The UK’s National Institute for Health and Care Excellence (NICE) has published a draft guidance that does not recommend the use of five major Covid-19 therapies. This news came as many organisations and patient advocacy groups have been campaigning for the adoption of some of the rejected drugs for several months, amidst concerns about access to medicines in the UK.

The therapies with a negative appraisal included three anti-Covid-19 antibodies; Regeneron Pharmaceuticals’ Ronapreve (casirivimab + imdevimab), GSK’s Xevudy (sotrovimab) and, AstraZeneca’s Evusheld (tixagevimab + cilgavimab).

Between November 5 and November 12, a total of 20,588 people have reported testing positive for Covid-19 in England, according to government data. This number is likely an underestimation given the lack of testing amongst the population. Furthermore, in that same period, 3,407 patients were admitted to a hospital in the country for severe cases of Covid-19. While these are lower numbers than last month, the British government has acknowledged the need to continue building momentum to reduce the spread and severity of the disease, and the use of Covid-19 therapeutics is an important part of that Covid-19 strategy.

NICE is the official UK organisation that provides an assessment of new health technologies and makes decisions about which new technologies and medications will be implemented into the National Health Service (NHS). NICE’s technology appraisals calculate appropriate costs for drugs using the incremental cost-effectiveness ratio (ICER). Based on such an analysis, the draft guidance recommended the use of Pfizer’s Paxlovid (nirmatrelvir + ritonavir), Roche’s RoActemra (tocilizumab) and Eli Lilly’s Olumiant (baricitinib). The other two Covid-19 therapies that NICE rejected were two antivirals; Merck’s Lagevrio (molnupiravir) and Gilead Sciences’ Veklury (remdesivir).

Last week, at the Financial Times’ Global Biotech and Pharma Summit in London, experts at an “In conversation with the NHS” panel discussed, amongst other things, the concern that UK may be falling behind Europe in terms of access to new medicines such as Covid-19 drugs. At the time Amanda Pritchard, chief executive of NHS England, doubled down on the issue of medicine access. “If we look at the average number of drugs that are available in Europe versus here [the UK], it is clear that for every four medicines available in Europe there is an additional medicine available in the UK.”

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NICE rejects Covid-19 drugs

The use of Evusheld has received significant backing from patient advocate groups and charities including Blood Cancer UK. In August, representatives from seven organisations signed an open letter to the UK government pleading for the approval of Evusheld, following the decision not to procure the drug before a NICE appraisal in 2023. The letter asked for the UK government to consider a real world evidence study that showed that immunocompromised people who took Evusheld were half as likely to become infected with Covid-19, and 92% less likely to be hospitalised and/or die. Last month, the nonprofit also released a guide on accessing the monoclonal antibody through private channels.

Evusheld has been a major player in Covid-19 therapeutics space, being the US Food and Drugs Administration’s (FDA’s) first authorised Covid-19 antibody therapy for pre-exposure prophylaxis. This was followed by authorisations in the EU, Japan and many other countries.

However, NICE remains uncertain about how the drug may hold up against other Covid-19 variants. In its appraisal, NICE highlighted that for many of the rejected drugs, the submitted clinical trial data was from studies conducted before the emergence of the Omicron variant of SARS-CoV-2. Thus, despite an acknowledgement that the treatments were generally effective, these drugs were rejected due to uncertainties surrounding their efficacy against Omicron. Furthermore, the cost effectiveness of the drugs came into question.

Lagevrio, Veklury, Ronapreve, Xevudy, and Evusheld were rejected at this stage because the “likely” ICER values were beyond the acceptable threshold for NHS commissioning. The ICERs for drugs indicated for severe disease that requires hospitalisations tends to be higher, improving their chances of winning a NICE recommendation. This was the case for two of the three therapies recommended by NICE, namely Olumiant and RoActemra. However, all the drugs that were not given a positive recommendation were meant for people who were not hospitalised and had an increased risk for progressing to severe disease.

At the conference, Pritchard affirmed the importance of staying true to the NHS cost effectiveness guidelines saying, “We are continuing to try and make sure that we’re getting the best deals out of the whole medicines budget”.

This initial rejection of the five drugs may not be the end of the line for their run in the UK health system. NICE has made it clear that future consultation with the drugs’ developers is not out of the question. However, these discussions would have to address the aforementioned clinical uncertainties and cost effectiveness issues.

Access to medicines in the UK

Since the departure of the UK from the European Union, there have been concerns that the access to medicines in the UK may worsen in comparison to the EU. These fears have been supplemented by the EU’s plans to build a European Health Union that aims to standardise the EU member states’ approaches to healthcare. In theory, this change stands to improve access to medicines in Europe due to faster evaluation processes and standardised methods. On the other hand, it could drive an even greater wedge between the UK and European pharmaceutical industry.

However, Pritchard combatted claims that the UK’s healthcare system may suffer from access to less new drugs saying, “It isn’t unusual now for the NHS to be the first system to have access to new medicines or indeed first in the world and first in Europe deals.”