The health department says ViiV Healthcare’s newly announced nonprofit price — between R540 and R570 a shot — for a two-monthly anti-HIV jab is more than four times what it can afford to pay.
ViiV confirmed the price to Bhekisisa in an email; it was also shared with activists and donors earlier this month. The amount has come down from a previous tag of R729 a 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.
The jab, made by the UK-based drug company, essentially wipes out someone’s chances of contracting HIV through sex, if taken every eight weeks. The medication, which is injected into the buttocks, contains an antiretroviral drug, cabotegravir, that is released over a two-month period, which is why it’s called CAB-LA (short for long-acting cabotegravir).
Antiretroviral drugs are the same medication that HIV-infected people take to keep the virus at bay, but in the case of CAB-LA, it’s used as pre-exposure prophylaxis, also known as PrEP. In other words, the medication protects an uninfected person from contracting the virus.
Just over 13% of the South African population has HIV, according to the Thembisa model, 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 (about R570) a shot in 2023 and £23.50 (about R540) in 2024 to 90 countries that the World Bank classifies as having low- and middle-income status. This group includes all sub-Saharan African states, as well as donors who will buy it on behalf of most African countries. The jabs won’t be sold individually, but only in packs of 25 vials.
In the United States, ViiV sells CAB-LA for $3 700 (about R70 000, depending on the exchange rate) a pop; some health insurance companies pay for it upon a doctor’s prescription. The nonprofit price is therefore about 127 times cheaper than what a US customer would pay, but it is still more than four times what the health department pays for a daily HIV prevention pill (R64.50 for a month’s supply per patient, according to the department). The pill also lowers someone’s chances of infection significantly — but only if it’s taken each day, with which some people struggle.
“For CAB-LA to be cost effective to the South African 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,” says the national health department’s chief director of procurement, Khadija Jamaloodien.
Finance Minister Enoch Godwongana announced a R1 billion cut from the health department’s HIV treatment budget in his medium-term budget earlier this month.
“What’s more,” says Jamaloodien, “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 South African rands that includes transport and logistics, as we do with all our other tenders. We’re still waiting to hear back.”
Malawi, Zambia and Zimbabwe’s shipments on the way
One way of getting around CAB-LA’s high price is to allow donors such as 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 antiretroviral treatment in Africa and also funds oral PrEP in several African countries.
ViiV has already shipped Pepfar-sponsored supplies to Malawi, Zambia and Zimbabwe, which will arrive in late November, according to Mitchell Warren of the Coalition to Accelerate Access to Long-Acting PrEP. ViiV has confirmed the shipment to Bhekisisa, but not the donor or countries.
Warren, however, says the US government has confirmed that the stock was bought by Pepfar. The coalition is a group convened by Pepfar, the Global Fund, UNAids, Unitaid and the World Health Organisation; 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 also several South African HIV researchers, says Pepfar has told them that South Africa is on the list for donations for programmatic use in early 2024. But Pepfar told Bhekisisa it’s “not able to comment on this issue at this stage because we are still in a deliberative stage with the national health department and other stakeholders”.
The health department, however, says it is yet to decide if it will accept CAB-LA donations.
Jamaloodien explains: “It’s certainly not something we will outright refuse, but we also need to look at sustainability. South Africa, for instance, pays for all 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 (in other words, for research purposes). According to health department data, seven such trials will start as soon as the stock arrives and 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.
Implementation studies look at how well people adhere to treatment in “real life”, the best ways to get the medicine to them and how to create demand for a product (as opposed to whether the drug works, because implementation trials are done only after efficacy data has become available).
“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,” explains Linda-Gail Bekker, who will head up the Desmond Tutu Health Foundation’s implementation study.
“It’s pretty much the same as when people go to a public health facility to fetch medicines, with the difference that we carefully monitor the use of the medicine so that it can inform mass roll-out.”
Warren says 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 nonprofit 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 that we simply don’t yet know what the market size will be,” Warren explains. “That’s why we need all the implementation studies — to show us if the novelty experience and good uptake during efficacy trials translate into ‘real life’ uptake.”
Lesson from America
In the United States, where CAB-LA became available in late 2021, uptake has been slow, a small study presented at Infectious Diseases Week (an annual meeting of infectious diseases experts in the US) shows — 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’d like them to use it,” says 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 and so have to be given by a health worker. Couriering shots to users is therefore not feasible — unlike for the daily pill, says Bekker.
Over a million people in South Africa have used the pill, which was introduced in 2016.
“We need to think about PrEP like we think about fast food delivery,” says Bekker. “You’ve got drive-throughs, at-home deliveries or pick-up points. So there’s a choice in how you’d like it to get your fast food. The more delivery options, the higher the chance that you’d order it.”
Since August, following a North Gauteng high court ruling, HIV prevention pills can be handed out by trained pharmacists, so users no longer have to go to a doctor for a prescription.
Bekker concludes: “This makes enormous sense, as we’d want a variety of pick-up points to make access as easy as possible.”
Can South Africa 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 United Nations-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 get the technology in place (that process has started), build facilities and then, once they’ve produced the medicine, run trials that will prove their product works in the same way as the branded drug (this is known as bioequivalence trials).
Generic products will therefore become available in 2027, at the earliest, says Warren, which means until then, we need the price of the branded drug 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 [nonprofit] price could drop considerably. We believe within the next couple of years, the branded product could cost closer to $100 (about R1 830) or $120 (around R2 200) for a year’s injections [as opposed to the current $175 or R3 200—R3 400]”, Warren says.
CAB-LA is considerably more complex to make than oral PrEP, and the health department is able to get the pill at a low price because its ingredients (the antiretroviral drugs tenofovir and emtricitabine) are also widely used for HIV treatment in South Africa, so our tender allows for exceptionally large orders, which brings down the price.
Bekker, however, points out that CAB-LA’s affordability has two sides.
“We also have to say it’s very expensive for young women and men to become infected with HIV because we need to provide them with lifelong antiretrovirals, and there’s a risk that they can transmit the virus to others, and in the case of women, also to their babies.
“We need to ask what is the price tag for saving someone from an infection and therefore giving them a better handle on a healthy life.”
This story was produced by the Bhekisisa Centre for Health Journalism. Sign up for the newsletter.
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