Will new TB treatments reach those who need them most?

The global corporation — part of which focuses on developing affordable medicines for diseases that are more common in low- and middle-income countries — is testing two compounds that could lead to a new four-month treatment for TB, including multidrug-resistant strains, which is a huge improvement on current treatment times.

But Barros-Aguirre said any future treatments won’t be made widely available without collaboration and sustainable funding models to translate scientific discoveries into benefits for the most vulnerable.

“We want to have the drugs with the patients and ... we’re not going to do it alone. We’re being very outspoken — we are saying we’re going to do this if governments, if funding agencies, if the treasuries of lower-middle income countries are aligned with us,” said Barros-Aguirre, who is based at GSK’s Tres Cantos research facility in Madrid, Spain, and leads its NGO partnerships.

However, while drug pricing has historically been based on recouping the high costs involved in research and development, Blessina Kumar, CEO at the Global Coalition of TB Activists, said large companies need to start "putting lives before profit" and provide open access to information on potential new compounds.

In 2017, 10 million people were newly diagnosed with TB and 1.6 million people died from the disease, which is spread by coughing and sneezing. The current treatment lasts between six and 24 months, depending on drug resistance. It involves up to 14,000 pills and 180 injections made up of four different drugs.

While there have been some developments in TB treatment in recent decades — including the rapid diagnostic tool Gene-Xpert and the World Health Organization-recommended drug rifapentine — a lack of affordability means not everyone has been able to access them, said Erica Lessem, deputy executive director for programs at the Treatment Action Group.

“That’s been really disappointing to see … [especially] after a long history of not having better options,” she said.

Following 16 years of research and development, the two GSK compounds — which are currently in phase two trials, where they are being assessed for efficacy against the disease — represent the company’s biggest breakthrough so far and could be effective for all forms of TB, the company says. Other groups such as Johnson & Johnson, Ostuka, and the TB Alliance are also seeing some pipeline success in the development of new TB treatments.

Barros-Aguirre said the next stage of development for GSK — phase three clinical trials — would be extremely expensive if reached.

“We want to deliver medicines, not compounds. And for that, sustainable funding mechanisms are required ... Incentive mechanisms allow us to go to a country, allow us to go through all the regulatory processes, market access, all those things, and that requires a whole breadth of economic support … That’s where governments, foundations, the World Health Organization, and the Global Fund [to Fight AIDS, Tuberculosis and Malaria] need to step in to find the right mechanisms for allowing companies to make this financially viable,” he said.

However, GSK did not give details of what such mechanisms might look like, with a spokesperson saying that sustainable funding models will need to be tailored to specific needs and situations, and be led by local, international, and supranational partners.

With that in mind, Kumar said it was too early to be thinking about funding models for a treatment that is still many years’ away, with phase three trials not expected to be reached until around 2030. “It’s a bit ridiculous that they’re looking at funding now,” she said.

And Lessem called for a total overhaul of the TB funding model, explaining that even if the sponsor of the drug is a private company, many are backed by public or philanthropic financing. In some cases, “that means the public ends up paying twice: First for the research to be conducted and then for the high price of medicines that the company is selling, even though they used public dollars to fund the research to get it approved,” she added. 

“Ultimately a model for funding innovation that delinks the cost of research from the price of drugs will be essential for supporting ... medicines for markets perceived to be less profitable, while ensuring broad and equitable access," she said.

Source: Devex