Table 3

Summary of miltefosine access barriers and strategies to address them

Key areaAccess barriersAccess strategyAction(s) proposed
Governance and coordinationLack of consolidated coordination to ensure miltefosine access among stakeholders in the public and private sectorsIdentify effective leadership;
ensure that partnerships developing drugs for NTDs include safeguards to access
  • Establish a WHO-led Working Group on Access to Leishmaniasis Drugs and Diagnostics (WHO, MSF, DNDi, IDA, KalaCORE…) which help consolidate approach and coordination111

  • Identify mechanism(s) to enforce binding agreements ensuring drugs’ access

  • Include an access plan or strategy in any PDP for NTDs

AffordabilityHigh product priceLowering prices and ensure a healthy market (non-single supplier)
  • Negotiation to decrease the price to an acceptable level for governments and end users

  • Advocacy for transparency in the drug production cost and a list price of miltefosine in different markets

  • Financial or other support to encourage generic manufacturers

  • Curb possibility of a monopolistic situation in setting prices

AvailabilityInconsistent supply
  • Ensure sustainability of production

  • Assure quality

  • Expand availability

  • Advocacy on the access problem

  • Combined procurement, consolidation of demand forecasts or advance market commitments

  • Review registration status in endemic countries and renew as necessary

  • The supplier should seek registration in disease-endemic countries

  • Improve information flow to procurers (on drug availability, lead time, compassionate programmes, etc) and supplier(s) (on tender mechanisms, potential markets, etc)

  • Strengthen the supply chain in the country to improve delivery

  • DNDi, Drugs for Neglected Diseases initiative; IDA, International Drug Association; KalaCORE, UKaid-funded consortium to tackle VL; MSF, Médecins Sans Frontières; NTD, neglected tropical disease; PDP, Product Development Partnership; WHO, World Health Organization.