Treatment for drug-resistant TB
Pretomanid is used with other anti-TB drugs to form a highly effective treatment regimen for drug-resistant tuberculosis.
Our volume guarantee is helping to increase access in countries with high TB burden.
Our
partners
The challenge
Public health
Tuberculosis (TB) is one of the world’s most deadly infectious diseases, claiming more than 1.1 million lives in 2022 alone. TB is preventable and curable but can require specialised treatment if resistant to first line antibiotics. Drug-resistant tuberculosis (DR-TB) is increasingly a global public health crisis, with cases identified on every continent.
The World Health Organization (WHO) estimates that 410,000 people are living with DR-TB and approximately 150,000 receive treatment. Of those treated in 2020, only 63% were treated successfully. This is partly because previously recommended treatment options required patients to take up to 20 pills per day for up to 20 months. Some of the drugs have toxic side effects, making adherence a challenge.
In 2022, the WHO recommended a treatment regimen called BPaLM that is only six months and includes newer, more effective TB drugs. Trials found the regimen to be more than 89% effective in curing patients with multidrug-resistant TB.
Market situation
Pretomanid (the Pa in BPaLM) was developed by the TB Alliance, which has granted non-exclusive licenses for high-burden, low- and middle-income countries to multiple drug manufacturers, including Viatris. Pretomanid was approved by the US Food and Drug Administration in 2019 and is registered in more than 20 countries and the European Union.
When the WHO recommended BPaLM, the regimen was much more expensive than the standard of care, meaning procurers and governments faced difficult decisions with limited budgets.
In December 2022, MedAccess, Viatris and the TB Alliance announced that Viatris had agreed to reduce the price of pretomanid by 34% in more than 130 low- and middle-income countries. This price reduction brought the overall price of the BPaLM regimen much closer to current treatment costs, allowing countries to more easily switch to this new, more effective regimen, and is made possible by a volume guarantee agreement.
Impact to date
By the end of 2023:
9,200
additional patients with favourable outcomes
7,900
potential adverse events avoided as patients switch from current standard of care
$7m
direct savings for procurers
The product
Pretomanid is used with other anti-TB drugs to form a highly effective treatment regimen. This all-oral, six-month regimen was recommended by the WHO in December 2022 as the preferred option for most people with DR-TB. The regimen (BPaLM) is made up of:
- bedaquiline (B)
- pretomanid (Pa)
- linezolid (L)
- and moxifloxacin (M)
The partnership
MedAccess provided a volume guarantee to Viatris.
Viatris has agreed to reduce the price of pretomanid in over 130 low- and middle-income countries and will continue to produce and supply pretomanid, increasing availability and access.
The new ceiling price is available to more than 130 governments, and NGOs and public sector procurers purchasing pretomanid in those countries.
This price reduction, coupled with a price reduction on bedaquiline in August 2023 reduced the cost of BPaLM to below $500 per six-month patient course.
TB Alliance first developed six-month drug-resistant TB treatment regimens and helped facilitate the volume guarantee. TB Alliance is also supporting countries to plan for and scale up introduction of the BPaLM regimen.
Impact projections
Our guarantee has reduced the price of pretomanid by 34% when compared to previously offered prices, in more than 130 low- and middle-income countries. This price reduction brings the price of BPaLM much closer to the cost of previously recommended MDR-TB treatment regimens, allowing countries to more easily switch to this new, more effective regimen and accelerating access to innovative treatments.
This agreement also sets a benchmark price for future generic entrants and increases competition in the TB market by supporting a newer entrant.
The partnership will support countries to switch to this new WHO-recommended regimen and facilitate widespread uptake of this highly effective treatment.
We estimate that the partnership will contribute to:
- enable an additional 36,000 patients to be treated successfully with BPaLM
- help avert 31,000 potential adverse events that require hospitalisation or cause disability as patients switch from the current standard-of-care
- save governments and global procurers more than $15.6 million, with additional savings for national healthcare budgets as they care for fewer patients with long-term DR-TB.
How we calculate the impact of this agreement
Lives changed
Downstream patient outcomes were estimated based on final results of the TB PRACTECAL study presented at TB Union 2022, and represent relative risk as compared to current standard-of-care regimens.
Money saved
Impact is estimated based on actual price reductions for pretomanid over the course of the volume guarantee, taking into account expected market dynamics.
Markets shaped
We work with partners, including donors, procurers and Ministries of Health, to track changes in health markets where our investments are supporting access to products. We monitor for changes to policy, procurement practices and supplier movement, all of which affect markets and contribute to the long-term sustainability of impact.
Sustainable Development Goals (SDGs)
SDG 17
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SDG 17
Strengthen the means of implementation and revitalize the Global Partnership for Sustainable DevelopmentSDG 17 targets:
SDG 3
3.3
By 2030, end the epidemics of AIDS, tuberculosis, malaria and neglected tropical diseases and combat hepatitis, water-borne diseases and other communicable diseases
3.8
Achieve universal health coverage, including financial risk protection, access to quality essential health-care services and access to safe, effective, quality and affordable essential medicines and vaccines for all
3.b
Support the research and development of vaccines and medicines for the communicable and non-communicable diseases that primarily affect developing countries, provide access to affordable essential medicines and vaccines, in accordance with the Doha Declaration on the TRIPS Agreement and Public Health, which affirms the right of developing countries to use to the full the provisions in the Agreement on Trade-Related Aspects of Intellectual Property Rights regarding flexibilities to protect public health, and, in particular, provide access to medicines for all
SDG 10
10a
Implement the principle of special and differential treatment for developing countries, in particular least developed countries, in accordance with World Trade Organization agreements
SDG 17
17.6
Enhance North-South, South-South and triangular regional and international cooperation on and access to science, technology and innovation and enhance knowledge sharing on mutually agreed terms, including through improved coordination among existing mechanisms, in particular at the United Nations level, and through a global technology facilitation mechanism
17.7
Promote the development, transfer, dissemination and diffusion of environmentally sound technologies to developing countries on favourable terms, including on concessional and preferential terms, as mutually agreed
17.10
Promote a universal, rules-based, open, non-discriminatory and equitable multilateral trading system under the World Trade Organization, including through the conclusion of negotiations under its Doha Development Agenda
17.17
Encourage and promote effective public, public-private and civil society partnerships, building on the experience and resourcing strategies of partnerships
Discover more about this partnership
19 December 2022
8 things to know about drug-resistant tuberculosis
Key contacts
If you would like more information about this agreement, please reach out to our key contacts.
