Major Setback for HIV Prevention: NICE Rejects Funding for Groundbreaking Injectable PrEP on NHS

London, UK – October 2026 – The fight to eliminate new HIV transmissions in England by 2030 has been dealt a significant blow, following an initial recommendation by the National Institute for Health and Care Excellence (NICE) against the routine use and reimbursement of Gilead’s revolutionary twice-a-year injectable HIV pre-exposure prophylaxis (PrEP), lenacapavir (marketed as Yeytuo), on the NHS. This preliminary decision has ignited a fierce backlash from leading HIV charities, who describe it as a "profound disappointment" and a "missed opportunity" to leverage the most significant innovation in HIV prevention in years.

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While not yet final, NICE’s draft guidance states that lenacapavir does not represent "value for money" for the NHS in preventing HIV in adults and young people at high risk of contracting the virus. This stance, coming less than a year after the drug received regulatory approval in the UK, casts a shadow over the potential for enhanced access to long-acting prevention methods and could impede the nation’s ambitious public health targets.

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A Setback for HIV Prevention: NICE’s Initial Stance

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NICE’s evaluation committee, tasked with assessing the clinical and cost-effectiveness of new treatments and technologies for the NHS, issued a draft recommendation stating that lenacapavir should not be used as a PrEP option. The drug, which requires only two injections per year, was heralded upon its regulatory approvals as a potential game-changer due to its ability to significantly improve adherence compared to daily oral PrEP regimens.

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Lenacapavir, known under the brand name Yeytuo for PrEP, is designed to reduce the risk of HIV-1 virus multiplying and spreading throughout the body after exposure. Its unique mechanism of action involves binding to the virus’s outer layer, interfering with multiple crucial steps in the viral lifecycle. This innovative approach promises a discreet and highly effective method of prevention, offering a welcome alternative for individuals who struggle with daily pill-taking or prefer a less frequent intervention.

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This initial recommendation effectively means that, if upheld, NHS England would not be required to fund Yeytuo, preventing its routine availability to those who could benefit most. The decision has sparked widespread concern among public health advocates who argue that limiting access to such a powerful tool could hinder progress toward the government’s target of ending new HIV transmissions by the end of the decade.

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Chronology of Approvals and Expectations

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The journey of lenacapavir towards becoming a cornerstone of HIV prevention has been marked by a series of global regulatory successes, building high expectations for its widespread adoption.

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Global Recognition: FDA and EC Approvals

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The scientific community and public health bodies worldwide have keenly anticipated the impact of long-acting injectable PrEP. Lenacapavir first received significant international recognition in June 2025 when the US Food and Drug Administration (FDA) approved its twice-yearly treatment under the brand name Yeztugo for PrEP. This was followed swiftly in August of the same year by the European Commission (EC) granting approval for Yeytuo across the European Union, further solidifying its global standing as a groundbreaking prevention method. These approvals underscored the drug’s robust clinical profile and its potential to transform HIV prevention strategies on an international scale.

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UK Regulatory Green Light: MHRA Approval

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The momentum continued into the UK, where the Medicines and Healthcare products Regulatory Agency (MHRA) followed suit in December 2025, approving the PrEP formulation of lenacapavir. This approval, coming after an earlier UK authorisation in 2022 for a different formulation of lenacapavir (Sunlenca) for the treatment of multi-drug resistant HIV infection, was widely celebrated. Public health experts and patient advocates hailed Yeytuo’s approval as a "momentous step" for HIV prevention in the UK.

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The excitement stemmed from the drug’s potential to address a critical challenge in PrEP effectiveness: adherence. While daily oral PrEP has proven highly effective, its real-world impact is often limited by individuals struggling to take a pill every day. A twice-yearly injection offers a solution to this, potentially reaching more people, including those from vulnerable communities who might face stigma or practical barriers to daily medication. The MHRA’s approval set the stage for lenacapavir’s integration into the NHS, creating a sense of optimism that has now been tempered by NICE’s draft decision.

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The Core of the Disagreement: NICE’s Rationale and Unanswered Questions

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NICE’s role is to evaluate health technologies to ensure they are both clinically effective and a good use of taxpayer money. Their decision-making process, known as Health Technology Assessment (HTA), typically weighs clinical benefits against cost-effectiveness, often using metrics like Quality-Adjusted Life Years (QALYs). In this instance, NICE’s committee concluded that lenacapavir did not meet the necessary threshold for "value for money."

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Value for Money and Clinical Uncertainties

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The core of NICE’s argument rests on its assessment of the available evidence. While acknowledging that lenacapavir reduces the risk of HIV more effectively than current oral counterparts, the committee pointed to several "uncertainties in clinical evidence." These include:

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• Trial Population Reflection: Concerns were raised regarding how well the population studied in lenacapavir’s clinical trials reflects the diverse demographics and specific needs of the UK population at high risk of HIV. This is a common challenge in HTA, as trial data, while robust, may not always perfectly translate to real-world national health systems.

