The concept of essential drugs and the WHO Model List of Essential Medicines Hans V. Hogerzeil, MD, PhD, FRCP Edin Department of Essential Drugs and Medicines

The concept of essential drugs and the

WHO Model List of Essential Medicines

Hans V. Hogerzeil, MD, PhD, FRCP Edin

Department of Essential Drugs and Medicines Policy

World Health Organization, 2002

EDC/Model List 2 Department of Essential Drugs and Medicines Policy

Essential medicines

The concept of essential medicines

A limited range of carefully selected essential medicines leads to better health care, better drug management, and lower costs

Definition of essential medicines

Essential medicines are those that satisfy the priority health care needs of the population

(Report to WHO Executive Board, January 2002)


History of the WHO Model List of Essential Drugs

1977 First Model list published, ± 200 active substances

List is revised every two years by WHO Expert Committee

Last revision (Dec.1999) contains 306 active substances

2002 Revised procedures approved by WHO

The first list was a major breakthrough in the historyof medicine, pharmacy and public health Médecins sans Frontières, 2000


The Essential Medicines Target

S S

All the drugsin the world

Registered medicines

National list ofessential medicines

Levels of use

Supplementaryspecialistmedicines

CHWdispensary

Health center

Hospital

Referral hospital

Private sector


List of common diseases and complaints

Treatment choice

TreatmentTrainingSupervision

Supply of drugs

Treatment guidelines List of essential drugs National formulary

Relation between treatment guidelines and a list of essential medicines


National Essential Drugs List

< 5 years (127)> 5 years (29)No NEDL (19)Unknown (16)

156 countries with EDLS

1/3 within 2 years

3/4 within 5 years

Number of countries with a national list of essential medicines


Use of the WHO Model List of Essential Drugs

156 countries have a national list of essential drugs, of which 81% have been updated in the last 5 years

Major international agencies (UNICEF, UNHCR, IDA) base their catalogue on the WHO Model List

Sub-sets: UN list of recommended essential drugs for emergency relief (85 drugs); interagency New Emergency Health Kit (55 drugs for 10,000 consultations)

Normative tools: WHO Model Formulary, International Pharmacopoea, Basic Quality Tests, and development of reference standards follow the WHO Model List


Example of challenge:New essential drugs are expensive

Antibiotics for gonorrhoea: 50-90x price of penicillins

Antimalarial drugs: chloroquine $0.10 per treatment

coartem® $3/pp developing country (30x)

malarone® $40 per dose (400x)

Antituberculosis: $20 for DOTS vs $400 for MDR (20x)

Antiretrovirals: $300-600/year; but 38 countries with a drug budget <$2 pp/year


Perceived problems with updating and dissemination the WHO Model List

Range of diseases covered by the Model List is not clear

Discrepancies between Model List and treatment guidelines

Selection is more consensus-based than evidence-based

Use of data on cost and cost-effectiveness unclear

Reasons for selection insufficiently recorded

Drugs included without pharmacopoeal standard or supplier

Official report comes out too late, and in English only


WHO Model List of Essential Drugs 1999 compared with drugs included in WHO Treatment Guidelines

306 active substances on 405 drugsWHO Model List mentioned in WHOof Essential Drugs Treatment Guidelines

25056* 155

*e.g. cytotoxics, hormones, diagnostic agents, gastrointestinal drugs


Review process of the new procedures (1):Process and time table

Nov ‘99 Seminar by WHO Expert Committee on Ess.Drugs

Jan ‘00 Cabinet decision to develop standard procedures

Mar ‘01 Informal consultation

Jun Presentation at MIP, Member States review

Sep Review by all stakeholders

Oct Discussion at Reg.C’ees in PAHO and EMRO

Nov Cabinet discussion

Jan ‘02 Report to Executive Board


Review process of the new procedures (2):Stakeholders consulted

WHO clusters, regional and country offices

Member States, essential drugs programmes

Members of WHO Expert Panels

UN agencies (UNICEF, UNFPA, UNHCR, UNAIDS)

NGO’s (ICRC, FRCS, WCC, Caritas Int, OXFAM, MSF, PSF)

Pharmaceutical industry (IFPMA, IGMA, WSMI)


The WHO Model List of Essential Medicines is amodel product, model process and public health tool

Model product: list of essential drugs with information

Core list: minimum drug needs for a basic health care system, listing the most cost-effective drugs for priority conditions (selected on the basis of burden of disease and potential for safe and cost-effective treatment).

