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#1Zinc/ORS Scale-up in Nigeria CHAI Diarrhea & Pneumonia Working Group June 20, New York CLINTON HEALTH ACCESS INITIATIVE#2Under-five mortality is highest in the North Sokoto NGA: USMR by State Quantiles Under-five mortality (deaths per 1,000 live births) Katsina Zamfara Jigawa Yobe 51 to 105 (obs 7 Kebbi Kano Borno 109 to 123 (obs-71 127 to 152 (obs-71 Bauchi Kaduna Gombe Niger 159 to 182 (obs-7) 197 to 258 (obs 9 Adamawa Kwara Plateau Abuja Nassarawa Oye Taraba Osun Ekill Kogi Benue Ogun Ondo Lagos Eda Anambra Enugu beta Ebony Cross River Imo Rivers Bayelsa o Abia Akwa bom The majority of child deaths are concentrated in the far northern states. To make progress on child mortality in Nigeria, programs must focus on these states. Source: CHAI morbidity analysis based on NDHS 2008 diarrhea prevalence rates. 2#3Diarrhea morbidity affects the North disproportionately Sokoto Yobe Katsina Jigawa Borno Zamfara Kano Kebbi Kwara Bauchi Gombe Kaduna a Niger a Plateau Abuja Nassarawa Oyo Ekiti Kogi Benue Osun Ogun Lagos Ondo Edo Enugu Anambra Delta Cross River Abia Imo Bayelsa Akwoom 12 Ones Spot Image 2012 TerraMetocs US Navy Taraba Source: CHAI morbidity analysis based on NDHS 2008 diarrhea prevalence rates. Estimated % of national diarrhea morbidity burden, by state 0.4-0.9 1.0 1.3 1.4-2.7 2.8-4.8 5.0-10.1 Adamawa Over ten percent of all child deaths in Nigeria are caused by diarrhea-representing nearly 100,000 children every year. ~80% of the burden of diarrhea is found in the North 3#4Pneumonia morbidity affects the North disproportionately Sokoto Estimated % of national pneumonia morbidity burden, by state Katsina Zamfara 回 Jigawa Yobe 13% to.66% Borno Kebbi Kano 0.68% to 1.28% Kwara □ Niger ם Bauchi Gombe Kaduna Abuja Plateau D Nassarawa 1.38% to 1.76% 1.89% to 2.58% Adamawa 3.15% to 16.60% Taraba Benue Oyo Ekiti Osun D Kogi D Ogun Ondo Edo Lagos Anambra Delta Imo Rivers Abia Akwa Ibom Bayelsa o Enugu Ebonyl Cross River 2013 Coes/Spot Imana Over 17 percent of all child deaths in Nigeria are caused by diarrhea-representing over 140,000 children every year. Nearly 75% of the burden of pneumonia is found in the North Source: CHAI morbidity analysis based on NDHS 2008 diarrhea prevalence rates. 4#5Access to treatment and treatment seeking behavior varies across regions 28% 27% 24% 39% 41% 46% 3% 4% 9% 2% 5% 26% 15% 41% 4% 8% 44% 41% 10% 19% 5% 9% Public sector 6% 12% 28% 29% 25% 18% 18% 16% North North North South South West Central East South West South East • In the North: • ~30-40% do not leave their home to seek care No treatment sought Traditional/other Pharmacy/drug shop Private clinic • . • • • ~30% goes to the public sector ~30%-40% to the private sector In the South: • • ~25-50% do not leave their home to seek care ~15-25% goes to the public sector ~27%-56% to the private sector BUT: Over 30% of children treated at home receive some allopathic treatment Appropriate treatment is more likely in the public sector There is still a major opportunity for scale-up in private sector channels. Hence, the private sector remains a critical channel, particularly for our target population: low-income families in rural areas. No treatment 9% 18% 25% Other (no ORS) 40% 62% 48% 54% ORS 51% 28% 34% 21% 9% 20% 7% 27% 17% Public facility Private Private drug Home facility clinic dispenser (PPMV, treatment Shop) Source: Nigeria DHS 2008, CHAI secondary analysis | 5#6As of mid-2013, a foundation for implementation has been laid. National scale-up plan endorsed • The National Essential Medicines Scale-Up Plan was endorsed by the Government of Nigeria in early 2012 and is a key pillar of the Government's SOML. OTC status secured for zinc • NAFDAC categorized zinc and ORS as OTC drugs for sale in mid- 2012. Amoxicillin as 1st-line treatment Favorable policy change for amoxicillin Coordination mechanism established . · Amoxicillin has been recommended as 1st-line treatment and cotrimoxazole as 2nd -line for iCCM and IMCI. To support the change, the national treatment guidelines will need to be updated to