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Case study: limits and potential impact of multidimensional assessment of paroxetine at regional level
Case study: limits and potential impact of multidimensional assessment of paroxetine at regional level
Case study: limits and potential impact of multidimensional assessment of paroxetine at regional level
Case study: limits and potential impact of multidimensional assessment of paroxetine at regional level
Case study: limits and potential impact of multidimensional assessment of paroxetine at regional level
Case study: limits and potential impact of multidimensional assessment of paroxetine at regional level
Case study: limits and potential impact of multidimensional assessment of paroxetine at regional level
Case study: limits and potential impact of multidimensional assessment of paroxetine at regional level
Case study: limits and potential impact of multidimensional assessment of paroxetine at regional level
Case study: limits and potential impact of multidimensional assessment of paroxetine at regional level
Case study: limits and potential impact of multidimensional assessment of paroxetine at regional level
Case study: limits and potential impact of multidimensional assessment of paroxetine at regional level
Case study: limits and potential impact of multidimensional assessment of paroxetine at regional level
Case study: limits and potential impact of multidimensional assessment of paroxetine at regional level
Case study: limits and potential impact of multidimensional assessment of paroxetine at regional level
Case study: limits and potential impact of multidimensional assessment of paroxetine at regional level
Case study: limits and potential impact of multidimensional assessment of paroxetine at regional level
Case study: limits and potential impact of multidimensional assessment of paroxetine at regional level
Case study: limits and potential impact of multidimensional assessment of paroxetine at regional level
Case study: limits and potential impact of multidimensional assessment of paroxetine at regional level
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Case study: limits and potential impact of multidimensional assessment of paroxetine at regional level

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Case study: limits and potential impact of multidimensional assessment of paroxetine at regional level.

Case study: limits and potential impact of multidimensional assessment of paroxetine at regional level.