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• Expected HIV Incidence: NICE questioned the projections on how many people at high risk of acquiring HIV, and who are not currently on PrEP, would be expected to contract the virus. Accurate modelling of this baseline risk is crucial for determining the incremental benefit and cost-effectiveness of a new prevention method.

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• Comparison with Existing Options: NICE highlighted the breadth of existing PrEP options, including GSK’s Apretude (cabotegravir). It is important to note that cabotegravir, another long-acting injectable PrEP option requiring injections every two months, was recommended by NICE for NHS use in March 2023. This precedent makes NICE’s hesitancy regarding lenacapavir, a six-monthly injection, particularly perplexing to patient advocates and further fuels the charities’ disappointment. The availability of an existing injectable option might lead NICE to scrutinise the incremental benefits and cost-effectiveness of a second long-acting injectable more rigorously.

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Economic Modelling and Broader Context

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Beyond clinical data, NICE also raised questions about the economic modelling submitted by Gilead. These included:

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• Patient Favourability: The models may not have sufficiently captured the true extent of patient preference for a less frequent injectable option over daily oral PrEP, or even over a two-monthly injectable. The convenience and discretion offered by a twice-yearly regimen are significant factors for many individuals, potentially leading to higher uptake and better adherence in the real world, which in turn could lead to greater public health benefits.

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• HIV-Impacted Quality of Life: NICE sought more clarity on how the economic models measured the impact of HIV prevention on the quality of life for individuals and society. Preventing an HIV infection not only saves lives but also avoids significant long-term healthcare costs and improves overall societal well-being, factors that should be robustly incorporated into cost-effectiveness analyses.

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NICE’s rigorous approach is designed to ensure responsible allocation of NHS resources. However, the perceived disconnect between a highly effective, innovative drug and its perceived lack of "value for money" has sparked a contentious debate about the parameters of such assessments, especially when dealing with preventative medicines that have far-reaching public health implications. The pricing strategy adopted by pharmaceutical companies plays a critical role in these evaluations, and it appears that Gilead’s proposed price for Yeytuo did not align with NICE’s cost-effectiveness thresholds, particularly given the availability of other PrEP options.

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Unanimous Disappointment: Official Responses from HIV Charities

The initial recommendation from NICE has been met with a wave of profound disappointment and strong criticism from leading HIV charities and advocacy groups across the UK. Their responses underscore a collective belief that this decision represents a significant step backward in the nation’s efforts to combat HIV.

Richard Angell OBE, Chief Executive of the Terrence Higgins Trust, one of the UK’s largest HIV and sexual health charities, minced no words: "We are profoundly disappointed by this initial decision by NICE. Twice-a-year injectable PrEP is the most exciting innovation in HIV prevention for years. PrEP is a gamechanger for HIV prevention and innovations like this must be jumped on and maximised – not kicked into the long grass and squandered." Angell’s statement reflects the deep frustration that a cutting-edge medical advancement, globally recognised for its potential, might be withheld from those who need it most in the UK. He emphasised the transformative potential of such infrequent dosing, highlighting its ability to overcome adherence barriers and reach individuals who might not engage with daily oral regimens.

Echoing this sentiment, Daniel Fluskey, Director of Policy at the National AIDS Trust, articulated the financial dimension of the disappointment. "We are deeply disappointed with the news today that a significant new HIV prevention drug will not yet be made available because of the failure to agree an affordable price," Fluskey commented. His statement directly implicates the negotiation process between Gilead and NICE, suggesting that the impasse is primarily financial rather than purely clinical. He stressed the broader societal benefits of preventing HIV, which extend far beyond individual health outcomes.

Both charities collectively highlight the urgency and shared vision for a future free from new HIV transmissions. They see lenacapavir not just as another drug, but as a strategic tool that could significantly accelerate progress towards the UK Government’s ambitious 2030 target. Their strong reactions underscore the high stakes involved and the perceived misalignment between NICE’s assessment and the broader public health imperative.

Implications for the UK’s 2030 HIV Elimination Goal

The UK Government has set an ambitious and commendable target: to end new HIV transmissions and AIDS-related deaths in England by 2030. This goal requires a multi-faceted approach, encompassing robust testing, rapid treatment initiation, and comprehensive prevention strategies, including widespread access to PrEP. NICE’s draft recommendation regarding lenacapavir could have significant repercussions for achieving this target.

The Current Landscape of HIV in the UK

The latest available data indicates the scale of the challenge. In 2023, there were 6,402 new diagnoses of HIV in the UK, and 107,949 people were receiving HIV care. While significant progress has been made in reducing new diagnoses in recent years, reaching the "zero new transmissions" goal requires sustained and intensified effort. This means ensuring that all effective prevention tools are readily available and accessible to those at highest risk.