reflect these The Bill and Melinda Gates Foundation and USAID have committed funding for case management studies for pneumonia. PCN waivers are being sought for these programs NPHCDA and FMOH established a Coordinating Mechanism Committee. Partners include: CHAI (secretariat), MI, NAFDAC, PATHS2, PCN, PMG MAN, SFH, SHOPS, SURE-P, USAID, WBF Africa, NMCP, UNICEF and UNH4. The committee currently meets on a monthly basis. | 6#7Total funding need for Diarrhea and Pneumonia Scale-Up, 2012 - 2015 USD17 M USD47.5 M USD26 M Commitment Under Negotiation Tentative Gap •Total estimated funding need: ~USD90.5 mln (updated figure) •Committed funding from: •NORAD •MI ⚫USAID •Private Sector •SURE-P •Funding under consideration from: •CIDA •BMGF ⚫DFID 7#8Progress through Q2 2013 1. Partner coordination & resource mobilization • Secured commitments toward zinc/ORS scale-up from 15 organizations and counting. NORAD: USD 9M grant to CHAI to start implementation in three states: Kano, Lagos, and Rivers. Finalizing second USD14M grant to expand program implementation to 5 additional states (tentative selection: Kaduna, Katsina, Niger, Bauchi, Cross-Rivers). At least one additional major investment is being planned for 2014. Joint workplan/activity mapping document and M&E Framework development initiated 2. Provider & consumer demand generation • Completed Market Activation Plan for producing a national marketing campaign. Completed qualitative research on consumer and provider studies RFP issued for activation and creative demand generation messaging PCN finalized and began implementing childhood illness management in CME for PPMVS, CPs 3. Supplier engagement • Fidson, Emzor, Tyonex and CHI-four major pharmaceutical suppliers-have registered zinc/ORS products CHI launched zinc/ORS in Q1; Olpharm launched zinc in Q2; Emzor, Fidson to launch Q3 Engaged pharmaceutical companies on cost-reduction opportunities and co-packaging designs 4. Regulatory environment NAFDAC confirmed zinc and ORS as OTC products; PCN added zinc to list of PPMV-approved medications. NAFDAC appointed a focal person to oversee the progress of zinc and ORS registration dossiers. | 8#9In order to scale up zinc/ORS, several barriers need to be overcome Affordable Supply Distribution Provider demand Caregiver demand Retail prices of the zinc/ORS products are high, due to high ex-factory prices and highly fragmented distribution chain that accumulate high, variable mark- ups. Most products are therefore more expensive in rural markets than urban. Very few pharmaceutical products reach rural markets because distribution systems are fragmented and inefficient, promotional activities in rural markets cost more money and reach fewer people, and rural markets are perceived to have lower consumer spending profiles. Public sector: Public health centers struggle to provide quality health services, due to limited availability of stock and training. Private sector: Private drug sellers typically untrained, leading to inconsistent and poor treatment of diarrheal diseases. Consumers' preferences play a strong role in product selection when attending PPMVs, often leading to inappropriate treatment. Diarrhea perceived as normal for young children in Nigeria. Caregivers cite teething as a major cause of diarrhea. Alternative treatment regimens are often preferred, and treatment itself is frequently unaffordable. Scale Due to anemic demand, suppliers have limited incentive to invest in distribution and promotion of zinc and ORS, resulting in reduced competition, poor product access and high consumer prices. | 9#10Nigeria's zn/ORS supply landscape has improved dramatically since 2012 Supplier engagement efforts are bearing fruit: • By mid-2012, there was only one Nigerian manufacturer of L-ORS, and no local manufacturers of dispersible zinc tables suitable for pediatric use. • As of Q2 2013, after intensive engagement by CHAI through quarterly zinc/ORS supplier forums, both zinc and L-ORS products are now available in Nigeria. NAFDAC and PCN have secured an improved regulatory environment: • NAFDAC has confirmed