Multi-Country Independent Evaluation Report Independent ... · AMFm Independent Evaluation Team...

Multi-Country Independent Evaluation Report

Independent Evaluation of the

Affordable Medicines Facility - malaria (AMFm) Phase 1

Final Report

September 28, 2012

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Independent Evaluation of Phase 1 of the Affordable Medicines

Facility - malaria (AMFm)

Multi-Country Independent Evaluation Report:

Final Report

September 28, 2012

AMFm Independent Evaluation Team

ICF International:

London School of Hygiene and

Tropical Medicine:

Fred Arnold

Yazoume Ye

Ruilin Ren

Stan Yoder

Kara Hanson

Catherine Goodman

Sarah Tougher

Andrea Mann

Barbara Willey

Submitted to:

The Global Fund to Fight AIDS, Tuberculosis and Malaria

Submitted by:

ICF International

11785 Beltsville Drive, Suite 300, Calverton, MD 20705, USA

and

The London School of Hygiene and Tropical Medicine

Recommend citation:

AMFm Independent Evaluation Team (2012). Independent Evaluation of Phase 1 of the

Affordable Medicines Facility - malaria (AMFm), Multi-Country Independent Evaluation Report:

Final Report. Calverton, Maryland and London: ICF International and London School of Hygiene

and Tropical Medicine.

This version of the report includes the following information not previously included in the Preliminary

Report of July 18, 2012: (i) results from the remote areas study; (ii) results from the logo study (exit

interviews and focus group discussions); (iii) an annex describing the Consultative Forum held in June

2012 in Nairobi; and (iv) some new content to Section 1.2 Overview of the AMFm, including orders

requested, approved and delivered as of end September 2012. None of this new information has affected the

assessment of the achievements of the Phase 1 benchmarks that were included in the preliminary report of

July 18, 2012.

This version of the report does not include findings from the endline household surveys. Those findings will

be included in a supplemental report when endline data become available.

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Data Contributors (Institutions in alphabetical order):

Data Contributors for Outlet Surveys

African Population and Health Research Centre, Kenya

Marilyn Wamukoya

Yohannes Kinfu

Blessing Mberu

Centre de Recherche pour le Développement Humain (CRDH) / International d'Etudes et de

Recherches sur les Populations Africaines (CIERPA), Niger

Salif Ndiaye

Idrissa Alichina Kourgueni

Moctar Seydou

Oumarou Malam

Drugs for Neglected Diseases initiative (DNDi)/Research and Development Unit, Komfo Anokye

Teaching Hospital (KATH), Ghana

Graciela Diap

John Amuasi

Samuel Blay Nguah

Ohene Buabeng

Ifakara Health Institute (IHI) - IMPACT 2 Project, Tanzania

Rebecca Thomson

Johanes Boniface

Admirabilis Kalolella

Charles Festo

Mark Taylor

Katia Bruxvoort

Population Service International (PSI) - ACTwatch Project, Kenya, Madagascar, Nigeria, Uganda,

Zanzibar

Tanya Shewchuk

Kate O’Connell

Hellen Gatakaa

Stephen Poyer

Julius Njogu

Mitsuru Toda

Illah Evance

James Kajuna

Baraka Kaaya

Jacky Raharinijatovo

Ekundayo Arogundade

Peter Buyungo

Edna Adhiambo Ogada

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Data Contributors for Remote Area Surveys

African Population and Health Reseach Centre (APHRC)

Catherine Kyobutungi

Blessing Nberu

Marylin Wamukoya

Fredrick Wekesa

Komfo Anokye Teaching Hospital (KATH)

John Amuasi

Samual Blay

Daniel Ansong

Independent consultant – Defining the remote areas

Abdisalan Noor

Data Contributors for Logo Study (Exit Interviews and Focus Group Discussions)

Ghana: TNS RMS Ghana

Adewake Obaseki

Agyakwa Ayisi Addo

Marilyn Oduro-Ntiamoah

Kenya: African Institute for Health and Development (AIHD)

Mary Amuyunzu-Nyamongo

Monica Wabuke

Madagascar: Institut National des Statistiques de Madagascar (INSTAT)

Victor Rabeza Rafaralahy

Heretiana Randriandrasana

Nigeria: TNS RMS Nigeria Limited

Mariam Fagbemi

Olugbenga Afolabi Ogunmefun

Data Contributors for Country Case Studies

Ghana Elizabeth Juma

Kenya Abdinasir Amin

Madagascar Sergio Torres Rueda

Niger Diadier Diallo

Nigeria Catherine Adegoke

Tanzania – mainland Catherine Goodman

Uganda Sarah Tougher

Zanzibar Yazoume Ye

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Table of contents

TABLE OF CONTENTS .................................................................................................................................. III

LIST OF TABLES ............................................................................................................................................ VII

LIST OF FIGURES .......................................................................................................................................... XII

LIST OF ABBREVIATIONS ......................................................................................................................... XIV

DEFINITION OF KEY TERMS ................................................................................................................. XVIII

OVERVIEW OF THE INDEPENDENT EVALUATION OF AMFM ....................................................... XIX

EXECUTIVE SUMMARY .......................................................................................................................... XXIV

1 BACKGROUND AND METHODS .......................................................................................................... 1

1.1 EVALUATION BACKGROUND ..................................................................................................................... 1 1.2 OVERVIEW OF AMFM ............................................................................................................................... 2

1.2.1 Origins of the AMFm ...................................................................................................................... 2 1.2.2 Technical Design of the AMFm ...................................................................................................... 3 1.2.3 Global Fund’s Hosting and Management of the AMFm ................................................................. 3 1.2.4 Funding sources .............................................................................................................................. 5 1.2.5 Negotiations with eligible manufacturers ....................................................................................... 5 1.2.6 AMFm copayments processed and volume of copaid ACTs delivered ............................................ 7 1.2.7 Typical ordering behavior: Differences between public and private sector buyers ..................... 12 1.2.8 Implementation and country-level effects of demand-shaping levers ........................................... 14 1.2.9 Evolution of adult versus child pack orders over time .................................................................. 15 1.2.10 Disbursement delays for supporting interventions ................................................................... 17 1.2.11 Overview of timing of AMFm implementation ......................................................................... 17 1.2.12 Summary of AMFm implementation ......................................................................................... 20

1.3 OVERVIEW OF AMFM PHASE 1 COUNTRIES ............................................................................................ 22 1.3.1 Ghana ........................................................................................................................................... 22 1.3.2 Kenya ............................................................................................................................................ 23 1.3.3 Madagascar .................................................................................................................................. 24 1.3.4 Niger ............................................................................................................................................. 25 1.3.5 Nigeria .......................................................................................................................................... 27 1.3.6 Tanzania – mainland .................................................................................................................... 28 1.3.7 Uganda ......................................................................................................................................... 29 1.3.8 Zanzibar ........................................................................................................................................ 30

1.4 EVALUATION FRAMEWORK ..................................................................................................................... 32 1.4.1 Impact model ................................................................................................................................ 33 1.4.2 Evaluation design ......................................................................................................................... 36 1.4.3 Additional studies ......................................................................................................................... 37

1.5 KEY EVALUATION QUESTIONS AND INDICATORS ..................................................................................... 38 1.6 EVALUATION APPROACH ......................................................................................................................... 41