Oral PrEP has already demonstrated its effectiveness in reducing new infections. However, its impact is limited by factors such as adherence, stigma associated with daily medication, and the need for frequent clinic visits. Injectable PrEP, particularly a twice-yearly option, offers a solution to many of these barriers, potentially expanding the reach of prevention efforts to communities where daily regimens have proven challenging.

The Role of Innovative Prevention Strategies

Daniel Fluskey of the National AIDS Trust underscored the potential significance of lenacapavir: "This is a real missed opportunity in the fight to end new HIV transmissions in England. The potential significance of lenacapavir is not in doubt… We believe it would save lives, reduce health inequalities, and go towards achieving the UK Government’s goal of ending new HIV transmissions by 2030."

The benefits of a twice-yearly injectable PrEP extend beyond mere adherence:

• Enhanced Discretion and Reduced Stigma: For many, daily pill-taking can be a constant reminder of their risk of HIV or can be difficult to conceal. An infrequent injection offers greater discretion, potentially reducing psychological burden and stigma.
• Addressing Health Inequalities: Certain populations, including some ethnic minority groups, men who have sex with men (MSM), and trans individuals, disproportionately bear the burden of HIV. These groups may also face greater barriers to accessing and adhering to daily oral PrEP due to social, economic, or healthcare access issues. A highly convenient injectable option could help bridge these gaps and reduce health inequalities.
• Increased Personal Choice: Offering a diverse range of PrEP options empowers individuals to choose the method that best fits their lifestyle, preferences, and personal circumstances, thereby increasing overall uptake and effectiveness of prevention strategies.

By potentially restricting access to Yeytuo, NICE’s decision could inadvertently slow the pace of decline in new HIV transmissions, making the 2030 target even more challenging to achieve. The charities argue that the long-term societal benefits of preventing HIV infections, including averted healthcare costs and improved quality of life, far outweigh the initial investment in innovative prevention methods.

The Path Forward: Awaiting the Final Decision

Despite the current disappointment, the fight for lenacapavir’s inclusion on the NHS is not over. NICE’s recommendation is a draft guideline, and there is a formal process for stakeholders to challenge the decision and submit further evidence.

A crucial second evaluation committee meeting is scheduled for 3 November. This meeting represents a vital opportunity for Gilead, HIV charities, and other interested parties to present additional data, address NICE’s stated concerns, and potentially negotiate a more acceptable pricing structure. Gilead will likely be preparing a robust defence of Yeytuo’s value, emphasizing its unique benefits and long-term cost-effectiveness from a broader public health perspective. They may also highlight its successful implementation in other countries.

The outcome of this next meeting will determine whether the draft recommendation is upheld, amended, or even overturned. If the recommendation stands, it would significantly impact patient access, likely forcing individuals to seek private prescriptions or explore other, potentially less convenient, PrEP options. It could also lead to a public outcry and renewed lobbying efforts to reconsider the decision. The formal consultation period allows for a public voice, and the strength of the collective advocacy from HIV charities suggests that this issue will remain a high-profile debate.

Broader Perspective: The Global Race for HIV Prevention

The situation in the UK with lenacapavir reflects a broader global challenge: balancing the imperative of public health innovation with the realities of healthcare budgets and equitable access. Across the world, there is a clear recognition of the transformative potential of long-acting injectables in the fight against HIV. Countries are grappling with how to integrate these advanced prevention tools into their national health systems.

The approvals by the FDA and EC underscore the global consensus on Yeytuo’s clinical efficacy and its role in diversifying prevention strategies. However, the path from regulatory approval to widespread patient access is often fraught with hurdles, particularly concerning pricing and cost-effectiveness evaluations. The UK’s decision, whatever its final form, will be closely watched by other nations as they navigate their own assessments of innovative HIV prevention technologies. It highlights the critical need for pharmaceutical companies, governments, and public health bodies to collaborate on sustainable solutions that ensure groundbreaking medicines reach those who need them most, without undue financial burden on health systems.

Conclusion

NICE’s initial recommendation against the routine NHS funding for Gilead’s twice-yearly injectable PrEP, lenacapavir (Yeytuo), marks a moment of intense tension in the UK’s HIV prevention landscape. While NICE maintains its commitment to value for money, HIV charities are profoundly disappointed, arguing that the decision jeopardises the nation’s ambitious 2030 target to end new HIV transmissions.

The stakes are exceptionally high. At one end lies the promise of a groundbreaking innovation that could overcome significant barriers to PrEP adherence and reach underserved communities. At the other, the rigorous financial scrutiny deemed necessary to maintain the sustainability of the NHS. As the November 3rd evaluation committee meeting approaches, all eyes will be on NICE, Gilead, and the unwavering advocates who believe that the long-term health and societal benefits of preventing HIV infections far outweigh the immediate financial considerations. The final decision will not only shape the future of HIV prevention in the UK but also send a powerful message about the country’s commitment to leveraging medical innovation in its public health battles.