A promising new tuberculosis (TB) drug produced by the Japanese pharmaceutical company, Otsuka, will be made available to developing countries - but there’s a catch. The drug has been priced at $1 700 (about R27 000) per treatment course.
The drug, delamanid, is one of only two new TB drugs that have been developed in the last 50 years. It is effective against drug-resistant TB – a form of TB that is unaffected by many of the other drugs used to treat the condition – which can take up to two years of daily treatment. The World Health Organisation (WHO) estimates that about 480 000 people developed drug-resistant TB in 2014.
Research has shown that drug-resistant TB has only a 50% cure rate.
But clinical trials have shown that delamanid can help 45% of extremely drug-resistant patients show improvement in only two months if it is taken in combination with other TB drugs for a period of six months. It also has fewer side effects than current treatment regimens.
Humanitarian aid organisation Médecins Sans Frontières (MSF) has reacted strongly to the news, demanding that the drug’s price is cut by more than a third to $500. Countries with high rates of drug resistant TB won’t be able to afford the drug at $1700, according to MSF.
Julia Hill, MSF’s deputy head of mission for South Africa, says there are at least 7,000 people in South Africa who could benefit from the drug.
“It’s the most expensive drug in the [TB treatment] regime and it’s really unaffordable if your aim is to treat thousands of patients each year,” Hill told Bhekisisa.
Treating drug-resistant TB is already expensive. According to the WHO’s 2015 Global Tuberculosis Report, in countries with extremely high rates of TB, the cost of treating a patient with drug-resistant TB is between $5 000 and $10 000.
Delamanid needs to be taken in combination with other TB drugs to effectively treat drug-resistant TB. “It’s really shocking that they’re charging $1 700 dollars for a treatment course when the need is so high,” says Hill.
Hill pointed to a paper presented at the 15th European Aids Conference in 2015, which claimed that the price of the latest medications for drug-resistant TB could drop by up to 95% if they were produced by drug companies that produce generics. In theory, this would put the price of delamanid at between $21 and $52 per treatment course.
Otsuka and the Stop TB Partnership, an alliance of 1300 technical, government and civil groups concerned with TB research and treatment, announced last week that the drug would be made available to developing countries through the Global Drug Facility.
The Global Drug Facility, which is administered by the WHO, aims to improve access to TB drugs and create better systems for their procurement and distribution. It also uses mechanisms like pooling, tenders and grants to help developing countries get access to need drugs more cheaply.
But delamanid has been approved for use in only three countries so far - the European Union, Japan and South Korea – none of which has a high TB disease rate.
According to the WHO, 22 countries account for 80% of the tuberculosis cases in the world. Nine of these countries are in Africa - Nigeria, South Africa, Zimbabwe, Ethiopia, Kenya, Mozambique, Uganda, Tanzania and the Democratic Republic of the Congo.
“It’s really important the drug be registered in countries with high TB burdens,” says Hill. “While we’re waiting for that, efforts should be made to provide the drugs for compassionate use and to get early access for patients who really need it.”
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