Litigation threat may prompt access to cheaper DR-TB drug
South Africa may finally allow access to a cheaper form of the drug-resistant tuberculosis (DR-TB) drug linezolid following the lodging of a high court case.
At more than R700 per daily pill, linezolid remains out of reach for most South African extensively drug- resistant (XDR-TB) patients.
To expand access to the drug, MSF has attempted since December 2013 to appeal to the Medicines Control Council (MCC) to let it provide a cheaper, generic version to more patients. After successive attempts, MSF has begun litigation although MSF Access Campaign Advocacy Officer Julia Hill says she is hopeful that current out-of-court negotiations will be successful by the end of this week.
In December MSF applied to the MCC 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 would be used to allow limited use of an unregistered medicine for a short period of time.
Despite having granted similar past Section 21 approvals to MSF to allow the use generic antiretrovirals on the basis of brand name unaffordability, the MCC rejected MSF’s application, claiming that affordability was not a consideration.
“We strongly disagree with the MCC’s reason for rejecting our application,” said Hill in a statement released late Wednesday. “The high price of linezolid is the main barrier to MSF providing greater access for our patients.”
“The MCC 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 DR-TB,” she added.
MSF appealed the decision in March but because an appeals review committee had not been set up with in the statutory 30 days, MSF has been forced to turn to litigation, according to Hill.
While she expects current negotiations over the use of generic linezolid to bear fruit by Friday, she said the MCC’s inconsistent judgments have highlighted the need for policy guidance to specify on what grounds special or Section 21 access to drugs may be granted.
Government officials inaccurately indicated that MSF had obtained access to generic Linezolid Wednesday night at the SA TB Conference. They also admitted that South Africa would never be able to afford widespread use of the Pfizer drug at current pricing.
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 multi-drug resistant TB.
Less than half of these patients were ever started on treatment. According to Department of Health Director of DR-TB, TB and HIV Dr. Norbert Ndjeka, while TB cases continue to decline he says drug-resistant TB is growing.
He expects the Department of Health will diagnose more than 15,000 such cases next year alone.
Linezolid may be key to government programme success
Meanwhile, government’s hopes of duplicating recent successes as part of a small XDR-TB programme it has begun may rest on cheaper linezolid reaching more patients.
In March 2014, the Department of Health began a programme to treat a small number of extensively drug-resistant 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 MCC to approve it for wider use in South Africa.
The programme’s early results show that more patients are getting better faster and Ndjeka said that such results would not been impossible with currently registered XDR-TB treatment alone.
Speaking at the on-going South African TB Conference, Ndjeka also admitted that most of the programme’s patients are also being treated with linezolid. However some programme patients have not been able to access 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 not because…there was not funding in their provinces to support that,” said Dr. Francesca Conradie, who works on the programme with the nongovernmental organisation Right to Care. “To me, that is a tragedy.” – Health-e News Service.