Concept and Process IPC Meeting June 6 2014 WHO Geneva Nicola Magrini WHO EMP Essential Medicines Guiding principle A limited range of carefully selected essential medicines leads to better health care better medicines management and lower costs ID: 135379
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Slide1
WHO Essential Medicines List
Concept and Process
IPC Meeting
June 6, 2014 – WHO Geneva
Nicola Magrini – WHO, EMPSlide2
Essential Medicines
Guiding principle: A limited range of carefully selected essential medicines leads to better health care, better medicines management, and lower costs
Definition: 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 Committee2002 Revised procedures approved by WHO (EB109/8): more evidence-based, more transparent and participated processLast revision EML (
April 2013): 374 medicines
The first list was a major breakthrough in the
history of
medicine, pharmacy and public health
Médecins
sans Frontières, 2000Slide4
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, WHOSlide5
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 AcceptabilitySlide6
18th WHO Model List of Essential Medicines - 2013
Report of the WHO Expert Committee, 2013
N. = 208
N. = 374Slide7
EML 2013 in numbers
374 – total number of drugs/medicines
Core
list:
282 (FDC
:
23)
Complementary
list:
68 (FDC
: 1)Slide8
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)Slide9
Process
Evidence Based and TransparentApplications invited and received - 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 EC member (2 or 3 indipendent reviewers)Peer reviews go onlineComments invited from any one interested (WHO Depts., Professional Societies, International agencies, Academia)
Comments go on lineExpert Committee makes final decisions (full report - TRS)Slide10
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” Slide11
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) Slide12
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 Slide13
A walk through the process
http://www.who.int/selection_medicines/committees/en/ Slide14
The application form/templateSlide15
EML criteria:
evidence review is centralA systematic review of the best available evidenceSystematic review (synthesis and appraisal) more important than
metanalysis Importance of evidence table presentation … and appraisal of risk of bias (study defect/reliability) to evaluate confidence in estimates (for both outcomes of efficacy and safety) … once called quality of evidenceSlide16
GRADE evidence table
for benefits and harmsexample 1: single RCTs Slide17
EML and evidence:
for benefits and harmsGRADE … example 2Slide18
GRADE evidence table for benefits and harms
example 2: RCTs and observational studiesSlide19
GRADE evidence table for benefits and harms
example 3: systematic review (meta-analysis)Slide20
EML and evidence table for benefits and harms
GRADE … example 4Slide21
EML and evidence table for benefits and harms
… example 5 …Slide22
Simplifying (by commenting)
the application formSlide23
Opportunity to improve EML updating (2015)
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: rituximab, erlotinib/gefitinib, sunitinib/everolimus, … New highly HCV drugs (new direct antiviral, single agents and combinations, IFN free regimens)Slide24
Opportunity to improve EML updating (2015)
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). Other medicines: rituximab, erlotinib/gefitinib, … New highly HCV drugs (new direct antiviral, single agents and combinations, IFN free regimens)WHO could have a leadership role in improving access to highly effective medicines (as was for HIV in 2002) Slide25
Opportunity to improve EML updating (2015)
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: rituximab,
erlotinib/gefitinib, sunitinib
/
everolimus
, …
New highly HCV drugs (new direct antiviral, single agents and combinations, IFN free regimens
)
New anticoagulants: oral (NAC) and surely LMWH
Endocrinology medicines chapter, anti-TNF medicines (for rheumatoid arthritis and IBD), …Slide26
EML 2015 timelineSlide27
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
2015
timelineSlide28
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
2015
timelineSlide29
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
2015
timelineSlide30
Apr 2014
EML web publication
June-
Dic
2014
Jan-March 2015
Apr 2015
EC meeting 20-25 April 2015
EML published end of April with a summary of decisions taken
TRS
finalisation
for publication (…)
In progress
: Availability of a EML database of decisions taken and indications evaluated (history and summary of all decisions)
EML
2015
timelineSlide31
What about devices in EML?Slide32
Just a few devices in EML
To strengthen a WHO policy (on contraception)To be consistent across various WHO GL/documentsIf apply, be supported by a WHO technical Dpt
Suggestion: first be in a WHO policy document or GL and then apply to EML (rather than the other way round)Slide33
Conclusions
Application for EML will be opened soon and will remain open for 6 monthsIt is strongly reccomended to make an application connected with a WHO technical departmentAnd to frame the proposal within a WHO policy document/GL
Send it early enough to be reviewed Expert Committee 2015 EML Meeting: April 2015