Forecasting of
antiretrovirals and diagnostics
Report of a WHO-UNICEF technical consultation
Geneva, Switzerland
28-29 June 2004
World Health Organization Departments of:
Essential Drugs and Medicines Policy Essential Health Technologies
HIV/AIDS - AIDS Medicines and Diagnostics Services
UNICEF Supply Division, Copenhagen, Denmark
WHO
© World Health Organization 2005
All rights reserved. Publications of the World Health Organization can be obtained from Marketing and Dissemination, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel: +41 22 791 2476; fax: +41 22 791 4857; email: bookorders@who.int). Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to Publications, at the above address (fax: +41 22 791 4806; email: permissions@who.int).
The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement.
The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters.
The World Health Organization does not warrant that the information contained in this publication is complete and correct and shall not be liable for any damages incurred as a result of its use.
The named authors alone are responsible for the views expressed in this publication.
Contents
Abbreviations and acronyms ...i
Executive summary... iii
1. Introduction ... 1
1.1 Background ... 1
1.2 Purpose of the technical consultation... 2
1.3 Objectives of the technical consultation ... 2
1.4 Expected outputs from the technical consultation ... 2
1.5 Technical consultation ... 3
2. Presentations... 5
2.1 Quantification methodologies countries use to forecast ARVs and diagnostics... 5
2.1.1 Forecasting HIV diagnostics, presented by Dr Guy‐Michel Gershy‐Damet, AFRO/EHT ... 5
2.1.2 Forecasting ARVs, presented by Mr Peter Graaff, HIV/AMD ... 7
2.1.3 Country experiences: UNICEF/Malawi — forecasting of ARVs and diagnostics, presented by Dr Jane Muita... 9
2.1.4 USAID experience in global forecasting and procurement of health commodities, presented by Mr Carl Hawkins... 12
2.1.5 Country experiences: Zimbabwe ‐ forecasting of ARVs and diagnostics, presented by Mr Charles Mwaramba, NatPharm, Zimbabwe ... 14
2.1.6 Forecasting of ARVs and diagnostics, experience of MSF, presented by Ms Chantal Saint‐Arnaud, Homa‐Bay District Hospital, Kenya ... 17
2.2 Methodologies used by procurement agencies to forecast ARVs and diagnostics... 20
2.2.1 ARV procurement, MSFʹs experience, presented by Mr Fernando Pascual ... 20
2.2.2 ARV procurement ‐ prospective quantification of ARVs, presented by Mr Paul Verhoeven, International Dispensary Association Foundation... 23
2.2.3 Experiences in ARV procurement, presented by Mr Laurent Lombart, Missionpharma ... 24
2.2.4 Estimating medicine requirements ‐ MEDS experience, presented by Dr Jane Masiga ... 25
2.2.5 Procurement agency experience: WHO procurement of ARVs and diagnostics, presented by Ms Françoise Mas, WHO/CPS ... 27
2.2.6 Procurement agency experience: UNICEF procurement of ARVs and diagnostics, presented by Dr Hélène Möller... 27
2.2.7 UNAIDS’ experiences in procurement of ARVs and diagnostics, presented by Dr Françoise Renaud‐Théry and Dr Jantine Jacobi ... 28
2.3...Software packages for forecasting ARVs and diagnostics
... 29
2.3.1 Quantimed: quantification software for HIV/AIDS, presented by Ms Laila Akhlaghi, Management Sciences for Health ... 29
2.3.2 ProQ: Quantification software for HIV tests, presented by Ms Claudia Allers, JSI/DELIVER... 30
2.3.3 FoCaMED: Forecasting and costing of medicines: module on ARVs, presented by Mr Gert Kaasschieter, MedICT ... 31
3. Working group discussions ... 33
3.1 Reporting back by working group 1 — Central versus peripheral quantification ... 33
3.2 Reporting back by working group 2 — Quantification of paediatric ARV needs ... 35
3.3 Reporting back by working group 3 — Estimating HIV diagnostics and laboratory equipment ... 38
3.4 Reporting back by working group 4 — Specifications of software tools for estimating needs. ... 40
3.5 Reporting back by working group 5 — National quantification policy ... 42
3.6 Reporting back by working group 6 — Implementation and capacity building ... 44
4. Discussions ... 47
5. Recommendations ... 53
Quantification at country level... 53
Paediatric HIV/AIDS ... 53
Quantification tool development ... 54
Next steps ... 55
Annex 1: Technical consultation agenda... 57
Annex 2: List of participants... 59
Annex 3: Malawi simplified ART regimen ... 65
Annex 4: Forecasting of ARVs for the two year scaling‐up plan in Malawi... 67
Annex 5: Working groups and topics... 69
Abbreviations and acronyms
Abbreviations and acronyms
AIDS Acquired immunodeficiency syndrome
ART Antiretroviral therapy
ARV Antiretroviral
CHAK Christian Health Association of Kenya CHAM Christian Health Association in Malawi CMS Christian Medical Association
FDC Fixed‐dose combination
GFATM Global Fund to Fight AIDS, Tuberculosis and Malaria HAART Highly active antiretroviral therapy
HMIS Health management information system
HIV Human immunodeficiency virus
ICD International classification of disease IDA International Dispensary Association
JSI John Snow Inc.