1.6.1 Overview of methods and tools ..................................................................................................... 41 1.6.2 Outlet surveys ............................................................................................................................... 42 1.6.3 Household survey data - Secondary analysis................................................................................ 51 1.6.4 Implementation process and contextual information .................................................................... 53 1.6.5 Remote area study ......................................................................................................................... 55 1.6.6 Public awareness - AMFm logo study .......................................................................................... 60 1.6.7 Interpretation and operationalization of success metrics ............................................................. 63 1.6.8 Ethical approval ........................................................................................................................... 67 1.6.9 Discussion of strengths and limitations of the Independent Evaluation ....................................... 67

1.7 CONSULTATIVE FORUM .......................................................................................................................... 73

2 RESULTS FROM OUTLET SURVEYS ................................................................................................ 74

2.1 DESCRIPTION OF SAMPLE AND CHARACTERISTICS OF OUTLETS ............................................................... 74 2.1.1 Description of sample at baseline and at endline ......................................................................... 74 2.1.2 Characteristics of the outlets ........................................................................................................ 82

2.2 EVALUATION QUESTION ON ACT AVAILABILITY .................................................................................... 94 2.2.1 Antimalarials in stock ................................................................................................................... 94

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2.2.2 Antimalarials in stock by type ....................................................................................................... 97 2.2.1 Stockouts of quality-assured ACTs ............................................................................................. 112 2.2.2 Population coverage of outlets with quality-assured ACTs ........................................................ 115

2.3 EVALUATION QUESTION ON ACT AFFORDABILITY ................................................................................ 118 2.3.1 Cost to patients of antimalarials ................................................................................................. 118 2.3.2 Gross markup between purchase price and retail selling price .................................................. 141 2.3.3 Total gross markup from first line buyer purchase price to retail selling price ......................... 152 2.3.4 Availability and cost to patients of diagnostic tests (RDT/microscopy) ..................................... 155

2.4 MARKET SHARE OF QUALITY-ASSURED ACTS ...................................................................................... 170 2.5 PROVIDER KNOWLEDGE OF FIRST LINE ANTIMALARIAL TREATMENT AND QUALITY-ASSURED ACT DOSING REGIMEN ............................................................................................................................................ 182

2.5.1 Provider Knowledge of first line antimalarial treatment ............................................................ 182 2.5.2 Provider knowledge of quality-assured ACT dosing regimen for an adult and a child .............. 185 2.5.3 Reasons for not stocking quality-assured ACTs.......................................................................... 190

2.6 AMFM LOGO, RECOMMENDED RETAIL PRICE AND PROVIDER TRAINING ................................................ 193

3 RESULTS FROM HOUSEHOLD SURVEYS ..................................................................................... 211

3.1 FEVER PREVALENCE .............................................................................................................................. 211 3.2 ANTIMALARIAL TREATMENT AMONG CHILDREN WITH FEVER ............................................................... 213 3.3 DIAGNOSTIC TESTING ............................................................................................................................ 220 3.4 ANTIMALARIAL TREATMENT AMONG CHILDREN WITH FEVER FROM THE POOREST HOUSEHOLDS.......... 222

4 IMPLEMENTATION PROCESS AND CONTEXT - FINDINGS FROM THE COUNTRY CASE STUDIES ........................................................................................................................................................... 224

4.1 GHANA .................................................................................................................................................. 224 4.1.1 AMFm implementation process .................................................................................................. 224 4.1.2 Implementation of AMFm supporting interventions ................................................................... 226 4.1.3 Implementation of non-AMFm interventions .............................................................................. 227 4.1.4 Key events and context ................................................................................................................ 228 4.1.5 Conclusion .................................................................................................................................. 228

4.2 KENYA .................................................................................................................................................. 231 4.2.1 AMFm implementation process .................................................................................................. 231 4.2.2 Implementation of AMFm supporting interventions ................................................................... 234 4.2.3 Implementation of non-AMFm interventions .............................................................................. 238 4.2.4 Key events and context ................................................................................................................ 239 4.2.5 Conclusion .................................................................................................................................. 239

4.3 MADAGASCAR ...................................................................................................................................... 242 4.3.1 Description of the AMFm implementation process ..................................................................... 242 4.3.2 Implementation of AMFm supporting interventions ................................................................... 243 4.3.3 Key events and context ................................................................................................................ 247 4.3.4 Conclusion .................................................................................................................................. 247

4.4 NIGER ................................................................................................................................................... 250 4.4.1 AMFm implementation process .................................................................................................. 250 4.4.2 Implementation of AMFm supporting interventions ................................................................... 253 4.4.3 Key events and context ................................................................................................................ 257 4.4.4 Conclusion .................................................................................................................................. 257

4.5 NIGERIA ................................................................................................................................................ 260 4.5.1 AMFm intervention process ........................................................................................................ 260 4.5.2 Implementation of AMFm supporting intervention ..................................................................... 262 4.5.3 Key events and context ................................................................................................................ 265 4.5.4 Conclusion .................................................................................................................................. 266

4.6 TANZANIA - MAINLAND ........................................................................................................................ 270 4.6.1 AMFm implementation process .................................................................................................. 270 4.6.2 Implementation of AMFm supporting interventions ................................................................... 272 4.6.3 Key event and context ................................................................................................................. 277 4.6.4 Conclusion .................................................................................................................................. 277

4.7 UGANDA ............................................................................................................................................... 280 4.7.1 AMFm implementation process .................................................................................................. 280 4.7.2 Implementation of AMFm Supporting Interventions ................................................................... 285 4.7.3 Key events and context ................................................................................................................ 289

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4.7.4 Conclusion .................................................................................................................................. 290 4.8 ZANZIBAR ............................................................................................................................................. 292

4.8.1 AMFm implementation process .................................................................................................. 292 4.8.2 Implementation of AMFm supporting interventions ................................................................... 295 4.8.3 Key events and context ................................................................................................................ 299 4.8.4 Conclusion .................................................................................................................................. 299

5 RESULTS FROM THE REMOTE AREA STUDY............................................................................. 302

5.1 DESCRIPTION OF THE SAMPLE ............................................................................................................... 302 5.2 AVAILABILITY OF QUALITY-ASSURED ACTS IN REMOTE AREAS ........................................................... 305

5.2.1 Stockouts of quality-assured ACTs in remote areas ................................................................... 308 5.2.2 Population coverage of outlets with quality-assured ACTs in remote areas .............................. 308

5.3 PRICING OF QUALITY-ASSURED ACTS IN REMOTE AREAS ..................................................................... 310 5.4 GROSS MARKUP BETWEEN PURCHASE PRICE AND RETAIL SELLING PRICE OF QUALITY-ASSURED ACTS IN REMOTE AREAS ............................................................................................................................................... 314 5.5 AVAILABILITY AND COST TO PATIENTS OF MALARIA DIAGNOSTIC TESTS IN REMOTE AREAS ................. 316 5.6 MARKET SHARE FOR QUALITY-ASSURED ACTS IN REMOTE AREAS ....................................................... 319 5.7 AMFM LOGO IN REMOTE AREAS ........................................................................................................... 321 5.8 SUMMARY OF RESULTS ......................................................................................................................... 323

6 RESULTS FROM THE LOGO STUDY (EXIT INTERVIEWS AND FOCUS GROUP DISCUSSIONS) ................................................................................................................................................ 324

