From outsider to policy game changer? An example of partnership,research
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From outsider to policy game changer? An example of partnership, research and beneficiary-orientated outcomes in India S Burza 1 , MA Lima 2 , S Ellis 3 , M Balsegaram 4 , R Mahajan 1 , J Vanpeteghem 1 1 MSF – New Delhi, India 2 MSF – Barcelona, Spain 3 DNDi, Geneva 4 Campaign for Access to Essential Medicines, Geneva Aim: To demonstrate how MSF, in partnership with local and national agencies, can impact government policy through operational research. Background: Visceral Leishmaniasis accounts for the second-highest worldwide burden of parasitic disease. India has 50% of these cases. For over five decades, treatment in India had been limited to monotherapies exhibiting toxicity, higher mortality, and emerging drug-resistance. Intervention: In 2007, MSF proposed a ´new´ treatment modality to treat VL in India, Liposomal Amphotericin-B (L-AmB/ Ambisome®), a short course treatment already shown to be exceptionally safe and effective in Europe. A complex process of negotiations and partnerships with Indian authorities ensued leading to a cohort study where 250 patients were successfully treated in collaboration with government medical research institutions. Conclusion: The results generated will help refine government VL management guidelines in the sub-continent and improve patient management. MSF experience in India demonstrates the potential of multi-lateral partnerships and operational research to impact policy and practice on a large scale. Local policy change and success: The outcomes allowed the State Health Society to sign a formal MoU with MSF to increase activities. The district-wide expansion of the project led to the successful treatment of >12000 patients over the following 5-years, with a mortality rate of <1% and generated a wealth of data and field experience. Lessons learned: By utilizing existing MoH staff and facilities to treat patients in rural PHCs, MSF demonstrated that L-AmB could be feasibly introduced into existing Indian government peripheral structures. Meanwhile, the Drugs for Neglected Diseases Initiative (DNDi) and Indian Council of Medical Research (ICMR) studied combination-based-treatments with existing registered drugs. In 2012, a pilot study under government supervision commenced combining MSF operational field experience with the DNDi study results. The objective is to examine pharmacovigilance, field- effectiveness, and risk-benefit ratios of these new treatment modalities on a much larger scale. Year Initiative Treatment Patients treated Results 2007 L-AmB 20mg/kg 250 ITT success rate 98.8% 2008-12 L-AmB 20mg/kg >12000 Initial cure rate 99.3% 2012-13 Stage 1: MF+PM MF+L-AmB L-AmB 10mg/kg Target: 3 x 300 Interim result Initial cure rate 100% 2014 Stage 2: Govt to choose which treatment modalities to scale up Target: 2 x 3000 Pending 2015 An optimal, feasible and cost effective treatment Policy Change: Revised National Protocol?
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S Burza, MA Lima, S Ellis, M Balsegaram, R Mahajan and J Vanpeteghem
Transcript of From outsider to policy game changer? An example of partnership,research
From outsider to policy game changer? An example of partnership,
research and beneficiary-orientated outcomes in India
S Burza1, MA Lima2, S Ellis3, M Balsegaram4, R Mahajan1, J Vanpeteghem1
1MSF – New Delhi, India 2MSF – Barcelona, Spain 3DNDi, Geneva 4Campaign for Access to Essential Medicines, Geneva
Aim:
To demonstrate how MSF, in partnership with local and national agencies, can impact government policy through operational research. Background: Visceral Leishmaniasis accounts for the second-highest worldwide burden of parasitic disease. India has 50% of these cases. For over five decades, treatment in India had been limited to monotherapies exhibiting toxicity, higher mortality, and emerging drug-resistance.
Intervention: In 2007, MSF proposed a ´new´ treatment modality to treat VL in India, Liposomal Amphotericin-B (L-AmB/Ambisome®), a short course treatment already shown to be exceptionally safe and effective in Europe. A complex process of negotiations and partnerships with Indian authorities ensued leading to a cohort study where 250 patients were successfully treated in collaboration with government medical research institutions.
Conclusion: The results generated will help refine government VL management guidelines in the sub-continent and improve patient management. MSF experience in India demonstrates the potential of multi-lateral partnerships and operational research to impact policy and practice on a large scale.
Local policy change and success: The outcomes allowed the State Health Society to sign a formal MoU with MSF to increase activities. The district-wide expansion of the project led to the successful treatment of >12000 patients over the following 5-years, with a mortality rate of <1% and generated a wealth of data and field experience. Lessons learned: By utilizing existing MoH staff and facilities to treat patients in rural PHCs, MSF demonstrated that L-AmB could be feasibly introduced into existing Indian government peripheral structures. Meanwhile, the Drugs for Neglected Diseases Initiative (DNDi) and Indian Council of Medical Research (ICMR) studied combination-based-treatments with existing registered drugs. In 2012, a pilot study under government supervision commenced combining MSF operational field experience with the DNDi study results. The objective is to examine pharmacovigilance, field-effectiveness, and risk-benefit ratios of these new treatment modalities on a much larger scale.
Year Initiative Treatment Patients treated
Results
2007
L-AmB 20mg/kg 250 ITT success rate 98.8%
2008-12
L-AmB 20mg/kg >12000 Initial cure rate 99.3%
2012-13
Stage 1: MF+PM MF+L-AmB L-AmB 10mg/kg
Target: 3 x 300
Interim result Initial cure rate 100%
2014
Stage 2: Govt to choose which treatment modalities to scale up
Target: 2 x 3000
Pending
2015
An optimal, feasible and cost effective treatment
Policy Change: Revised National Protocol?
