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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.