6.1 EXIT INTERVIEWS .................................................................................................................................. 324 6.1.1 Description of the sample ........................................................................................................... 324 6.1.2 Reasons for choosing a malaria treatment ................................................................................. 325 6.1.3 Source of information about ACTs ............................................................................................. 326 6.1.4 Knowledge of AMFm logo .......................................................................................................... 327 6.1.5 Meaning of the AMFm logo ........................................................................................................ 330 6.1.6 Summary of results from exit interviews ..................................................................................... 331

6.2 FOCUS GROUP DISCUSSIONS .................................................................................................................. 332 6.2.1 Description of the sample ........................................................................................................... 332 6.2.2 Knowledge of treatment of malaria ............................................................................................ 332 6.2.3 Knowledge and perceived availability of ACTs .......................................................................... 333 6.2.4 Knowledge and perception of the AMFm logo ........................................................................... 334 6.2.5 Summary of the results of the focus group discussions ............................................................... 335

7 SUMMARY OF KEY FINDINGS FROM RELEVANT OPERATIONAL RESEARCH ............... 337

8 SUCCESS METRICS AND INTERPRETATION .............................................................................. 343

8.1 GHANA .................................................................................................................................................. 343 8.1.1 Achievement of AMFm objectives ............................................................................................... 343 8.1.2 Supply of AMFm copaid drugs ................................................................................................... 346 8.1.3 Implementation of supporting interventions ............................................................................... 347 8.1.4 Context ........................................................................................................................................ 348 8.1.5 Summary ..................................................................................................................................... 348

8.2 KENYA .................................................................................................................................................. 350 8.2.1 Achievement of AMFm objectives ............................................................................................... 350 8.2.2 Supply of AMFm copaid drugs ................................................................................................... 353 8.2.3 Implementation of supporting interventions ............................................................................... 354 8.2.4 Context ........................................................................................................................................ 355 8.2.5 Summary ..................................................................................................................................... 355

8.3 MADAGASCAR ...................................................................................................................................... 356 8.3.1 Achievement of the objectives ..................................................................................................... 356 8.3.2 Supply of AMFm copaid drugs ................................................................................................... 360 8.3.3 Implementation of supporting interventions ............................................................................... 360 8.3.4 Context ........................................................................................................................................ 361 8.3.5 Summary ..................................................................................................................................... 362

8.4 NIGER ................................................................................................................................................... 363 8.4.1 Achievement of the objectives ..................................................................................................... 363 8.4.2 Supply of AMFm copaid drugs ................................................................................................... 365 8.4.3 Implementation of supporting interventions ............................................................................... 366

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8.4.4 Context ........................................................................................................................................ 367 8.4.5 Summary ..................................................................................................................................... 367

8.5 NIGERIA ................................................................................................................................................ 368 8.5.1 Achievement of the objectives ..................................................................................................... 368 8.5.2 Supply of AMFm copaid drugs ................................................................................................... 370 8.5.3 Implementation of supporting interventions ............................................................................... 371 8.5.4 Context ........................................................................................................................................ 373 8.5.5 Summary ..................................................................................................................................... 373

8.6 TANZANIA MAINLAND ........................................................................................................................... 374 8.6.1 Achievement of AMFm objectives ............................................................................................... 374 8.6.2 Supply of AMFm copaid drugs ................................................................................................... 376 8.6.3 Implementation of supporting interventions ............................................................................... 377 8.6.4 Context ........................................................................................................................................ 378 8.6.5 Summary ..................................................................................................................................... 379

8.7 UGANDA ............................................................................................................................................... 380 8.7.1 Achievement of AMFm objectives ............................................................................................... 380 8.7.2 Supply of AMFm copaid drugs ................................................................................................... 383 8.7.3 Implementation of supporting interventions ............................................................................... 384 8.7.4 Context ........................................................................................................................................ 385 8.7.5 Summary ..................................................................................................................................... 385

8.8 ZANZIBAR ............................................................................................................................................. 386 8.8.1 Achievement of AMFm objectives ............................................................................................... 386 8.8.2 Supply of AMFm copaid drugs ................................................................................................... 389 8.8.3 Implementation of supporting interventions ............................................................................... 389 8.8.4 Context ........................................................................................................................................ 390 8.8.5 Summary ..................................................................................................................................... 391

9 CONCLUSION........................................................................................................................................ 392

9.1 CONCLUSION ......................................................................................................................................... 392

10 REFERENCES ........................................................................................................................................ 396

11 ACKNOWLEDGEMENTS .................................................................................................................... 403

12 APPENDICES ......................................................................................................................................... 404

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List of tables Table 1: Quantity of copaid quality-assured ACTs delivered, July 2010 – December 2011 ........................... xxviii

Table 2: Quantity of copaid quality-assured ACTs delivered, January 2012 – September 2012 .................... xxviii

Table 1.2.1: Quantity of copaid quality-assured ACTs requested, approved, and delivered, July 2010 –

December 2011 ............................................................................................................................................. 8

Table 1.2.2: Quantity of copaid quality-assured ACTs requested, approved, and delivered, January 2012 –

September 2012........................................................................................................................................... 10

Table 1.2.3: Differences between public and private sector buyers ..................................................................... 12

Table 1.2.4: Number of first-line buyers which received deliveries* of quality-assured ACT treatments through

AMFm ......................................................................................................................................................... 13

Table 1.2.5: Quality-assured ACT treatments requested by private not-for-profit and private for-profit first-line

buyers and approved by the Global Fund, 3rd

quarter and 4th

quarter of 2011 ............................................ 15

Table 1.2.6: Quality-assured ACT treatments requested by private not-for-profit and private for-profit first-line

buyers and approved by the Global Fund, 1st quarter, 2

nd quarter and 3

rd quarter of 2012 .......................... 15

Table 1.2.7: Summary of AMFm implementation ................................................................................................ 21

Table 1.5.1: List of key indicators for the independent evaluation ....................................................................... 40

Table 1.6.1: Link between outlet and household surveys and the evaluation questions ....................................... 41

Table 1.6.2: Timing of data collection for outlet surveys and arrival of copaid ACTs by country ...................... 43

Table 1.6.3: Number of clusters by domain for each country ............................................................................... 44

Table 1.6.4: Local currencies and their USD equivalents using the average interbank rate, 2010 ....................... 50

Table 1.6.5: Summary of existing household surveys that include information on ACT use ............................... 52

Table 1.6.6: Timing of data collection for baseline and endline household surveys in relation to arrival of the

first copaid ACTs by country ...................................................................................................................... 53

Table 1.6.7: Number and dates of key informant interviews conducted ............................................................... 54

Table 1.6.8: Remote area clusters selected for the AMFm Independent Evaluation remote area survey ............. 58

Table 1.6.9: E2Pi metrics and benchmarks for success and their operationalization by the IE ............................ 64

Table 2.1.1: Survey sample breakdown: Number of outlets enumerated and number stocking antimalarials by

urban-rural location, according to country at baseline (2010) and endline (2011) ...................................... 75

Table 2.1.2: Number of outlets by final interview status and urban-rural location, according to country at

baseline (2010) and endline (2011) ............................................................................................................. 76

Table 2.1.3: Number of outlets enumerated by type of outlet and urban-rural location, according to country at

baseline (2010) and endline (2011) ............................................................................................................. 78

Table 2.1.4: Number of outlets with antimalarials in stock by type of outlet and urban-rural location, according

to country at baseline (2010) and endline (2011) ........................................................................................ 80

