Lenacapavir EAP in the UK closed to new referrals: NHS England and Gilead fail to agree a price after more than two years

20 April 2025. Related: Early access, Antiretrovirals, Treatment access, Drug resistance, BHIVA news.

Simon Collins, HIV i-Base

In early April, Gilead notified HIV doctors in the UK that the early access programme (EAP) for lenacapavir would now be closed to new participants. People already enrolled will be able to continue to access free drug. [1, 2]

BHIVA responded with a statement although this was so fae just to members and this is not yet online. [3]

Lenacapavir is a capsid inhibitor that was approved in 2022 as a treatment for people with multiple drug resistance. The EAP was set up for the small number of people who urgently needed access while discussions about pricing were still ongoing. [4]

EAP: to enable urgent short-term access

Since 2022, the EAP has steadily increased to now be providing lenacapavir free to about 30 people living with HIV on a case-by-case basis. However, this is also without any administrative charge that drug companies sometimes apply. [5]

Now more than two and a half years after UK approval, NHS England, who have had responsibility to commission lenacapavir for most of this time, have not only not agreed a price, but they also put this process on hold. There is no indication of a restart date.

Although NICE are generally responsible for approving all HIV drugs, NHE England sometimes takes on this role when the use is expected to be low, including for MDR HIV. This led NICE to defer the decision to NHS England in May 2023 to save NICE the costs involved for a full review. [6]

However, without NICE approval, NHS England are not required to provide access, even although the approval decision has now been transferred to NHS England.

Gilead say that this delay on agreeing a price is the reason the company has closed further access to the EAP. Gilead also say that the NHS can still technically purchase lenacapavir. This would be at at £17,653 for each 6-monthly injection plus approximately £2500 for the initial oral lead-in dose. but less an undisclosed discount that is not publicly available. [5].

Lenacapavir requires oral dosing for the first two days and is then given by subcutaneous injection every six months.

Options for urgent access now

The following options may still enable access to lenacapavir before the decision by NHS England, for people not already enrolled in the EAP.

• Contact NHS England with the clinical details supporting any cases requiring urgent, life-saving access to lenacapavir.
• Contact Gilead with the same details asking for an exception to their current decision.
• Apply using an Individual Funding Request (IFR). These are allowed when a policy is not in place and thre are no alternative options to meet an important clinical need. [11, 12]

comment

Although Gilead are continuing to provide treatment to people currently enrolled in the EAP it seems a short-sight decision to stop future enrolment given the low numbers involved when they could easily just make an administrative charge that approximates to the production cost for this drug.

|t is also not acceptable for NHS England to accept responsibility for approving access to a life-saving drug and to then for whatever reason, to delay and stop this process. 

The current price as a treatment for multidrug resistance HIV this is due to significantly drop when lenacapavir is approved as PrEP and is liekly to be similar to other injectable PrEP.

Lenacapavir has already been submitted to the US FDA and European Medicine’s Agency (EMA) for use as HIV pre-exposure prophylaxis (PrEP). MHRA approval in the UK usually follows within a month of EMA approvals. [7]

This leaves a short window for the current lenacapavir price, and such low likely demand that it is difficult to understand why they decided to stop the EAP now, however frustrating the current process has been. NICE has already started a scoping exercise for lenacapavir PrEP. [8]

If lenacapavir can be produced at significantly lower cost for PrEP then it will have similarly lower production costs for use as treatment. Gilead has also committed to a single price for both indications, although this price has not be disclosed.

The secrecy behind decisions on drug pricing is also not helpful, as is the lack of transparency for the costs of research, development and manufacturing. Although modelling for very widespread use in low- and middle-income countries, estimates for the price of generic lenacapavir drop to well under $100 per year. [9, 10]

.References

1. BHIVA social media post (bSKY). (4 April 2025)
   https://bsky.app/profile/bhiva.bsky.social/post/3llw3i7l4vk2a
2. Laura Waters. Gilead Sciences have ceased the lenacapavir compassionate access scheme in England. LinkedIn post. (4 April 2025).
   https://www.linkedin.com/posts/laura-waters-817a4479_gilead-sciences-have-ceased-the-lenacapavir-activity-7313159696717107200-LOYa
3. BHIVA. BHIVA statement on closure to new patients of the lenacapavir for highly treatment experienced (HTE) Individual Patient Access Scheme (IPS)
   email to members. (8 April 2025)
   Available on request or contact BHIVA directly..
4. Lenacapavir approved in the EU and UK to treat multidrug resistant HIV. HTB (1 September 2022).
   https://i-base.info/htb/43776
5. Gilead. Personal communication. (16 April 2025).
6. NICE. Lenacapavir for treating multidrug resistant HIV-1 [ID6196]. (May 2023)
   https://www.nice.org.uk/guidance/topic-selection/gid-ta11125
7. Lenacapavir submitted to the US FDA with an indication for HIV PrEP. HTB (1 January 2025).
   https://i-base.info/htb/49765
8. NICE. Lenacapavir for preventing HIV-1 in people aged 16 years or older ID6495. (5 March 2025).
   https://www.nice.org.uk/guidance/indevelopment/gid-ta11638
9. Lenacapavir could be produced for $40 a year: 1000-fold lower than current US price for treating MDR HIV. HTB (28 July 2024).
   https://i-base.info/htb/48224
10. Urgency of planning broad vaccine-like access to lenacapavir PrEP globally. HTB (13 October 2024.
    https://i-base.info/htb/49073
11. NHS England. Individual funding requests for specialised services: a guide for patients.
    https://www.england.nhs.uk/long-read/individual-funding-requests-for-specialised-services-a-guide-for-patients/
12. NHS England. Commissioning policy: individual funding requests Version 3. (8 February 2023).
    https://www.england.nhs.uk/wp-content/uploads/2017/11/B2086-commissioning-policy-individual-funding-requests-v3.pdf