Complementary list: essential drugs for priority diseases which are cost-effective but not necessarily affordable or for which specialised health care facilities may be needed; and essential drugs for less frequent diseases



Independent Membership of the Committee, careful consideration of conflict of interest,

Transparent process, standard application, review Link to evidence-based treatment recommendations, in

accordance with WHO Recommended Process for Developing Clinical Practice Guidelines

Systematic review of comparative efficacy, safety and cost-effectiveness, and review of public health relevance

Rapid dissemination, electronic access Regular review


Model process (1):Link to Guidelines for Guidelines(approved by WHO Cabinet in January 2001)

Guideline development group with wide representation Careful consideration of conflict of interest Systematic computer search for evidence Evaluation of strength of evidence Systematic cost-effectiveness analysis for WHO: evaluation of public health considerations Graded recommendations with linked references External review of draft recommendations If there is insufficient evidence: consensus expert opinion

Systematic and transparent process


Model process (2):Steps in review of applications to the Model List

1 Summary of application posted on WHO Medicines web site

2 Specialist assessment of comparative efficacy, safety and cost-effectiveness

3 Review of assessments by Expert Committee member (“presenter”); formulation of draft recommendation

4 Review of draft recommendation by relevant Expert Advisory Panel members; and posted on WHO Medicines web site

5 Review by presenter, prepares final draft recommendation

6 Discussion of draft recommendation and proposed text for WHO Model Formulary by the Expert Committee


Model process (3):Presentation of recommendations, report

Presentation of recommendations:

Summary of reasons for each recommendation

Reference to underlying evidence and systematic reviews

Reference to existing clinical guidelines

Report, web site, translations:

Report of the meeting published on WHO Medicines web site

Report issued in WHO Technical Report Series

List and recommendations translated into other languages



Main public health advocacy messages:

Essential drugs are the most cost-effective drugs for a given condition

A limited range of carefully selected medicines can cater for most health care needs

There is much waste through irrational selection and use

Access to health care is a human right - to be progressively realized - and includes access to life-saving medicines

The essential medicines concept is globally applicable


Remaining issues for the next Expert Committee:(1) Description of essential drugs

Definition: Essential medicines are those that satisfy the priority health care needs of the population

Selection criteria: Essential medicines are selected with due regard to disease prevalence, evidence on efficacy and safety, and comparative cost-effectiveness

Purpose: Essential medicines are intended to be available within the context of functioning health systems at all times. in adequate amounts, in the appropriate dosage forms, with assured quality, and at a price the individual and the community can afford


Remaining issues for the next Expert Committee:(2) Role of treatment cost and global cost-effectiveness analyses

High cost alone should not exclude an essential medicine

Cost-effectiveness (C/E) comparisons will be made among alternative medicines within the same therapeutic group

Price information from existing UN sources will be used; all information sources will be identified

Simple indicators will be used: cost per unit, cost per treatment/month, cost per cure, cost per case prevented

Emphasis on usual outcome measures, and use of existing and published comparative cost-effectiveness analyses

New C/E calculations will be transparent and can be adapted


Seven steps to get a new medicine onthe WHO Model List of Essential Drugs

1. Identification of public-health need for a medicine2. Development of the medicine; phase I - II - III trials3. Regulatory approval in a number of countries

> Effective and safe medicine on the market4. More experience under different field circumstances; post-marketing

surveillance5. Price indication for public sector use6. Review by WHO disease programme; define comparative

effectiveness and safety in real-life situations, comparative cost-effectiveness and public health relevance

> Medicine included in WHO treatment guideline7. Submission to WHO Expert Committee on Essential Drugs

> Medicine included in WHO Model List


WHO Essential Medicines Library

WHOModel List

Summary of clinical guideline

Reasons for inclusionSystematic reviewsKey references

WHO Model Formulary

Cost:- per unit- per treatment- per month- per case prevented

Quality information:- Basic quality tests- Intern. Pharmacopoea- Reference standards

Clinical guideline

Statistics:- ATC- DDD


WHO Essential Medicines LibraryCombining information from various partners

WHOModel List

Summary of clinical guideline

Reasons for inclusionSystematic reviewsKey references

WHO Model Formulary

Cost:- per unit- per treatment- per month- per case prevented

Quality information:- Basic quality tests- Intern. Pharmacopoea- Reference standards

Clinical guidelineBNF

WHO clusters

MSHUNICEF

MSF

WHO/QSM

WHO/EDM

WHO/EC, Cochrane

Statistics:- ATC- DDD

WCCs Oslo/Uppsala


Conclusion

WHO clinical guidelines are the foundation for the Model List of Essential Drugs

The Model List remains a strong public health tool

The WHO Essential Medicines Library is a valuable information base for all Member States, international organisations, drugs and therapeutic committees and health insurance organisations

Documents

The concept of essential drugs and the WHO Model List of Essential Medicines Hans V. Hogerzeil, MD, PhD, FRCP Edin Department of Essential Drugs and Medicines