KEC Kenya Episcopal Conference
LMIS Logistics management information system MEDS Mission for Essential Drugs and Supplies
MOH Ministry of Health
MSH Management Sciences for Health MTCT Mother‐to‐child transmission
NAC National Aids Council
NDTPAC National Drug and Therapeutics Policy Advisory Committee
NGO Nongovernmental organization
PCR Polymerase chain reaction PLWHA People living with HIV/AIDS
PMTCT Preventing mother‐to‐child transmission
RTDs Rapid test devices
SCM Supply chain management
STI Sexually transmitted infection
TB Tuberculosis
UNAIDS Joint United Nations Programme on HIV/AIDS UNICEF United Nations Childrenʹs Fund
USAID United States Agency for International Development VCT Voluntary counselling and testing
CPS Contracting and Procurement Services (WHO)
WHO World Health Organization
Forecasting of antiretrovirals and diagnostics
Executive summary
Executive summary
On 28th‐29th June 2004, 32 participants from 14 organizations met at WHO Headquarters in Geneva to review best‐practices and identify common problems in quantifying antiretrovirals and diagnostics for treating HIV/AIDS patients ‐ over 39 million people worldwide. The purpose of the joint WHO/UNICEF Technical Consultation on Forecasting Antiretrovirals and Diagnostics was to support efforts towards better forecasting for these products, and to promote the use of software packages that estimate needs against available budgets.
The Consultation involved formal presentations; six working groups (on central versus peripheral quantification; quantification of paediatric ARV needs; quantification of HIV diagnostics and laboratory equipment; specifications of software tools; national quantification policy; and implementation and capacity‐building) and a final plenary session. Three software systems currently under development for estimating and forecasting needs were demonstrated. From different country‐ and industry‐perspectives, a number of lessons surfaced. Of particular importance are the complexity and scale of the disease; its status in different countries and countriesʹ varying capacities at the different levels of their health systems. Additional issues are raised by the characteristics of supply management for a variety of products with differing purposes, regimens and shelf‐life, and the critical requirement that a patient’s treatment should not be discontinued. Price, availability and donor‐community views were also addressed. Accuracy of data and market‐intelligence were seen to be key challenges for health services and the pharmaceutical industry. Important gap‐analysis included the unsuitability of adult formulations for children and recognition that HIV in children cannot be properly diagnosed (although, for example, a 30‐40% mother‐to‐child transmission rate was reported from Zimbabwe) and that paediatric HIV/AIDS appears to be a “neglected disease”. The key policy decision for health authorities of who should receive treatment was also discussed.
Participants decided to form a Forecasting Technical Consultation Group to continue working together, sharing information through a restricted access web site. A five‐point action plan was agreed, including field‐testing of the newly developed software packages in two countries by June 2005. Also, on request, WHO will validate existing quantification software packages in the second half of 2005. One important theme of the Consultation was the continued need for networking to share best‐practices amongst all involved, and to develop capacity building and training for health practitioners. A key outcome should be the sustainable availability and uninterrupted supply of antiretrovirals and diagnostics to patients, based upon improved accuracy of forecasting, to reduce the impact of this chronic disease.
Forecasting of antiretrovirals and diagnostics
Introduction
1. Introduction
1.1 Background
Over the last four years, access to antiretrovirals (ARVs) and diagnostics for people living with HIV/AIDS (PLWHA) have become more of a reality owing to more affordable prices, generic products of assured quality and public pressure to overcome access barriers. In addition, substantial funding became available through the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM).
The World Health Organization (WHO) has committed itself, in collaboration with partners, to the goal of 3 million people on ARV treatment by 2005 (the 3 by 5 Initiative).
This requires massive scale up in country‐level operations. As many publications describe, gaining access to services providing care and treatment to PLWHA is complex. Human immunodeficiency virus (HIV) patients can enter the health system at various entry points. Continuous access to ARVs and diagnostics will be crucial to ensure that no treatment interruptions occur and that new patients can get treatment as soon as they become eligible.
Three factors will soon boost increased take‐up of ARVs and diagnostics:
• increasing commitment of governments to provide ARVs within public health services;
• availability of guidelines for simplified ARV treatment;
• availability of prequalified generic fixed‐dose combinations (FDCs) of ARVs and prequalified diagnostic test kits.
Presently, the United Nations Childrenʹs Fund (UNICEF) Supply Division purchases and monitors ARV orders which are used in their, as well as WHO’s, country programmes.
The UN Bulk Procurement Scheme for HIV Test Kits facilitates easy access to HIV tests and information.
Frequently, WHO and partners receive requests from countries to help out in the area of forecasting or quantifying ARV needs. Various methods for quantification are available, such as the “morbidity” or “consumption” methods. A priority is to determine how best to apply these methods of quantifying needs, in the simplest way possible, and make the data available by spreadsheet or database for use by individual health facilities or at national level.
Forecasting of antiretrovirals and diagnostics
1.2 Purpose of the technical consultation
The purpose of this consultation is to support efforts towards better forecasting of ARVs and diagnostics; promoting the use of software packages which estimate ARV and diagnostic needs in relation to available funds. Successful national experience will be used to guide development of other national, and at a later stage, globally‐supported needs forecasting system.
The two‐day technical consultation aims to bring together key partners experienced in developing software tools or those involved in the area of supply management and forecasting of country needs of ARVs and diagnostics.
This consultation was organized by WHO/Essential Drugs and Medicines Policy Department (EDM) and WHO/Essential Health Technologies (EHT), and UNICEF Supply Division, in collaboration with HIV/AIDS Medicines and Diagnostic Services (AMD) and was made possible by a grant from the Rockefeller Foundation.
1.3 Objectives of the technical consultation
In order to promote faster access to appropriate medicines and services for greater numbers of people, the consultationʹs objectives were:
• to review current experience; approaches and quantification tools to estimate ARV and diagnostic needs at country and global levels;
• to identify common trends and missing components from existing quantification tools for ARVs and diagnostics;
• to identify and agree upon basic information inputs and functionalities required for a ʺgenericʺ forecasting tool;
• to agree on technical recommendations to inform the International AIDS Conference in Bangkok in July 2004.
