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Final Report

September 28, 2012

1

Independent Evaluation of Phase 1 of the A ffordable M edicines Facility - malaria (A M Fm)

Multi-Country Independent Evaluation Report:

Final Report

September 28, 2012

AMFm Independent Evaluation Team

I C F International:

London School of Hygiene and T ropical 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: F inal 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 prel iminary 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.

i

Data Contributors (Institutions in alphabetical order):

Data Contributors for Outlet Surveys

African Population and H ealth Research C entre, K enya Marilyn Wamukoya Yohannes Kinfu Blessing Mberu Centre de Recherche pour le Dveloppement Humain (C RD H) / International d'E tudes et de Recherches sur les Populations A fricaines (C I E RPA), Niger Salif Ndiaye Idrissa Alichina Kourgueni Moctar Seydou Oumarou Malam Drugs for Neglected Diseases initiative (DNDi)/Research and Development Unit, Komfo Anokye Teaching Hospital (K A T H), Ghana Graciela Diap John Amuasi Samuel Blay Nguah Ohene Buabeng Ifakara H ealth Institute (I H I) - I M PA C T 2 Project, Tanzania Rebecca Thomson

Johanes Boniface Admirabilis Kalolella Charles Festo Mark Taylor Katia Bruxvoort

Population Service International (PSI) - A C Twatch Project, K enya, Madagascar , Niger ia, Uganda, Zanzibar

Tanya Shewchuk !"#$%&'()**$++ Hellen Gatakaa Stephen Poyer Julius Njogu Mitsuru Toda Illah Evance

James Kajuna

Baraka Kaaya

Jacky Raharinijatovo

Ekundayo Arogundade

Peter Buyungo

Edna Adhiambo Ogada

ii

Data Contributors for Remote Area Surveys

African Population and H ealth Reseach C entre (APH R C) Catherine Kyobutungi Blessing Nberu Marylin Wamukoya Fredrick Wekesa

Komfo Anokye Teaching Hospital (K A T H) 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: T NS R MS Ghana Adewake Obaseki Agyakwa Ayisi Addo

Marilyn Oduro-Ntiamoah

K enya: A frican Institute for H ealth and Development (A I H D)

Mary Amuyunzu-Nyamongo Monica Wabuke

Madagascar : Institut National des Statistiques de M adagascar (INST A T)

Victor Rabeza Rafaralahy Heretiana Randriandrasana

Niger ia: T NS R MS Niger ia L imited 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

iii

Table of contents T A B L E O F C O N T E N TS .................................................................................................................................. I I I

L IST O F T A B L ES ............................................................................................................................................ V I I

L IST O F F I G UR ES .......................................................................................................................................... X I I

L IST O F A BBR E V I A T I O NS ......................................................................................................................... X I V

D E F IN I T I O N O F K E Y T E R MS ................................................................................................................. X V I I I

O V E R V I E W O F T H E IND EPE ND E N T E V A L U A T I O N O F A M F M ....................................................... X I X

E X E C U T I V E SU M M A R Y .......................................................................................................................... X X I V

1 B A C K G R O UND A ND M E T H O DS .......................................................................................................... 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 !"#$%"&'()*+,&-#,./)0&%)*&1%)%0232).&.52&61'3 ................................................................. 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 7 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 E thical approval ........................................................................................................................... 67 1.6.9 Discussion of strengths and limitations of the Independent Evaluation ....................................... 67

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

2 R ESU L TS F R O M O U T L E T SUR V E YS ................................................................................................ 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 R ESU L TS F R O M H O USE H O L D SUR V E YS ..................................................................................... 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 I M PL E M E N T A T I O N PR O C ESS A ND C O N T E X T - F INDIN GS F R O M T H E C O UN T R Y C ASE ST UDI ES ........................................................................................................................................................... 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

v

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 R ESU L TS F R O M T H E R E M O T E A R E A ST UD Y ............................................................................. 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 R ESU L TS F R O M T H E L O G O ST UD Y (E X I T IN T E R V I E WS A ND F O C US G R O UP DISC USSI O NS) ................................................................................................................................................ 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 SU M M A R Y O F K E Y F INDIN GS F R O M R E L E V A N T OPE R A T I O N A L R ESE A R C H ............... 337

8 SU C C ESS M E T RI CS A ND IN T E RPR E T A T I O N .............................................................................. 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

vi

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 C O N C L USI O N ........................................................................................................................................ 392

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

10 R E F E R E N C ES ........................................................................................................................................ 396

11 A C K N O W L E D G E M E N TS .................................................................................................................... 403

12 APPE NDI C ES ......................................................................................................................................... 404

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L ist 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

-".+$%/0/0123%4$56$*#"7$%)8%#9$%:):;+"#

viii

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

ix

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

-".+$%E0/0E3%4$56$*#"7$%)8%#9$%:):;+"#

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

L ist 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

L ist 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 Mdicales 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 Dveloppement Humain CRS Catholic Relief Services

CSI Centre de Sant Intgr DAMM 8/92:./#)&*+602):2&*2&12*/:%32).&*2&1%*%0%,:%9

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

G9H 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 ;%$#9%.#/92&

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 45$?

