Viatris: Treatment for drug-resistant TB
Pretomanid is used with other anti-TB drugs to form a highly effective, shorter regimen for drug-resistant tuberculosis.
Since 2022, we have partnered with Viatris and the TB Alliance using a volume guarantee to help reduce the price of pretomanid, increasing access in countries with a high TB burden.
The challenge
Public health
Tuberculosis (TB) is one of the world’s most deadly infectious diseases. In 2022, when this agreement was signed, more than 1.1 million people died from the disease. 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.
In 2022, the World Health Organization (WHO) estimated that 410,000 people are living with DR-TB and approximately 150,000 received treatment. Of those who began treatment in 2020, only 64% 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.
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 2025:
46,200
additional patients cured or completing treatment
39,700
adverse health events averted
$20.4m
saved 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.