1.4 Expected outputs from the technical consultation
Expected outputs of the technical consultation are:
1. A meeting report;
2. Technical recommendations to inform the International AIDS Conference to be held in Bangkok in July 2004*;
3. A Plan of Action to develop a ʺgenericʺ forecasting tool for ARVs and diagnostics.
Introduction
1.5 Technical consultation
The consultation brought together a large number of experts from countries with ARV and diagnostics forecasting experience, including: Zimbabwe; international nongovernmental organizations (NGOs) with ARV and diagnostics forecasting experiences; Médecins Sans Frontières (MSF), including the MSF ARV Programme in Kenya; WHO; Regional Office for Africa (AFRO) Regional Pharmaceutical Advisers, WHO/HQ departments EDM, EHT, HIV/AMD and Contracting and Procurement Services (CPS); UNICEF Supply Division (USA and Denmark), and country staff from Senegal; the Peopleʹs Republic of China, Malawi and Kenya; The Joint United Nations Programme on HIV/AIDS (UNAIDS); Management Sciences for Health (MSH); John Snow Inc. (JSI); low‐cost suppliers: International Dispensary Association (IDA)/the Netherlands, Missionpharma/Denmark and Mission for Essential Drugs and Supplies (MEDS)/Kenya; information technology staff from WHO and MedICT; and donor agencies: United States Agency for International Development (USAID) and the Global Fund to Fight AIDS, Tuberculosis and Malaria.
A detailed agenda of the consultation forms Annex 1; the list of participants forms Annex 2.
Presenters at the consultation had been requested to address:
• which methods are currently used to estimate ARV and diagnostics needs;
• what practical information is used to estimate needs and where this information can be obtained;
• which tools (spreadsheets, database) are used;
• what basic information inputs and functionalities will be required for a ʺgenericʺ forecasting tool.
Chapter 2 covers Day 1 of the consultation, and contains firstly, the presentations from country representatives and organizations, summarizing their present data and future expectations, and secondly, the plenary discussions which followed.
After Day 1, issues identified by participants about quantifying data became the agendas for six working groups:
1. central versus peripheral quantification;
2. quantification of paediatric needs;
3. quantification of HIV diagnostics and laboratory equipment;
4. specifications of software tools for quantifying needs;
5. national quantification policy;
6. implementation and capacity‐building.
These working groups held detailed discussions on the morning of Day 2. Chapter 3 contains their feedback reports, including specific recommendations, which were presented by the working groups.
Forecasting of antiretrovirals and diagnostics
During the two days, many technical problems and possible solutions were highlighted in quantifying ARVs and diagnostics. Chapter 4 summarizes the debate from the final plenary session, structured around nine different questions, to reach a common understanding about the issues raised during the consultation.
Chapter 5 summarizes the recommendations of the technical consultation, collected under three broad headings:
1. quantification at country level;
2. paediatric HIV/AIDS;
3. developing quantification tools.
Participants decided to continue to work together by forming a Forecasting Technical Consultation Group for sharing information through a restricted web‐based site. The organizations which are developing quantification software tools, will regularly inform the Group about their progress. They also committed themselves to include user manuals within software package development. The activities of the action plan for the Forecasting Technical Consultation Group are listed as “next steps” on page 55.
Presentations
2. Presentations
2.1 Quantification methodologies countries use to forecast ARVs and diagnostics
2.1.1 Forecasting HIV diagnostics, presented by Dr Guy‐Michel Gershy‐Damet, AFRO/EHT
Currently, two methods are used to quantify HIV diagnostic needs:
1. the HIV zero‐prevalence method; using information on population coverage or demand and HIV prevalence figures;
2. the adjusted consumption method by using data from stock records.
Generally, it is advisable to use both quantification methods, in order to verify the estimated quantities of HIV diagnostics.
It was stressed that practical information is needed and should be available for quantifying HIV diagnostic requirements:
• HIV zero‐prevalence rate;
• screening algorithm;
• number of patients to be diagnosed;
• number of health facilities by categories;
• number of tests used for quality assurance;
• discordant results (%);
• wastage;
• reliable inventory control data or stock records from facilities, regions, etc.
The necessary information can be provided by:
• the National AIDS Programme or the National AIDS Council;
• hospitals and other health facilities;
• reference, regional or district laboratories;
• government medical stores;
• UN agencies, partners and NGOs involved in HIV/AIDS programmes.
Forecasting of antiretrovirals and diagnostics
The ʺtoolsʺ listed below can be consulted for detailed information about the quantification methods:
• Chapter 14 of Managing Drug Supply, 2nd ed., 1997 (MSH/WHO). This chapter provides an overview of the various quantification methods, including a step‐by‐
step approach on how to apply the various quantification methods for estimating medicines and health commodities;
• Commodity Management in VCT Programs: A Planning Guide, 2002 (FHI/
MSH/USAID).
It was explained that the basic information required for a generic forecasting tool for HIV diagnostics comprises:
1. HIV sero‐prevalence rate;
2. number of facilities carrying out HIV tests;
3. number of clients to be screened;
4. monthly consumption of first tests, second tests, and third tests (tiebreaker);
5. number of tests used for quality assurance;
6. discordant results (%);
7. wastage.
Discussion
In general, limited data are available on the use of HIV diagnostics. However, data from monitoring systems in some African countries are available. Where no reliable data exist at central level it is acceptable to use data from other organizations and partners. UNICEF commented that the number of clients estimated for HIV testing is often higher than the actual number who come to HIV testing services. A ʺreality checkʺ should be made, using prevention of mother‐to‐child transmission (PMTCT) programme data. A similar check is also needed for the numbers of expected clients by using HIV sero‐prevalence data. The adjusted figures are often much lower. There should be a continuous process of data verification based on what was expected (estimated numbers and quantities) and what was actually documented (real numbers and quantities).
UNICEF also mentioned that equitable access to HIV treatment is not feasible in practice, even in a country like Botswana (which is relatively wealthy for the region and has a good infrastructure) because health facilities cannot cope with the larger numbers. Eligibility criteria were introduced to screen patients. A similar approach would be valid for accessibility to HIV diagnostics.
