Q and A

Question

When will long-acting injections be available in the UK?

Hi, do you know when injectable  monthly medications and implants will become available in the UK? A doctor at a workshop I attended in November 2017 suggested it could be 2018.
Is this realistic?

Answer

Hi

Thanks for your question as this is something lots of people are interested in. A friend even asked me this yesterday.

Unfortunately, 2018 sounds optimistic, unless you are already taking part in a research study. Regular approval on the NHS will probably not be until 2019 or more likely 2020.

Sometimes the timeline for drug development is difficult to predict. Research often takes longer than expected. As well as the early research this involves large phase 3 studies that usually need at least a year of results. Then the regulatory agency (ie the FDA in the US or EMA in Europe) takes 6 to 9 months to decide if the drug is safe and effective. In the UK, the NHS then takes another 6 to 12 months (at least) to decide if it will pay for the drug.

Currently, the phase 3 studies for long-acting cabotegravir plus rilpivirine are still ongoing. According to listed information online, the ATLAS and FLAIR studies are now fully enrolled. The first results are expected in June and September 2018, respectively. The company then needs several few months to compile the results. This means, if good, the regulatory agencies are unlikely to start evaluating long-acting injections until late 2018/early 2019. If approved later in 2019, the NHS will take at least until 2020 to decide if they will pay for access.

Links to each of these phase 3 studies is below:

Update (April 2019)

The main results from both the ATLAS and FLAIR studies were presented at CROI 2019. This means that submission to FDA and EMA for drug approval is expected shortly.

Phase 3 results with dual therapy cabotegravir/rilpivirine long-acting injections: ATLAS and FLAIR studies
http://i-base.info/htb/35812

Named-patient/expanded access programmes are also now available for both long-acting formulations.
Cabotegravir LA – expanded access programme.
Rilprivirine LA – expanded access programme.

This answer was updated in April 2019 from an original Q&A posted in January 2018.

8 comments

  1. Roy Trevelion

    Hi Anonymous,

    As Simon says above, the long-acting injectables have been or will shortly be submitted for approval in the US and Europe.

    But you could contact the Treatment Action Campaign to ask about availability in South Africa.

  2. anonymous

    Hello . I would like to ask if the long-acting HIV drugs are available in SOUTH AFRICA?.

  3. Lisa Thorley

    Hi Matthew,

    As of yet the injectable ARV isn’t available, It is still in the development stages.

  4. Matthew

    Hi..
    Is the injectable ARV available in South Africa.. And if privately so at pharmacies.. And what are the costs?

  5. Simon Collins

    Hi Sam, it is good to ask your doctor about whether your hospital is a site for these studies. Both the ATLAS and FLAIR studies are international, and the links in the main answer above includes a list of countries and hospitals that are sites. Unfortunately, Uganda isn’t listed but there might be other studies I do not know about.

  6. Sam

    I was reading in Uganda there is an approved injection trial underway ? Do you have any updates or additional information . Is this permanent or just another trial ?

  7. Simon Collins

    Hi Sam

    The hope is that it will be priced as comparable to current combinations.

    Most companies only decide the price after a drug is approved. This then varies between different countries and even within the same country. So in the UK, a company has to submit a tender for each of the seven main health regions and access can sometimes be different.

    In the UK, all companies now realise that if they premium price (is charge more for a new drug) that their new drug would not be used. So in recent years, new HIV drugs have been priced roughly similar to existing drugs. In some cases, this even allows for the lower prices of generic drugs that might be used in the combination.

    Most new drugs will always be available for some people, but the lower the price, the easier it will be to make them widely available as a choice for everyone. This would be a much better strategy for the company as there are a lot of people who are interested in an alternative to daily pills.

    These injections are being developed by ViiV Healthcare who recently priced the dolutegravir fixed dose combination Triumeq to allow for the fact that the other two drug in the pill are now available as cheaper generics. That is an indication that access might be possible.

  8. Sam

    Does any medical professional know if injecting treatments will be cheaper than pills for the NHS ?
    Obviously if more expensive …NHS will not approve it .

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