ConceptProcess and Update on EML 2015 WHO Technical Briefing Seminar Nicola Magrini WHO EMP November 4 2014 WHO Geneva Essential Medicines Guiding principle A limited range of carefully selected essential medicines leads to better health care better medicines management and l ID: 597363
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Slide1
WHO Essential Medicines List
Concept/Process and Update on EML 2015
WHO Technical Briefing Seminar
Nicola Magrini – WHO, EMP
November 4, 2014 – WHO GenevaSlide2
Essential Medicines
Guiding principle: A limited range of carefully selected essential medicines leads to better health care, better medicines management, and lower costsDefinition:
Essential medicines are those that satisfy the priority health care needs of the populationSelection: Selected with due regard to disease prevalence, evidence on efficacy and safety, and comparative cost-effectiveness.Slide3
… 38 years of EML
1977 1st Model list published, 208 active substances
- List is revised every two years by WHO Expert Committee - 2002 Revised procedures approved by WHO (EB109/8) - Last revision EML (April 2013) contains 374 medicines
The first list was a major breakthrough in the history of medicine, pharmacy and public health
Médecins
sans
Frontières
, 2000Slide4Slide5
The Essential Medicines List
and concept"The concept of essential medicines is one of the major public health achievements in the history of WHO
. It is as relevant today as it was at it inception over 30 years ago." Dr Margaret Chan — Director-General, WHOSlide6
Why is it 'model'
Model for its selection process (“one medicine per class” approach unless clinically relevant differences demonstrated)Model to facilitate efforts to 'improve health' of population Regulation Quality
(Rational) Responsible and evidence-based use Procurement and SupplyAccess: Availability, Affordability, A
ccessibility and AcceptabilitySlide7
18th WHO Model List of Essential Medicines - 2013
Report of the WHO Expert Committee, 2013
N. = 208
N. = 374Slide8
EML 2013 in numbers
374 – total number of drugs/medicines
Core
list:
282 (FDC
:
23)
Complementary
list:
68 (FDC
: 1)Slide9
EML 2013 in numbers
Adult List
374 – total number of drugs/medicines
Core
list:
282 (FDC
:
23)
Complementary
list:
68 (FDC: 1)Pediatric List278 in totalCore list: 206 (FDC: 11)Complementary list: 60 (FDC: 1)Slide10
ProcessEvidence Based and Transparent
Applications invited - addition/deletion/modificationFormat proposed (see Applications) and WHO technical Dpt involved Deadlines: a semester the year before next EC (…, 2013, 2015, … yearly?)
All applications go onlineApplications peer reviewed by expertsPeer reviews go onlineComments invited from any one interested (WHO Depts., Professional Societies, International agencies, Academia)Comments go on lineExpert Committee makes final decisionsReport goes on lineSlide11
EML criteria (EB 109/8, 2001)
Disease burden and public health needSound and adequate data on the efficacy, safety and comparative cost-effectiveness of available treatmentsNeed for special diagnostic or treatment facilities considered“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
” Slide12
Application
period for EML 2015(Expert Committee
April 2015) Open for 6 months: 15 June
2014 – 30 November 2014Applications evaluated for methodology: systematic review, evidence appraisal and synthesis (when needed, changes and new application requested)Application can be rejected
(
by
EML
secretariat
)
for
lack of sufficient rigour in reporting available evidenceApplication sent to 2 or 3 Panel members (acting indipendently as blinded referees) Slide13
EML: applications
, referees and ECThe opinions and
evaluations expressed by the 2 (or 3) referees are brought to the attention
of WHO Expert Committee (EC)EC has a plenary discussion
and
takes
a
decision
Usually
without voting Slide14
A walk through the processhttp://www.who.int/selection_medicines/committees/en/
Slide15
The application form/templateSlide16
EML Application: additional info posted
on how to prepare an applicatioSlide17
EML criteria and GRADE … the basics
A systematic review of the best available evidenceA systematic review (synthesis and appraisal) is more important than a metanalysis (pooled estimate) Importance of summary evidence table … with appraisal of risk of bias (study defect/reliability) to evaluate confidence in estimates (for both outcomes of efficacy and safety) …
this was once called quality of evidenceSlide18
EML and evidence table for benefits and harms
GRADE … example 1Slide19
EML and evidence table for benefits and harms