In answer to a question about “wastage”, 4% was agreed to be an acceptable level. It was stated that wastage of reagents for HIV testing was low, although the contrary is often assumed. To avoid under‐estimates, all entry points for HIV testing should be identified.
Voluntary counselling and testing (VCT) and PMTCT services were often forgotten.
Presentations
2.1.2 Forecasting ARVs, presented by Mr Peter Graaff, HIV/AMD
Before the consultation, the six WHO regions were asked:
• the percentage of patients on first‐line and on second‐line treatment;
• the percentage of patients with toxicities against basic ARVs requiring treatment change;
• the percentage of patients who are tuberculosis (TB) co‐infected;
• the percentage of pregnant women.
Responses were received from two regions:
SEARO reported that:
• the percentage of patients on variations of first‐line treatment is 100%;
• no country in the region supports second‐line treatment regimens;
• no data on toxicity are collected;
• policy on ART for TB patients is non‐existent;
• policy on ART for pregnant women is non‐existent.
EURO reported that data are not readily available except from Western European countries.
The data in Tables 1 to 5 were obtained from the WHO/HIV Department, and are for demonstration purposes only.
Table 1: TB co-prevalence data
(based on 2002 estimates of HIV prevalence in adult TB patients)
Countries TB co‐prevalence %
Zimbabwe 75.3
South Africa 60.1
Kenya 51.4
United Republic of Tanzania 33.8
Ethiopia 29.1
Nigeria 27.0
India 4.6
Peopleʹs Republic of China 0.7
Forecasting of antiretrovirals and diagnostics
Table 2: Example of an HIV treatment site 1 (based on collected data)
HIV treatment site 1 No. of patients who have ever received ART
Current no. of patients benefiting from ART
PMTCT 170 170
ART – total patients 400 445
ART ‐ adults (≥ 18yrs) 380 380
ART – paediatric (0 ‐ 18 yrs) 10 10
ART ‐ total female 280 280
ART ‐ total male 120 120
Diagnosis and TB treatment ‐ ‐
Table 3: Example of an HIV treatment site 2 (based on collected data)
HIV treatment site 2 No. of patients who have ever received ART
Current no. of patients benefiting from ART
PMTCT 20 20
ART – total patients 70 65
ART ‐ adults (≥ 18yrs) 70 65
ART ‐ paediatric (0 ‐ 18 yrs) 3 3
ART ‐ total female 50 50
ART ‐ total male 20 20
Diagnosis and TB treatment ‐ ‐
Table 4: Example of an HIV treatment site 3 (based on collected data)
HIV treatment site 3 No. of patients who have ever received ART
Current no. of patients benefiting from ART
PMTCT ‐ ‐
ART – total patients 554 445
ART ‐ adults (≥ 18yrs) 515 414
ART ‐ paediatric (0 ‐ 18 yrs) 39 31
ART ‐ total female 59% 59%
ART ‐ total male 41% 41%
Diagnosis and TB treatment ‐ ‐
ART = Antiretroviral therapy
Presentations
Table 5: Example of patient flow for ART with complications (based on collected data)
Annual occurrence (% of total patients)
Minor side‐
effects
Drug‐related toxicity/resistance
Additional pharmacy support (dosing/adherence)
Antenatal clinic 40 20 50
TB clinic 40 40 50
In‐patients 80 40 50
Discussion
It was pointed out that different kinds of data need to be collected to use a quantification tool correctly. But data are often unavailable or inaccessible, at country level. MSF has documented its ART activities, routinely collecting data from their projects. Data analysis showed that outcomes varied by country. It was agreed that any generic quantification tool should be simple to use and pragmatic, in design, following the “KISS” principle (ʺkeep it short and simpleʺ).
It was stressed that national ART policies should be clear before starting upon an ARV and diagnostics quantification exercise. A frequently debated issue is who will be treated and who will not, as the policy is not always clear. Because information about various treatment regimes is often incomplete or unavailable, it was stressed that it is important to keep in contact with any other information provider, so that treatments or quantities can be quickly adjusted. Best practice suggests that quantification should be undertaken regularly so that quantities can be adjusted accordingly.
2.1.3 Country experiences: UNICEF/Malawi — forecasting of ARVs and diagnostics, presented by Dr Jane Muita
The presentation began with an overview of Malawiʹs HIV/AIDS profile:
• population: 11.7 million;
• HIV prevalence (15‐49 yrs): 14.4%;
• rural prevalence: 23.0%;
• urban prevalence: 12.4%;
• number of people infected with HIV: 900,000, of whom:
• infected adults: 760,000 (84.5%);
• infected women: 440,000 (48.9%);
• number of people (> 60 yrs) infected: 60,000 (6.7%);
• number of children (0‐14 yrs) infected: 80,000 (8.9%).
• Antenatal prevalence by district by using data from the 19 sentinel sites;
• PMTCT sites: 20 comprehensive centres;
• VCT sites in the country, but exact number unknown;
• ARV treatment sites: a total of 9 sites (public and private sector);
Forecasting of antiretrovirals and diagnostics
• Sexually transmitted infection (STI) treatment provided in all public and Christian Health Association in Malawi (CHAM) facilities;
• annual births: 497,000.
To undertake quantification exercises various data are required and should be made available at the various health care levels, as Figure 1 indicates:
Figure 1: Information sources and flow envisaged by UNICEF
Quantification of drug needs
Global
National/
Central level
District Level
Health facility level
Morbidity, patient and consumption data Coordinating body for compiling and exchanging data from countries
ARV stock data, morbidity and consumption data
Morbidity, patient and consumption data
Both morbidity and consumption methods can be used, provided that data are available.
Limitations of the data available in Malawi were discussed in relation to the quantification methods:
1. Morbidity method
• Limited data available on HIV morbidity in Malawi, but quality data available from the National TB Programme;
• High antenatal attendance rate (90%);
• In‐patient data available through the health management information system (HMIS).
