. 14. 6037 4530 50 Adults Children/adolescents Age unknown more than 40% of study participants were children as from the age of 1 year 439 426 1852 820 200 608 Tonsillopharyngitis (children) Acute sinusitis (adults) Acute bronchitis (adults) Acute bronchitis (children) Chronic bronchitis Common Cold 4345 patients in placebo-controlled clinical trials Kaloba-Extensively Clinically Investigated 16 14
  15. 15. Aims of Study O Evaluate a CRP test in community pharmacy O Assess the acceptability of point of care CRP testing in community pharmacy O Investigate any reduction in GP appointments for non- LRTIs. O Assess impacts upon a subsequent antibiotic prescribing. O Deliver a scalable model
  16. 16. Supporting Materials O A brief introduction to CRP for Healthcare professionals O Cough/Chest Infection Poster A3 O Doctor letter O Patient Information Sheet O FAQs O Patient Questionnaire O Service Level Agreement O Symptoms of a cold O V4 TYI leaflet for community pharmacy
  17. 17. Patient pathway
  18. 18. Day 3 Follow-up O Day 3 questions only: O Were you expecting the test? (yes/no) O Did the test help your understanding? (yes/no) O Was it painful? (yes/no) O Were the results easy to understand? (yes/no) O Would you have otherwise have visited the GP? (yes/no) O Would you have otherwise have visited another healthcare professional? (yes/no) O Would you have expected antibiotics? (yes/no) O Can I call back in 4 days? (yes/no)
  19. 19. Day 3 and 7 follow-up O Day 3 and 7 questions: O On a scale of 1–5 how would you assess the following symptoms: O Shortness of breath (likert scale 1–5) O Wheezing (likert scale 1–5) O Chest pain (likert scale 1–5) O Breathing abnormalities (likert scale 1–5) O Perspiring (likert scale 1–5) O Headache (likert scale 1–5) O Myalgia (likert scale 1–5) O Feeling generally unwell (likert scale 1–5) O Others (please state) O Do you have a fever (>38°C)? (yes/no) O Have you subsequently needed to visit a GP or another healthcare professional as a result of these symptoms? (yes/no) O If yes, did you receive an antibiotic prescription? (yes/no)
  20. 20. Outcomes
  21. 21. Conclusions
  22. 22. https://www.pharmaceutical-journal.com/research/research-article/point-of-care-c-reactive- protein-testing-in-community-pharmacy-to-deliver-appropriate-interventions-in-respiratory-tract- infections/20204635.article
  23. 23. Supporting UK pharmacist study O Evaluating a point-of-care C-reactive protein test to support antibiotic prescribing decisions in a general practice pharmaceutical-journal.com/research/research-article/evaluating-a-point-of-care-c-reactive- protein-test-to-support-antibioticprescribing-decisions-in-a-general-practice/20201688.article
  24. 24. Extending the Service O Engagement of more pharmacies O Reimbursement model O Seeking Funding O Remodelling the proposition
  25. 25. Thank You
  26. 26. Greg Quinn, Director, Public Policy & Advocacy UKI,Corporate/Shared Services, BD How industry are driving Diagnostic usage
  27. 27. Confidential—For Internal Use Only Greg Quinn Industry’s Approach to driving diagnostic usage 2 9
  28. 28. • Public policy, solution development and implementation • Driving best practice through guideline development and implementation at a patient, regional • Local and national partnership • Risk and gain share • Quicker time to treatment, precision diagnostics leading to gold standard diagnostic and treatment pathways • Targeted diagnostics for each patient • Automation and consolidation • Improving the speed to delivering best access and outcomes Industry’s Approach to driving diagnostic usage
  29. 29. Lab automation / NHSI / Path cons / workforce Efficiency Flexibility Performance Reducing labor costs by increasing capacity with high throughput integrated solutions Large Regional Hub Evolving standalone solutions - Automate the most challenging processes Integrating Diagnostics with ID/AST and Imaging applications – Reduce time to ID and AST results Simplifies and standardizes user workflows for all samples and assays to reduce workflow complexity Interconnected molecular and cytology testing across scalable and modular platforms supporting multiple standards and guidelines Differentiated and Highly Valued Multiplex assays designed to provide actionable results & improve clinical outcomes
  30. 30. Microbiology & Molecular Patient Management Performance Targeted disease solutions enable extended coverage and appropriate diagnostic utilization- offering wider portfolio choice addressing crucial disease states Evolving standalone solutions - Integrate diagnostics with standalone incubation and imaging applications-offering modularity enabling future proofing capabilities as networks evolve Integrating Diagnostics with blood culture and ID/AST connected to Synapsys – focusing on connectivity linking satellite solutions Increased flexibility on menu utilization improves efficiency and reduces costs while expanding connectivity simplifies user interaction Microbiology Growth & Detection Molecular Spoke Hospitals
  31. 31. The role of Health Technology Assessment for Diagnostics Dr Sarah Byron,Associate Director,Diagnostics Assessment Programme, National Institute for Health and Care Excellence
  32. 32. © NICE 2018. All rights reserved. Subject to notice of rights. NICE Assessment of Diagnostic Technologies Sarah Byron Associate Director, Diagnostics Assessment Programme Sarah.Byron@nice.org.uk
  33. 33. National Institute for Health and Care Excellence Improves outcomes for people using the NHS and other public health and social care services.  Produces evidence-based guidance and guidelines  Develops quality standards and performance metrics  Provides a range of information services • reduce inequalities and variation • ensure quality and value for money for the NHS
  34. 34. Diagnostics Assessment Programme All types of diagnostic technology: • Imaging • Monitors • IVDs • Digital • Combination 36 5 main uses: • Diagnosis • Monitoring • Screening • Prognostic • Predictive All diseases and conditions
  35. 35. Value of Diagnostics System Benefits Reduce length of stay Speed up recovery Different staff grade or type Reduce Process Time Required Patient Benefits Improve comp- liance Decision or care nearer home Reduce unnecessary interventions Enhance dignity Enable Self Care Improve health outcome Reduce hospital -isation Optimise treatment choice Diagnostics Assessment Programme (DAP) examine the VALUE of all types of diagnostic technologies
  36. 36. Evolving role • Encourage innovation and increase NHS uptake • Support adoption of cost effective technologies • Highlight evidence gaps and promote further research • Stop inappropriate testing • Support new clinical pathways • Encourage equitable access to technologies 38
  37. 37. Aim of Assessment Is the technology clinically effective? Is it cost effective? Current NHS practice Current NHS practice Technology vs.