Table 2.2.1: Outlets with antimalarials in stock at baseline (2010) and endline (2011) ....................................... 95

Table 2.2.2: Outlets with non-artemisinin therapy in stock at baseline (2010) and endline (2011)...................... 99

Table 2.2.3: Outlets with artemisinin monotherapy in stock at baseline (2010) and endline (2011) .................. 101

Table 2.2.4: Outlets with oral artemisinin monotherapy in stock at baseline (2010) and endline (2011) ........... 103

Table 2.2.5: Outlets with non-quality-assured ACTs in stock at baseline (2010) and endline (2011)................ 105

Table 2.2.6: Outlets with quality-assured ACTs in stock at baseline (2010) and endline (2011) ....................... 107

Table 2.2.7: Outlets with quality-assured ACTs with and without the AMFm logo in stock at endline, 2011 .. 109

Table 2.2.8: Public health facilities with quality-assured ACTs in stock among ALL public health facilities at

baseline (2010) and endline (2011) ........................................................................................................... 111

Table 2.2.9: Outlets with stock-outs of quality-assured ACTs at baseline (2010) and endline (2011) ............... 113

Table 2.2.10: Percentage of the population living in “subdistricts” with outlets with quality-assured ACTs in

stock at baseline (2010) and endline (2011) .............................................................................................. 116

Table 2.3.1: Cost to patients of non-artemisinin therapy, in 2010 US dollars, at baseline (2010) and

endline(2011) ............................................................................................................................................ 121

Table 2.3.2: Cost to patients of artemisinin monotherapy, in 2010 US dollars, at baseline (2010) and endline

(2011) ........................................................................................................................................................ 123

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Table 2.3.3: Cost to patients of oral artemisinin monotherapy, in 2010 US dollars, at endline, 2011 ................ 125

Table 2.3.4: Cost to patients of non-quality-assured ACTs, in 2010 US dollars, at baseline (2010) and endline

(2011) ........................................................................................................................................................ 127

Table 2.3.5: Cost to patients of quality-assured ACTs (including formulations for adults and children), in 2010

US dollars, at baseline (2010) and endline (2011) .................................................................................... 129

Table 2.3.6: Cost to patients of quality-assured ACTs (including formulations for adults and children) by

presence of the AMFm logo, in 2010 US dollars, at endline, 2011 .......................................................... 131

Table 2.3.7: Cost to patients of quality-assured ACTs (pediatric formulations only), in 2010 US dollars, at


Table 2.3.8: Cost to patients of quality-assured ACTs (pediatric formulations only) by presence of the AMFm

logo, in 2010 US dollars, at endline, 2011 ................................................................................................ 135

Table 2.3.9: Cost to patients in private for-profit outlets, of the most popular antimalarial which is not a QAACT

in terms of private for-profit outlet sales volumes for TABLETS and ALL DOSAGE FORMS in 2010 US

dollars at endline 2011 .............................................................................................................................. 138

Table 2.3.10: Ratio of the cost to patients of quality-assured ACTs with the AMFm logo to the cost to patients

of the most popular antimalarial which is not a QAACT for TABLETS in private for-profit outlets in 2010

US dollars, at endline, 2011 ...................................................................................................................... 138


of the most popular antimalarial which is not a QAACT for ALL DOSAGE FORMS in private for-profit

outlets in 2010 US dollars, at endline, 2011.............................................................................................. 139


of artemisinin monotherapy TABLETS in private for-profit outlets in 2010 US dollars, at endline, 2011

.................................................................................................................................................................. 139


of artemisinin monotherapy for ALL ORAL DOSAGE FORMS in private for-profit outlets in 2010 US

dollars, at endline, 2011 ............................................................................................................................ 140

Table 2.3.14: Gross markup between purchase price and retail selling price of non-artemisinin therapy at


Table 2.3.15: Gross markup between purchase price and retail selling price of artemisinin monotherapy at


Table 2.3.16: Gross markup between purchase price and retail selling price of non-quality-assured ACTs at


Table 2.3.17: Gross markup between purchase price and retail selling price of quality-assured ACTs, at baseline

(2010) and endline (2011) ......................................................................................................................... 148

Table 2.3.18: Gross markup between purchase price and retail selling price of quality-assured ACTs, by

presence of the AMFm logo, at endline, 2011 .......................................................................................... 150

Table 2.3.19: Median total gross markup from first line buyer price to retail selling price for quality-assured

ACTs bearing the AMFm logo, in 2010 US dollars, at endline, 2011 ...................................................... 153

Table 2.3.20: Availability of any diagnostic test for malaria at baseline (2010) and endline (2011) ................. 156

Table 2.3.21: Availability of malaria microscopy at baseline (2010) and endline (2011) .................................. 158

Table 2.3.22: Availability of RDTs at baseline (2010) and endline (2011) ........................................................ 160

Table 2.3.23: Cost to adult patients of malaria microscopy, in 2010 US dollars, at baseline (2010) and endline

(2011) ........................................................................................................................................................ 162

Table 2.3.24: Cost to child patients of malaria microscopy, in 2010 US dollars, at baseline (2010) and endline

(2011) ........................................................................................................................................................ 164

Table 2.3.25: Cost to adult patients of rapid diagnostic tests for malaria (RDTs), in 2010 US dollars, at baseline

(2010) and endline (2011) ......................................................................................................................... 166

Table 2.3.26: Cost to child patients of rapid diagnostic tests for malaria (RDTs), in 2010 US dollars, at baseline

(2010) and endline (2011) ......................................................................................................................... 168

Table 2.4.1: Percent distribution of antimalarial sales volumes for public health facilities, at baseline (2010) and

endline (2011) ........................................................................................................................................... 173

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Table 2.4.2: Percent distribution of antimalarial sales volumes for private not-for-profit facilities, at baseline

(2010) and endline (2011) ......................................................................................................................... 174

Table 2.4.3: Percent distribution of antimalarial sales volumes for private for-profit facilities, at baseline (2010)

and endline (2011) .................................................................................................................................... 175

Table 2.4.4: Percent distribution of antimalarial sales volumes for all outlets (all sectors combined), at baseline

(2010) and endline (2011) ......................................................................................................................... 176

Table 2.4.5: Market share of quality-assured ACTs, by presence of the AMFm logo at endline, 2011 ............. 177

Table 2.4.6: Percent distribution of antimalarial sales volumes of ALL antimalarials by outlet type at baseline

(2010) and endline (2011) ......................................................................................................................... 178

Table 2.4.7: Percent distribution of antimalarial sales volumes by private for-profit outlets by outlet type at


Table 2.4.8: Percent distribution of sales volumes of quality-assured ACTs by outlet type at baseline (2010) and

endline (2011) ........................................................................................................................................... 180

Table 2.5.1: Provider knowledge of first line antimalarial treatment at baseline (2010) and endline (2011) ..... 183

Table 2.5.2: Provider knowledge of dosing regimen for quality-assured ACTs (QAACTs) for an adult, at


Table 2.5.3: Provider knowledge of dosing regimen for quality-assured ACTs (QAACTs) for a child, at baseline

(2010) and endline (2011) ......................................................................................................................... 188

Table 2.5.4: Reasons for not stocking quality-assured ACTs (QAACTs) for private providers, at baseline (2010)

and endline (2011) .................................................................................................................................... 191

