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Jornadas #PatientInHTA · Jesús González

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Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017

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Jornadas #PatientInHTA · Jesús González

  1. 1. Zaragoza, 27-28 April 2017 How can we build into the system the ability to review decisions made on the basis of results? Monitoring Technologies for their inclusion in the Spanish Health System Benefits Basket Jesús González Enríquez AETS-ISCIII PUBLIC HEALTH CONFERENCE 10th anniversary of the Spanish Network of Health Technology Assessment (HTA) Agencies: Insights for collaborative networking Towards Patient and public engagement in HTA
  2. 2. Coverage with evidence generation. CEG Heath authority decisions on coverage/funding conditional on the collection of data on effectiveness and cost-effectiveness (evidence generation/development), an option when there is uncertainty of net benefits of a technology.  Experimental or under research within the framework of CCT or registers.  Research in treatments with few or no alternatives.  Potential benefits still not clearly demonstrated against alternatives.  Without coverage, it is not possible to generate new relevant evidence.
  3. 3. Coverage with evidence generation. CEG Assumption of risks making decisions under uncertainty: Type I error : Covering technologies that are clinically ineffective or harmful. Type II error: Denying access to potentially beneficial or cost- effective technologies.  Specific coverage only in research (for patients involved in the research).  Temporary post-introduction covering with research (all patients are given access).  Covering with risk sharing (payment linked to results or performance, number of patients).
  4. 4. Coverage with evidence generation Technology selection criteria:  Due to diferencies on regulatory approval and access to the market: Medical devices, diagnostic tecnologies, surgical procedures and surgical implants.  Expected improvement in health benefits but still not clearly shown comparing with rutine effective alternatives.  Potential impact for widespread and risks with little evidence.
  5. 5. Coverage with evidence generation Technology selection criteria:  Required regulatory approval.  Insufficient evidence to answer key questions.  In the absence of CEG evidence would not become available.  Feasibility/usefulness of the study design (value of new evidence)  The benefits of generating additional evidence justify costs, resources and time.  Time framework for decision adapted to technology life- cycle.
  6. 6. Potential Advantages and Disadvantages associated with CEG Advantages Disadvantages Decision makers Managed entry of promising tech. Evidence generation. Investment in tech. that prove not to be CE. Additional costs of monitoring, difficulty in withdrawing tech. Healthcare Providers Earlier access to promising tech. Risks using tech. not fully evaluated. Manufacturers Initial adoption of tech. with equivocal evidence. Delays to market access for effective tech. Additional burden of monitoring. Patients Access to promising tech. otherwise not available. Access to tech. that may prove to be ineffective or unsafe.
  7. 7. *Prior pilots of CEG (2000-2015) *Positron Emission Tomography (PET) in Oncology *Surgery for epilepsy *Chondrocyte transplantation *Stent for Abdominal Aortic Aneurysm *Artificial Anal Sphincter in Severe Fecal Incontinence *Neurosurgical treatment for Parkinson *Intracoronary brachitherapy Pre - introduction coverage: *Surgical treatment for HIV-related facial lipoatrophy
  8. 8. Monitoring studies Concept (MoH order 1356 / 2015, 2 July) Registers for the assessment of health interventions and techniques (implants) in phase of post-introduction in benefits basket when:  There is uncertainty about its effectiveness or its efficiency in clinical practice.  Unknown effects in specific population groups.  Expected high economic or organizational impact.
  9. 9. *Monitoring studies Features  Technical coordination by an agency of HTA (Spanish Network of HTA Agencies).  Application only in health centers designated by the autonomous communities on the basis of the Protocol.  Access to all users of the NHS that comply with the Protocol.  Final report to Health Authority to inform on the inclusion, exclusion or modification of use in the benefits basket.
  10. 10. *Monitoring studies Objectives To collect and analyze data that allow you to provide relevant new information to: Inform on the inclusion of the technologies in the benefits basket of services under the current conditions of use or modify its conditions of use, or their exclusion Order by the MoH
  11. 11. Data registry 13 Monitoring studies MS Specific requirements CCAA DECISION A G E N C Y H T A Health centers Protocol •Inclusion •Exclusion •Modify Final report CPAF Benefits Basket Commission MoH order Decision of MoH CISNS
  12. 12. * The agencies of HTA are responsible for Technical coordination Coordinating the protocol consensus process Defining the duration of the study Defining the criteria for inclusion and exclusion of patients and the variables and outcomes in the MS Collecting and analyzing the data Monitoring and quality control of data Reporting serious adverse effects occurred during the study Drawing up the final report
  13. 13. *MS AGENCIES Biodegradable stents for the treatment of refractory or recurrent benign esophageal stenosis AETS-ISCIII Reduction of persistent air leak with endobronchial valve implants SECS Percutaneous mitral valve repair with MitraClip for severe symptomatic mitral regurgitation and heart failure OSTEBA Percutaneous left atrial appendage closure device in patients with atrial fibrillation AETS-ISCIII
  14. 14. * Monitoring Studies main characteristics Objectives Size Follow-up Study duration Device Company Esophageal stent Safety Effectiveness 130 1 year 36 m SX-ELLA BiOMED SA Endobronquial valve Safety Effectiveness Costs 40 1 year 24 m Zephyr IBV Assut Europe Olimpus Mitra Clip Safety and Efectiveness Cost- effectiveness 140 1 year 26 m MitraClip ABBOT Left Atrial Appendage closure Safety Effectiveness 150 2 years 48 m Watchman Amplatzer LAA Ultraseal Lambre Boston Sc St Jude Med Mercé V Evomed SL
  15. 15. *MS protocol elaboration Elaboration of the first part of the protocols (tech description, evidence, requirements, objectives). Consensus process meetings (clinical experts, MoH, Spanish Agency of Medicinal Products and Medical Devices, agencies). Protocol draft (inclusion/exclusion criteria, variables, outcomes, follow-up periods, sample size, analysis, model for informed consent).
  16. 16. *MS protocol elaboration Other characteristics of the study methodology. Characteristics and requirements of the centers to participate in the study (expertise, clinical training, resources). Reviewed by other designated clinical experts, companies. involved, and members of the Benefits Basket Commission (CPAF). Protocol final approval.
  17. 17. *SIEM The MoH has developed a web based tool to record information from each monitoring study (Information System of Monitoring Studies (SIEM). User manuals for the coordinating agency and for other users have been developed (secure access, working with the tool, designing formularies, statistics). The agencies design the specific protocol database using SIEM. Authorized clinician at each participating center load the data of the intervened patients. The information is finally analyzed by the agency.
  18. 18. *Current situation All final MS protocols have been approved. Designation by the autonomous regions of the centers participating in the MS (requirements, authorizations, signature for adhesion, self-assessment questionnaire, conflict of interest). 27 Hospital centers in 12 autonomous regions. Information System of Monitoring Studies (SIEM) is already operational. Specific protocol databases design using the tool (SIEM) completed. MS in the phase of inclusion of patients.
  19. 19. *Discussion MS is an option for decisions on coverage/funding conditional on evidence generation when there is uncertainty of net benefits of a technology. We need a clear procedure of identification, selection and prioritisation of technologies suitable for MS. We have made progress in standardization of procedures (protocol consensus, handling conflicts of interest, process of designation of centers). We need to define the role of companies with interest in the process. Adaptation of long technology cycle and the decision of coverage with additional evidence.
  20. 20. *Thank you

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