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Medical devices from patients' perspectives


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Medical devices from patients' perspectives

  1. 1. Policy Debate I Valuing Innovation: Patientperspectives from across Europe Prof Rosanna Tarricone (Chair) Executive Director EHTI Professor, Università Bocconi
  2. 2. Policy Debate I Valuing Innovation: Patientperspectives from across Europe Klara Zalatnai Associate Prof Dr Zoltan Kalo Ros Meek Prof Bruce Campbell
  3. 3. Policy Debate I Valuing Innovation: Patientperspectives from across Europe Klara Zalatnai PresidentHungarian Osteoporosis Patient Association (HOPA)
  4. 4. Medical devicespatients’ perspective from Hungary Klara Zalatnai Hungarian Osteoporosis Patient Association Hungary (HOPA) MedTech Forum Policy Debate I Valuing innovation Brussels 2010
  5. 5. Challenges and opportunities• Public Health System • Emerging needs• Medical device industry (e.g. developing a shared understanding of future healthcare goals) • Increasing expectation • (e.g. overcoming health inequalities) • Societal changes (e.g. ageing society) • New medical technologies (e.g. e-health technologies)
  6. 6. Public Health Challenges• Demographic pressures – (e.g. ageing of population, low birth rate, etc)• Increasing prevalence of age and life-style related chronicle disease• Previously fatal diseases . . . into chronic conditions . . .• Patient in the public health - patients’ empowerment – Increasing compliance – Decision making – Self making – Self care – Self management
  7. 7. Public Health Policies expectations• Well formulated patient needs• Patient-centered approaches in healthcare systems• Clarity and visibility with regard to public health policies and strategies• Harmonization on best practices and guidelines between Member States
  8. 8. Public Health Policies in Hungary from patients’ perspective• Patient societies are isolated – patients’ needs are formulated not sufficiently• Lack of the resources (human and financial)• No coalition of the patient societies – Poor advocacy• Poor patient-centered approaches in healthcare systems• Poor clarity and visibility with regard to public health policies and strategies
  9. 9. Involvement, education and training of different actors expectations• The role of all actors needs to be acknowledged• Development new skills and professional curricula training and skills for healthcare professionals and also patients• Education and interaction platforms needed between technology, patients and healthcare professionals• Necessary for all stakeholder to develop a shared understanding of future education needs
  10. 10. Education and training of patients in Hungary• „Patients’ university” program under preparation• Exampels for thematic sites on the facebook – „Ne ess, ne törj” Don’t fall, don’t break!, – „Osteoporosis and dance”• should be extended – almost unlimited sites and groups
  11. 11. Patient Safety & Quality of Care expectations• Critical component of quality of healthcare• Patient can be injured or be exposed to adverse events• The exchange of information on best practice and on technologies improving patient safety
  12. 12. Patient Safety & Quality of Care in Hungary• Adverse / side effect reporting - works – at the medicines – at medical devices ??• The exchange of information on best practice and on technologies improving patient safety
  13. 13. Value of and access to medical devices expectations• Measure appropriately the value of medical devices,• Enhance better access of patients to medical devices – looking at the different factors including • pricing and reimbursement policies. • waiting lists • well defined patients routs • Huge inequity• Patient involvement in – measurement the value of medical devices - clinical trials – decision making process – Quality of the patients’ contribution
  14. 14. Quality health information for empowered patient expectations• Identifying the fundamental need of patients for health information• Tools that aid assessment and use of relevant health information• Obstacles to accessing relevant health information• Positive action in Europe and across the globe – Health authorities – Medical products agencies – Healthcare assessment agencies – Healthcare providers – Healthcare professionals – Consumer organizations – Patients’ associations
  15. 15. Patient voice - Partnership – Communication expectations• Well articulated, formulated, powerful – quality and quantity• Partnership - strengths – health professionals – medical doctors – medical devices manufacturers, suppliers – other patient organizations• Media – written – electronic• Social Web sites - information exchanges
  16. 16. Patient Involvement in Health Technology Assessment Process expectations• HTA Evaluation of health care technology aiming at providing objective information to support health care decision – Technology: drug, procedure, medical devices – Providing decision makers with appropriate information – Need to develop patients’ expertise to enable the patients to put the case forward in a satisfactory and meaningful way