zinc & ORS as OTC products; PCN has added zinc to the list of PPMV-approved medications NAFDAC has appointed a focal person to oversee the progress of zinc and ORS registration dossiers. ORS Products Supplier Brand name CHI Emzor Fidson Tyonex Olpharm Archy Sam-Ace Olpharm CHI ORS Emzorlyte TBC Orasure N/A TBC ORS Product Yes Yes Yes Yes Awaiting N/A Awaiting Registered approval approval Zinc Products Brand Paediatric TBC Motitec Zinc Baby Zinc TBC N/A name Zinc Sulphate Sulphate Product Awaiting Awaiting Yes Yes Yes Yes N/A Registered approval approval 10 10#11The national coordinating mechanism ensures that partner activities are in line with the national plan, and are rolled out to be complementary North-Central North-East North-West State Abuja Benue Kogi Kwara Nas'rawa Niger Plateau Adamawa Bauchi Borno Gombe Taraba Yobe Jigawa BtL DtP-PPMV Training SFH SHOPS,SFH SHOPS (CHAI) (CHAI) Kaduna Kano SFH, (CHAI) SFH, CHAI Katsina Kebbi Sokoto Zamfara BtL DtP-PPMV Detailing SFH SHOPS, SFH SHOPS (CHAI) (CHAI) BtL DtP- Pharmacists SHOPS, SFH SHOPS (CHAI) (CHAI) BtL DtC P2 (CHAI) (CHAI) P2 AtL-Radio SFH WBF WBF (CHAI) (CHAI) (CHAI) SFH, P2 SFH SFH, (CHAI) SFH, CHAI CHAI SFH SFH, (CHAI) SFH (CHAI) SFH SFH SFH SFH SFH SFH, CHAI, P2 SFH, (CHAI) SFH SFH SFH SFH, WBF SFH SFH SFH SFH AtL-TV SFH WBF WBF CHAI, WBF AtL-SMS AtL-Print WBF WBF WBF Public Facility Supply P2 MI, WINNN P2, MI, WINNN P2 P2 MI, WINNN WINNN MI, WINNN Private Facility Supply (CHAI) (CHAI) (CHAI) CHAI (CHAI) State Procurement P2 MI, WINNN P2, MI, WINNN P2 P2 MI, WINNN WINNN MI, WINNN Community Distribution SFH SFH MI, MI SFH SFH, MI SFH SFH SFH, MI Public Facility Training P2 (CHAI) State Coordination (CHAI) (CHAI) (CHAI) MI, WINNN P2, MI, WINNN P2 (CHAI) P2 MI, WINNN WINNN MI, WINNN (CHAI) CHAI (CHAI) Diarrhea Burden-Zone Leaders 1.02% 1.87% 0.46% 0.62% 1.50% 3.30% 2.53% 2.83% 10.08% 2.79% 3.97% 1.61% 4.54% 3.56% 6.58% 7.40% 10.05% 4.81% 4.99% 6.66% Key (CHAI) Org is negotiating funding for this activitity. SHOPS Org is funded for this activity No org identified for this activity. Scale is simply too large for one partner to fill. The national coordinating mechanism is mapping partner efforts to ensure that the high burden areas are covered and efforts are complementary - if a partner is primarily focused on demand generation in a particular area, the coordinating mechanism helps to ensure that another partner is securing supply in the same area. | 11#12CHAI has secured funding from one donor to support scale-up over the next 3 years in select states - with another potential donor onboard Objective: To increase usage of ORS/zinc from <1% to 50% in Nigeria by end of 2015 Geographic focus: Kano, Lagos, and Rivers (Phase 1) Bauchi, Cross River, Kaduna, Katsina, Nassarawa, and Niger (Phase 2) Duration: February 2013 - Dec 2015 Lagos These 8 states represent 51% of the national diarrhea burden Katsina Kano Kaduna Bauchi Niger Nassarawa Cross Rivers River Key Program Components: 1) Generate demand: Target consumers/providers based on analysis of most effective messages and communication channels; developing creative solutions to reach beyond traditional urban markets 2) Catalyze political will: Mobilize and harmonize investments from governments and partners toward state-wide scale up goals 3) Ensure supply of zinc/ORS: Ensure wide-spread availability of affordable, high-quality products in public and private sector 12#13At the national level, Nigeria will institutionalize zn/ORS for diarrhea treatment Nigeria will solidify gains and expand progress on supply, availability, and provision. Creating a durable framework for scale-up that can be leveraged by states. Supply Availability Provision • Forecasts help suppliers plan production cycles; ● Identify and act on cost reduction opportunities (COGS, Distribution, Regulation); • Product innovation research and support improves cost and demand. • Work with MoH, NPHCDA to solidify progress on federal procurement and supply through SURE-P, MSS, and MNCHWS; · Lobby Faith-Based health networks (i.e. CHAN, ECWA) to stock ORS and Zinc. Lobby