The HIV-prevention strategy PrEP (pre-exposure prophylaxis) has long been touted as a game changer. Through taking the drug Truvada, an HIV-negative person can near eliminate the risk of infection, giving particular hope to those with an HIV-positive sexual partner.
However, Truvada is not a cheap drug, and it has been subject to an intense pushback from funding bodies. According to NHS England, because PrEP is a preventative measure, it falls under the domain of public health, and therefore should be funded by local authorities. And while a High Court judgment at the beginning of August ruled otherwise, determining that PrEP could be legally commissioned on the NHS, NHS England is appealing the decision.
At the time of writing it is unclear which way the chips will fall. AIDS campaigners were “delighted” at the High Court ruling, with Deborah Gold, chief executive of the National AIDS Trust (NAT), calling it “vindication for the many people who were let down when NHS England absolved itself of responsibility for PrEP”.
On the other hand, if the drug is to be funded by the NHS, it will be dipping from the same pot of money as 146 different specialist services, which will force some agonising decisions. It will be competing, for instance, with rare cancers, life-threatening genetic disorders, and paediatric cystic fibrosis, none of which have preventative medications.
Prevention versus treatment
Anxious to avoid this kind of conflict, NHS England has asked Gilead, which manufactures Truvada, to submit its “best and final” price for the treatment. Should it lose its appeal, it will need to have a contingency plan, with a strategy for allocating its £15.6bn per year commissioning budget.
As David Fratoni, GlobalData’s analyst covering infectious diseases, explains, the issue is far from straightforward.
“On the surface, there appears to be a compelling argument for cost-savings generated by prescribing Truvada as a means of curtailing HIV transmission,” he says. “While providing Truvada to high-risk individuals would cost approximately £4,800 a year for each person, Atripla, which is currently the most prescribed HIV treatment for initial therapy in England, would cost an estimated £6,400 a year for each person being treated for HIV. But Atripla’s patent expiration is expected next year, which means that a cheaper version of the blockbuster drug will be available for newly infected HIV subjects.”
Around 4,000 people in the UK contract HIV every year (including an average of eight gay men a day). A further 103,700 people are living with the condition, each of whom costs a lifetime average of £360,000 to treat. This figure includes not just their drug regimens, but also psychological assistance and other interventions to improve their quality of life.
On top of this, there are thought to be around 10,000-15,000 people at very high risk of transmission. If PrEP is commissioned, the rates of infection among this group will most likely start to fall – according to the Centers for Disease Control and Prevention (CDC), when taken consistently PrEP has shown the ability to reduce their risk by up to 92%.
However, because Truvada used as PrEP has not yet been fully assessed for cost-effectiveness, it is unlikely that we will see wide uptake unless a clear cost benefit can be demonstrated. Once Atripla goes off patent, the health economics are likely to become hazier still.
“Ultimately, Gilead will play a fundamental role in what happens, as the cost of its preventative drug in England will potentially influence the outcomes,” says Fratoni.
In fact, a 2015 study found that PrEP would not necessarily be cost-effective unless Truvada’s price dropped significantly. Researchers at Public Health England calculated that at present-day prices, the cost per person of offering PrEP would exceed the cost of the HIV infections that would otherwise occur by £34,000.
Counting the costs
Given that preventing HIV in the first place is clearly more desirable than treating it, to what extent will Gilead now come under pressure to lower its costs, and what are the chances that the drugmaker will do so?
“Pricing is a multi-faceted process which involves multiple stakeholders, and there are several factors influencing these decisions,” says Fratoni. “Drug manufacturers are very often in the news because of the high prices of their products. However, drug development is an extremely long and expensive process, and very often promising candidates fail in clinical trials, resulting in a considerable loss of investments for companies. Gilead has weathered criticism of its HIV drug pricing schemes in the past, so it is difficult to foresee a drastic change in their pricing strategy for PrEP.”
He concedes that there is some hope for a cost reduction. Gilead recently marketed three novel HIV regimens (Genvoya, Odefsey, and Descovy) that may be positioned at a premium price relative to older brands. This strategy could ultimately result in pricing other products, such as Truvada for PrEP, more cheaply.
Prices haven’t come from nowhere
That said, the current pricing strategy has not arisen from nowhere. As Fratoni points out, companies such as Gilead are already paying close attention to market factors, and are fully equipped to assess and balance economic variables when setting the price of their drugs.
“Pharmaceutical companies are multi-structured environments composed of several departments, which work in conjunction and in alignment with external stakeholders to ensure that their cutting-edge products are best-positioned in the market,” he says. “In the last ten years, Health Economics and Outcomes Research (HEOR) has become increasingly important in healthcare, to the point where, when seeking for regulatory approval for new medicines, Health Outcomes and Real World Evidence are now considered as important as the outcomes of randomised clinical trials.”
The fate of PrEP is therefore somewhat up in the air. Although AIDS campaigners are still hopeful the drug will be funded, any potential commissioning is unlikely to take place for months. It may be that the final commissioning strategy is somewhat nuanced, with only a specific population receiving the drug for free.
Whatever happens, the decision will depend heavily on Gilead’s “best and final” price, alongside how much the NHS is prepared to prioritise PrEP over other services. For the thousands of people who could benefit, this is set to be a tense few months.