  38. 38. Population Technology Diagnostic and Care Pathway Treatment Diagnosis Condition Outcomes Costs Scope: Assessment Framework
  39. 39. DAP Approach to Diagnostics Challenges LINKED EVIDENCE MODELLING Diagnostic Accuracy Impact on Treatment Decisions Impact on Outcomes Utilises existing evidence for parts of the care pathway to develop models Can utilise existing models (directly or with modification ) Topic/clinical expert input into model structure and evidence gaps
  40. 40. Process Public Consultation Decision Stakeholder Perspectives Independent Review of evidence Input from topic experts Independent decision-making Committee Recommend for Routine Use Do Not Recommend for Routine Use Recommend Further Research
  41. 41. Challenges for diagnostics guidance Complexity and variation in diagnostic and care pathways End to end clinical studies following patients from diagnosis through care to outcomes rarely available Rapid product evolution Lower level of resources available in diagnostic ‘sector’ Alternative technologies Real world implementation uncertainty Benefits typically result indirectly from treatments
  42. 42. Implementation uncertainty Tests for rapidly identifying bloodstream bacteria and fungi LightCycler SeptiFast test MGRADE SepsiTest IRIDICA BAC BSI assay 62 studies reporting diagnostic accuracy data 41 studies reporting intermediate and clinical outcome data
  43. 43. Tests for rapidly identifying bloodstream bacteria and fungi LightCycler SeptiFast Test MGRADE SepsiTest IRIDICA BAC BSI Insufficient evidence to recommend routine adoption Clinical utility Levels of certainty needed to change treatment Children and neonates
  44. 44. Another diagnostics example…… Procalcitonin testing for diagnosing and monitoring sepsis stopping antibiotic treatment in people with confirmed or highly suspected sepsis in the intensive care unit starting and stopping antibiotic treatment in people with suspected bacterial infection presenting to the emergency department 18 RCTs available with end clinical outcome data No UK based studies
  45. 45. Clinically equivalent to current practice but uncertain costs Procalcitonin testing for diagnosing and monitoring sepsis stopping antibiotic treatment in people with confirmed or highly suspected sepsis in the intensive care unit starting and stopping antibiotic treatment in people with suspected bacterial infection presenting to the emergency department Research recommendations to explore the impact on resource use in the NHS
  46. 46. Potential challenges in AMR diagnostics Treatment tailored to patients Silo working Evidence of impact Scientific knowledge of AMR Clinical risk Patient and clinical understanding Value for money Innovation Cost of antibiotics Funding Behavioural change
  47. 47. Engaging with NICE 49
  48. 48. INNOVATE UK EMA NICE AHSNs The evolving landscape Product Development PRODUCT ADOPTION? ? PRODUCT EVALUATION Patients and healthcare systems need access to clinically and cost effective products as quickly as possible New initiatives in landscape (EAMS, PRIME, AAR, Life Sciences Industrial Strategy…) Early engagement with healthcare system decision makers and payers is a key enabler for the journey along the evolving product development to adoption pathway DIT = Department for Trade and Investment MHIR = National Institute for Health Research EMA = European Medicines Agency MHRA = Medicines and Healthcare Products Regulatory Agency AHSNs = Academic Health Science Networks NHSI = NHS Improvement NHSI NHS ENGLAND Cancer Drugs Fund MHRA (& notified bodies) NIHR DIT 50
  49. 49. The need for joined-up early dialogue with the system Dialogue with NICE and other stakeholders is often limited Dialogue often occurs within the formal guidance process (often in high-risk situations) Companies generally interact with system stakeholders individually which can lead to conflicting information or lack of clarity Need for greater dialogue Need for dialogue outside of formal guidance process Need for more coordinated dialogue Multi- stakeholder safe harbour engagement Company NHS Englan d Patient orgs Clinical experts NICE 51
  50. 50. 52 www.HealthTechConnect.org.uk
  51. 51. Thank you for listening 53 ? Sarah.Byron@nice.org.uk
  52. 52. What the Landscape for Diagnostics is telling us
  53. 53. Identifiying the roadblocks to diagnostic acceleration and the opportunities the system can cease Daniel Berman, Lead of Global Health Team, Nesta

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