health insurance networks (i.e. NHIS, Hygeia) to cover ORS and Zinc. • Develop national curricula and job aides for retailers (i.e. PPMVS, CPs) and CHEWS; • Integrate diarrhea management curricula into PCN CER for PPMVS, NAPPMED seminars, and ACPN CER for CPs; • Integrate diarrhea management curricula into pre-service training for CHEWS. | 13#14State strategies will pursue increased public-sector supply and state- coordination Partners will work with State governments to advocate for and support public-sector supply. Partners will support state governments to coordinate scale-up and introduce supportive policy. Policy and regulatory changes (e.g. EML) Tendering and Procurement (e.g. links to suppliers) State-driven Public- Sector Supply Activity Coordination (i.e. Mapping, M&E) Forecasting and planning support | 14#15Demand generation strategies will employ influencer marketing through a combination of high-impact channels Various groups can be used to enhance the effectiveness and extend the reach of messaging. State strategies will identify and engage the most influential opinion leaders. •Sales reps encourage stocking and distribute point-of- sale materials. •Professional associations (e.g. NAPPMED) endorse zn/ORS and promote appropriate care to members. •Regulators train providers on diarrhea management through continuing education requirements. •Consumers influence stocking behavior through requests for zn/ORS. Religious Leaders Community Groups Professional Associations Regulators Sales Reps Consumers Providers Trade/Labor Associations Providers Caregivers •Trade (e.g. NURTW) associations engaged to reach their members, as well as visibly promote zn/ORS. •Religious leaders deliver messaging through sermons and congregation activities. •Community groups promote appropriate care at the grassroots through their members. •Providers influence caregiver treatment choices at routine services like ANCs and Immunization clinics. | 15#16CHAI aims to shift the fragmented, high-markup distribution landscape toward a more efficient system to directly serve rural retailers Using a disseminated sales force targeting retailers in peri-urban and rural areas. Factory or Port Supplier In Major Urban Hubs 10% Distributor In Large Urban/Peri- Urban Towns In Peri-Urban Towns Factory or Port to Major Supplier Urban Hubs In Large Urban/Peri- Urban Towns Sales Reps 15% Wholesaler In Small Towns and Villages Large Pharmacy Small Retailer Large Pharmacy 30% In Small Towns and Villages Small Retailer 30% Sales reps based in LGA headquarters detail retailers directly, connecting them to supplier distribution chains and cutting out marginal costs in the supply chain. | 16#17Priorities for Q3 1. Partner coordination and resource mobilization • • State-level mapping and advocacy to help secure inclusion of zinc/ORS on state essential medicines lists and increased awareness of OTC status. Joint workplan/Activity mapping document • Joint M&E Framework 2. Provider and consumer demand generation • Launch marketing campaign in urban Lagos, Kano and Rivers • Baseline survey for zinc/ORS scale-up 3. Supplier engagement • • Help suppliers drive down costs by identifying cost-saving opportunities Formalize packaging formats and design 4. Regulatory environment • Work with NAFDAC to clarify position on WHO-approved ORS formulation • • Continue to monitor registration approvals for zinc and ORS | 17#18Key lessons learned: planning and implementation . • Developing a supply base takes a really long time and has a high attrition rate. Start early and with many suppliers. Also, when in doubt, play them against each other. No one works at workshops. Most progress is made through one-on-one negotiations with partners and stakeholders. Generating interest and momentum is the easy part. Moving forward on implementation requires detailed planning, sustained leadership, and an excess of communication and coordination. Start coordinating early. Not having a full picture of who's doing what, where from the beginning can lead to early overlaps. 