A London high court ruled that England’s National Health Service (NHS) must cover Gilead’s HIV treatment. The pre-exposure prophylaxis (PrEP) drug – called Truvada – has a 92 percent success rate of preventing HIV infection in those individuals who are at-risk of being exposed to the virus.
As the PrEP is a preventive drug, the NHS argued that it should not be required to cover a patient’s costs associated with the treatment. However, the court ruled that the treatment must be covered by the NHS because no barriers – whether financial or legal – stand in the way of them paying for the drug. The NHS has since appealed the court’s ruling.
In July, the PrEP was recommended for approval by the Committee for Medicinal Products – a division of the European Medicines Agency (EMA) – however, the treatment could be costly. The NHS estimates that the drug could cost as much as $26 million per year.
Because of its effectiveness at preventing HIV infection, the National AIDS Trust, amongst other HIV advocacy groups, are great supporters of the treatment. While the HIV prevention data for Truvada comes from clinical trials conducted in the US, a UK-based study – known as the Pre-Exposure Option for Reducing HIV in the U.K.: Immediate or Deferred (PROUD) – has also confirmed the efficacy of the drug.
A total of 545 at-risk men took part in the PROUD study, which evaluated the efficacy of immediate or delayed treatment with the PrEP. The first treatment group began receiving Truvada immediately, while the second group waited to begin treatment a year after the study commenced. The study investigators found that three high-risk men in the first treatment group became infected with HIV, compared to 19 men in the second group.
“Over 4,000 people are getting HIV every year in the UK—we desperately need further prevention options to add to condom use,” said Deborah Gold, Chief Executive of the National AIDS Trust. “PrEP works. It saves money and it will make an enormous difference to the lives of men and women across the country who are at risk of acquiring HIV. The delay to commissioning PrEP is both unethical and expensive.”
Though the NHS will appeal the decision, it plans to investigate how PrEP could be covered in a cost-effective manner through its partnership with Public Health England. According to a press release issued by the health provider, the NHS will also consider less-expensive treatments with similar clinical results. Should these alternative treatments come up short, Gilead “will be asked to submit better prices, which would clearly affect the likelihood that their drug could be commissioned.”