Next Generation Long-lasting Insecticidal Nets (LLIN)

Transcription

1 Next Generation Long-lasting Insecticidal Nets (LLIN) August 27, 2018

2 Pyrethroid net market has grown 5x in past decade and prices have declined enabling significant scale-up of distributions LLIN Pricing and Volumes USD, Millions $5.0 $4.5 $4.0 $3.5 $3.0 $2.5 $2.0 $1.5 $1.0 $0.5 $ Discussion Volumes have historically ranged between M units annually Significant yearto-year variance due to countrylevel campaign cycles Global LLIN Volumes UNICEF Avg. Price, 180x160x150cm Source: The Alliance for Malaria Prevention, The AMP Net Mapping Project, 2017; UNICEF, Price Transparency Report, updated January 2018; UNITAID, Malaria Vector Control Commodities Landscape, 2 nd ed., December

3 The countries that have distributed the most LLINs have all reported significant pyrethroid resistance Pyrethroid Resistance in Anopheline Vectors Susceptibility Possible resistance Confirmed resistance LLIN Distribution top 15 countries Aggregate data 2 Country LLINs Distributed Nigeria 139,861,828 DRC 87,674,362 Uganda 55,311,082 Ethiopia 55,132,255 Tanzania 41,790,752 India 40,311,569 Kenya 39,192,092 Côte d'ivoire 35,560,270 Mozambique 34,309,373 Ghana 30,624,086 Burkina Faso 26,293,011 Zambia 23,971,924 Madagascar 22,980,032 Sudan 20,814,867 Angola 19,183,422 TOTAL 673,010,925 Sources: 1 - IR Mapper: (August 2018); 2 - The Alliance for Malaria Prevention: The AMP Net Mapping Project (2017) 3

4 Mechanism Over the next 5-10 years we expect that a significant percentage of the LLIN market will shift to products that address pyrethroid resistance PBO Nets Dual AI Pyrethroid Nets Dual AI Non- Pyrethroid Nets Pyrethroid + PBO Pyrethroid + 2 nd AI 2 nd AI + 3 nd AI Addition of synergist piperonyl butoxide ( PBO ) restores mortality of pyrethroid AIs on vectors with moderateintensity, monooxygenasebased resistance Addition of second AI to kill or sterilize pyrethroid-resistant mosquitoes, and slow the development of resistance in non-resistant settings Nets treated with two nonpyrethroid AIs to target most resistant populations and slow the development of future resistance Recent Evidence 1 Olyset Plus RCT demonstrated significant reduction in malaria transmission compared to standard Olyset net in Tanzania Laboratory data from >28 trials demonstrated that PBO LLINs can kill most pyrethroid-resistant mosquito strains compared to standard nets, except in those with very high resistance and with mechanisms unaffected by PBO* Olyset Duo RCT demonstrated a 12% reduction in malaria compared to standard pyrethroid nets in a holoendemic part of Burkina Faso Interceptor G2 demonstrated increased vector mortality amongst pyrethroid-resistant mosquito strains compared to standard nets 2 Products are currently in development. Not yet available Note (1) Summarizes key recent evidence it is non comprehensive Note (2) Additional epidemiological evidence is required for product to be recommended for use in resistant settings compared to a standard net Source: *MPAC, Recommendations on the use of LLINs treated with a pyrethroid and a synergist: An update, March

5 As new nets enter the market, producers face uncertainty on demand for new versus existing products Challenges for Suppliers The timeline for meeting regulatory requirements can be uncertain so procurers are not sure what products will be available and when Low levels of initial demand and lack of predictability as countries await guidance on new products Low capacity utilization and uncertain order cycles leads to higher prices Large number of product presentations (e.g. net sizes) Relatively high logistics and shipping costs Greater predictability of the volume and timing of orders for newer products could lead to lower production costs 5

6 Transitioning to next-generation nets requires intervention across multiple fronts, with a VG the topic of today s discussion Influences on Vector Control Procurement Selected 1 Projects Under Way to Support Transition The WHO recommends universal coverage Donors continue to have significant budget constraints Price is a key determinant of whether new nets can be procured Limited data regarding epidemiological efficacy and cost effectiveness for nextgeneration nets to satisfy WHO policy requirements Volume guarantees consideration by Bill & Melinda Gates Foundation and MedAccess to lower prices Focus of this presentation Unitaid, Global Fund, and IVCC efforts to develop robust trial data using nextgeneration nets and implement large-scale pilot launches. WHO guidance and donor purchasing policies are changing rapidly Registration status of various nets remain unclear Note (1) non-comprehensive Innovation to Impact ( I2I ) initiative 6

7 A volume guarantee could address structural challenges in the next generation LLIN market in order to accelerate scale-up Stable Low-Cost Supply Increased product uptake generates economies of scale and reduces COGS Multi-year visibility into demand expectations and reduces risk premium Guaranteed procurement facilitates investments in CapEx, capacity, and longterm supply of inputs Increased Demand Reduced pricing allows for increased uptake and coverage Transparency and consistency in pricing across LMICs allows procurers to better forecast demand & plan scale-up work Guarantee monitoring requires increased order visibility, supporting broader efforts to coordinate supply planning & forecasting Reduced incidence of malaria through accelerated scale-up and use of new, best in class LLINs in moderately to severely pyrethroid-resistant settings 7

8 How they work: volume guarantees are contractual backstop agreements with price and volume commitments Contract Structure Procurement Monitoring Guarantors (Gates Foundation & MedAccess) provide fixed annual volume commitments to suppliers for a defined period of time typically 3-5 years Suppliers commit to i) respond to tender opportunities and bid no more than an agreed-upon (FOB) maximum price during the term of the agreement; ii) make an agreed upon minimum volume of capacity available for each year of the guarantee; and iii) conduct supporting regulatory and other activities The maximum price will apply to defined buyers and countries, with all such sales counting towards satisfaction of the guarantee If sales are less than the agreed upon annual target, the Guarantors will either purchase the shortfall volume or make a payment to reflect the shortfall, per the terms of the contract Guarantees may be offered to one or more suppliers, with different terms for each agreement Procurement groups such as PMI, GF, UNICEF, NMCPs buy product under normal tender procedures (i.e. call for bids, make selection, sign contracts and send purchase orders to order) Suppliers track qualifying product sales under the agreement and provide quarterly reports to partners on shipments, orders, and inquiries 8

9 The Gates Foundation and MedAccess will consider supporting products based on public health and financial risk analyses Products to be considered for a potential volume guarantee must be either PBO or Dual-AI LLINs. Pyrethroid-only nets will not be considered Nets must be eligible for procurement by the Global Fund and PMI to be considered Products must have WHO-reviewed and acknowledged entomologic evidence against resistant mosquito populations: Evidence against pyrethroid-susceptible populations will not be considered. Randomized control trials ( RCTs ) with a disease-based primary outcome are not required to satisfy this provision. If WHO is not able to review data in a timely matter, the foundation may consider requesting an independent review by a third party to satisfy this provision 9