GRADE … example 2Slide20
EML and evidence table for benefits and harms
GRADE … example 2Slide21
EML and evidence table for benefits and harms
GRADE … example 2Slide22
EML and evidence table for benefits and harms
GRADE … example 2Slide23
EML and evidence table for benefits and harms
GRADE … example 3Slide24
EML and evidence table for benefits and harms
… example 4Slide25
The application review process (EB109/8)Slide26
EML: transparency and dialogue
All applications - publicExpert reviews – publicComments and clarifications letters – publicTechnical Report (summarising all the discussion) - publicSlide27
E
ML transparency: web applicationsSlide28
EML transparency
: Expert ReviewsSlide29
EML transparency
: CommentsSlide30
EML criteria (EB 109/8, 2001)
Disease burden and public health needSound and adequate data on the efficacy, safety and comparative cost-effectiveness of available treatmentsNeed for special diagnostic or treatment facilities considered“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
” Slide31
EML 2015
A few big challengesSlide32
Opportunity to improve EML updating
When highly effective drugs are available Cancer drugs: how to choose the few highly effective (patented, high cost) medicines (2 discussed in EML 2013: trastuzumab in breast cancer and imatinib in chronic myeloid
leukemia). Other medicines: see next table, … New HCV drugs (new direct antiviral, single agents and combinations, IFN free regimens)TB large updateNew anticoagulants: oral (NAC) and surely LMWHSlide33
Opportunity to improve EML updating
When highly effective drugs are available Cancer drugs: how to choose the few highly effective (patented, high cost) medicines (2 discussed in EML 2013: trastuzumab in breast cancer and
imatinib in chronic myeloid leukemia). Other medicines: see next table, … New HCV drugs (new direct antiviral, single agents and combinations, IFN free regimens)TB large updateNew anticoagulants: oral (NAC) and surely LMWHSlide34
EML cancer update: first line treatmentSlide35
EML cancer drugs: candidates (15-20)Slide36
Opportunity to improve EML updating
When highly effective drugs are available Cancer drugs: how to choose the few highly effective (patented, high cost) medicines (2 discussed in EML 2013: trastuzumab in breast cancer and imatinib in chronic myeloid
leukemia). Other medicines: see next table, … New HCV drugs (new direct antiviral, single agents and combinations, IFN free regimens)TB large updateNew anticoagulants: oral (NAC) and surely LMWHSlide37
EML and New HepC drugs
Very effective oral drugs (IFN free regimens)A WHO GL with a strong recommendationSofosbuvir and Ledipasvit/sofosbuvir
combination (already IN the applications)What to di with financial implications What to do with new drugs in the pipeline Slide38
Opportunity to improve EML updating
When highly effective drugs are available Cancer drugs: how to choose the few highly effective (patented, high cost) medicines (2 discussed in EML 2013: trastuzumab in breast cancer and imatinib in chronic myeloid
leukemia). Other medicines: see next table, … New highly HCV drugs (new direct antiviral, single agents and combinations, IFN free regimens)TB large updateNew anticoagulants: oral (NAC) and surely LMWHSlide39
WHO guidance on the management
of drug-resistant TB, 1996-2014Slide40
The candidate drugs
1) New molecules
Bedaquiline, Delamanid
2) Repurposed for TB, in EML
Amoxicillin-
clavulanate
, Azithromycin,
Clarithromycin,
Clofazimine
,
Imipenem/cilastatin, Meropenem
3) Repurposed, not in EML
Linezolid,
Gatifloxacin
,
TerizidoneSlide41
Opportunity to improve EML updating
When highly effective drugs are available Cancer drugs: how to choose the few highly effective (patented, high cost) medicines (2 discussed in EML 2013: trastuzumab in breast cancer and imatinib in chronic myeloid leukeima
). New highly HCV drugs (new direct antiviral, single agents and combinations, IFN free regimens)TB drugs (12)WHO could have a leadership role in improving access to highly effective medicines (as was for HIV in 2002) Slide42
EML timelineSlide43
Apr 2014
EML TRS 2013 printed
June-
Dic
2014
Jan-March 2015
Apr 2015
Preparation of a 6 month application period
(15
th
June – 1
st
December 2014)
Contacts and exchanges with WHO technical
Dpts
and other UN agencies
Reviewing application forms and criteria towards full systematic reviews and GRADE adoption
EML 2014 - 2015 timelineSlide44
Apr 2014
Application period open
June-
Dic
2014
Jan-March 2015
Apr 2015
Commissioning and coordination of applications
Alignment of WHO GL with EML timeline (HIV, TB, RH, MH
