DNDi‘s work does not end with drug registration or WHO recommendation. DNDi takes on the responsibility of ensuring that the new therapies it develops become useful treatments.
Since its creation, DNDi has delivered eight treatments across a range of diseases and supported their registration and introduction. From this experience, we have learnt that the transition from registration to access is one of the most challenging aspects of our mission. DNDi‘s access strategy relies on partnerships with health ministries, national control programmes, industrial partners, NGO allies, and others to reach neglected patients and communities, and achieve maximum public health impact.
Treatments distribution scenarios vary depending on the disease, drugs, relevant countries, and degree of innovation: DNDi taps into existing distribution networks or works with partners to create new channels (e.g. public or not-for-profit).
Chagas: Innovative partnerships to spur access Chagas
DNDi has long sought to mobilize energies and funds in a bid to address the unacceptable situation for Chagas disease, where less than 1% of infected individuals are diagnosed and even fewer receive treatment.
These efforts received a considerable boost in August 2017, when pharmaceutical company Insud, with DNDi’s support, received a priority review voucher as a result of registering benznidazole for the treatment of Chagas disease with the US FDA. As part of the collaboration agreement between Insud and DNDi, half of the revenues from the sale of the PRV will be dedicated to increasing access to diagnosis, treatment and prevention throughout the Americas.
A Regional Access Framework for Chagas Disease has been developed by DNDi and Insud’s corporate social responsibility partner Fundación Mundo Sano, to be implemented in collaboration with members of the Chagas Coalition. The project was first implemented in Colombia in collaboration with the Ministry of Health and Social Protection, targeting a highly endemic area for Chagas disease.
The positive experience and promising results of the Colombia project led to the development of a collaborative project in the U.S. focused on advancing public health research on Chagas disease, including the first large-scale prevalence study in a major U.S. city in 2017.
Projects were also launched along the same model in Guatemala with local and international partners, and in Brazil in partnership with the Oswaldo Cruz Foundation. Seminars were held in Jutiapa, Guatemala, and in Rio de Janeiro and Recife, Brazil to identify the main barriers and develop actions to strengthen disease control and treatment access.
Fexinidazole: Using the regulatory process to pave the way for access Sleeping sickness
For the regulatory review of fexinidazole, DNDi’s newly delivered oral treatment for sleeping sickness, industrial partner Sanofi submitted a dossier for evaluation by the European Medicines Agency (EMA) under Article 58. This innovative regulatory pathway is designed for the review of medicines that will not be used in Europe. The review involves national regulators from target countries – in this case, the Democratic Republic of Congo (DRC) and Uganda – as well as the World Health Organization (WHO).
Due to the involvement of in-country experts and WHO in the review process, using this innovative process facilitated registration of fexinidazole in DRC in a record 39 days, with registration in Uganda expected soon.
Hepatitis C: A public health approach for access Hepatitis C
Although there are now several effective and safe treatment options for hepatitis C, access to affordable medicines is impossible for millions of people. Middle-income countries are the most affected. DNDi aims to bring a solution to this situation through multiple partnerships with widely different stakeholders who all share the common aim of increasing access to hepatitis C treatment.
DNDi has partnered with Pharco, an Egyptian pharmaceutical company, in the development of ravidasvir, a new chemical entity with potential effectiveness against all genotypes of the disease. In 2016, DNDi began working with the Malaysian Ministry of Health to introduce a public health approach within the framework of the country’s National Strategic Plan on viral hepatitis. The second stage of the trial was launched in December 2018 in Malaysia and in Thailand in May 2019. Other trials are envisioned in other parts of the world, for vulnerable patient groups, such as people who use drugs.
Promising results suggest that the ravidasvir/sofosbuvir combination is comparable to the very best hepatitis C therapies available, with one radical difference: its price. Thanks to partnerships in Malaysia (Pharmaniaga) and Argentina (Insud/Elea), DNDi has secured a target price of USD 300 to 500 per treatment course, a fraction of the price of what is available today in countries where patent barriers block generic options, and which are excluded from pharmaceutical company discount schemes.
However, to use this drug combination, countries would also need access to affordable sofosbuvir. In September 2017, Malaysia issued a “government use” licence to source generic sofosbuvir, a move which has allowed it to accelerate access to affordable hepatitis C treatment in its public hospitals.
Working together to find the missing millions
In July 2018, DNDi and diagnostic product development and delivery partnership FIND announced a partnership, in collaboration with the Ministry of Health in Malaysia, to generate evidence to support policy change and scale up hepatitis C diagnosis and treatment.
As a part of the project, simplified decentralized screening for hepatitis C has been initiated in Malaysia. People who screen positive and are subsequently confirmed to have hepatitis C are linked to treatment either in government hospitals or, on a voluntary basis, as part of the DNDi clinical trial.
Last updated: August 2019