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12th
Expert Committee on the Selection and Use of Essential
Medicines, 15-19 April 2002
Procedure
to update and disseminate the WHO Model List of Essential
Medicines1
Document
EB109/8 (Annex), 7 Dec 2001
WHO
Expert Committee on the Use of Essential Drugs
Applications
for inclusion, change or deletion
Review
of applications and draft recommendations
Criteria
for the selection of essential medicines
Presentation
of recommendations, report of the Expert Committee
WHO
Essential Medicines Library
WHO
Expert Committee on the Use of Essential Drugs
1.
The Model List is drawn up by the WHO Expert Committee on the
Use of Essential Drugs, following the Regulations for Expert
Advisory Panels and Committees2.
Since 1977 the Expert Committee has been convened every two
years, but could meet more often if needed.
2.
The Expert Committee comprises eight to 12 members drawn from
the WHO Expert Advisory Panels3
for Drug Evaluation and for Drug Policies and Management, and,
where appropriate and in consultation with the relevant cluster,
from other expert advisory panels. Expert Committee members are
selected by the Director-General to represent a wide range of
geographical and professional backgrounds, including clinical
pharmacology, clinical medicine, international public health,
guideline development methodology, systematic literature search
methods, risk-assessment and cost-effectiveness analysis.
3.
Meetings of the Expert Committee are private2
and members are required to complete a WHO declaration of
interest form before the meeting. Observers may be invited in
accordance with Regulations for Expert Advisory Panels and
Committees to attend all or parts of the meetings of the Expert
Committee. Patient advocacy groups and representatives of the
health care industry are invited to comment on the applications
and draft recommendations (see below), but are not invited to
attend decision-making parts of meetings of the Expert
Committee.
Applications
for inclusion, change or deletion
4.
Applications for inclusions, changes or deletions to the Model
List are submitted by or through relevant departments in WHO to
the secretary of the Expert Committee. The opinion of the
relevant department in WHO is conveyed to the secretary with the
application and is presented to the Expert Committee. The
information that should be submitted with the application is
summarized in Box 1. The application should be received at least
four months before the meeting of the Expert Committee. For
therapeutic categories for which no specific department exists
in WHO the application can be submitted by the department of
Essential drugs and medicines policy.
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Box
1. Information to be included with an application for
inclusion or deletion of
a medicine in the WHO Model List of Essential Medicines
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1.
Summary statement of the proposal for inclusion,
change or deletion
2.
Name of the focal point in WHO submitting the
application
3.
Name of the organization(s) consulted and/or
supporting the application
4.
International Nonproprietary Name (INN, generic
name) of the medicine
5.
Whether listing is requested as an individual
medicine or as an example of a therapeutic group
6.
Information supporting the public health
relevance (epidemiological information on disease
burden, assessment of current use, target population)
7.
Treatment details (dosage regimen, duration;
reference to existing WHO and other clinical guidelines;
need for special diagnostic or treatment facilities and
skills)
8.
Summary of comparative effectiveness in a variety
of clinical settings:
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Identification
of clinical evidence (search strategy, systematic
reviews identified, reasons for selection/exclusion
of particular data)
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Summary
of available data (appraisal of quality, outcome
measures, summary of results)
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Summary
of available estimates of comparative effectiveness
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9.
Summary of comparative evidence on safety:
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Estimate
of total patient exposure to date
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Description
of adverse effects/reactions
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Identification
of variation in safety due to health systems and
patient factors
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Summary
of comparative safety against comparators
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10.
Summary of available data on comparative cost1
and cost-effectiveness within the pharmacological class
or therapeutic group:
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range
of costs of the proposed medicine
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comparative
cost-effectiveness presented as range of cost per
routine outcome (e.g. cost per case, cost per cure,
cost per month of treatment, cost per case
prevented, cost per clinical event prevented, or, if
possible and relevant, cost per quality-adjusted
life year gained)
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11.
Summary of regulatory status of the medicine (in
country of origin, and preferably in other countries as
well)
12.
Availability of pharmacopoieal standards (British
Pharmacopoeia, International Pharmacopoiea, United
States Pharmacopoeia)
13.
Proposed (new/adapted) text for the WHO Model
Formulary
_______________
1The information on cost and
cost-effectiveness should preferably refer to average
generic world market prices as listed in the International
Drug Price Indicator Guide, an essential medicines
pricing service provided by WHO and maintained by
Management Sciences for Health. If this information is
not available, other international sources, such as the
WHO, UNICEF and Médecins
sans Frontières price information service, can be
used. All cost analyses should specify the source of the
price information.
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Review
of applications and draft recommendations
5.
The step-wise approach for reviewing applications and draft
recommendations is summarized in Box 2. A similar process is
used periodically to review whole sections of the Model List. In
that case the need for review and the selection of the
reviewer(s) are considered in close collaboration with the
relevant department in WHO.
