Drug-resistant TB

DR-TB patients, activists demand registering generic linezolid

Phumeza Tisile, 23 years, takes her last pill for XDR-TB at Lizo Nobanda TB Care Centre, Khayelitsha. Photo:Sydelle WIllow Smith

Pretoria, 30 October - Three drug-resistant tuberculosis (DR-TB) patients-turned-activists, including Phumeza Tisile, Andaleeb Rinquest and Morgan Scholtz will be joined by health advocates in handing over a letter to the Registrar of Medicines signed by over 100 clinicians, organisations and patients with DR-TB. The letter demands the immediate registration of a generic version of linezolid, which has been under a significantly delayed fast-track review process since May 2013.

In June 2014, Doctors Without Borders (MSF) was granted special approval by the MCC to use generic linezolid in treatment regimens for its DR-TB patients in Khayelitsha near Cape Town. This enabled an 88% price reduction on the brand-name product that MSF had been purchasing.

However, the MCC has yet to approve the same generic product for national use, despite the dossier being under fast-track review since May 2013. According to MCC regulations, decisions should be made on fast-track dossiers within nine months; the deadline has long passed.

Currently, the national Department of Health does not provide linezolid for the treatment of DR-TB in the public sector, due to the high cost of the brand-name product manufactured by Pfizer - the only linezolid currently registered in South Africa. One 600mg pill costs over R700; patients like Andaleeb and Morgan, who can only purchase the drug through the private sector, pay up to R24,000 per month, for up to two years.

MSF MDR and XDR-TB patients meet weekly at the community-based DR-TB care facility Lizo Nobanda, located in Khayelitsha, a township outside Cape Town. Photo:Samantha Reinders

Since Pfizer’s patent on linezolid expired in August 2014, registration by the MCC is now the only barrier standing between XDR-TB patients and much more affordable linezolid alternative.

The MCC picket and letter handover coincides with the launch of MSF’s new report ‘Out of Step: Deadly implementation gaps in the TB response’, at the 45th Global Tuberculosis Symposium (28 Oct – 1 Nov) where Health Minister Aaron Motsoaledi is attending.

The report finds critical gaps in the DR-TB response in eight countries, including South Africa. One of the deadly gaps identified is the failure of countries to register key DR-TB drugs like linezolid in a timely manner. South Africa has one of the world’s highest DR-TB burdens, with 15,419 new cases diagnosed a year. In 2012, only 42% of these patients were placed on treatment, due in part to problems with implementing the country’s decentralised model of care for DR-TB, as well as the high cost and limited availability of DR-TB drugs.

Find out more about MSF in South Africa.