Table 2.6.1: Provider recognition of AMFm logo, at baseline (2010) and endline (2011) ................................. 195

Table 2.6.2: Provider knowledge of the meaning of the AMFm logo at endline, 2011 ...................................... 197

Table 2.6.3: Sources from which providers have seen or heard of the AMFm logo at endline, 2011 ................ 199

Table 2.6.4: Percentage of quality-assured ACTs bearing the AMFm logo, at baseline (2010) and endline (2011)

.................................................................................................................................................................. 201

Table 2.6.5: Percentage of all antimalarials other than quality-assured ACTs bearing the AMFm logo, at


Table 2.6.6: Provider knowledge of the AMFm program at endline, 2011 ........................................................ 205

Table 2.6.7: Sources from which providers heard of the AMFm program at endline, 2011 .............................. 206

Table 2.6.8: Providers stating that there is a maximum/recommended retail price (RRP) for antimalarials with

the AMFm logo at endline, 2011 .............................................................................................................. 208

Table 2.6.9: Providers stating the correct maximum/recommended retail price (RRP) for antimalarials with the

AMFm logo at endline, 2011 .................................................................................................................... 209

Table 2.6.10: Providers who have received training on antimalarials with the AMFm logo at endline, 2011 ... 210

Table 3.1.1: Prevalence of fever among children under five years by selected background characteristics ....... 212

Table 3.2.1: Any antimalarial treatment of fever among children under five years by selected background

characteristics ............................................................................................................................................ 214

Table 3.2.2: ACT treatment among children under five years with fever by selected background characteristics

.................................................................................................................................................................. 216

Table 3.2.3: Prompt ACT treatment of fever among under five children by selected background characteristics

.................................................................................................................................................................. 219

Table 3.3.1: Diagnostic testing among children under five years with fever by selected background

characteristics ............................................................................................................................................ 221

Table 3.4.1: Treatment of fever among children under five years from the poorest households (lowest two

wealth quintiles), by urban-rural residence ............................................................................................... 223

Table 4.1.1: Summary of key factors likely to have supported or hindered achievement of AMFm goals in

Ghana ........................................................................................................................................................ 229


Kenya ........................................................................................................................................................ 240

Table 4.3.1. Summary of key factors likely to have supported or hindered achievement of AMFm goals in

Madagascar ............................................................................................................................................... 248

x

Table 4.4.1: Summary of key factors likely to have supported or hindered achievement of AMFm goals in Niger

.................................................................................................................................................................. 258


Nigeria....................................................................................................................................................... 267


Tanzania mainland .................................................................................................................................... 278

Table 4.7.1 Recommended retail prices for AMFm copaid ACTs in 2010 US dollars ...................................... 287


Uganda) ..................................................................................................................................................... 290


Zanzibar .................................................................................................................................................... 300

Table 5.1.1: Number of remote area outlets enumerated and number stocking antimalarials at the time of the

survey, according to country, 2011-2012 .................................................................................................. 303

Table 5.1.2 Number of outlets in remote areas at endline by final interview status, according to country, 2011-

2012 .......................................................................................................................................................... 303

Table 5.1.3: Number of outlets enumerated by type of outlet in remote areas at endline, according to country,

2011-2012 ................................................................................................................................................. 304

Table 5.1.4: Number of outlets with antimalarials in stock by type of outlet in the remote areas at endline,

according to country, 2011-2012 .............................................................................................................. 304

Table 5.2.1: Outlets in remote areas and non-remote areas with antimalarials in stock at endline, 2011-2012 . 306

Table 5.2.2:Outlets in remote areas and non-remote areas with quality-assured ACTs in stock at endline, 2011-

2012 .......................................................................................................................................................... 306

Table 5.2.3: Outlets in remote areas and non-remote areas with quality-assured ACTs with the AMFm logo in

stock at endline, 2011-2012 ...................................................................................................................... 307

Table 5.2.4: Outlets in remote areas and non-remote areas with stockouts of quality-assured ACTs at endline,

2011-2012 ................................................................................................................................................. 308

Table 5.2.5: Percentage of the population living in “subdistricts” in remote areas and non-remote areas with

outlets with quality-assured ACTs in stock at endline, 2011-2012 ........................................................... 309

Table 5.3.1: Cost to patients of quality-assured ACTs (including formulations for adults and children) in remote

areas and non-remote areas at endline, in US dollars, 2011-2012 ............................................................ 311

Table 5.3.2: Cost to patients of quality-assured ACTs (pediatric formulations only) in remote areas and non-

remote areas at endline, in US dollars, 2011-2012 .................................................................................... 312

Table 5.3.3: Cost to patients of non-quality-assured ACTs (including formulations for adults and children) in

remote areas and non-remote areas at endline, in US dollars, 2011-2012 ................................................ 313

Table 5.4.1: Gross markup between purchase price and retail selling price of quality-assured ACTs in remote

areas and non-remote areas at endline, in US dollars, 2011-2012 ............................................................ 315

Table 5.5.1: Availability of malaria diagnostic tests in remote areas and non-remote areas at endline, 2011-2012

.................................................................................................................................................................. 317

Table 5.5.2: Cost to patients of malaria diagnostic tests in remote areas and non-remote areas at endline, in US

dollars, Kenya, 2011-2012 ........................................................................................................................ 318

Table 5.6.1: Percent distribution of antimalarial sales volumes in remote areas and non-remote areas at endline,

2011-2012 ................................................................................................................................................. 320

Table 5.7.1: Provider recognition of the AMFm logo in remote areas and non-remote areas at endline, 2011-

2012 .......................................................................................................................................................... 322

Table 5.7.2: Percentage of quality-assured ACTs bearing the AMFm logo in remote areas and non-remote areas

at endline, 2011-2012 ................................................................................................................................ 322

Table 6.1.1: Number of individuals contacted by the interviewer and the number who were interviewed by

urban/rural clusters, according to country, 2012 ....................................................................................... 324

Table 6.1.2: Number of respondents by sex, age and urban/rural cluster, according to country, 2012 .............. 325

Table 6.1.3: Reasons for choosing a malaria treatment ...................................................................................... 326

Table 6.1.4: Source from which respondents had most recently heard of ACTs ................................................ 327

Table 6.1.5: Respondents who saw the AMFm logo in the outlet they visited ................................................... 328

xi

Table 6.1.6: Respondents who saw the AMFm logo in the outlet they visited (among those who visited the outlet

to obtain an antimalarial) .......................................................................................................................... 329

Table 6.1.7: Source from which respondents have ever seen the AMFm logo ................................................... 330

Table 6.1.8: Meaning of the AMFm logo: Respondents who have seen the AMFm logo before ....................... 331

xii

List of figures

Figure 1: Overview of the achievement of the AMFm Success Benchmarks by county, indicating benchmarks

achieved (in green), nearly or possibly achieved (in amber) and not achieved (in red), (point estimate, and

p-value for statistical test of whether the level stated in the benchmark was achieved) ......................... xxiii Figure 2: Timeline of AMFm Phase 1 Independent Evaluation data collection; grant amendments and

disbursements; arrival in-country of copaid QAACTs; launch events; IEC/ BCC implementation; and

application of demand levers by the Global Fund ................................................................................... xxvii Figure 3: Breakdown of outlets stocking antimalarials by outlet type at endline Figure .................................... xxx Figure 4: Breakdown of private for-profit outlets stocking antimalarials market structure by outlet type at

endline, 2011 ............................................................................................................................................ xxxi Figure 5: Percentage of outlets with QAACTs in stock at baseline and endline, and the Success Benchmark 1

threshold (20 percentage point increase in availability of QAACTs) ..................................................... xxxii Figure 6: Percentage of public health facilities and private for-profit outlets with QAACTs in stock at baseline

and endlin ............................................................................................................................................... xxxiii Figure 7: Percentage of outlets with QAACTs in stock in urban and rural areas at baseline and endline ....... xxxiii Figure 8: Percentage of outlets with QAACTs in stock by presence of the AMFm logo at endline ............... xxxiv Figure 9: Percentage of outlets with oral AMT and non-artemisinin therapies in stock at baseline and endline

