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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
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
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Agenda
• Multidimensional assessment• The approch of an Italian Region• Case study: paroxetine• SWOT analysis • Weaknesses• HTA implementation• Conclusions
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Multidimensional assessment
The need to assess health technologies according to a multidisciplinary framework is a growing necessity at different levels of National Health System (NHS).
As far concern the drug market, safety and efficacy are the main dimensions taken into account.
HTA principles and competition among producers and molecules require to consider other aspects as effectiveness and cost-effectiveness at different levels of NHS.
Safety Effectiveness
Budget impact Cost-effectiveness
Social impactOrganizational
impact
Ethical issues
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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.
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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
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The assessment moment
WHO
WHAT
Macro
Meso
Micro
BEFOREDURING
AFTER
DRUGS DEVICES PROCEDURES
WHEN
What: drugWho: Region
When: years after approval
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ParoxetineParoxetine was one of the molecules under assessment for each of the therapeutic 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.
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Work doneThe group of experts of “A.Gemelli” University Hospital participated at the assessment.
It was composed by:• Medical doctors• Health Economists• Statisticians• Bioethical experts• Experts of organizational issues• Literature search experts.
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TimingTime available: 3 months
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Data sourcesThe 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 specific
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PICO modelTechnology
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 impact
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SWOT analysis
STRENGHTS WEAKNESSES
OPPORTUNITIES THREADS
Full assessmentMultidisciplinary approachHTA model with manualAttention to quality of evidence
Lack of model flexibilityOpen issue: transferabilityLack of synthesis
Regional involvementHTA approach
Workload & Timing Interpretation of the reportUse of the report
The paroxetine case study could be useful to consider the applicability of a HTA model in real life setting.
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Flexibility
Case 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?
WEAKNESSES Lack of model flexibilityOpen issue: transferabilityLack of synthesis
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Transferability
Transferability of available evidence:• Lack of operative indications • Transferability regard many item, such as:
WEAKNESSES Lack of model flexibility
Open issue: transferabilityLack of synthesis
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In order to improve HTA model impact:Need to interpret different domains in a coordinated manner in order to obtain a broad picture of the drug/molecule potentials and limits
Synthesis
Summary of evidence: • The proposed model lacked a summary section• Need to adopt a short and a long run perspective
WEAKNESSES Lack of model flexibilityOpen issue: transferability
Lack of synthesis
THREADS Workload & Timing
Interpretation of the reportUse of the report
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Cost effectiveness
Efficacy and Safety
in the short run
Efficacy and Safety in the long run
Ethical and Social impact
Budget Impact
Cost-effectiveness
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Implementing HTADespite its weakness an HTA report is now available for paroxetine.And now?
Need
Evidence
Action
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Implementing HTAAnd now?
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Implementing HTA
Many studies investigate how to implement HTA evidence.
Elements of a successful implementation strategy are: a) defining a clear policy question b) 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 parties
Reference: Drummond M, Weatherly H. IMPLEMENTING THE FINDINGS OF HEALTH TECHNOLOGY ASSESSMENTS (If the CAT Got Out of the Bag, Can the TAIL Wag the Dog?). International Journal of Technology Assessment in Health Care (2000), 16 : pp 1-12
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ConclusionsThe case study of the Multidimensional Impact of an health technology (Stima di Impatto Multidimensionale (SIM) della tecnologia sanitaria ) for paroxetine enlighted 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.