Government is fuming over the newly announced price of the two-monthly anti-HIV injection from Viiv Healthcare, calling its non-profit price – between R540 and R570 per shot –exorbitant.
The amount has come down from the previous R729 per jab, which wasn’t officially announced by ViiV, but was, for the past year, widely regarded as the agreed-upon price by influential scientists and policymakers, writes Mia Malan for Bhekisisa.
The injection, made by the UK-based drug company, essentially wipes out someone’s chances of contracting HIV through sex if taken every eight weeks, and contains the ARV drug cabotegravir that is released over a two-month period – hence CAB-LA (short for long-acting cabotegravir).
Just more than 13% of the South African population has HIV and an estimated 164 228 people were infected with the virus in 2022.
ViiV is selling CAB-LA, which was registered with South Africa’s medicines regulator in December 2022, at £24.70 per shot in 2023 and £23.50 in 2024 to 90 countries that the World Bank classifies as having low- and middle-income status. This includes all Sub-Saharan African states, as well as donors who will buy it on behalf of most African countries.
The jabs will be sold in packs of 25 vials.
In the US, ViiV sells CAB-LA for $3 700 a pop. The non-profit price is therefore about 127 times cheaper than what a US customer would pay, but it is still four times more, at least, than what the health department pays for a daily HIV prevention pill (R64.50 for a month’s supply per patient, according to the department).
“For CAB-LA to be cost-effective to the government, the price would need to be within a reasonable range of oral PrEP (the daily pill), which is R129 for a two-month supply. We can’t afford to pay double or thrice the price, especially not within the context of the budget cuts our department has faced,” said the national Health Department’s chief director of procurement Khadija Jamaloodien.
“What’s more,” she added, “is that ViiV’s non-profit price doesn’t include distribution costs, so it will be even higher than the currently quoted R540-R570 per vial. We’ve asked ViiV for a quote in rands that includes transport and logistics, as we do with all our other tenders. We’re still waiting to hear back.”
One way of getting around CAB-LA’s high price is to allow donors like the US Government’s President’s Emergency Plan for Aids Relief (Pepfar) to pay for it. Pepfar has paid the most of any government donor for ARV treatment in Africa and also funds oral PrEP in several African countries.
ViiV has already shipped Pepfar-sponsored supplies to Malawi, Zambia and Zimbabwe, to arrive later this month, said Mitchell Warren of the Coalition to Accelerate Access to Long-Acting PrEP.
ViiV has confirmed the shipment, but not the donor or countries.
However, Warren said the US Government has confirmed to the coalition that the stock was bought by Pepfar. The coalition is a group convened by Pepfar, the Global Fund, UNAids, Unitaid and the WHO; Avac, the New York-based advocacy group which Warren heads up, is the secretariat.
Between 2023 and 2025, Malawi is expected to receive 10 000 jabs, Zimbabwe between 10 000 and 12 000, and Zambia between 8 000 and 10 000. The stock will be used by government health programmes and not for research.
Warren, and several South African HIV researchers, said Pepfar had told them that South Africa was on the list for donations for programmatic use in early 2024.
But Pepfar told Bhekisisa it’s “not able to comment …at this stage because we are still in a deliberative stage with the health department and other stakeholders”.
The Health Department, however, said it was yet to decide if it would accept CAB-LA donations.
Said Jamaloodien: “It’s certainly not something we will outright refuse, but we also need to look at sustainability. South Africa, for instance, pays for all of its antiretroviral drugs for HIV treatment itself, and we still have to consider what route we will follow with CAB-LA.”
Will people use the jab?
In early 2024, South Africa will receive ViiV-sponsored CAB-LA shipments that will be used in implementation studies – or for research purposes. According to health department data, seven such trials will start as soon as the stock arrives, which has been approved for distribution by the South African Health Products Regulatory Authority.
The studies will be carried out by the Wits Reproductive Health Research Institute and Ezintsha at Wits University, the Africa Health Research Institute at the University of KwaZulu-Natal, the Desmond Tutu Health Foundation at the University of Cape Town, the South African Medical Research Council and the Human Sciences Research Council.
“We’ll count how many people come for CAB-LA, check which groups are using it, who struggles, and how people adhere to it within the context of all the ups and downs of a ‘real life’ health system,” said Professor Linda-Gail Bekker, who will head up the Desmond Tutu Health Foundation’s implementation study.
Warren said ViiV has told the coalition it will be able to make 995 000 CAB-LA jabs for low- and middle-income countries between 2023 and 2025 at its non-profit price (up from a previous commitment of between 360 000 and 590 000 vials).
“It’s still short of what we think the market might be, but the reality is we simply don’t yet know what the market size will be,” Warren said.
Lesson from America
In the US, where CAB-LA became available in late 2021, uptake has been slow, mainly because of the high cost and the complicated admin of health insurance companies.
Only slightly more than half (52.9%) of HIV-negative study participants who got a prescription for CAB-LA followed through to get their first injection.
“An important lesson to learn from this is that you need to make it easy for people to get preventive medication if you want them to use it,” said Bekker. “We may need to take CAB-LA into communities with mobile clinics or create separate, fast lines at clinics.”
CAB-LA jabs need to be injected deep into someone’s muscles, so have to be given by a health worker. Couriering shots to users is therefore not feasible – unlike for the daily pill, she said.
More than 1m South Africans have used the pill, which was introduced in 2016.
Since August, after a Gauteng High Court ruling, HIV prevention pills can be handed out by trained pharmacists, so users no longer have to visit a doctor for a prescription.
Can SA afford to go without CAB-LA?
In March, ViiV awarded licences to three Indian drugmakers to produce cheaper, generic versions of CAB-LA in collaboration with the Medicines Patent Pool, a UN-backed organisation that helps poorer countries to get access to medicines. One of the companies, Cipla, has a plant in Durban, where they’re planning to manufacture the jab.
But for this to happen, Cipla first needs to get the technology in place (that process has started), build facilities and then, once it has produced the medicine, run trials that will prove its product works in the same way as the branded drug (bioequivalence trials).
Generic products will therefore become available in 2027, at the earliest, said Warren, which means until then, the price of the branded drug needs to be as low as possible.
“ViiV has indicated that as volumes go up, and they get orders from large buyers like Pepfar, the Global Fund and governments like South Africa, the [non-profit] price could drop considerably. We believe within the next couple of years, the branded product could cost closer to $100 or $120 for a year’s injections, as opposed to the current $175.”
See more from MedicalBrief archives:
HIV prevention pill uptake in SA climbs to 1m users
Generics green-light for new HIV drug, but Africa peeved
Start planning cabotegravir injection rollout, say SA experts
Cipla to produce anti-HIV injection in Benoni, Durban