................................................................................................................................................................ xxxv Figure 10. Median cost to patients of one adult equivalent treatment dose (AETD) of QAACTs in public and

private for-profit outlets (2010 US dollar equivalent), at baseline and endline ..................................... xxxvi Figure 11. Median cost to patients of one AETD of QAACTs in private for-profit outlets in rural and urban

areas (2010 US dollar equivalent), at baseline and endline ................................................................... xxxvii Figure 12. Median cost to patients of one AETD of QAACTs in private for-profit outlets by presence of the

AMFm logo (2010 US dollar equivalent), at baseline and endline ...................................................... xxxviii Figure 13: Median cost to patients of one AETD of QAACTs with the AMFm logo and the recommended retail

price in private for-profit outlets (2010 US dollar equivalent) at endline ............................................ xxxviii Figure 14: Median cost to patients in private for-profit outlets of one AETD of QAACTs bearing the AMFm

logo compared with the cost per AETD of the most popular antimalarial that is not a quality-assured ACT

(2010 US dollar equivalent) at endline, and the Success Benchmark 2 threshold (median price ratio

xiii

Figure 24: Overview of the achievement of the AMFm Success Benchmarks by county, indicating benchmarks

achieved (in green), nearly or possibly achieved (in amber) and not achieved (in red), (point estimate, and

p-value for statistical test of whether the level stated in the benchmark was achieved) Figure .............. lxviii Figure 1.2.1: Artemether-lumefantrine: Relative percentage of pack sizes, pre- and post-revision of co-payment

structure and introduction of levers ............................................................................................................. 16 Figure 1.2.2: Artesunate-Amodiaquine: Relative percentage of pack sizes, pre- and post-revision of co-payment

structure and introduction of levers ............................................................................................................. 17 Figure 1.2.3: Timeline of AMFm Phase 1 Independent Evaluation data collection; grant amendments and

disbursements; arrival in-country of copaid QAACTs; launch events; IEC/ BCC implementation; and

application of demand levers by the Global Fund ....................................................................................... 19 Figure 1.3.1: Location of the AMFm Phase 1 countries ....................................................................................... 22 Figure 1.4.1: AMFm Phase 1 Results Framework ................................................................................................ 33 Figure 1.4.2: AMFm Theory of Change ............................................................................................................... 35 Figure 1.4.3: The Independent Evaluation Design ............................................................................................... 37 Figure 1.4.4: AMFm logo ..................................................................................................................................... 38 Figure 1.6.1: Remoteness classification (quintiles) based on the remoteness index, Kenya and Ghana .............. 57 Figure 1.6.2: Remoteness classification map showing the location of clusters sampled in the remote areas for the

AMFm Independent Evaluation remote area survey ................................................................................... 59 Figure 4.1.1:Timeline of key events related to AMFm implementation process and context in Ghana ............. 230 Figure 4.2.1: Timeline of key events related to AMFm implementation process and context in Kenya ............ 241 Figure 4.3.1: Timeline of key events related to AMFm implementation process and context in Madagascar ... 249 Figure 4.4.1: Timeline of key events related to AMFm implementation process and context in Niger ............. 259 Figure 4.5.1: Timeline of key events related to the AMFm implementation process and context in Nigeria ..... 268 Figure 4.6.1: Timeline of key events related to AMFm implementation process and context in Tanzania

mainland .................................................................................................................................................... 279 Figure 4.7.1: Timeline of key events related to AMFm implementation process and context Uganda .............. 291 Figure 4.8.1: Timeline of key events related to AMFm implementation process and context in Zanzibar ........ 301 Figure 8.1.1: AMFm success metrics scorecard – Ghana ................................................................................... 344 Figure 8.2.1: AMFm success metrics scorecard – Kenya ................................................................................... 352 Figure 8.3.1: AMFm success metrics scorecard – Madagascar .......................................................................... 358 Figure 8.4.1: AMFm success metrics scorecard – Niger .................................................................................... 364 Figure 8.5.1: AMFm success metrics scorecard – Nigeria ................................................................................. 369 Figure 8.6.1: AMFm success metrics scorecard – Tanzania mainland ............................................................... 375 Figure 8.7.1: AMFm success metrics scorecard – Uganda ................................................................................. 381 Figure 8.8.1:AMFm success metrics scorecard – Zanzibar ................................................................................ 387 Figure 9.1.1: Overview of the achievement of the AMFm Success Benchmarks by county, indicating

benchmarks achieved (in green), nearly or possibly achieved (in amber) and not achieved (in red), (point

estimate, and p-value for statistical test of whether the level stated in the benchmark was achieved) ..... 395

xiv

List of abbreviations ACT Artemisinin-Based Combination Therapy

ADDO Accredited Drug Dispensing Outlets

AETD Adult Equivalent Treatment Dose

AGOA Africa Growth Opportunity Act

AHC Ad Hoc Committee

AL Artemether-Lumefantrine

ALMA

AM

African Leaders Malaria Alliance

Antimalarial

AMT Artemisinin monotherapy

AMFm Affordable Medicines Facility – malaria

AMFmCC AMFm Coordinating Committee

API Active Pharmaceutical Ingredient

ARI Acute Respiratory Infection

ASAQ Amodiaquine and Artesunate

BCC

CAPSS

Behavior change communication

Consortium for ACT Private Sector Subsidy

CCA Community Change Agent

CCM County Coordinating Mechanism

CEM Cohort Event Monitoring

CERMES Centre de Recherches Médicales et Sanitaires

CHAG Christian Health Association of Ghana

CHAI Clinton Health Access Initiative

CHW Community Health Worker

CI Confidence Interval

CIERPA Centre International d'Etudes et de Recherches sur les Populations Africaines

