Consultancy to Develop a Global Demand Forecast for Malaria Rapid Diagnostic Tests, Artemisinin Based Combination Therapies and Artemisinin

1. INTRODUCTION

1.1 Objective of the RFP

The purpose of this Request for Proposals (RFP) is to enter into a contractual agreement with a successful bidder and select a suitable contractor or consortium to assist UNITAID in developing a global demand forecast for malaria RDTs and artemisinin-based combination therapies (ACTs), and calculating the resulting demand for artemisinin raw material, on a quarterly basis.

The desired timeframe for this activity is 36 months from mid-2013.

Bidders are requested to propose the best and most cost-effective solution to meet the requirements, while ensuring a high level of service.

1.2 About UNITAID

UNITAID is a global health initiative, established to provide sustainable, predictable and additional funding to significantly impact on market dynamics to reduce prices and increase the availability and supply of high quality medicines, diagnostics and related commodities for the treatment of HIV/AIDS, malaria and tuberculosis, primarily for populations in low-income and lower-middle income countries. UNITAID provides funding for the procurement of medicines, diagnostics and related commodities on the basis of project proposals approved by the UNITAID Board and works primarily through collaborative actions with strategic partners. UNITAID is supported by public funding and is hosted by the World Health Organization ("WHO"). For the purpose of this document UNITAID is hereinafter referred to as UNITAID or UNITAID/WHO.

UNITAID provides funding support to programmatic partners across three disease areas (HIV, tuberculosis and malaria) to procure medicines and diagnostics with the aim of addressing gaps in the provision of quality medicines, diagnostics and other health commodities through market-based approaches and interventions. Please refer to the UNITAID website ( www.unitaid.eu) for further information.

UNITAID works to improve access to medicines and other health commodities through market interventions in HIV/AIDS, tuberculosis (TB), and malaria markets, and aims to promote innovation, healthy competition, and rapid and diffuse uptake of new, improved health technologies in low-resources settings. The ultimate goal of UNITAID, however, is to improve the public health of people living in low- and middle-income countries.

1.3       About WHO

The World Health Organization was established in 1948 as a specialized agency of the United Nations. The objective of WHO (www.who.int) is the attainment by all peoples of the highest possible level of health. Health, as defined in the WHO Constitution, is a state of complete physical, mental and social well being and not merely the absence of disease or infirmity. WHO's main function is to act as the directing and coordinating authority on international health work.
 

1.4 Definitions, Acronyms and Abbreviations

ACT Artemisinin-based combination therapy
AL Artemether Lumefantrine
API Active Pharmaceutical Ingredient
AS+AQ Artesunate + Amodiaquine
FPP Finished Pharmaceutical Product
MIS Market Intelligence System
PQR Price Quality Reporting
PMI President’s Malaria Initiative
RDT Rapid Diagnostic Test
SRA Stringent Regulatory Authority
TOR Terms of Reference
WHO-GMP WHO - Global Malaria Programme


2.  DESCRIPTION OF SUBJECT / PRESENT ACTIVITIES

2.1      Background

ACT Forecasting

ACTs are recommended by WHO as the preferred treatment for malaria. Current access to ACTs remains low largely due to high prices compared to those charged for suboptimal, alternative medicines. High ACTs prices are in large part due to high manufacturing costs including the expensive and variable price of artemisinin raw material. The upstream supply of artemisinin is based on a long and complex agricultural process; the entire cycle from planting Artemisia Annua crops to final production of ACTs takes approximately 12-18 months. The long artemisinin production cycle limits market responsiveness to sudden changes in demand, and in the past has resulted in a volatile market with large price fluctuations. Maintaining and communicating up-to-date market intelligence on the demand for ACTs has therefore been identified as a key mechanism for stabilizing the price of both artemisinin and ACTs, and promoting a consistent supply of ACTs enabling improved global access to quality malaria treatment.

UNITAID has been supporting the production of a quarterly global ACT demand forecast since 2011. The quarterly demand forecasts, including information about the forecasting methodology, are available at: http://www.unitaid.eu/actforecasting. UNITAID’s past interest in funding a global ACT forecast was largely due to concerns about supply shortages that could arise from the recent growth of the global market of ACTs and artemisinin. In particular, the large increase in demand for ACTs under the Affordable Medicines Facility – malaria (AMFm) warranted investment into a forecasting service that could anticipate significant changes in global demand. Indeed, in the summer of 2011 the many stakeholders in the global malaria community expressed concerns about relative ACT supply vs demand. The ACT Forecasting Service was able to respond to these concerns by providing real-time information on ACT demand, which allowed for risk-management and mitigation strategies to be put into place.