  17. 17. Recommendation• Investing in Health Literacy and training• Patients’ having access to information in a concise and timely way• Develop patients’ expertise to enable the patients to put the case forward in a satisfactory and meaningful way• European wide platforms to support patients organisations in participating in HTA• Patient’s organisation themselves should be able to improve the way they interact with each other and with decision-makersSource: EPF
  18. 18. Policy Debate I Valuing Innovation: Patientperspectives from across Europe Associate Prof Dr Zoltan Kalo Director of Health Economics Research Centre at Eötvös Loránd University Past President Hungarian Health Economics Association (META)
  19. 19. Role of HTA and transparent decision-making criteria toimprove the access of patients to medical devices: the case of Hungary Zoltán KalóHealth Economics Research Centre Eötvös Loránd University Budapest, Hungary
  20. 20. Affordability and reimbursement of medical devices Lack of EU guidance to member states to improve transparency of their pricing and reimbursement systems for medical devices (potential key elements: individual decisions; verifiable and objective criteria; predictability of timing; availability of remedies for negative decisions) Difficult to assess the value of medical devices  countries pay attention to credible HTA sources, e.g. NICE appraisals – Caveat: effectiveness and cost-effectiveness of medical devices is more country / health care system specific than pharmaceuticals Price of medical devices is usually adjusted to local settings and purchasing power  increased likelihood of reimbursement of innovative medical devices in lower income countries (as opposed to pharmaceuticals) In many countries budget impact / affordability is the main criteria for reimbursement  innovative medical devices are reimbursed with volume control mechanisms
  21. 21. Reimbursement algorithm of medical devices in Hungary Before 2010 no objective and verifiable criteria: decisions without explanation no explanation  there is no basis for remedy no guidelines for budget impact analysis cost-effectiveness is not defined – no official threshold no criteria on when, why and how to revise previous decisions timelines are not predictable inconsistencies due to individual deals and trade-offs
  22. 22. Access of patients to medical devices: reimbursement in Hungary Before 2010 non-transparent criteria for reimbursement and formulary listing no involvement of patients into decisions, lack of civil control Unpredictability of decisions: lucky winners and unfortunate losers Even winners were controlled by local budget caps Huge inequity: non-transparent waiting lists, gratuity Lack of managed patient routes  poor health outcomes in complex diseases e.g. oncology, diabetes
  23. 23. New regulation in 2010 Reimbursement and formulary decisions only once a year (1st July) Transparent point system including HTA elements No experience yet
  24. 24. The Hungarian Point System I Health Care Priority 20 point I.1. Public Health Programme 6 point I.2. Health Policy priorities 7 point I.3. Aggregated health gain of population 7 point II. Severity of disease 15 point II.1. Life-threatening acute disease 13-15 point II.2. Life-threatening chronic disease 10-12 point II.3. Non life-threatening acute disease 8-9 point II.4. Non life-threatening chronic disease 6-7 point III. Equity 15 pointIII.1. Size of patient population (i.e. rare diseases) 8 pointIII.2. Accessability 7 point IV. Cost-effectiveness, QoL benefit 30 pointIV.1. ICER 15 pointIV.2. QALY gain per patient 15 point V. Aggregated budget impact 10 point VI. Local and National professional opinion 10 pointVI.1. Opinion of Professional College 3 pointVI.2. International guidelines 3 pointVI.3. Level of scientific evidence 4 point Total 100 point
  25. 25. Health Policy Priorities Services to improve the efficiency of health care ( technical efficiency) Services to reduce inpatient care Telemedicine Minimal invasive of non-invasive care Services to improve rehabilitability of patients Services to replace symptomatic care with targeted curative care Preventive services
  26. 26. Market access of medical devices:Assessment of cost-effectiveness Methodological problems – multiple indications (e.g. diagnostics) – frequent product modifications – low level of clinical evidence base  head-to-head RCTs - no registration criteria - problems with randomization & blinding  observational studies - subject to selection bias - only after reimbursement decisions
  27. 27. Market access of medical devices:Assessment of cost-effectiveness (2) Methodological problems – ICER is not constant over time  learning curves  role of medical personnel (e.g. laparoscopic surgery) – local production function  economies of scale (e.g. technologies with high fixed costs)  need for organisational changes, training etc. – calculation of costs  list prices or internal transfer prices (see dialysis providers)  costs (average or marginal)  charges  reimbursement
  28. 28. Other problems Capacity of assessors (including HTA Office) Training Budget for single HTA Revision of decisions Frequency of reimbursement: – Pharmaceuticals: continuously – Medical devices: once a year Progressivity: – where to place innovative medical devices? – How to facilitate equitable access?