CIF Cost-Insurance-Freight

CMS Central Medical Stores

CP Condition Precedent

CPC Consumer Protection Council

CPD Continuing Professional Development

CRDH Centre de Recherche pour le Développement Humain

CRS Catholic Relief Services

CSI Centre de Santé Intégré

DAMM Direction d’Agence de Medicament de Madagascar

DCs Data Contributors

DFID Department for International Development

DHAP Dihydroartemisinin-Piperaquine

DHS Demographic and Health Survey

DLDB Duka la Dawa Baridi

DNDi Drugs for Neglected Diseases initiative

DOMC Division of Malaria Control

ERP Expert Review Panel

E2Pi Evidence to Policy Initiative

FBO Faith-Based Organization

xv

FCO Focal Coordinating Office

FGD Focus group discussion

FLB First Line Buyer

FMOH Federal Ministry of Health

FOB Free on Board

GDP Gross Domestic Product

Gh₡ Ghana Cedis

GHS Ghana Health Service

Global Fund The Global Fund to Fight AIDS, Tuberculosis and Malaria

GoU Government of Uganda

HAI Health Action International

HBC Home Based Care

HMM Home Management of Malaria

HPLC High-performance Liquid Chromatography

ICCM Integrated Community Care and Management

ICH The International Conference on Harmonisation of Technical Requirements for

Registration of Pharmaceuticals for Human Use

IE Independent Evaluation/Evaluator

IEC Information, Education and Communication

IPT Intermittent Preventive Treatment

IMCI Integrated Management of Childhood Illnesses

IOM Institute of Medicine

IQR Interquartile Range

IRB Institutional Review Board

IRS Indoor Residual Spraying

IOM Institute of Medicine

ITN Insecticide-Treated Net

JHU Johns Hopkins University

JMS Joint Medical Stores

KAP Knowledge, Attitude, and Perception

KCM Kenya Country Mechanism

KEMSA Kenya Medical Supplies Agency

KII Key Informant Interview

LANSPEX Laboratoire National de Santé Publique et d’Expertise

LCS Licensed Chemical Sellers

LFA Local Fund Agent

LGA Local Government Area

LLIN Long-lasting Insecticidal Net

LTR Local Technical Representative

LSHTM London School of Hygiene and Tropical Medicine

MEEDS Malaria Early Epidemic Detection System

MICC Malaria Interagency Coordinating Committee

MICS Multiple Indicator Cluster Survey

MIS Malaria Indicator Survey

MMV Medicines for Malaria Venture

MOF Ministry of Finance

MOFEA Ministry of Finance and Economic Affairs

xvi

MOH Ministry of Health

MoHSW Ministry of Health and Social Welfare

MOMS Ministry of Medical Services

MOPHS Ministry of Public Health and Sanitation

MSA Master Supply Agreement

MVU Mobile Video Unit

NAFDAC National Agency for Food and Drug Administration and Control

nAT Non-Artemisinin Therapy

NDA National Drug Authority

NGO Nongovernmental Organization

NHIS National Health Insurance Scheme

NHS National Health System

NMCP National Malaria Control Program

NMS National Medical Stores

NOC National Oversight Committee

nQAACT Non-Quality-Assured Artemisinin-Based Combination Therapy

NSA National Strategy Application

OJT On-the-Job Training

ONEN Organisation National des Educateurs Novateurs

OS Outlet survey

ONPPC Office National des Produits Pharmaceutiques et Chimiques

OTC Over-the-Counter

PCN Pharmacists Council of Nigeria

PDA Personal Digital Assistant

PHCC Primary Health Care Center

PHCU Primary Health Care Unit

PMI President’s Malaria Initiative

PNLP Programme National de Lutte contre le Paludisme

POM Prescription-Only Medicines

POP Part One Pharmacy

PPB Pharmacy & Poisons Board

PPS Probability Proportional to Size

PR Principal Recipient

PSI Population Services International

PSM Procurement Supply Management

PV Pharmacovigilance

PwC PricewaterhouseCoopers

QAACT Quality-Assured Artemisinin-Based Combination Therapy

QCIL Quality Chemicals Industries Limited

RBM Roll Back Malaria

RDT Rapid Diagnostic Test

RFP Request for Proposal

RMCG Role Model Care Givers

RMS Regional Medical Stores

RRP Recommended Retail Price

RSE Relative standard error

SADC Southern Africa Development Community

xvii

SC Steering Committee

SI Supporting Intervention

SMOH State Ministry of Health

SOP Standard Operating Procedures

SP Sulfadoxine-Pyrimethamine

SR Sub-Recipient

SSA sub-Saharan Africa

SSF Single Stream Funding

SuNMaP Support to National Malaria Control Program

SURE Securing Ugandans’ Rights to Essential Medicines

TANAM Tanzania National Malaria Movement

TERG Technical Evaluation Reference Group

TFDA Tanzania Food and Drug Authority

TLC Technologie de l’Information et de Communication

TWG Technical Working Group

TZ-RDIP Tanzania Remote Distribution Incentive Program

UGP Unité de Gestion de Projet

UN United Nations

UNDP United Nations Development Program

UNICEF United Nations Children's Fund

USD United States Dollar

VHT Village Health Team

VPP Voluntary Pooled Procurement

WHO World Health Organization

WHO/AFRO World Health Organization/Africa region

YGC Yakubu Gowon Centre

ZFDB Zanzibar Food and Drug Board

ZILS Zanzibar Integrated Logistics System

ZMCP Zanzibar Malaria Control Program

xviii

Definition of key terms Key terms Definition

Adult Equivalent Treatment

Dose (AETD)

An AETD is the number of milligrams (mg) of an antimalarial drug needed to treat a 60 kg

adult.

Antimalarial Any medicine recognized by WHO for the treatment of malaria. Medicines used solely for

the prevention of malaria are excluded from analysis in this report.

Artemisinin-Based

Combination Therapy (ACT)

An antimalarial that combines artemisinin or one of its derivatives with an antimalarial or

antimalarials of a different class.

Artemisinin monotherapy An antimalarial medicine that has a single active compound, where this active compound is

artemisinin or one of its derivatives.

Booster Sample A booster sample is an extra sample of units (or in this case outlets) of a type not adequately

represented in the main survey, but which are of special interest.

In this survey, we have included a booster sample of public health facilities and Part One

pharmacies in the entire district that includes the selected subdistrict, consisting of all of the

public health facilities and Part One pharmacies in the district that are not in the selected

subdistrict.

Censused subdistrict A subdistrict where field teams conducted a full census of all outlets with the potential to sell

antimalarials.

Combination therapy The use of two or more classes of antimalarial drugs/molecules in the treatment of malaria

that have independent modes of action.

Dosing/treatment regimen The posology or timing and number of doses of an antimalarial used to treat malaria. This

schedule often varies by patient weight.

Enumerated Outlets Outlets that were visited by a member of one of the field teams and from which at a

minimum basic descriptive information was collected (Sections C1-C9 of the outlet survey

questionnaire).

First-line treatment The government-recommended treatment for uncomplicated malaria.

Monotherapy An antimalarial medicine that has a single mode of action. This may be a medicine with a

single active compound or a synergistic combination of two compounds with related

mechanisms of action.

Non-artemisinin therapy An antimalarial medicine that does not contain artemisinin or any of its derivatives.

Outlet Any point of sale or provision of a commodity to an individual. Outlets are not restricted to

stationary points of sale and may include mobile units or individuals.

Pediatric formulation Antimalarial drug packaged specifically for children.

Quality-Assured

Artemisinin-Based

Combination Therapies

(QAACTs)

QAACTs are ACTs that comply with the Global Fund to Fight AIDS, Tuberculosis and

Malaria’s Quality Assurance Policy.

For the purpose of the Independent Evaluation, a QAACT is any ACT that appeared on the

Global Fund's indicative list of antimalarials meeting the Global Fund's quality assurance

policy prior to baseline or endline data collection (see

http://www.theglobalfund.org/en/procurement/quality/pharmaceutical/#General), or which

previously had C-status in an earlier Global Fund quality assurance policy and was used in a

program supplying subsidized ACTs.