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Box
2. Systematic review of applications
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1.
The secretary of the Expert Committee checks the
application for completeness
2.
A summary of the application is posted on the WHO
web site1 for review and comments
3.
Specialist assessment(s) are made of the data on
comparative efficacy, safety and cost-effectiveness, in
close collaboration with relevant departments in WHO
4.
The outcome of these assessments is summarized by
an expert invited to attend the next meeting of the
Expert Committee as a member (“the presenter”) who
formulates a draft recommendation for the Committee
5.
The draft recommendation and proposed text of the
WHO Model Formulary are reviewed by the relevant
department in WHO and members of relevant expert
advisory panels. They are also posted on the WHO web
site for comments, for a minimum of 30 days
6. The
presenter reviews the comments and formulates a final
text for consideration by the Expert Committee
7. The
Expert Committee reviews and adopts the application as a
recommendation to the Director-General
_______________
1
http://www.who.int/medicines/
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Criteria
for selection4
6.
The choice of essential medicines depends on several factors,
including the disease burden and sound and adequate data on the
efficacy, safety and comparative cost-effectiveness of available
treatments. Stability in various conditions, the need for
special diagnostic or treatment facilities and pharmacokinetic
properties are also considered if appropriate. When adequate
scientific evidence is not available on current treatment of a
priority disease, the Expert Committee may either defer the
issue until more evidence becomes available, or choose to make
recommendations based on expert opinion and experience.
7.
Most essential medicines should be formulated as single
compounds. Fixed-ratio combination products are selected only
when the combination has a proven advantage in therapeutic
effect, safety or compliance over single compounds administered
separately. Examples of combination medicines that have met
these criteria include new formulations for tuberculosis and
malaria.
8.
In cost comparisons between medicines, the cost of the total
treatment, and not only the unit cost of the medicine, is
considered. Cost and cost-effectiveness comparisons may be made
among alternative treatments within the same therapeutic group,
but will generally not be made across therapeutic categories
(for example, between treatment of tuberculosis and treatment of
malaria). The 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. The patent status
of a medicine is not considered in selecting medicines for the
Model List.
9.
In adapting the WHO Model List to national needs, countries
often consider factors such as local demography and pattern of
diseases; treatment facilities; training and experience of the
available personnel; local availability of individual
pharmaceutical products; financial resources; and environmental
factors.
Presentation
of recommendations, report of the Expert Committee
10.
In its report the Expert Committee summarizes the reasons for
each recommendation with reference to the underlying evidence.
The Expert Committee may grade its recommendations depending on
the nature of the underlying evidence. When insufficient
evidence is available, the Expert Committee specifies that its
recommendations are based on expert opinion and experience. The
Committee's report also refers to existing standard clinical
guidelines. The Expert Committee may specifically indicate in
the list medicines for which specialized health care facilities
may be needed or which meet all the selection criteria and which
are cost-effective within their therapeutic group, but which are
not necessarily affordable for all health systems.
11.
Presentation of the Model List will be recommended by the Expert
Committee based on considerations of clarity and practicality.
Previous model lists have been presented in various formats,
including one in which medicines considered to be in the main
list appear first under each therapeutic group, followed by
medicines considered to be in a complementary list.
12.
Immediately after the meeting and subject to final approval by
the Director-General, the recommended changes to the Model List,
the summary of the Expert Committee's considerations and other
relevant information are posted on the WHO web site. The full
report of the meeting is published in the WHO Technical Report
Series. Translations of the report are published as soon as
possible and in close collaboration with WHO regional offices.
WHO
Essential Medicines Library
13.
In addition to the information on whether a medicine is in the
Model List or not, it is important for end-users to have access
to information that supports the selection, such as summaries of
relevant WHO clinical guidelines, the most important systematic
reviews, important references and indicative cost information.
Other information is also linked to the medicines in the Model
List such as the WHO Model Formulary and information on
nomenclature and quality-assurance standards. All this
information is presented on the WHO web site as the "WHO
essential medicines library" (see figure) intended to
facilitate the work of national committees.
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[3]
Members of Expert Advisory Panels are proposed
by WHO and, when approved by their respective government,
appointed for one or more periods of up to four years.
[4]
Since the first meeting of the Expert
Committee in 1977, criteria for selection of essential medicines
have focused on disease prevalence, treatment facilities,
safety, efficacy, quality, availability, and cost factors.
Descriptions of selection criteria appear in the Ninth Report of
the WHO Expert Committee on the Use of Essential Drugs (WHO
Technical Report Series, No. 895, 2000), the Eighth Report of
the WHO Expert Committee on the Use of Essential Drugs (WHO
Technical Report Series, No. 882, 1998), and previous reports of
the Committee.
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Last
update:31-Oct-2002
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