2. Consumption method
• 9 sites provide ARV treatment, 2 offering free ARV treatment, 7 sites charge for ARV treatment;
• Data from these sites help determine the proportion of patients requiring first‐
line, alternative first‐line (10‐15%), and second‐line ARV treatments;
• Existing PMTCT sites have useful data on utilization but there are only a few
Presentations
Practical information that is available in Malawi and is used to calculate ARVs and other supplies includes:
• TB burden (used to categorize health facilities into ʺlow burdenʺ (75 clients per quarter), ʺmedium burdenʺ (150 clients per quarter) and ʺhigh burdenʺ (450 clients per quarter);
• experience of Ministry of Health (MOH); National AIDS Council (NAC); Central Medical Stores (CMS); clinicians from MOH, CHAM, and NGO sites offering ARV treatment;
• anticipated increase in demand following sensitization and mobilization which will precede the start of the ARV scaling‐up phase;
• clear implementation plan for scaling‐up ART, including site assessment procedures and the process of phasing‐in;
• clear protocols for first‐ and second‐line ARV treatment.
Annex 3 gives detailed information about treatment regimes; Annex 4 provides a table on forecasting ARVs for the different categories of TB burden.
To estimate needs for children, these data ʺgapsʺ must be filled:
• information on age‐specific magnitude of disease on which to model needs;
• criteria to determine initiation of therapy (e.g. CD4 % , clinical criteria, lymphocyte count);
• diagnostic tests, especially for children (<18 months);
• range of paediatric formulations;
• specification of dosage requirements;
• clarity on approaches to scale up treatment for children in various settings (e.g.
PMTCT‐plus programmes, paediatric units, therapeutic centres).
Key assumptions making for better quantification of needs include:
• minimal (preferably no) discrimination against PLWHA;
• ARV treatment free of charge in the public sector;
• continuity of ARV supplies will be guaranteed;
• PLWHA on treatment will not die within the period of availability of ARVs;
• in the start‐up phase only adult ART will be scaled up;
• paediatric care will be offered at referral sites;
• a clear position on equity of ART will be developed in a consultative process, with MOH, NAC, CMS, CHAM, NGOs and international organizations.
These “tools” or methods are used to collect data:
• spreadsheets;
• generic information;
• initial use of cliniciansʹ estimates. At a later stage, consumption data can be used.
Forecasting of antiretrovirals and diagnostics
Inputs of basic information required for a “generic“ quantification tool are:
1. Target population
• agreed numbers of clients to be reached.
2. Approved treatment protocols (adherence to be considered)
3. Selected products
• starter pack, continuation pack and alternative ARV regimes – unit size; pack size; price;
• generic/branded ARVs and diagnostics;
• patent status of products in‐country;
• WHO list of prequalified suppliers and products;
• registration status of products in‐country;
• quantities of packs needed (e.g. per six months, per year).
Discussion
The scaling‐up phase in Malawi will start in September 2004. Various sources of data were used for the forecasting exercise and resulted in different estimates, but agreements were reached on the policy of free‐of‐charge ART and on the prevalence rate in Malawi. Data reliability depended upon good record keeping, although standards vary. Data retrieved from the HMIS are reliable and are being used for the preparation of the scaling‐up phase.
It was recognized that the equity policy rarely reaches ʺeverybodyʺ, and that in reality a ʺfirst come, first servedʺ policy was being implemented. It was explained that in practice, the poor will be treated in the public sector and the rich in the private sector.
2.1.4 USAID experience in global forecasting and procurement of health commodities, presented by Mr Carl Hawkins
Mr Hawkins asserted that forecasting cannot be disconnected from procurement.
The history of USAIDʹs support to supply chain management (SCM) of family planning commodities was summarized:
• Active since the late 1960s, USAID is a major donor of contraceptives and condoms in 136 countries;
• forecasting and procurement principles were refined over a period of more than 30 years;
• USAID became a key player in the development of software for forecasting, procurement planning and management of country supply “pipelines”;
• compiled data were used by donors, manufacturers, suppliers and country programme managers.
Presentations
Currently, USAIDʹs support to SCM of HIV/AIDS commodities includes:
• extensive support to SCM of HIV/AIDS commodities provided through JSI/DELIVER and MSH/Rational Pharmaceutical Management (RPM) Plus activities in Africa, Asia and Latin America;
• technical assistance providing forecasting of HIV test kits and ARVs.
Issues identified in forecasting needs of HIV test kits and ARVs include:
• forecasting principles and data sources remain the same as for other health commodities;
• forecasting can be modified in order to include:
• characteristics of specific commodities and their use;
• environmental challenges such as, policies, programmes and stakeholders.
Characteristics affecting successful forecasting of HIV test kits, are:
1. Each use of an HIV test kit may have a different testing protocol;
2. Demand for HIV test kits has to be adjusted by adding estimated quantities for:
• laboratory controls and quality control testing;
• wastage/loss due to damage, loss or expiry.
3. HIV test kits have short shelf‐lives and require cold chain/cold storage conditions;
4. ʺFullʺ supply of HIV test kits is required.
Characteristics affecting forecasting of ARVs, include:
1. Data on number of:
• new patients who will start treatment on each regimen;
• patients who will substitute single ARVs due to toxicity;
• patients who will switch regimes due to treatment failure;
• defaulters, or patients who stop their treatment.
2. Selection of products:
• Single dose ARVs, fixed‐dose combinations and paediatric formulations;
• packaging requirements for e.g. starter packs, single dose ARVs.
3. ʺFullʺ supply of ARVs is required.
Prevailing environmental challenges are:
• absence of clearly established, harmonized treatment guidelines and testing protocols;
• poor availability and quality of data on product use;
• coordination of multiple sources of financing;
Forecasting of antiretrovirals and diagnostics
• manufacturing capacity and coordination of suppliers;
• service delivery and supply chain capacity;
• quantification/estimating is often budget‐based, short‐term and unrelated to needs.