At baseline, QAACTs were defined as any ACT that appeared on the Global Fund’s

indicative list of antimalarials meeting its quality assurance policy as at June 2010, or which

previously had C-status in an earlier Global Fund quality assurance policy and was used in a

program supplying subsidized ACTs.

At endline, QAACTs were defined as any ACT that appeared on the Global Fund’s

indicative list of antimalarials meeting its quality assurance policy as of September 2011, or

which previously had C-status in an earlier Global Fund quality assurance policy and was

used in a program supplying subsidized ACTs.

Rapid-Diagnostic Test

(RDT) for malaria

A test used to confirm the presence of malaria parasites in a patient‘s bloodstream.

Screened An outlet that was administered the screening questions (S1 to S4) of the outlet survey

questionnaire (see screening criteria).

Screening criteria The set of requirements that must be satisfied before the full questionnaire is administered.

In this survey, an outlet met the screening criteria if (1) it had antimalarials in stock at the

time of the survey visit, or (2) it reported having stocked them in the past three months.

Subdistrict (SD)

The primary sampling unit, or cluster, for the outlet survey. It is an administrative unit that

has a population size of approximately 10,000 to 15,000 inhabitants. These units frequently

are defined by geographical, health or political boundaries.

Treatment/dosing regimen The posology or timing and number of doses of an antimalarial used to treat malaria. This

schedule often varies by patient weight.

http://www.theglobalfund.org/en/procurement/quality/pharmaceutical/#General

xix

Overview of the Independent Evaluation of AMFm

The success of malaria control efforts depends on a high level of coverage in the use of

effective antimalarials such as artemisinin-based combination therapies (ACTs). Although

these antimalarials have been procured in large amounts by countries, evidence suggests that

ACT use still remains far below target levels. In response to this issue, the Affordable

Medicines Facility – malaria (AMFm) hosted by the Global Fund to Fight AIDS,

Tuberculosis and Malaria (Global Fund) was set up. AMFm comprises three key elements: (i)

price reductions through negotiations with ACT manufacturers; (ii) a buyer subsidy through a

‘co-payment’ for ACTs at the top of the global supply chain; and (iii) supporting

interventions to promote appropriate use of ACTs. Examples of these supporting

interventions include training providers and outreach to communities to promote ACT use.

All ACTs subsidized through AMFm bear a green leaf logo on their packaging. The four

main objectives of AMFm are to: (i) increase ACT affordability; (ii) increase ACT

availability; (iii) increase ACT use, including among vulnerable groups; and (iv) “crowd out”

oral artemisinin monotherapies, chloroquine and sulfadoxine-pyrimethamine (SP) by

increasing the market share for ACTs.

The Independent Evaluation of AMFm was designed to assess whether, and to what extent,

AMFm Phase 1 achieves its objectives. The evaluation was carried out in all of the currently

operational Phase 1 pilots (Ghana, Kenya, Madagascar, Niger, Nigeria, Tanzania mainland,

Uganda, and Zanzibar). The evaluation is based on a non-experimental design with a pre- and

post-test intervention assessment in which each participating country is treated independently

as a case study. The evaluation includes two major components: (1) a pre-intervention

(baseline) and post-intervention (endline) study of key outcomes through nationally

representative outlet surveys and use of secondary household survey data; and (2)

documentation of key features of the context at baseline and endline and the AMFm

implementation process in each country. The results of the outlet and household surveys are

compared to the AMFm success benchmarks (see Figure 1), and interpreted using the process

and context data to facilitate interpretation of the changes in outcomes over the

implementation period and to judge whether any observed changes are likely to be due to

AMFm. Availability, price and market share benchmarks focus on quality assured ACTs

(QAACTs) defined as products meeting the Global Fund’s quality assurance criteria. (At the

time this report was written, no endline household survey data were available to measure use

of ACTs to treat fever in young children, but it is expected that household data will be

available for some countries before November 2012.) In addition, two complementary studies

were carried out in selected countries at endline. The remote area study examined the

availability, price and market share of ACTs at the end of the main endline outlet survey in

areas considered remote and those considered non-remote. The AMFm logo study assessed

whether or not the AMFm logo achieved its intended effect with respect to public awareness

and marketing.

xx

A number of key findings can be distilled:

1. Achievement of success benchmarks – Figure 1 provides an overview of the

performance of each pilot against the AMFm success benchmarks. Of the 8 pilots,

success benchmarks were clearly met in 5 pilots for availability, 5 pilots for QAACT

price relative to the most popular antimalarial that is not a QAACT, and 4 pilots for

QAACT market share (all shaded green). It is also possible that benchmarks were met in

one additional pilot for availability and price, and in 3 additional pilots for market share,

although the evidence is not as strong (shaded amber). The success benchmarks related to

artemisinin monotherapy (AMT) price and market share were met in all pilots with

sufficient AMTs in the market to make these benchmarks relevant.

2. AMFm and the private for-profit sector – AMFm has been a “game changer” in the

private for-profit sector for all pilots except Niger and Madagascar, with a dramatic

impact on the antimalarial market, through large increases in QAACT availability,

decreases in QAACT prices, and increases in QAACT market share. These changes were

substantial and achieved in only a few months, demonstrating the power of tapping into

the distributional capacity of the private sector. The changes are very likely to be largely

attributable to AMFm. The private for-profit sector response was similar in rural and

urban areas, in some cases reducing or closing a rural-urban gap in availability and

market share. There was considerable penetration of copaid QAACTs even in remote

areas in Ghana and Kenya, where this was evaluated.

3. AMFm and the public sector – AMFm led to fewer fundamental changes to public

sector antimalarial supply, where QAACT supply continued to be hindered by problems

with procurement and grant requirements, leading to substantial delays in ordering.

Increases in QAACT market share were seen in the public sector in four pilots (Ghana,

Nigeria, Uganda and Zanzibar), although in Nigeria most QAACTs distributed through

the public sector were not copaid. QAACTs were available in less than 80% of all public

facilities at endline in five pilots, and there was generally no change in public sector

QAACT prices as most countries already provided QAACTs for free at baseline (except

Ghana where public sector QAACT prices fell).

4. Limited impact in Madagascar and Niger – The impact of AMFm on the private for-

profit sector was limited in Madagascar and Niger, where orders of copaid ACTs were

very low. Explanations may include (i) the lack of full-scale mass media campaigns; (ii)

the structure of the private for-profit antimalarial sector, which had a much higher

proportion of general stores, and in Niger itinerant vendors, who are not allowed to stock

QAACTs; and (iii) an unfavourable context of political and/or economic instability and

severe weather conditions.

5. Effect of duration of implementation – Longer duration of implementation appears to

be positively correlated with performance, if the combined presence of copaid ACTs and

the operation of a large-scale sustained IEC/BCC campaign is considered a proxy for full

xxi

AMFm implementation. With the exception of Zanzibar, pilots with earlier start dates

achieved more success benchmarks. No large-scale sustained IEC/BCC campaign was in

place by the end of 2011 in Madagascar, Niger or Uganda, and these pilots achieved

fewer benchmarks. However, it is possible that delayed start dates reflect weaker

implementation capacity in general, and therefore one should be cautious in attributing

performance to duration of implementation alone.

6. Prices and markups in the private for-profit sector – The price of copaid QAACTs in

the private for-profit sector at endline was very variable across pilots, ranging from USD

0.51 in Madagascar to USD 1.96 in Uganda. Reasons for this variability are unclear but

may include (i) variations in the recommended re

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