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  • 1. Case study: limits and potential impact of multidimensional assessment of paroxetine at regional level Rossella Di Bidino *, Angelica Carletto *, Silvia Coretti **, Paola Codella**, Matteo Ruggeri**, Marco Marchetti*, Americo Cicchetti*** Health Technology Assessment Unit – Health Directorate – University Hospital “A. Gemelli” – Rome *** Faculty of Economics - Catholic University of the Sacred Heart – Rome Member of
  • 2. Agenda• Multidimensional assessment• The approch of an Italian Region• Case study: paroxetine• SWOT analysis• Weaknesses• HTA implementation• ConclusionsMember of
  • 3. Multidimensional assessment The need to assess health technologies according to a multidisciplinary Safety Effectiveness framework is a growing necessity at different levels of National Health System (NHS). Cost- Budget impact effectiveness As far concern the drug market, safety and efficacy are the main dimensions Organizational Social impact taken into account. impact HTA principles and competition among Ethical issues producers and molecules require to consider other aspects as effectiveness and cost-effectiveness at different levels of NHS. Member of
  • 4. The approach of an Italian Region In Italy, Lombardy Region requested to producers to assess pharmaceuticals according to a given HTA model. Multidimensional Impact of an health technology (Stima di Impatto Multidimensionale (SIM) della tecnologia sanitaria ) model focused on:  General relevance  Safety  Efficacy and Effectiveness  Economic and Financial impact  Equity  Social and Ethical impact  Organizational impact The proposed model articulated each domain in a rich set of questions. In particular, attention was devoted to antidepressant drugs. Member of
  • 5. The approach of an Italian Region For each domain, evidence should be collected, reported and evaluated according to a given quality scale. Level Domain: Efficacy and Effectiveness Ideal situation Real practice Other aspects 1 Randomized survey Disease specific registries Expert opinions on: 2 Sistematic Literature Review of recent surveys Analysis of administrative databases Disease severity 3 Sistematic Literature Review of no randomized samples Clinical audit and case series Patient population 4 Sistematic Literature Review of case studies Summaries, posters, other studies Health policy goals 5 Grey literature Description of techology Member of
  • 6. The assessment moment What: drug Who: RegionWhen: years after approval WHO AFTER Macro DURING BEFORE Meso Micro WHAT DRUGS DEVICES PROCEDURES WHEN Member of
  • 7. ParoxetineParoxetine was one of the molecules under assessment for each of thetherapeutic indication for which it granted EMA’s authorization:• major depression• obsessive -compulsive disorder• panic disorder, social anxiety disorder• generalized anxiety disorder• post-traumatic stress disorder.Member of
  • 8. Work doneThe group of experts of “A.Gemelli” University Hospital participated at theassessment.It was composed by:• Medical doctors• Health Economists• Statisticians• Bioethical experts• Experts of organizational issues• Literature search experts. Member of
  • 9. TimingTime available: 3 months Member of
  • 10. Data sources The main sources of information have been: • Literature databases • Clinicaltrials.gov • National and International clinical guidelines • Regulatory agencies websites • HTA doers websites It was considered evidence:  Drug specific  Competitor specific  Disease specific  Context specificMember of
  • 11. PICO model Technology Daparox (paroxetine): selective serotonin reuptake inhibitors (SSRI) MeSH: paroxetine Intervention Health conditions: major depression obsessive -compulsive disorder panic disorder, social anxiety disorder generalized anxiety disorder post-traumatic stress disorder. MeSH: Depressive Disorders, Depressive Disorders, Major Disorder, Obsessive-Compulsive Anxiety Disorders Target population: Adults with one of the above mention conditions. Healthcare setting: MMG, outpatient settings, hospitals Comparators SSRI:citalopram, fluoxetina, fluvoxamina, sertralina Tricyclic antidepressant: amitriptylina, clomipramine, dosulepina, imipramine, lofepramine, nortriptylina, trimipramina Escitalopram Monoamine oxidase inhibitors: moclobemida, phenelzina Tricyclic-related antidepressants: mianserin, trazodone Third generation antidepressants: duloxetina, mirtazapina, reboxetina, venlafaxina Other treatments for anxiety disorders : pregabalin, antipsicotici, benzodiazepine Outcomes Efficacy: clinical relevant for patients Work related Sheehan Disability Scale Quality of life scales Safety Costs Clinical pathway Equity Social and organizational impactMember of
  • 12. SWOT analysisThe paroxetine case study could be useful to consider the applicability of a HTA model inreal life setting. STRENGHTS WEAKNESSES Full assessment Lack of model flexibility Multidisciplinary approach Open issue: transferability HTA model with manual Lack of synthesis Attention to quality of evidence OPPORTUNITIES THREADS Regional involvement Workload & Timing HTA approach Interpretation of the report Use of the report Member of
  • 13. WEAKNESSESLack of model flexibilityOpen issue: transferability FlexibilityLack of synthesisCase study’s critical elements:• Availability of scientific evidence and timing of policy decision making• Duplication of evidence requested in the model• Low relevance of some questions for the specific drug• Uncompleted coverage of drug specific issues HTA model framework: need to be adapted to specific drug peculiarities? Member of
  • 14. WEAKNESSESLack of model flexibilityOpen issue: transferability TransferabilityLack of synthesis Transferability of available evidence: • Lack of operative indications • Transferability regard many item, such as: Member of
  • 15. WEAKNESSES Lack of model flexibility Open issue: transferability Synthesis Lack of synthesis Summary of evidence: • The proposed model lacked a summary section • Need to adopt a short and a long run perspective THREADS Workload & Timing Interpretation of the report Use of the reportIn order to improve HTA model impact:Need to interpret different domains in a coordinated manner in order to obtain a broadpicture of the drug/molecule potentials and limits Member of
  • 16. Efficacy and Safety in the short run Budget Efficacy and Safety in the long runCost effectiveness Impact Ethical and Social impact Cost-effectivenessMember of
  • 17. Implementing HTADespite its weakness an HTA report is now available for paroxetine.And now? Need Evidence Action Member of
  • 18. Implementing HTAAnd now? Member of
  • 19. Implementing HTAMany studies investigate how to implement HTA evidence.Elements of a successful implementation strategy are:a) defining a clear policy questionb) defining a clear research questionc) making recommendations commensurate with the evidenced) identifying the implementation mechanisme) paying attention to incentives and disincentivesf) clarifying the roles and responsibilities of the various partiesReference: Drummond M, Weatherly H. IMPLEMENTING THE FINDINGS OF HEALTH TECHNOLOGYASSESSMENTS (If the CAT Got Out of the Bag, Can the TAIL Wag the Dog?). International Journal ofTechnology Assessment in Health Care (2000), 16 : pp 1-12 Member of
  • 20. ConclusionsThe case study of the Multidimensional Impact of an health technology (Stimadi Impatto Multidimensionale (SIM) della tecnologia sanitaria ) for paroxetineenlighted opportunities and limits.It demonstated the value of a:• multidisciplinary approach;• multidisciplinary group of experts;• in depth literature search and review.Critical points remain:• how to deal with single drug peculiarities;• how to sum up evidence. In the SIM model the synthesis moment is missing;• final use of the HTA report;• Integrate HTA report in a strategy for HTA implementation. Member of

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