BHEKISISA | 'Cut the price by three-quarters' says government on anti-HIV jab
The health department says ViiV Healthcare’s newly announced non-profit price — between R540 and R570 per 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 via email; it was also shared with activists and donors earlier this month. The amount has come down from a previous tag of 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.
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, released over two months, which is why it’s called CAB-LA (short for long-acting cabotegravir).
Antiretroviral drugs are the same medication 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 more than 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 (R570) per shot in 2023 and £23.50 (R540) in 2024.
The World Bank classifies 90 countries 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 in packs of 25 vials.
In the US, ViiV sells CAB-LA for $3,700 (R70,000). Some health insurance companies pay for it on a doctor’s prescription. The non-profit price is therefore about 127 times cheaper than what a US customer would pay, but it is still more than four times higher 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). 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 with 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 R1bn cut in the health department’s HIV treatment budget in his medium-term budget statement earlier this month.
“What’s more,” said Jamaloodien, “is ViiV’s non-profit price doesn’t include distribution costs, so it will be higher than the quoted R540 — R570 per vial.
“We’ve asked ViiV for a quote in rand that includes transport and logistics, as we do with all our other tenders. We’re still waiting to hear.”
In the bag: Malawi, Zambia and Zimbabwe’s shipments are 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 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 World Health Organisation; Avac, the New York-based advocacy group which Warren heads, 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 has told them 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 because we are still in a deliberative stage with the national health department and other stakeholders”.
The health department, however, said it is yet to decide if it will accept CAB-LA donations.
“It’s not something we will outright refuse, but we also need to look at sustainability,” Jamaloodien said.
“South Africa, for example, 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? Implementation studies will tell us
In early 2024, South Africa will receive ViiV-sponsored CAB-LA shipments that will be used in implementation studies (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 in all the ups and downs of a ‘real life’ health system,” said Linda-Gail Bekker, who will head the Desmond Tutu Health Foundation’s implementation study.
“It’s the same as when people go to a public health facility to fetch medicines, with the difference that we monitor the use of the medicine so it can inform mass roll-out.”
Warren said ViiV 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 don’t yet know what the market size will be. That’s why we need the implementation studies — to show us if the novelty experience and good uptake during efficacy trials translate into ‘real life’ uptake.”
Lesson from America: Make CAB-LA easy to get
In the US, 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 you need to make it easy for people to get preventive medication if you’d like 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 and so have to be given by a healthworker. Couriering shots to users is therefore not feasible — unlike for the daily pill, said Bekker.
More than 1-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,” said Bekker. “You’ve got drive-throughs, at home deliveries or pickup 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 you’d order it.”
Since August, after 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.
“This makes enormous sense as we’d want a variety of pickup points to make access as easy as possible,” said Bekker.
Can South Africa afford to go without CAB-LA?
In March, ViiV awarded licenses 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 access 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 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, said 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 such as Pepfar, the Global Fund and governments such as South Africa, the [non-profit] price could drop considerably. We believe within the next few years the branded product could cost closer to $100 (R1,830) or $120 (R2,200) for a year’s injections [as opposed to $175 (R3,200 — R3,400) now],” Warren said.
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 CAB-LA’s affordability has two sides.
“We also have to say it’s 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 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.”
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