Lessons learned:
• forecasting is based on informed assumptions rather than real evidence until better‐quality data become available;
• forecasting of needs for new and expanding programmes cannot be based on logistics data because these are often unavailable or not predictive of demand;
• forecasted quantities need to be reviewed and updated frequently;
• there is a need for a paradigm shift in countries to conduct:
• forecasts based on the principle of ʺfull supplyʺ
• medium‐ to long‐term forecasts rather than only short‐term estimates;
• better coordination between financing and procurement planning will improve commodity availability both in‐countries and at global level;
• while HIV/AIDS is a relatively new disease treated with recently‐marketed products, there is experience to draw on for shaping policy decisions critical for effective forecasting and procurement.
Discussion
It was confirmed that different funding is available for different activities, such as HIV testing. Accurately estimating HIV commodities is only possible once all different funding sources are known. In principle, it is possible to include various donor sources in the quantification exercise, but spreadsheets will become larger to accommodate additional data.
Different donors often require specific terms for procurement of HIV commodities. In response to a question about whether the robustness of a forecasting tool will be influenced by decentralized, national or private procurement systems, as well as the differences in prevalence status and stigma between countries or continents, it was explained that both simplicity and robustness of forecasting tools can be maintained when addressing these differences.
2.1.5 Country experiences: Zimbabwe ‐ forecasting of ARVs and diagnostics, presented by Mr Charles Mwaramba, NatPharm, Zimbabwe
The HIV/AIDS profile of Zimbabwe was summarized:
• population: 11.5 million;
• estimated number of people living with HIV/AIDS: 1.8 million (15.7%);
• HIV prevalence (15‐49 yrs): 24.6%;
• 90% of people infected are not aware of their HIV status;
• 600,000 have signs and symptoms and require some form of HIV care and support;
• on average, 2,500 people per week die as a result of HIV/AIDS;
Presentations
• 60‐70% of < 5 yrs deaths are a result of HIV/AIDS;
• Mother‐to‐child (MTCT) transmission rate: 30‐40%.
Basic information is required for estimation of needs:
1. Prevalence, e.g. 24.6% in the 15‐49 age group:
• prevalence of MTCT.
2 Resources available (number of people who can be treated)
3 Standard treatment guidelines:
• first‐line treatment (proportion of 85% found);
• alternate first‐line treatment (proportion of 10% found);
• second‐line treatment (proportion of 5% found).
4. Numbers of patients to be treated (formula):
• proportion of people living with HIV (15‐20%);
• mortality from AIDS in previous year (x2);
• what proportion can possibly be treated? (e.g. 50% of the above?).
or
1. Financial resources
• average treatment cost per patient per year/period - number of patients who can be treated.
The following sources of information can be made available:
1. HIV zero‐prevalence, from:
• Ministry of Health and Child Welfare (MOH and CW)‐AIDS and TB Unit;
• National AIDS Council;
• VCT and PMTCT Centres.
2. Resources available and numbers of people targeted, from:
• MOH and CW.
3. Treatment guidelines, from:
• MOH and CW/ National Drugs and Therapeutics Policy Advisory Committee (NDTPAC).
In Zimbabwe currently:
• quantification is based on the morbidity method and the resources available (initial stages);
• target of the global ʺ3 by 5ʺ initiative is 171,000 people on ART by December 2005;
Forecasting of antiretrovirals and diagnostics
• target of the two pilot sites under the Government Initiative is 1,000 people on ART in 2004;
• treatment protocols are defined as:
- first‐line treatment: stavudine 30mg or 40mg lamuvidine/nevirapine;
- alternative first‐line treatment: stavudine 30mg or 40mg lamivudine/
efavirenz;
- second‐line treatment: zidovudine/didanosine/lopinavir/ritonavir;
- PMTCT: nevirapine.
• weight of people on ART:
- in low‐weight category: 60%
- in high‐weight category: 40%
• private sector not yet in line with public sector.
The tools used, are:
• Excel spreadsheet with the following information:
- dosage (number of tablets) per day/year;
- formula for number of patients;
- number of patients projected in the scaling‐up plan;
- period of supply or period to be covered.
These basic data inputs are required for a generic forecasting tool:
• prevalence/scaling‐up plan (number of patients);
• consumption patterns of previous periods;
• number of tablets/person/day;
• treatment period;
• estimation period.
Mr Mwaramba concluded that:
• there is a need for a refined quantification tool that will cater for scaling‐up of ART;
• this consultation will result in development of a reliable estimating tool.
Discussion
It was suggested that clinical information is important in addition to CD4 count (<200).
Currently there is clinical information per criteria for adults. However, for paediatrics, clinical information may be available but suitable diagnostic tests are lacking, especially for children (< 18 months); perhaps paediatric HIV is a ʺneglected diseaseʺ? It was also suggested that the mortality variable (ʺprevious year mortality x 2ʺ) included in the formula is a new idea which should be seriously considered. To get a clearer picture of HIV services, it was proposed that when a cohort of patients (e.g. 50 patients) is ʺstableʺ in its ART and diagnostics consumption, a new cohort of patients could be taken up for treatment. It was pointed out that before finalizing the second or third ARV and diagnostics order, ʺreality checksʺ have to be included in the quantification and procurement phase.
Presentations
2.1.6 Forecasting of ARVs and diagnostics, experience of MSF, presented by Ms Chantal Saint‐Arnaud, Homa‐Bay District Hospital, Kenya
MSF began HIV/AIDS projects in countries with limited resources in 1997. The first ART projects started in 2001. To date, MSF has over 40 ART projects in more than 20 countries in Africa, Asia and Latin America. A total of approximately 13,000 patients are currently treated with ARVs.
MSF‐France supports MSF/Homa‐Bay District Hospital in Kenya, where ART was introduced in November 2001. By June 2004 the hospital had a total of 1,352 adults and 56 children (< 25 kg) on ART.