18#19Annex | 19#20Diarrhea morbidity affects the North disproportionately Northern Nigeria accounts for over 80% of the country's diarrhea burden. The Northwest zone alone accounts for 44% of child diarrhea cases - Over 32 mln cases annually. South South 5% South West North% South East 6% Central Est. Yearly U5 Diarrhea Cases per Zone, millions 11% 35 30 25 North East 20 26% 32 15 10 19 5 North 8 4 4 6 West 44% 0 North North Central East North West South South East South West South Source: CHAI morbidity analysis based on NDHS 2008 diarrhea prevalence rates. 20 20#21PLACEHOLDER: build out synthesis on how we're thinking about consumer demand Where are Public facility Private clinic mothers going? PPMV/ Pharmacy Home / shop/ traditional h. Share 23% 9% 31% 34% Current ORS use 51% 34% 21% 9% Current AB/AM ~50-70% ~50-60% ~40-55% ~15-20% use Provider CHEW Nurse characteristics Nurse Doctor Skilled retailer Unskilled retailer Doctor Provider KOLs, Medical KOLs, Medical Medical Reps, Canvassers, Influencers Reps, Canvassers Reps Canvassers, Customer Skilled HCPs Demand Level of provider High High Moderate Low influence Other Influencer Channels Facility based services (ANC, immunization) MNCHWs Community networks Limited facility based services Community networks MNCHWs (?) 21#22Initial state selection will be based on disease burden, early market potential, ease of penetration, and existing partnerships State-level implementation will begin in Lagos, Kano, and Rivers. These three states represent ~10% of Nigeria's diarrhea burden and are geographically representative. % of National % of National % of National Zone State Katsina Population Burden Zone 5,801,584 8.83% Kano 9,113,605 6.50% State Rivers C/River Population Burden Zone State 5,198,716 1.39% Lagos Population Burden 9,113,605 2.39% 2,882,988 1.23% Osun 3,416,959 1.12% Zamfara 3,278,873 5.85% Akwa Ibom 3,902,051 0.80% Ondo 3,460,877 1.11% North-West Kaduna 6,113,503 5.78% South-East Delta 4,112,445 0.65% South-West Ogun 3,751,140 0.95% Sokoto 3,702,676 4.38% Edo 3,233,366 0.65% Oyo 5,580,894 0.79% Kebbi 3,256,541 4.22% Bayelsa 1,704,515 0.42% Ekiti 2,398,357 0.34% Jigawa 4,361,002 3.13% Why Start here? •High burden relative other states in their regions; •Multiple partners already on ground, providing opportunities for early collaboration; •Major commercial centers where suppliers have existing distribution infrastructure; •Existing CHAI presence and relationships, decreasing start-up time; •Representative of major Nigerian geopolitical regions. Source: CHAI morbidity analysis based on NDHS 2008 diarrhea prevalence rates. 22 22#23Subsequent state selection will be driven by disease burden and penetration potential Additional focus states will be added as funding becomes available. CHAI anticipates two additional "waves" of states, with full implementation covering 12-15 states. Zone State Total Pop % Nat'l Burden Zone State Total Pop % Nat'l Burden Zone State Total Pop % Nat'l Burden Abuja Benue Kogi 1,557,883 1.02% 4,677,684 1.87% 3,634,710 0.46% North-East North-Central Kwara 2,628,719 0.62% Adamawa 3,512,330 2.83% Bauchi 5,184,585 10.08% Borno 4,602,239 2.79% Gombe Jigawa 4,821,150 3.56% 2,609,639 3.97% Kaduna Kano North-West Katsina 6,725,722 10,403,262 6,421,968 10.05% 6.58% 7.40% Nassarawa 2,065,728 1.50% Taraba 2,550,722 1.61% Kebbi 3,590,520 4.81% Niger 4,379,462 3.30% Yobe 2,573,843 4.54% Plateau 3,524,094 2.53% Sokoto Zamfara 4,098,695 4.99% 3,614,043 6.66% % Nat'l Zone State Total Pop Zone State Total Pop Burden Akwa Ibom 4,346,157 0.91% Abia Bayelsa 1,888,436 0.48% Anambra C/River 3,202,865 1.40% South-East Ebonyi South-South Delta 4,543,700 0.74% Enugu Edo 3,568,019 0.74% Imo % Nat'l Burden 3,141,926 1.04% 4,636,429 1.15% 2,409,662 1.15% 3,611,218 1.07% 4,362,444 0.92% % Nat'l Zone State Total Pop Burden Ekiti 2,643,268 0.39% Lagos 9,992,896 2.72% Ogun 4,133,173 1.08% South-West Ondo 3,814,907 1.27% Osun 3,795,518 1.28% Rivers 5,748,818 1.58% Oyo 6,199,141 0.90% Wave 1 Wave 2 Wave 3 Source: CHAI morbidity analysis based on NDHS 2008 diarrhea prevalence rates. 23 3

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