Doctors Without Borders (MSF) welcomes the recent news that a much-needed drug-resistant TB (DR-TB) medicine called delamanid has been registered for use in the country by the South African Health Products Regulatory Authority (SAHPRA), and is calling on the National Department of Health to speedily activate existing plans to make delamanid routinely available within the public health system for those who need it.
“South Africa has one of the best DR-TB programs in the world yet many patients are still not effectively treated and as many as 1 in 2 people with multi-drug resistant TB are dying because the options for treating DR-TB remain limited,” says Dr. Laura Trivino-Duran, the medical co-coordinator for MSF in South Africa, adding that delamanid can be a life-saving drug for many patients.
Only two new DR-TB drugs have been approved in the last 50 years – bedaquiline and delamanid – and both are now registered for use in South Africa, with bedaquiline having been incorporated into the standard treatment for DR-TB in 2018. This was a historic decision to improve patients’ chances of being cured and make DR-TB treatment more tolerable, however, bedaquiline is not yet approved for certain groups, including children under the age of 6, who can suffer from side-effects of the available treatment options.
“Delamanid is safe for use in young children, and with easy access to the drug TB doctors will be able to do more for our kids,” says Trivino-Duran.
Delamanid is also an important treatment option for people with extensively drug resistant forms of TB, as well as patients experiencing serious side-effects from other DR-TB drugs. Recognizing its importance, the National Department of Health launched the Delamanid Clinical Access Program (DCAP) in March 2017 with the pharmaceutical manufacturer Otsuka, providing selected patients in 5 locations across the country with access to delamanid while processes to register the drug locally were underway. However, strict criteria were put in place preventing many who would have benefited from delamanid from qualifying for access.
While working in a TB unit in a state hospital Dr. Hannetjie Ferreira applied to the Delamanid Clinical Access Program on behalf of a patient who had already spent years on treatment for extensively drug-resistant TB, without success. After the application was turned down Ferreira secured a six month course of delamanid for the patient by applying for compassionate use access, but another six-month course was needed, and with delamanid not yet registered for use in South Africa there was no way of getting it.
“This was devastating because without delamanid the chances of the patient being successfully treated were significantly lowered,” says Ferreira, who ultimately reached out to the MSF HIV/TB project in Khayelitsha, which has been supporting access to new and re-purposed drugs for strengthening DR-TB treatment regimens since 2007. MSF donated a six month course of delamanid, helping to keep the patient on effective treatment, and on March 29th, 2019, the patient was declared cured.
“Given the scale and urgency of the DR-TB problem in South Africa and the limited tools that doctors and patients have to fight with, the registration of delamanid is something to be celebrated.” says Trivino-Duran.
“However, registration doesn’t equal access and the true celebration will come when delamanid becomes easily available for all those in need,” she says, adding that the demand for delamanid will have to be accurately established by the National Department of Health in order to ensure that sufficient stock is procured.
“The price of delamanid must also be addressed with the manufacturer, as it is currently very high at US$1700 (approximately R23,750) for a 6-month course, and this could limit the extent to which delamanid ultimately becomes available,” Trivino-Duran says.
A 2017 study estimated that the cost of generic delamanid, if the production of generic delamanid were allowed, could be up to 98% lower than the current pricing. *
“The push for access to delamanid has been a long one, with government playing a leading role. Having easy access to this drug will be another big step on the even longer road towards being able to offer patients a treatment regimen for DR-TB that is drastically shorter and more effective,” says Trivino-Duran.
Source -SA Breaking News