Current uncertainties about the future funding mechanisms of The Global Fund, the future of AMFm, and a general constriction in donor funding, are making future demand for ACTs and artemisinin less predictable. In addition, the announced launch of semi-synthetic artemisinin is raising concerns among agricultural artemisinin suppliers and may result in decreased overall supply if these concerns are not mitigated through accurate demand forecasting. Going forward, the scale-up of malaria RDTs and changing disease epidemiology will also impact on ACT demand. In light of these unpredictable supply and demand situations,UNITAID is committed to maintaining a global ACT forecasting service to ensure reliable and timely information is collected and communicated to all actors in the supply chain. In this next phase of the project, forecasting of malaria RDTs will also be included in light of their emerging role in improving case management and in diminishing inappropriate (presumptive) use of ACTs for patients who do not have malaria.

The current ACT forecasting project will conclude in mid-2013. UNITAID is therefore issuing an RFP for a second phase of ACT forecasting to continue the development and publication of quarterly global demand estimates. As mentioned above, in this phase the scope of the forecasting will be broadened to include malaria RDTs. The second phase should build on the principles and processes of Phase 1, notably quarterly reporting with regular updating of assumptions based on newly available data; harmonizing multiple approaches and triangulating outputs from different models; and creating demand estimates for different scenarios that reflect a range of possible future situations. However, it is also envisaged that certain modifications to the original project will be required. In particular, methodological changes will be needed to adapt the forecast to The Global Fund’s new funding model and to the integration of the Affordable Medicines Facility – malaria (AMFm) into core Global Fund processes. In addition, UNITAID would like to build on the lessons learnt from the current ACT forecasting project in order to improve the usefulness of the demand estimates generated under the next project. Recognizing that availability of data about future funding cannot be guaranteed beyond a certain time horizon, it is important to include forecasting methods that can utilize multiple inputs including qualitative inputs. The changes include:

• A new forecast of global demand for malaria RDTs alongside ACTs;

• Inclusion of both short-term and longer-term estimates, recognizing that these will have different levels of precision;

• Diversification of data inputs, including the regular incorporation of data from manufacturers;

• Estimate of total artemisinin demand from other sources than donor-funded ACTs, such as non-SRA/WHO-prequalified ACTs, injectables, syrups, artemisinin monotherapy, etc.;

• Incorporation of longer-term market trends based on the impact of increased use of RDTs and the effect of prevention efforts on malaria incidence and transmission;

In addition to producing sound estimates, the forecasts are also expected to provide detailed analysis of the implications of the forecast findings and recommendations on action needed to ensure appropriate responses.

Relationship with other UNITAID initiatives/projects

As a separate but related activity, UNITAID is developing a market intelligence system (MIS) that will provide real-time access to reliable, updated information on disease and access trends as well as market dynamics. This will assist UNITAID in designing and implementing effective market-based interventions to improve public health. Specifically, the MIS will act as a “clearing house” that brings together market data from multiple sources to provide a standardized, easily accessible view of demand, supply and market efficiency. It will transform the disparate and heterogeneous data relating to markets for HIV/AIDS, TB and malaria commodities, creating a new analytical system that will provide efficient access to robust market intelligence. It is expected that the data inputs that are used in artemisinin, ACT and malaria RDT demand forecasting, as well as the demand estimates themselves, will feed into the MIS. Timely access to source data and analyses in a user-friendly format is therefore an important deliverable of this project.

UNITAID is also initiating a project with the Williamson Davidson Institute to collect market intelligence on APIs including artemisinin derivatives. This project, together with the ACT forecasting service, will allow for comparison of artemisinin supply and demand and will facilitate longer-term production planning. It is expected that the two project teams will communicate on a periodic basis in order to share and vet results and discuss the implications of the joint findings.

2.2      Objectives of the activity

A service provider is needed to assist UNITAID in developing a global demand forecast for malaria RDTs and artemisinin-based combination therapies (ACTs), and calculating the resulting demand for artemisinin raw material, on a quarterly basis.

2.3      Activity coordination

Within the UNITAID Secretariat, the focal point for this project will be the responsible Technical Officer in the Market Dynamics team.

The Project Steering Committee established to provide overall guidance to the current ACT forecasting project will be maintained for the next phase of work. Membership currently includes representatives from the AMFm, The Global Fund to Fight AIDS, Tuberculosis and Malaria, the Medicines for Malaria Venture, the Roll Back Malaria partnership, UNITAID and WHO, however this may be revised under the new project based on the agreed scope of work and the resulting expertise needed.


More Details: http://bit.ly/16TOXO8