  29. 29. Conclusion for Hungary (and for other CEE countries) compared to Western Europe – worse health status – even more limited health care resources – strategic pricing of new health care technologies is adjusted to large Western European countries minimal prospective health economic data collection few trained health economists low public budget for health technology assessment no excuse: must improve the appropriateness of reimbursement decisions
  30. 30. General conclusions Improvement is necessary – EU registration criteria: more information on patient benefits, failure rates, risks – health technology assessment: more information on value for money – reduce differences between market access processes for pharmaceuticals and medical devices EU guidance to member states to improve transparency of their pricing and reimbursement systems for medical devices Sustainability of innovation is essential Better involvement of patients into decisions is necessary Ramsey pricing supports innovation and access to medical devices  benefits from no international price referencing Performance based agreements may increase evidence base for medical devices without delaying patient access
  31. 31. Policy Debate I Valuing Innovation: Patientperspectives from across Europe Ros Meek Director, ARMA
  32. 32. Reflections on ARMA engagement with NICE Ros Meek DirectorArthritis and Musculoskeletal Alliance UK
  33. 33. Challenges facing the NHS Ever higher expectations Demand driven by demographics Health in age of information and connectivity Changing nature of disease Advances in treatment Changing workplaces Cost containment, Quality, Care closer to home
  34. 34. What can ARMA offer? Holistic view of the needs of people living with arthritis and musculoskeletal conditions, their clinicians, AHPs and the research community 34 member organisations local networks which can reflect our membership and work as a powerful advocate locally
  35. 35. What do patients/users want?(Quality) Availability and Accessibility Technical Competence Communication Skills Interpersonal Attributes of Care Continuity of care Range of On-Site Services
  36. 36. PIN Patients in NICE 3rd sector organisations are a crucial part of NICE’s stakeholder community raising concerns and promoting partnership between patients, carers, communities and the public PIN group has a large number of members that meet independently of NICE NICE also had a Partners Council
  37. 37. NICE Engagement with 3rd Sector Guidance and work programmes “stakeholder” undertaking responses to consultations and submission of evidence which would otherwise not be accessible Consultations on support manual production and individual projects such as the recent one on innovation Opportunity to support dissemination and implementation Equality Forum
  38. 38. Patients in NICE (PIN) Remit share information, including via an e-mail group provide a support network for group members including a mentoring/buddying scheme raise areas of mutual concern with NICE with a view to finding collaborative solutions where possible; but without compromising the position of organisations that wish to challenge decisions made by NICE raise areas of mutual concern, connected with NICE, and with other bodies such as the Department of Health
  39. 39. PIN remit cont: raise the profile of the role that patient groups play in NICE technology appraisals and other NICE guidance identify any training needs for organisations engaging with NICE that are not being met replying as a group to NICE wide consultations, including the end of life consultation and value of innovation project. PIN’s independent “critical friend “ role is crucial to NICE But concern about the value placed on their HTA appraisal contributions and impact on decision making
  40. 40. Patient and Public involvementtraining Advice support and training for 3rd sector organisations to participate and engage with NICE Work programmes Appropriate submissions of evidence Training on NICE Methodologies – health economics, critical appraisal, systematic reviewing etc
  41. 41. Strengthening relationships cont; encouraging more organisations to become members of PIN to reflect the diversity of the third sector stakeholders with whom NICE engages. include mental health in the NHS, and groups with an interest in our public health guidance. Support in marketing PIN to the wider stakeholder community formalising relationships between the PIN group and members of NICE’s Senior Management Team
  42. 42. Strengthening relationships cont; exploring other formal mechanisms for mutual feedback between PIN and NICE’s SMT could be established (such as regular meetings between NICE’s Chief Executive/Deputy Chief Executive and the Chair of PIN) encouraging PIN to engage with wider aspects of NICE’s work, as its involvement has historically been largely with the technology appraisals programme
  43. 43. Into the future? provide a sounding board for developments within NICE’s activities, including new developments, work streams etc provide a forum to allow testing of social and ethical issues Allow feedback on ongoing, developing and new NICE activities provide a dissemination route out to stakeholders on the work of NICE and provide NICE with feedback on stakeholders’ engagement experiences promote a greater understanding of both the extent and limitations of the work of NICE
  44. 44. Policy Debate I Valuing Innovation: Patientperspectives from across Europe Prof Bruce CampbellChair Committees on Procedures and Technologies NICE (UK)
