Aid organizations are working to address regulatory and legal barriers that could interrupt the treatment of people with tuberculosis outside Ukraine.
Ukraine has one of the highest TB burdens in Eastern Europe. According to World Health Organization estimates, 32,000 people developed TB in 2020 in the country. With the ongoing Russian war against Ukraine causing major disruptions to health services, health and aid officials are trying to find ways to continue TB patients’ treatment to prevent its further spread and the development of drug resistance.
With the war ongoing, “Ukraine has to fight on one side illnesses [like] TB, and on the other side aggression of the Russian Federation against Ukraine,” said Yana Terleeva, who heads Ukraine’s TB program at the ministry of health, during a Stop TB Partnership press briefing on Tuesday.
Yet the challenge is not just providing TB treatment inside Ukraine, but also in neighboring European countries. Out of the more than 3.5 million refugees from Ukraine, an estimated 1,400 adults and 160 children were already in need of TB treatment, and a third of that number will require treatment for multidrug-resistant TB, said Dr. Nino Berdzuli, director of the Division of Country Health Programmes for WHO Europe, in the same briefing.
One of the key challenges is the procurement of certain medications for MDR-TB treatment. Some of the medicines that WHO recommends, and that have been used in Ukraine under a strict protocol, are in limited supply in refugee host countries or unavailable because they’re not registered for use and are expensive, Dr. Askar Yedilbayev, WHO Europe’s regional adviser for TB, told Devex over email.
These include the medicines clofazimine and cycloserine, as well as the latest MDR-TB drugs bedaquiline and delamanid. The latter two are authorized for use by the European Medicines Agency, but costly.
“WHO is working around the clock to provide an emergency stock, and working with Member States and partners to ensure that treatment is not interrupted.”
— Dr. Askar Yedilbayev, regional adviser for TB, WHO Europe“[A]ll treatment regimens that the National TB program of Ukraine has used contain two relatively new TB medicines - Bedaquiline and Delamanid – which are much more expensive for EU countries than for Ukraine and other countries outside the EU,” Dr. Maya Kavtaradze, who works at the Stop TB Partnership’s Global Drug Facility, told Devex in an email.
Kavtaradze said she isn’t aware how much the two medicines cost in EU countries, but the GDF gets them at a concessional price of $272 for a treatment course of bedaquiline, and $1,700 for a treatment course of delamanid for more than 100 low- and middle-income countries.
Meanwhile, fluoroquinolones, such as Levofloxacin and Moxifloxacin, and Linezolid, which are also recommended by WHO for the treatment of MDR-TB, are registered in Europe, but their stocks are limited, WHO’s Yedilbayev said.
He added that WHO is working to establish an emergency stock of MDR-TB medicines, including pediatric formulations, to cover the needs of Ukrainian refugees in the European region. But procurement and distribution of these medicines in the countries where these patients currently reside will require special marketing authorizations or waiver importation permits from the national drug regulatory authorities.
“This is a temporary mechanism that will allow Member States to take action in response to public health emergencies within boundaries,” he said.
WHO is working with Stop TB Partnership’s GDF to stockpile on these live-saving treatments. GDF is seeking “special approvals” from manufacturers of both delamanid and bedaquiline so it can purchase both drugs at a lower price.
“GDF needs special permissions to supply these medicines at GDF’s concessional access prices in the EU. GDF is working with the suppliers and expects approval very soon,” Kavtaradze said.
These measures are critical to ensure MDR-TB patients’ treatment can continue.
The majority of TB and MDR-TB patients in Ukraine are men, according to Yedilbayev, and with most of them — those aged 18 to 60 years old — not allowed to leave the country, WHO expects there would be fewer TB patients among refugees, most of whom are women and children. But Yedilbayev added their treatment needs to continue to “avoid the risk of poor treatment outcome, including death.”
“In Ukraine, patients have been provided with 1-2 month supply of medicines, with the expectation that treatment will continue with the same regimen in a new destination country. That is why WHO is working around the clock to provide an emergency stock, and working with Member States and partners to ensure that treatment is not interrupted,” he said.
About the author
Jenny Lei Ravelo@JennyLeiRavelo
Jenny Lei Ravelo is a Devex Senior Reporter based in Manila. She covers global health, with a particular focus on the World Health Organization, and other development and humanitarian aid trends in Asia Pacific. Prior to Devex, she wrote for ABS-CBN, one of the largest broadcasting networks in the Philippines, and was a copy editor for various international scientific journals. She received her journalism degree from the University of Santo Tomas.