WHO NTDs Roadmap 2021-2030

The WHO Neglected Tropical Diseases (NTDs) Roadmap 2021-2030 was launched at the end of January after a long period of international consultation. There is an abbreviated version of the Roadmap, but we recommend the full version as well as the NTD Sustainability Framework, a companion document.

The Roadmap is exceptionally important for leprosy. The major themes, especially the cross-cutting approaches of integration, mainstreaming, country ownership and sustainability, form a new landscape for ILEP’s strategies and activities. The Roadmap also has four detailed pages of specific objectives and approaches for leprosy, which form the basis for the new WHO Global Leprosy Strategy, due to be launched in March.

Accelerate programmatic action

This is the first of the major themes in the Roadmap. There is an emphasis on the need for research and development into new interventions and new tools. For leprosy, three critical actions are listed:

• Update country guidelines to include use of single-dose rifampicin for postexposure prophylaxis for contacts, and advance research on new preventive approaches.
• Continue investment into research for diagnostics for disease and infection, and develop surveillance strategies, systems and guidelines for case-finding and treatment.
• Ensure medicines supply, including access to MDT, prophylactic drugs, second-line treatments and medicines to treat reactions; monitor adverse events and resistance.

Intensify cross-cutting approaches

This is the second major theme. The Roadmap promotes a shift is from a siloed disease-specific approach to cross-cutting approaches, including integration across multiple NTDs, mainstreaming in national health systems, and coordination with other sectors within and beyond health.

For leprosy, one fundamental issue is integration. The Roadmap encourages countries to integrate all NTDs on to a single platform that includes not only prevention but also treatment, care, rehabilitation and health education. There is a particular emphasis on integrating the eight skin NTDs: Buruli ulcer, leishmaniasis, leprosy, LF, mycetoma etc, onchocerciasis, scabies and yaws. One of the indicators in the Roadmap is the number of countries that implement integrated skin NTD strategies (currently 4, but the target is 40) so it can be assumed that leprosy-endemic countries will be urged by WHO to consider this. Figure 1 below shows some of the ways in which WHO expects that leprosy services will be integrated with other skin NTDs.

Figure 1

Mainstreaming in national health systems is another feature that is relevant in situations where leprosy programmes are implemented separately, or in parallel, with the country’s mainstream health system. The Roadmap is clear that NTD interventions, from prevention to diagnosis, treatment, care and rehabilitation, should be delivered through community, primary or secondary care facilities in the national health system. This contributes to sustainable, efficient NTD prevention and control and – in line with universal health coverage – it enables NTD patients to access all aspects of treatment, care and support. In many countries, health systems strengthening will be essential, otherwise the risk is that mainstreaming reduces patients’ access to leprosy and other NTD services. Figure 2 below describes how this mainstreaming could work in practice, though details would differ from country to country.

Figure 2

There is also emphasis on coordination with other departments in the Ministry of Health, and other sectors beyond it. For leprosy, some of the obvious intersections within Health are mental health, disability and inclusion, and eye health. There are other coordination opportunities beyond Health, including WASH, education, and justice and social welfare (particularly important for preventing structural discrimination including abolition of discriminatory laws, and working with communities to conduct anti-stigma interventions).

Country ownership

The third major theme is a shift is from an agenda driven by partner support and donor funding, to country ownership and (primarily) domestic financing. The sustainability framework is an important document in this regard, because it describes the crucial ongoing role of INGOs like ILEP in a context of country ownership.

The framework defines sustainability as ‘the ability of national health systems to maintain or increase effective coverage of interventions against NTDs to achieve the outcomes, targets and milestones identified in the new road map for 2030.’ To build sustainability, not only will NTD programmes need to be built upon national health systems, but also international donors and implementing partners will need to consider their potential roles in sustainability and especially in strengthening health systems. When countries depend on partners for NTD-specific expertise and funding, there is a risk of fragmentation, usually inadequate focus on health systems strengthening, and chronic uncertainty over whether partner funding will continue. The framework also raises the issue of power: who decides how NTD interventions are organised and implemented?

Partners like ILEP and its member associations are urged to use the framework to think through some of the deeper issues on sustainability. In particular, we are encouraged to identify opportunities in which technical assistance and funding assistance can be used, and possibly redirected, to better support sustainability.

Uniting to Combat NTDs

Uniting to Combat NTDs was established after the signing of the London Declaration on NTDs in 2012. During 2020, as part of a total review of structure and strategy, Uniting expanded its focus from 10 to all 20 NTDs. One facet of the new structure is a consultative forum, which includes Dr Wim van Brakel, chair of the ILEP Technical Commission.