  45. 45. Patient involvement in producing NICE guidance Bruce Campbell Chair, Interventional Procedures andMedical Technologies Advisory Committees NICE, UK. Brussels 13th Oct 2010
  46. 46. NICE Guidance• Technology Appraisals - Clinical and cost effectiveness• Interventional Procedures - Safety and efficacy Not cost• Clinical Guidelines - Specific conditions: Management/care pathway• Public Health• Medical Technologies devices/diagnostic adoption• Diagnostics - new
  47. 47. Technology assessment and guidelines• Patient organisations contribute to scope• Individual patients/carers attend committee• Guidelines may use workshops, interviews• Public consultations on scope and guidance open to all
  48. 48. ….. in addition• All NICE committees have lay members• Meetings are open to the public as observers (except certain parts)….and• Anyone can notify interventional procedures
  49. 49. Interventional Procedures guidance (whole UK)• First guidance published 2002• Now >350 procedures• Many being reviewed……. Patient involvement mandated 2006
  50. 50. Interventional Procedures Guidance on safety and efficacy• Procedures used for treatment or diagnosis that involve: – incision, puncture or entry into body cavity – ionising, electromagnetic, acoustic energy• First use in the NHS (or private sector)• New concerns about efficacy or safetyProcedures not specific devices
  51. 51. Evidence used by the InterventionalProcedures Advisory Committee (IPAC)• Published studies (abstracts for safety only)• Specialist Medical Advisers (questionnaires)• Committee Members’ knowledge (lay members)• Public consultation (public, patients)• 2006 >>> Patient Commentators
  52. 52. Patient input to IP guidanceWhat kind of input? For example:• Patients with condition on benefits ~ risks?• Personal experience of procedure?Some concerns about personal experience:• Influenced by expectations – what patients have been told (asked about this)• No experience of alternative management• “Lifesaving” procedures – only survivors (likely to be satisfied)
  53. 53. Patient input to IP guidance - practical difficulties• Identifying patients who have had procedure• Procedures done as part of another• Procedures used in palliative care• Data protection and ethics legislation• Numbers of procedures: many each meeting
  54. 54. Semi structured questionnaire via hospitals• Less time and resources• Compliance with data protection and ethics• Avoids direct NICE contact with patients• Patients may feel less inhibitionBUT• No chance for interactive exploration• Some do not reach patients• No opportunity for NICE to chase
  55. 55. Sending and retrieving patient questionnaires (“packs”)• NICE identifies hospitals doing procedure• Hospitals identify patients and send packs• Patients return packs to NICE (anonymous)• If < 5 responses committee sees all• If >5 summary and individual quotes• Lay committee members always see all
  56. 56. Questions 1- 10:“Epidemiological” / general information***Questions 11 – 22 include***:• How well procedure worked• Effect on different specified areas of life• Pain before/during/after procedure• Side effects• Concerns about safety (before and after)• Would you have again if in same situation?• Would you recommend to a friend?
  57. 57. Retrospective study (early 2009) 73 questionnaires on 9 procedures• Transcatheter aortic valve implantation• Laparoscopic gastrectomy for cancer• Laparoscopic cystectomy• Thoracoscopic epicardial RFA for AF• Deep dermal gel injection for HIV facial lipoatrophy• Single-incision suburethral tape insertion• Brachytherapy alone after breast cancer excision• Allogenic pancreatic islet cell transplantation for Type 1 diabetes; and after pancreatectomy (x2)
  58. 58. Committee Members asked to scoreevery response for 1-2 procedures• Usefulness (5 point score)• Nature (thematic categories) – No new insights – Insights help understanding of other evidence – New and original “evidence” – Insights on sociocultural or equalities issues – Suggests lack of understanding – Not relevant (e.g. about local matters)
  59. 59. Examples of findingsQuality and Safety in Healthcare 2010 (in press) Campbell B• Most “useful”: How well it worked; Effects on different areas of life*; Would have again?• Least useful: About pain; About information and consent (these questions now abandoned)• Most frequent category: “Supports other evidence but no new insights”• Only 0-3% (7%*):“New and original evidence”
  60. 60. New NICE Evaluation Pathway for Medical Technologies Aim: identify >>> evaluation >>> adoptionDevices and diagnosticsNotified by manufacturersSelected by MTACfor measurable improvements in: • patient outcome or experience • use of resources – facilities, staff, other tests • cost, sustainability
  61. 61. Medical Technologies Advisory Committee (MTAC)Routing of “selected” products• To other NICE Programmes – Technology Appraisals, Diagnostics, Interventional Procedures• MTAC guidance recommendations – Advice on adoption (+ clinical and cost data) – Research (may foster research collaborations: recommendations on data collection)
  62. 62. Patient input to Evaluation Pathway and MTACThrough relevant patient organisations• Questionnaire at selection stage• Committee identifies key areas for patient information (e.g. insights into living with the condition)• More specific questionnaire + statement• Public consultation – organisations and interested individuals notified
  63. 63. Patient input to Evaluation Pathway and MTAC• Limited experience so far• Most patient organisations have not offered responses• A very early stage: all this will evolve.