Verify the full adoption of systematic reviews and GRADE approach
Manage questions and feedbacks from countries on EML adoption and implementation
December (10
th
– 15
th
): web publication of all applications
EML 2014 - 2015 timelineSlide45
Apr 2014
EML reviewing and EC referees, and comments
June-
Dic
2014
Jan-March 2015
Apr 2015
Verify applications (the early the better) for full adoption of systematic reviews and GRADE approach
Answers to questions and feedbacks from Countries to be presented to Expert Committee (EC)
Summarise
a TRS text for EC and prepare the List
Merging adult and pediatric Lists into one List to facilitate readability
Increase usefulness of EML database
EML 2014 - 2015 timelineSlide46
Apr 2014
EML web publication
June-
Dic
2014
Jan-March 2015
Apr 2015
EC meeting 20-25 April 2015
EML published end of April and summary of decisions taken
TRS
finalisation
for publication (…)
TBC
: Availability of a EML database of decisions taken and indications evaluated/approved/rejected
EML 2014 - 2015 timelineSlide47
What about devices in EML?Slide48
Where do we start from
20062008Slide49
Just few devices are in EML
To strengthen a WHO policy (on contraception)To be consistent across various WHO GL/documentsIf apply, be supported by a WHO technical DptSuggestion: first be in a WHO policy document or GL and then apply to EML (rather than the other way round)Slide50
Conclusions
Application for EML will be opened soon and will remain open for 6 monthsIt is strongly encouraged to make an application connected with a WHO technical departmentFrame your proposal within a WHO policy document/GLSend it early enough to be reviewed Expert Committee 2015 EML Meeting: April 2015Slide51Slide52
Rational drug therapy (RDT)Quality use of medicines
Appropriate use of medicinesResponsible and evidence-based useAccess to essential medicines and implementation at country levelSlide53
Selection processSlide54
EML: why a model?
A model for process and transparencyEvidence-based rigorous process: high scrutiny on quality of evidence AND on its applicability at a global levelManagement of conflicts of interestsFeed backs from country implementationSlide55
Access and appropriate use of medicines:issues and challenges – PUSH MODE
How to give access to the best available evidenceFull access to all available evidence Understanding: critically appraised, highly scrutinised with multidisciplinary considerationsHow? Are TRS report enough? Probably NOT …
Connection and good alignment with WHO guidelinesExamples from: OC, TB, HIV, HepC, Mental Health, …Slide56
Access and appropriate use of medicines:issues and challenges – PULL MODE
New drugs are introduced different from EMLEML in delay … important new drugsLMWHCancer drugs …
Drugs lacking good enough supporting evidenceDrugs for memory… Slide57
How to support good prescribingSlide58
Two different level of action: one supporting the other
Access to available evidenceRetrieval, systematic review, critical appraisal, synthesis and user-friendly presentationUnderstanding, applicability and relevance,
Guidelines and recommendationStandard and conditional recommendation and indicators of useSlide59
The importance of the context
Actual medicines use at local/national levelAccess to available evidenceGuidelines and recommendationsDrug utilization data: international comparison, small and large area variability, …Slide60
The importance of the context
Actual medicines use at local/national levelAccess to available evidenceGuidelines and recommendationsDrug utilization data: international comparison, small and large area variability, …The need for a comprehensive pharmaceutical policy:Slide61
Pharmaceutical policy
By pharmaceutical policy we mean the conscious efforts of national governments to influence the pharmaceutical systemSlide62
Pharmaceutical policy
By pharmaceutical policy we mean the conscious efforts of national governments to influence the pharmaceutical systemSlide63
… health system
Equitable accessAffordabilityAppropriate useSlide64
Functions
of pharmaceutical sector
Registration of medicinesLicensing of pharmaceutical businessInspection of establishment Medicine promotion
Clinical trials and independent confirmatory research Indipendent drug informationGuidelines program and evidence-based recommendations
Selection
of essential medicines
Procurement
of medicines
Distribution
of medicines
Drug utilizationSlide65
There is a difference
Independent drug bulletinsCochrane reviewsClinical EvidenceUptodateGuidelinesRecommendations
Consensus conferencesInappropriate uses