Durban - South Africa may finally allow access to a cheaper form of the drug-resistant tuberculosis drug linezolid following the lodging of a high court case.
At more than R700 for a daily pill, linezolid remains out of reach for most South African extreme drug-resistant (XDR) TB patients, including some on the programme.
International medical humanitarian group Medicins Sans Frontieres (MSF) procures linezolid for about R80 a pill for its patients.
To expand access to the drug, MSF has attempted, since last December, to appeal to the Medicines Control Council (MCC) to let it provide a cheaper, generic version to more patients.
After successive attempts, MSF has started litigation, although access campaign advocacy officer Julia Hill says she is hopeful that out-of-court negotiations will be successful by the end of this week.
In December, MSF applied to the council for special section 21 permission to provide a cheaper, generic version of linezolid to more patients based on the unaffordability of the currently registered brand-name.
Such an approval is used to allow limited use of an unregistered medicine for a short time.
Despite having granted similar section 21 approvals to MSF to allow the use of generic antiretrovirals in the past on the basis of unaffordability, the council rejected the application, claiming that affordability was not a consideration.
“We strongly disagree with the council’s reason for rejecting our application,” said Hill.
“The high price of linezolid is the main barrier to Medicines Sans Frontières providing greater access for our patients.”
“The council is compelled to progressively realise the constitutional right of everyone in South Africa to have access to healthcare services – especially for life-threatening conditions” such as drug-resistant TB, she added.
Medicines Sans Frontieres appealed against the decision in March, but because an appeal review committee had not been set up with in the statutory 30 days, Medicines Sans Frontieres has been forced to turn to litigation, according to Hill.
While she expected negotiations over the use of generic linezolid to bear fruit today, she said the council’s inconsistent judgments had highlighted the need for policy guidance to specify on what grounds section 21 access to drugs could be granted.
The government’s hopes of duplicating recent success as part of a small XDR-TB programme it has begun may rest on cheaper linezolid reaching more patients.
In March, the Department of Health began a programme to treat a small number of XDR-TB patients with the drug bedaquiline, which is not yet licensed for use in South Africa. The programme aims to produce additional data in hopes of compelling the council to approve it for wider use in South Africa.
The Department of Health director of drug-resistant TB, TB and HIV, Dr Norbert Ndjeka, said that most of the programme’s patients were also being treated with linezolid.
However, some patients have not had access to the drug because their provinces could not afford to pay for the expensive brand-name marketed by the pharmaceutical company Pfizer.
“There were two patients who were not also given linezolid because… there was not funding in their provinces to support that,” said Dr Francesca Conradie, who works on the programme with the NGO Right to Care. “To me, that is a tragedy.”
In 2012, South Africa diagnosed about 1 500 patients with XDR-TB, which is resistant to both commonly used anti-TB drugs as well as at least half the second-line medicines used to treat multidrug-resistant TB.
Less than half of these patients were on treatment.
According to Ndjeka, while TB cases continue to decline, he expects to see an increase in drug-resistant TB cases. He expects the Department of Health will diagnose more than 15 000 such cases next year alone.– Health-e News Service.