WHO - EML at 40€¦ · Expert Committee on the Selection and Use of Essential Medicines 2017 –...
Transcript of WHO - EML at 40€¦ · Expert Committee on the Selection and Use of Essential Medicines 2017 –...
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Séminare sur les poliitiques pharmaceutiques, Sept 2015
EML at 40
Nicola Magrini Secretary,
WHO Expert Committee on the Selection and Use of Essential Medicines, Essential Medicines Department, WHO
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Essential Medicines List: Concept and Procedures 2 |
Expert Committee on the Selection and Use of Essential Medicines 2017 – Open Session
Contents of the presentation
• EML present rules and future approaches
• EB109/8
• Relationship with WHO GLs
• EML Working Groups and more comprehensive review
• Improving access to • Available evidence for decision-making
• Available drug utilization data on the use of Essential Medicines
and feedbacks from countries (NEMLs)
• Implementation at country level and feedbacks
from countries
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Essential Medicines List: Concept and Procedures 3 |
The EML reform in 2001:
more explicit criteria
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Essential Medicines List: Concept and Procedures 4 |
A more transparent and
evidence-based process (EB109/8 2001)
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Essential Medicines List: Concept and Procedures 5 |
EML criteria (EB 109/8, 2001)
Disease burden and public health need/relevance
Sound and adequate data on the efficacy (on relevant outcomes),
safety and comparative cost-effectiveness
– “Absolute cost of the treatment will not constitute a reason to exclude a
medicine from the Model List that otherwise meets the stated selected criteria”
– “Affordability changed from a precondition into a consequence of the selection”
(Hogerzeil, BMJ, 2004)
WHO responsible management and oversight of CoIs
2008: WHO new Guideline Manual, adopting GRADE
Other considerations: availability, guidelines
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Essential Medicines List: Concept and Procedures 6 |
Expert Committee on the Selection and Use of Essential Medicines 2017 – Open Session
Contents of the presentation
• EML present rules and future approaches
• EB109/8
• Relationship with WHO GLs
• EML Working Groups and more comprehensive review
• Improving access to
• Available evidence for decision-making
• Available drug utilization data on the use of Essential Medicines
and feedbacks from countries (NEMLs)
• Implementation at country level and feedbacks from
countries
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Essential Medicines List: Concept and Procedures 7 |
EML and WHO guidelines:
towards more explicit linkages
Share a “coordinated” evidence base: commissioned
systematic reviews, metanalysis and NMA
Share best available evidence: trials and SRs in press ,
issues on publication and outcome reporting bias, …
Privilege a comprehensive comparative approach among all
available options
Share/follow WHO policy recommendations
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Essential Medicines List: Concept and Procedures 8 |
Expert Committee on the Selection and Use of Essential Medicines 2017 – Open Session
Contents of the presentation
• EML present rules and future approaches
• EB109/8
• Relationship with WHO GLs
• EML Working Groups and more comprehensive review
• Improving access to
• Available evidence for decision-making
• Available drug utilization data on the use of Essential Medicines
and feedbacks from countries (NEMLs)
• Implementation at country level and feedbacks from
countries
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Essential Medicines List: Concept and Procedures 9 |
EML WGs
and more comprehensive reviews
Need for standing EML Working Groups to
– Propose more comprehensive approaches
– Prioritise drugs and interventions
– Define explicit criteria for evaluation
– Commission preparatory work
Reason: have a leadership role and reduce dependency on
applications of variable quality
Examples: cancer, antibiotics
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Essential Medicines List: Concept and Procedures 10 |
Expert Committee on the Selection and Use of EM – Open Session
Contents of the presentation
• EML present rules and future approaches
• EB109/8
• Relationship with WHO GLs
• EML Working Groups and more comprehensive review
• Improving access to
• Available evidence for decision-making
• Available drug utilization data on the use of Essential Medicines
and feedbacks from countries (NEMLs)
• Implementation at country level and feedbacks from
countries
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TRS TEMPLATE 2017
2017 e-EML
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ELECTRONIC EML
ELECTRONIC DATABASE
ONLINE SEARCH ENGINE
LINK TO WHO GUIDELINES
TEMPLATE EVIDENCE SYNTHESIS
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Essential Medicines List: Concept and Procedures 13 |
Expert Committee on the Selection and Use of EM – Open Session
Contents of the presentation
• EML present rules and future approaches
• EB109/8
• Relationship with WHO GLs
• EML Working Groups and more comprehensive review
• Improving access to
• Available evidence for decision-making
• Available drug utilization data on the use of Essential Medicines
and feedbacks from countries (NEMLs)
• Implementation at country level and feedbacks from
countries
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Essential Medicines List: Concept and Procedures 14 |
EML and drug utilization data
• Importance of drug utilisation data (benchmarking and
education) from countries: specifically for antibiotics
• Availability and shortages: surveys in place
• NEMLs and affordability /prices: surveys in place
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Essential Medicines List: Concept and Procedures 15 |
Expert Commiitee on the Selection and Use of EM – Open Session
Contents of the presentation
• EML present rules and future approaches
• EB109/8
• Relationship with WHO GLs
• EML Working Groups and more comprehensive review
• Improving access to
• Available evidence for decision-making
• Available drug utilization data on the use of Essential Medicines
and feedbacks from countries (NEMLs)
• Implementation at country level and feedbacks from
countries
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Essential Medicines List: Concept and Procedures 16 |
EML implementation at country level
• Link to NEMLs and reimbursement lists
• New website & implementation manual
• Feedback from countries for future updates
• Importance of preparatory work (in between EC meetings)
on specific topics:
• HIV, TB, Malaria, NTDs
• Cancer
• AB
• …
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