New medicine combines ARVs into one pill, making them easier to supply.
The health department says it will provide close to a million more HIV-infected South Africans with antiretroviral (ARV) medication over the next two years through its introduction of single-dose pills from April 1.
According to the department’s chief director of procurement, Gavin Steel, single-dose or fixed-dose combination drugs – which combine three different ARVs in one pill – are considerably cheaper to distribute.
Health department economist Anban Pillay said his department also managed to negotiate “the lowest fixed-dose combination drug price in the world”, enabling the government to drastically expand its ARV programme. The department now pays between R89 and R95 a month for the treatment of a single patient, compared with R150 a month in 2010.
HIV patients must take a combination of at least three different ARVs in order for the drugs to be effective. Until last month, public sector ARV patients had to take three pills twice a day, as the state did not provide fixed-dose combinations. This sometimes led to patients not taking all their pills all the time.
“The fixed-dose combination is easier to take and takes up less shelf space in pharmacies and clinics. This will enable us to stock more medication at a time,” said Steel.
It has taken the government 10 years to put 1.9-million people on HIV treatment. With the new fixed-dose combination drugs, the department plans to put about 500000 new patients on ARVs each year over the next three financial years.
According to Steel, the lower ARV prices have resulted in savings of R2.2-billion, which is why the department “can therefore afford to put 907000 new patients over two years on ARVs in a much shorter time than previously”.
Pillay said the price of medication could soon decrease further should competition between manufacturers increase as expected.
“There are only three companies – Aspen Pharmacare, Cipla Medpro and Mylan Pharmaceuticals – licensed to provide fixed-dose combination drugs in South Africa, but two more have applied for permission to do so and these applications will have been processed in the next couple of months. This situation is likely to lead to a further drop in cost,” he said.
The government will only offer first-line treatment – the most efficient drugs with the least side effects – as a single pill. Initially, single pills will only be prescribed for pregnant and breastfeeding mothers, and new patients.
The new treatment will be introduced in six phases to give manufacturers enough time to produce the new pills.
Steel said that “everyone who needs and wants to be on the fixed- dose combination should have access by the end of September”.
Kevin Rebe from the Anova Health Institute’s Health4Men HIV clinic in Cape Town warned that the government would have to ensure it has strategies in place for sufficient ARV supplies in order to prevent a repeat of previous crises when stocks ran out. “Since this is a new drug in the South African state-sector ARV programme, manufacturers may not have enough buffer stocks on hand. But this problem can be managed through careful implementation.”
According to Steel, the 2013/2014 ARV tender has been split into multiple contracts in an attempt to prevent the nationwide ARV shortages experienced last year, so if one supplier runs out of drugs there would be several other contracted manufacturers that could provide stock.
He said extra measures had been taken to ensure sufficient drug supply. These included monthly meetings with pharmaceutical companies weekly reports from provincial health departments.
The state’s plan aims to have 80% of HIV patients who qualify for treatment according to government guidelines on ARVs by 2016.
“The plan estimates that 3.6-million people will need HIV treatment by 2016. That means that we will have to double the number of people on treatment,” said Section27 head Mark Heywood.
He said that the government would have to improve its ability to keep accurate records of ARV patients.
“I don’t trust the monitoring systems used to track the ARV programme. When it comes to the treatment programme, the government should publish new figures quarterly detailing the number of people on treatment, how many men, how many women and the number of people retained in care.”
Heywood warned that fixed-dose combination pills can either strengthen or weaken the health system. “With the individual ARV drugs, if there is a shortage of one ARV, then people can still take the other two drugs, though it’s not ideal. However, if there’s a stock-out of the fixed-dose pill, then patients will have no recourse.”