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 K$6;5

xviii

Definition of key terms K ey 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

I"+"5

xix

Overview of the Independent Evaluation of A M Fm

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

R6)-:"DF$*#'% 8)5% P(-?% "#% #9$% #):% )8% #9$% 7+)."+% ?;::+D% 69"

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. A M Fm and the private for-profit sector , PIQF%9"?%.$$*%"%>7"F$%69"*7$5A%

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 retail price and its promotion through

national IEC/BCC campaigns; (ii) guidelines on markups (in Madagascar); (iii)

differences in cost structure including tax components; and (iv) time since copaid ACTs

first arrived in each country. The median retail gross markup on copaid QAACTs was

less than 70% in all pilots (which can be considered reasonable for the retail sector),

except Uganda (133%) and Zanzibar (100%).

7. C rowding out oral artemisinin monotherapy , Even at baseline, market share for oral AMT was less than 4% in Ghana and less than 1% in Kenya, Madagascar, Niger,

Tanzania Mainland and Uganda. In Nigeria and Zanzibar where oral AMT market share

was somewhat higher at baseline, large and significant falls were observed, likely

reflecting a combination of the AMFm subsidy and complementary regulatory measures

with particularly strong enforcement of the latter in Zanzibar.

8. Availability of non-artemisinin therapies , Availability of non-artemisinin therapies such as chloroquine and sulphadoxine-pyrimethamine fell in some countries, but

remained very high in most countries. However, most of the increase in QAACT market

share was at the expense of the market share of non-artemisinin therapies.

9. Market structure , The private sector was a major player in the antimalarial market in all pilots, accounting for between 40% and 97% of antimalarial sales volumes at baseline,

and between 49% and 92% at endline. There was no clear pattern across pilots in the

change in private for-profit market share between baseline and endline.

10. Availability of malaria diagnosis , Diagnostic availability (rapid diagnostic tests or microscopy) varied substantially in the public sector, from 29% in Nigeria to 98% in

Zanzibar at endline. However, in private for-profit outlets, only three pilots had

substantial availability at endline (Kenya - 14%, Uganda , 21%, Zanzibar - 32%). In this

sector, health facilities/pharmacies have higher availability of diagnostics than drug and

general stores.

11. Results of operational research , Results from studies of interventions to enhance the implementation of antimalarial subsidies by improving targeting and/or drug use show

that implementation of such interventions is feasible on a small scale, but more evidence

xxii

on effectiveness and cost-effectiveness of large-scale programs is needed to inform

policy.

12. Issues not covered by the Independent Evaluation , A number of important issues related to AMFm policy decisions were beyond the scope of the Independent Evaluation,

including the impact on targeting copaid ACTs to persons with parasitemia; advice

provided to patients; adherence to dosing regimens; global artemisinin supply; and

prevalence of counterfeit products.

13. Possible hindering factors for A M Fm in some countries include: ! Delays in the public sector procurement process for copaid ACTs

! Issues with Global Fund grants and delays in procurement of supporting interventions,

meaning that implementation of most interventions lagged behind the arrival of

copaid ACTs by several months

! Suspension of Global Fund disbursements or grants interrupting implementation of

supporting interventions

! Application of Global Fund demand levers to ration orders

! Political and/or economic instability

! An antimalarial provider market dominated by highly informal outlets operating

outside of regulated distribution channels (in Madagascar and Niger)

14. Possible facilitating factors for A M Fm in some countries include: ! Strong AMFm governance structures (including steering committees), involvement of

the private sector and technical assistance from the Clinton Health Access Initiative

! Generally smooth operation of the registration process for first-line buyers and

ordering through the copayment mechanism

! Strong, large-scale mass media campaigns, including promotion of the AMFm logo

! Longer duration of implementation

! Establishment and promotion of a recommended retail price set at an appropriate level

! Complementary regulatory changes, such as giving ACTs over-the-counter status, and

implementation of the AMT ban

! AMFm training in some countries (although only Ghana and Zanzibar had over 20%

training coverage)

xxiii

F igure 1: Overview of the achievement of the A M F m 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) 1.1.1

Benchmark Ghana K enya M adagascar Niger Nigeria Tanzania mainland Uganda Zanzibar*

1. 20 percentage point increase in

QAACT availability

52

(p

xxiv

Executive Summary

Overview of the independent evaluation

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

F"*;8"6#;5$5?S%T

xxv

The IE 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

through key informant interviews and document review, 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. These data sources are supplemented by additional

primary data on outlets in remote areas in Ghana and Kenya; and primary data on user views

of the AMFm logo in four pilots (Ghana, Kenya, Madagascar and Nigeria). Operational

research conducted by other groups was also reviewed. The results of the baseline and

endline outlet and household surveys are compared to the AMFm success metrics (see

below). The findings on achievement of success metrics are synthesized with the process and

context data collected for each country and the other studies outlined above to assess the

performance of AMFm in each operational pilot, and to help learn how and why this new

model unfolds in a variety of contexts, while drawing lessons that can help future operations.

