The Scottish Medicines Consortium (SMC) today announced that it had accepted tenofovir disoproxil/emtricitabine (TDF/FTC – Truvada) for use within the Scottish National Health Service as pre-exposure prophylaxis (PrEP) to prevent HIV infection.
It made the announcement in one paragraph of its April 2017 decisions press release. This says that Truvada “was accepted to help prevent sexually transmitted HIV-1 infection in adults who are at high risk of being infected. Emtricitabine / tenofovir disoproxil given as PrEP is one aspect of an HIV-prevention strategy and should be used in combination with safer sex practices such as using condoms."
It added that “Patient groups highlighted that current prevention methods have not managed to reduce the spread of HIV in Scotland over the last ten years.”
George Valiotis of HIV Scotland told aidsmap.com: “The decision was effectively taken a month ago when a public meeting made the recommendation to SMC that they should accept PrEP, but each SMC board member has then to go away and vote on it privately, so the official announcement was not made till today."
The next step, he said, is that SMC staff will now contact the budget holders of the 14 local Health Boards in Scotland to install a budget line for PrEP and ensure the money is there to pay for it.
Valiotis added: “There is no real deadline for this, but in practice it should not take more than three months to get everything in place. I doubt you could go to your sexual health clinic today to get PrEP, but in some of the larger health boards it could be available sooner."
A PrEP In Scotland paper written by the PrEP Short Life Working Group (SLWG) of the Scottish Health Protection Network (SHPN) in October 2016 calculates that there are approximately 1700-1900 men who have sex with men (MSM) in Scotland who would benefit from PrEP. If 58% of those eligible for PrEP start it, this would imply about 1000 people come forward for PREP in the first year.
There were an average of 359 HIV diagnoses per year in Scotland over the last five years; if PrEP is as effective as it was in the PROUD study, this rate of uptake implies that 179 of those, or almost exactly 50%, could be prevented. Scotland’s health boards vary hugely in size from Glasgow’s 1.1 million to Orkney’s 21,000 and it is likely that there may be little or no demand for PrEP in some rural areas, Valiotis commented.
The criteria recommended by the SLWG for eligibility for PrEP is having an HIV-positive sexual partner with an unsuppressed viral load, condomless anal intercourse with two or more partners in the past year, or diagnosis with a rectal sexually transmitted infection (STI). However, the paper recommends that “PrEP should be considered for all individuals whose circumstances place them at the highest risk of HIV acquisition, as agreed with another specialist clinician”, though says that risk data were very limited for other groups. It estimates that no more than 5% of those eligible for PrEP are likely to be non-MSM or non-transgender women. It specifically excludes people in monogamous relationships with an HIV-positive partner with an undetectable viral load, as well as people with conditions such as renal impairment that could be worsened by Truvada and people with chronic hepatitis B who might need the drug for treatment.
The cost of Truvada, whose list price is currently £4268.76 per person per year in the UK (though most health boards and English NHS Trusts will in practice pay substantially less), is likely to be about £4 million in the first year, though this may fall substantially if generic tenofovir/emtricitabine becomes available. The SLWG estimates that the additional cost of PrEP in the first year for 1000 people, over and above the cost of STI clinic provision already in place, will be £175,000 or only about 4% of the total cost of PrEP. NHS Scotland will also offer MSM the choice between daily dosing or intermittent dosing on the Ipergay regimen, which could bring costs down further.