In April 2004, 340 patients attended VCT services of whom:
• 222 females and 118 males had pre‐test counselling;
• 210 females and 116 males were tested for HIV;
• 169 (80%) females and 85 (73%) males tested positive.
Limiting factors in HIV care provision are:
• human resources: insufficient numbers of health personnel;
• maintaining quality of service: there is only a certain number of patients who can be tested and counselled each day because of staff and equipment limitations.
In April 2004, following WHO HIV staging guidelines identified:
• 36% of new and 35% of follow‐up clients were stage 4 (in January 2002: 73.3%);
• 47% of new and 56% of follow‐up clients were stage 3 (in January 2002: 26.7%);
• 12% of new and 7% of follow‐up clients were stage 2;
• 0.9% of new and 0.5% of follow‐up clients were stage 1.
Since November 2001, MSF/Homa‐Bay District Hospital has seen 5,029 patients at least once. One thousand six hundred and seventeen of them had never received ART. Of 4,820 patients, only 1,408 (29.2%) were on ART and the remaining 3,412 (67.8%) were non‐ARV patients by the end of June 2004.
The clinicians (three full‐time and one part‐time) working in the HIV clinic during a five‐
day working week observed a steady increase in their workload. In April 2004, they saw 2,408 patients; increasing to 2,522 patients by May 2004 (+ 4.4% over 1 month).
To cope with the increase in patients, three ʺdecentralizedʺ HIV centres were set up; the first in February 2003, and two others in May 2004. ARV patients from Homa‐Bay District Hospital are only referred to one of the decentralized HIV centres once they have become
ʺstableʺ ARV patients. Once patients are referred, travelling time to the clinic is reduced
Forecasting of antiretrovirals and diagnostics
and this encourages adherence to ART in rural settings. The following information was collected:
• only follow‐up clients are seen;
• 121 people are currently active ARV patients;
• decentralized HIV centres are open for 2½ days per week.
The selection of ARVs is linked to international and national treatment guidelines. The selection of suppliers is based on MSF and/or WHO prequalification lists of suppliers and products. During the period November 2001 to June 2002, innovator ARVs were locally purchased through local private wholesalers. Since June 2002, generic ARVs have been imported (from India).
Critical factors for improving the quantification of ARV needs:
1. Selection of ARVs in line with standard treatment protocols:
• first‐line regimen: D4T/3TC/NVP, and starting period of 2 weeks;
• second‐line regimen: AZT+DDI+NFV;
• children who need syrups: AZT+3TC+NVP.
2. Ongoing ARVs consumption:
• number of patients planned to start with ART:
- number of patients meeting the clinical criteria (stage 3 and 4);
- financial and human resources and space capacities;
- for example, every month 150 new patients receive ART in Homa‐Bay District Hospital, including seven children (< 25 kg).
3. Side‐effects expected:
• 20% of patients developed anaemia with AZT;
• 5% of patients developed a rash with nevirapine;
• 2% of patients developed neuropathy with D4T.
4. TB co‐infected patients expected (on regimen with EFV):
• 20% of adults;
• 45% of children.
5. Weight of the patient (< 60 kg or > 60 kg):
• 60% of adults (< 60 kg);
• When weight gains are observed, dosages are adjusted.
6. Availability of paediatric formulations:
• AZT+3TC+NVP syrups;
• option of cutting FDC tablets (D4T/3TC/NVP) in half. This is only possible with the FDC tablets produced by Ranbaxy.
Presentations
7. Expiry dates
• short expiry dates of certain products.
These MSF tools are currently in use:
• Every MSF project is linked to the FUCHIA system that contains MSF information, files, and documentation on:
- clinical information, HIV stage guidance, opportunistic infections;
- weight, height;
- medicines prescribed;
- side‐effects;
- number of pills missed by patients.
• In Kenya, spreadsheets are used for monitoring ARV consumption as well as for forecasting requirements and preparation of orders.
• MSF headquarters is in the process of developing a tool to link information about forecasted quantities with stocks‐in‐hand, stocks‐on‐order, and available budget.
MSF forecasting tools are:
• spreadsheet tool developed locally by MSF‐France in Kenya;
• spreadsheet tool under development by MSF headquarters.
These points are considered by MSF when ordering ARV supplies:
• Information sharing with suppliers:
MSF keeps their suppliers and/or producers informed about its yearly forecasts. This will help producers to plan their production, ensuring continuity of supplies;
• Frequency of ordering:
MSF has a four‐month ordering cycle but this is flexible, when needed;
• Delivery or lead‐time:
MSF observes a three‐month lead‐time when buying from international sources and therefore has buffer stocks at country level;
• Buffer stock:
MSF keeps two‐month buffer stocks to cover unpredictable needs and/or changes in treatment regimens (from side‐effects);
• International orders:
when MSF procures internationally for a four‐month period, it orders for a nine‐month period having subtracted the amounts of remaining stocks‐on‐
hand;
• Storage capacity:
sufficient storage capacity is needed, as ARV supplies are bulky;
• Split shipments:
ordered supplies may be delivered in split shipments;
Forecasting of antiretrovirals and diagnostics
• Storage arrangement:
wholesalers and suppliers may store part of the ordered supplies;
• Additional costs:
additional financial costs involved in supplies, e.g. stock immobilization and insurance.
These key factors must to be considered when forecasting HIV diagnostics:
1. HIV testing at VCT clinics:
• number of persons coming for VCT;
• HIV test needs will increase when ARVs are available;
2. ART monitoring based on standard protocols:
• no baseline CD4 for patient stage 4 only;
• CD4 follow‐up every six months;
• ALAT testing when regimen includes nevirapine;
• following standard operating procedures for each test;
3. Forecasting of laboratory supplies and reagents for HIV testing to be included:
• testing equipment capacity: limitations of testing machines, e.g. Dynabeads:
18 CD4/day;
• human resource capacity: numbers of trained staff to be available at the VCT clinics;
• follow‐up on consumption of HIV tests;
• spreadsheet or home‐made tool but data are generated by FUCHIA.
