Dr Laura Waters is an HIV and sexual health consultant at the Mortimer Market clinic and the Boyz Doc. Dr Laura answers your questions every two weeks in Boyz. If you have a question for Dr Laura please email her at firstname.lastname@example.org.
Dear Dr Laura,
I’ve read online that due to a court case the cost of PrEP might be coming down, what’s the story and how will this effect the NHS?
Thank you for your timely question!
So, the medication we use for PrEP is a combination of 2 drugs in one tablet: tenofovir-disoproxil + emtricitabine, and the branded version of that is called Truvada. This is also available in various non-branded, or generic, versions from several manufacturers. The effectiveness of tenofovir/emtricitabine at preventing HIV is not under question (more than 90% effective if you take it correctly, see here how to take it: http://i-base.info/guides/prep) but there has been a lot of legal debate about the generic version of the drug that I will summarise.
It takes a lot of time, and costs a lot of money, to bring a new drug to market. A lot of drugs in early stages of development never turn into marketable (or profitable) products. At early stages of drug development, the company developing a drug will apply for a patent, which protects the drug from anyone else developing it. This allows the original company a protected period of time to sell the drug in question to ensure it gets back the money it invested. There is an option to extend patents but typically any drug will not be protected for more than 15 years.
Once a patent has expired, unbranded (or generic) versions can be produced and marketed. Generic drugs are the same as branded products but their appearance may differ (such as colour) and they may contain different ‘additional ingredients’ i.e. the non-drug bits of a pill. The same regulations apply to generic and branded products, and they are considered interchangeable. In the NHS around 70% of all prescribed drugs are generics and they are typically at least 70% less expensive than the branded versions, so have the potential to save the NHS a lot of money
When it comes to HIV drugs there are generics already in general use, although most prescribing is of branded products. This is because there have been a lot of improvement in HIV medication over the last decade or so, and some drugs that are available as generic are no longer considered acceptable for modern use. Truvada, in combination with other drugs, is very commonly used for HIV treatment, but is also used, on its own, for HIV prevention (PrEP).
Despite a lot of pressure from the community and specialists, HIV PrEP is not available routinely in England. You can access it privately, you can (legally) buy generic versions online, or you can access it via a trial called IMPACT. The trial provides generic drug rather than branded. So far there is no evidence that generic PrEP is any different to the branded version in that it works just as well and has the same side effect profile.
The law is far from black and white when it comes to branded vs generic medication, and earlier this year an application by more than one generic company to make generic tenofovir-disoproxil + emtricitabine (following an attempt by Gilead, the producers of the branded drug, to extend the patent) was referred to the European Court. The European Court suggested the generic companies did have the right to produce the medicine and bounced the decision back to the UK courts, who recently ruled in favour of the generic companies. In theory this means that generic tenofovir-disoproxil + emtricitabine will be available, for HIV prevention and treatment, within a few months. However, Gilead have the right to appeal this decision (I bet my mortgage they will!) and even then it’s not necessarily easy. The generic companies have to be able to provide a reliable supply drug. Based on other generic HIV medication this is not necessarily the case and we need to be cautious in how we roll out use of generic tenofovir-disoproxil + emtricitabine. If supplies are interrupted this can result in rebound of HIV and the development of drug resistance; rebound of the virus also means that people can pass the virus on to others. Having said that, the supplies of generics purchased online for PrEP have been very reliable to date.
Ultimately, assuming any appeal by Gilead is unsuccessful, we should have generic tenofovir-disoproxil + emtricitabine (Truvada) available for HIV treatment and prevention soon. This has the potential to save millions each year in terms of HIV treatment costs and for NHS England to make PrEP available routinely, not just through a trial. Watch this space!