Uniting’s new mission is to create political will and an enabling environment for countries to achieve the WHO NTD road map targets and deliver the SDG goal to end NTDs by 2030. Recognising that there are many organisations working in the NTD ‘space’, UTC wants to add value in four ways:

• providing a platform for collective advocacy
• facilitating communications and active partnership across all the NTDs
• being a trusted and credible voice to open doors at the international level
• using its power to convene partners across and beyond NTDs to raise the profile of NTDs globally

The new strategy ‘Coming together to end the neglect’ has three main aims.

The first is to increase the relevance of NTDs in global and regional agendas. This includes using existing frameworks to provide accountability for policy and funding commitments, cultivating endemic country leaders as champions for NTDs, and working with partners to build strong campaigns to influence new and existing donors and endemic countries.

The second aim is to mobilise national and international resources for NTDs. This includes not only ongoing commitments from key NTD donors and the pharmaceutical industry, but also additional resources from key international donors, the private sector, and foundations. In line with the NTD Roadmap, there is also a focus on promoting inclusion of NTDs in endemic countries’ domestic health funding.

The third aim is to facilitate an engaged partnership to support NTDs. This involves working closely with NTD partner networks, like ILEP, to share information and create a unified voice throughout the NTD community, make connections among partners for collective advocacy and resource mobilisation, and collaborate so as to magnify partners’ own advocacy and resource mobilisation efforts.

A summary of the strategy can be read here. ILEP appreciates the particular capabilities that Uniting to Combat NTDS brings to the NTD world, especially towards building stronger international collaborations and mobilising new resources. ILEP looks forward to engaging with Uniting towards our mutual objectives.

Interim Advice on the use of Rifampicin for post-exposure prophylaxis (PEP)

Issued by the ILEP Technical Commission, February 2021. This is a non-technical version of the advice. The full version is available here.

 

Various problems have affected the supply of MDT this year. The most recent has been the discovery of impurities, known as nitrosamines, in rifampicin. The discovery came through a new drug screening process recommended by WHO. Nitrosamines appear to be a by-product in the production of rifampicin and have probably been present for many years.

Nitrosamines are assumed to pose a health risk if a high enough cumulative amount is consumed over a person’s lifetime. For this reason, they are not considered a serious issue when used for treatment with MDT (normally one dose a month for up to 12 months) or for leprosy prevention as SDR-PEP (one single dose). The US Food & Drug Administration (FDA) and the European Medicines Agency (EMA) have both indicated that rifampicin should continue to be used to treat TB (where it is given daily) and leprosy, while the manufacturing process is revised to minimise the impurities. However, no statements have been made about rifampicin use for SDR-PEP.

In line with the statements from FDA and EMA about MDT, the ITC considers the potential health risk of a single dose of rifampicin to be extremely small. However, since SDR-PEP is given to healthy individuals, we have an obligation to minimise all known risks to health. Since another drug with similar nitrosamine impurities is used for chemoprophylaxis in TB, ITC has consulted with the WHO Global Leprosy Programme, WHO Global TB Programme and WHO Pre-qualification Team – Medicines (WHO PQT/MED), a global quality assurance programme for medicines. WHO-PQT/MED is tackling this issue for TB and leprosy jointly and will give guidance on rifampicin when it has completed its investigation.

In view of the above, the ITC will withhold recommendations regarding SDR-PEP distribution until the various ongoing investigations and the conversation with the Global TB and PQ programmes have concluded and their position has become clear. In the meantime, the ITC makes four recommendations:

1. Where ILEP is involved in the distribution of MDT or rifampicin, batches should only be purchased or used that have maximum nitrosamine levels below 5ppm per day as recommended by the US FDA.
2. When there is an acute shortage of MDT, any available rifampicin may need to be used for treatment of leprosy patients, rather than for chemoprophylaxis among contacts.
3. Whenever active case-finding efforts are undertaken, including contact examinations, the availability of treatment for any new cases identified must be ensured (preferably MDT). MDT, with impurity levels below the safety level mentioned above, is essential and safe for treatment of leprosy patients.
4. ILEP offices should do everything in their power to facilitate nitrosamine testing of rifampicin already available in their country, that is designated for SDR-PEP. Ideally, such testing should be done by each company producing rifampicin and by the national authority in charge of monitoring the quality of drugs. Recent random samples from currently available batches of MDT have found levels of nitrosamine to be under this limit, so if testing is not possible at present, current stocks of MDT are deemed to be safe.