- A high court in London ruled the National Health Service England must cover Gilead's Truvada-based pre-exposure prophylaxis (PrEP) regimen against HIV, since there was no legal or financial burden preventing the health provider from paying for the treatment.
- NHS England had argued it should not be responsible for funding PrEP given its preventative nature, and therefore does not fall under the provider's responsibility to cover treatments. Upon receiving the ruling, the healthcare provider appealed the decision.
- Last month, the Committee for Medicinal Products recommended approval of PrEP to the European Medicines Association (EMA). But NHS England protests the treatment could cost up to $26 million each year.
When PrEP was approved in the U.S., clinical and confirmatory studies showed that PrEP prevents HIV infection at a rate of 92% for at-risk individuals. For this reasons, HIV advocates like the National AIDS Trust, which brought the case against NHS England to court, have long rallied in support of the treatment.
The advocacy group cited another UK-based study, the Pre-Exposure Option for Reducing HIV in the U.K.: Immediate or Deferred (PROUD), which confirms the findings of the U.S.-based studies.
The PROUD study evaluated two treatment groups totaling 545 high-risk men, who had an average of 10 partners during a 90-day period. One group began the PrEP treatment immediately, while the other group delayed treatment by a year. Only three men in the first group became HIV-infected, compared with 19 men in the deferred-treatment 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, condemning NHS England's decision to appeal in a press release. "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.”
NHS England plans to appeal the decision, but in the meantime will partner with Public Health England to research how, and whether, coverage for PrEP could be justified in a clinically and cost-effective way. This includes considering other treatment options with similar results and lesser costs than PrEP, according to NHS England's press release on the decision.
If PrEP did succeed against other treatments, however, Gilead "will be asked to submit better prices, which would clearly affect the likelihood that their drug could be commissioned.”