Methods for the IE outlet surveys were built on those developed for the ACTwatch project,

and cover outlets across the public, private for-profit and private not-for-profit sectors in rural

and urban areas. Baseline outlet surveys were conducted between April and December 2010

(except Nigeria which was conducted from September to November 2009), and endline outlet

surveys were conducted between October 2011 and January 2012. The midpoint of endline

survey fieldwork was between 6.5 and 15.5 months after the arrival in the country of the first

AMFm copaid drugs.

For the purpose of analysis, antimalarials were split into three categories: non-artemisinin

therapy (nAT) (e.g., SP, amodaquine, and quinine), artemisinin monotherapy (AMT) and

artemisinin-based combination therapy (ACT). AMTs were further classified into oral and

non-oral AMTs, as while non-oral AMT are recommended for treatment of severe malaria,

the removal of oral AMTs from the market is a key policy goal. ACTs were further

?;.@

xxvi

discussion of the household survey results in the interpretation of the success metrics in

Chapter 8, will be prepared if a sufficient quantity of endline data becomes available in the

coming months.

Interpretation and operationalization of success met rics -9$% G+)."+% Q;*@'?% PIQF% P@% Y)6% ()FF

xxvii

as it is a key intervention included in all pilot AMFm proposals). The figure also shows the

timing of the implementation of demand levers, and the dates of the Independent Evaluation

baseline and endline outlet survey data collection. This duration of effective implementation

needs to be taken into account when interpreting country performance against the

benchmarks, together with other elements of implementation process and country context.

F igure 2: T imeline of A M Fm Phase 1 Independent Evaluation data collection; grant amendments and disbursements; ar r ival in-country of copaid Q A A C Ts; launch events; I E C / B C C implementation; and application of demand levers by the G lobal Fund 1.1.1

Apr

May

Jun

Jul

Aug

Sept

Oct

Nov

Dec Jan

Feb

Mar

Apr

May

Jun

Jul

Aug

Sept

Oct

Nov

Dec Jan

Feb

Mar

GhanaX $

+ + + + + + + + + + + + + + + + + + + + + + +

L

K e nyaX $

+ + + + + + + + + + + + + + + + + + ++ + + + + + +

L

M adagas car X $

+ + + + + + + + ++ + +

L

Nige rX $

+ + + + + + + + ++ + + +

L

Nige riaX $

+ + + + + + + + + + + + + + ++ + +

L

Tanzania- mainland X $ $

+ + + + + + + + + + + + + + ++ +

L * L

UgandaX $

+ + + + + + + + + + ++ + + +

L *

Zanzibar X $

++

L

Copaid A C Ts in-country (public s ector)





Application of demand levers by the Global Fund


IEC/B C C implementation

Copaid A C Ts in-country (pr ivate s ector)








Grant amendment and disburs ementCopaid A C Ts in-country (pr ivate s ector)

Copaid A C Ts in-country (pr ivate s ector)



2012

IE outlet survey data collection




Grant amendment and disburs ement



IE outlet survey data collection **



Grant amendment and disburs ement




2010 2011









Notes: = Baseline and endline data collection for Independent Evaluation outlet surveys. = Signing of grant amendment

and Global Fund grant disbursements for implementation of Supporting Interventions. = Copaid QAACTs in-country

(although not necessarily in continuous supply); + = copaid QAACTs delivered, = Implementation of AMFm public

awareness (IEC/BCC) campaign at scale. =Interim AMFm public awareness (IEC/BCC) campaign i.e. Ghana: talk shows

only; Niger: activities not at scale; Nigeria: stop-gap soft launch; Uganda: stop-gap radio. = Application of Global Fund

demand levers. GA= grant amendment; $= disbursement for implementation of SIs; L= launch; L *= >K)8#A%[";*69S%

xxviii

Key findings The key findings begin with a presentation of the aggregate orders for copaid drugs and their

breakdown by country. The results of the baseline and endline outlet surveys and the changes

over time in availability, price and market share indicators across all countries are

subsequently presented. This is followed by presentation of results from household surveys,

the remote areas study, the public awareness/logo study and findings from operational

research. An assessment of the achievement of the AMFm Success Benchmarks is given for

each country individually, which draws on the country case studies of implementation

Documents

0/*./*%!123$#3%&)*!4/0)+%! …healthmarketinnovations.org/sites/default/files/Independent...Charles Festo Mark Taylor ... Marilyn Oduro-Ntiamoah Kenya: African Institute for Health

0/./%!123$#3%&)*!4/0)+%! …healthmarketinnovations.org/sites/default/files/Independent...Charles Festo Mark Taylor ... Marilyn Oduro-Ntiamoah Kenya: African Institute for Health