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

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
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2. Agenda
• Multidimensional assessment
• The approch of an Italian Region
• Case study: paroxetine
• SWOT analysis
• Weaknesses
• HTA implementation
• Conclusions
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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.
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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.
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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
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6. The assessment moment
What: drug
Who: Region
When: years after approval
WHO
AFTER
Macro
DURING
BEFORE Meso
Micro
WHAT
DRUGS DEVICES PROCEDURES
WHEN
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7. Paroxetine
Paroxetine 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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8. Work done
The 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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9. Timing
Time available: 3 months
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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 specific
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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 impact
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12. SWOT analysis
The paroxetine case study could be useful to consider the applicability of a HTA model in
real 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
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13. WEAKNESSES
Lack of model flexibility
Open issue: transferability
Flexibility
Lack of synthesis
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?
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14. WEAKNESSES
Lack of model flexibility
Open issue: transferability
Transferability
Lack of synthesis
Transferability of available evidence:
• Lack of operative indications
• Transferability regard many item, such as:
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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 report
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
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16. Efficacy and Safety
in the short run
Budget
Efficacy and Safety in
the long runCost effectiveness Impact
Ethical and Social impact
Cost-effectiveness
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17. Implementing HTA
Despite its weakness an HTA report is now available for paroxetine.
And now?
Need
Evidence
Action
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18. Implementing HTA
And now?
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19. 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 question
c) making recommendations commensurate with the evidence
d) identifying the implementation mechanism
e) paying attention to incentives and disincentives
f) 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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20. Conclusions
The 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.
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