Ms Saint‐Arnaud concluded:
• ART is difficult to forecast;
• forecasting of ART for paediatrics is still complex;
• to keep buffer stocks is essential to avoid treatment‐interruptions;
• fixed‐dose combinations (FDCs) have simplified the drug management of individual patients considerably.
2.2 Methodologies used by procurement agencies to forecast ARVs and diagnostics
2.2.1 ARV procurement, MSFʹs experience, presented by Mr Fernando Pascual
MSF uses different ARV procurement systems, including:
• centralized system: procurement is organized at international level by MSF procurement centres for supplies needed for countries, e.g. Democratic Republic of Congo; Guatemala, Lao Peopleʹs Democratic Republic, Liberia and Sudan;
Presentations
• decentralized system: procurement is undertaken at country level, in e.g. Burkina Faso, Cambodia, Cameroon, Honduras, Kenya, Malawi, Thailand, and Uganda (soon).
The decision on how to procure is based on factors including local availability of products and their quality, prices, possible constraints for importing products (registration and/or patent status of products), and the country situation.
The policy of MSF procurement centres is that they do not supply external organizations or projects. MSF procurement centres consider ARV medicines like any other essential medicine and they are stocked in Europe.
MSFʹs ARV suppliers include both generic and innovator manufacturers. They are selected from the MSF and/or WHO prequalification list of manufacturers and products.
Generic ARV products are stored in a transit warehouse. Innovator products are not stored in any MSF warehouses in Europe because different ARV products have different prices and conditions set by manufacturers for recipient countries. MSF reacts to project orders.
Difficulties faced by MSF in forecasting ARV quantities include:
• sources are related to the registration and patent status of products in recipient countries, so MSF procurement centres have to purchase ARV products from different sources;
• products have varying expiry dates;
• MSF is a relatively small customer and so faces unpredictable delays in ARV deliveries.
MSF’s specific problems include:
1. ARV treatment for paediatrics:
• dosage varies with weight;
• small number of patients;
• particular storage/distribution conditions for paediatric formulations, e.g. cold storage and refrigeration.
2. Second‐line ARV treatment
• small number of patients;
• particular storage/distribution conditions, e.g. Kaletra® needs cold storage and refrigeration;
• difficult to forecast as it is linked to first line treatment failure.
3. Mark‐up on costly products;
• MSF procurement centres have cost‐recovery mechanisms so handling costs should be recovered by including “mark‐ups” on products (higher for costly items).
Forecasting of antiretrovirals and diagnostics
The quantification method used by MSF procurement centres is the adjusted consumption method, based on previous consumption data, and adjusted using data obtained from ART projects, anticipating needs.
Issues affecting accuracy of forecasting and also access to ARVs and diagnostics include:
Donor’s conditions:
• donors demand regular forecasting of needs.
Price:
• when forecasting data are unreliable, it is difficult to negotiate better prices with either generic or originator manufacturers.
Suitable formulations:
• so far, there are hardly any signals received by manufacturers on the expected growth in the ARV market. So, there is limited interest from producers to develop formulations adapted to the specific needs of specific developing countries, e.g.
FDCs; paediatric formulations; non‐refrigeration, and labelling (known as
“variants”).
Product registration:
• similarly, there is limited interest from companies to register their products in countries where the local market is uncertain or too small.
Uninterrupted supply and availability of ARV and diagnostic products:
• there is a constant potential risk of stock‐outs at project level.
Mr Pascual concluded:
• ARV quantification and procurement present particular problems, similar to those discussed by earlier speakers;
• a standardized quantification method is not yet available at field level and this may affect uninterrupted access to HIV care and treatment;
• improved forecasting tools and better quality of data will better guarantee access to ARVs and diagnostics.
Discussion
In response to the question of whether FUCHIA was available to other organizations; it was explained that FUCHIA is mainly for MSF projects to follow up on patient cohorts as it collects epidemiological data. When asked why the number of 13,000 patients is considered small for an organization like MSF, it was explained that ART projects depend on available financing and human resource capacity. These can be used as ʺreality checksʺ for estimated quantities. In addition, MSF works closely with MOHs ‐ this is a different approach compared with those who operate independently. Scaling‐up ART may be possible. When asked why MSF has its own procurement centres; it was explained that
Presentations
2.2.2 ARV procurement ‐ prospective quantification of ARVs, presented by Mr Paul Verhoeven, International Dispensary Association Foundation
The work of the International Dispensary Association (IDA), a recently‐formed ARV procurement company, was briefly introduced. To date, 17 orders had been received from 10 different countries, including orders for generic as well as for originator ARVs.
Analysis of these orders revealed several common issues:
• age, gender, body weight, treatment guidelines, etc.:
– choice of products;
– PMTCT, paediatric formulations;
• rural versus urban settings; Africa versus South America versus Asia:
– different HIV prevalence rates, resistance patterns, and HIV prevention rates;
• disease patterns, including co‐infections and side‐effects:
– different treatment regimens;
• patent situation and registration requirements are different in each country:
– branded versus generic products;
• existing, possible channels for supply:
– one versus multiple supply channels; price differences; donors’
conditions;
– quantities for one particular order are not reliable for forecasting;
• starting treatments (e.g. 1,000 patients who do not all come for treatment at once):
– in‐country distribution schemes;
– quantities are at best an estimate;
• monitoring of treatment outcomes; ARV tolerance; treatment failures are not systematically documented;
– changing selection of products.
All of the above contribute to uncertainty about:
• choice of products and the different strengths to be stocked;
• the quantities to be expected from one order to the next;
• forecasting of strategic stock levels.
