The launch of new drugs seems to solve some clinical unmet problems, and theoretically, it seems to help improve the overall health of everyone.
However, a recent paper published in The Lancet arrived at the opposite conclusion. They believe that over the past two decades, the funds used by the UK's National Health Service (NHS) for newly approved drugs could actually bring more health benefits if they were instead invested in existing services.

Investigation on NICE Database

Researchers from the UK and the US first reviewed UK drug technology assessments published in the NICE (National Institute for Excellence in Healthcare Services) public database between 2000 and 2020. After investigating 183 drugs evaluated for 385 indications out of 339 evaluations in NICE's new drug evaluation, they found that the median gain in quality adjusted life years (QALYs) was 0.49 throughout the entire evaluation, with moderate dispersion.

Quality adjusted lifespan is an evaluation standard that comprehensively measures health outcomes, taking into account not only the extension of patients' survival time but also the improvement of their quality of life. Therefore, QALYs are widely used in medical research and clinical practice to compare the effectiveness of different health interventions.

However, when this median gain is applied to the actual benefit situation of 19.82 million patients, significant issues are found, with an estimated 3.75 million additional QALYs generated from NICE recommended drugs, at a cost of £ 75.1 billion to the NHS. The paper estimates that if this money (£ 75.1 billion) is used to improve existing NHS services, approximately 5 million QALYs will be generated. These 5 million QALYs include 1.71 million immunology related QALYs, 1.51 million oncology related QALYs, and 1.07 million cardiovascular medicine related QALYs.

The researchers concluded that the cumulative effect of NICE recommended drugs on population health is negative, with a net loss of approximately 1.25 million QALYs.

It is easy to understand why such losses occur.

At present, the development principle of many new drugs is "unmet clinical needs". Due to the exclusion of withdrawn new drug products from the data, these new drugs can indeed directly benefit patients. On the other hand, researchers believe that the development of these new drugs comes at the expense of populations who have not been able to benefit from them.

Professor Huseyin Naci from the London School of Economics and Political Science, who is also the main author of this paper, stated that for patients whose clinical needs have not been significantly met, new drugs may be their lifeline, but the price of innovative drugs themselves is expensive, and their cost does not always justify the benefits they bring.

Subdivision differences in different disease domains

In the researchers' investigation, they also found differences in segmentation between different disease domains. For example, the median incremental cost-effectiveness ratio (ICER) was £ 6478 in 12 evaluations of anti infective drugs, while it was as high as £ 30000 in 144 evaluations of cancer drugs (P<0.001).

Immunology (£ 25.7 billion), oncology (£ 22.7 billion), and cardiovascular (£ 16 billion) are the top three cost segments.

In the NHS, the net health impact of new drugs for anti infective drugs, ophthalmic treatment drugs, and other categories of drugs such as respiratory, gastrointestinal, endocrine, orthopedic, urological, dermatological, and mental health drugs is positive, resulting in approximately 360000 additional QALYs. However, other treatment areas have had a 'negative net health impact', with cancer drugs causing a loss of 870000 QALYs at the population level.

Daniel Howdon, a health economist at the University of Leeds who did not participate in the study, said that although the idea that "new drugs may harm the health of the population" may seem counterintuitive, it makes sense to think about it because if the funds consumed by new drugs are not used in other areas that require more funding, they may actually result in more health losses, and it is necessary to carefully weigh the objects of health expenditure.

What is NICE's response to the accusations?

This paper clearly points the finger at NICE, with the underlying message being that NICE has recommended too many inappropriate drugs to enter the guidelines. In response, NICE has also provided their response:

Using funds for new drugs does indeed incur opportunity costs, which can squeeze funds from other services in the healthcare system. This is precisely why NICE plays a crucial role: they will carefully evaluate new treatment methods and only recommend those that are worth the money to taxpayers. This is particularly important during a period when the National Health Service (NHS) in the UK is facing significant challenges. After all, every budget of the NHS can only be used once.

If NICE did not recommend these new drugs, they would almost certainly still be used in the NHS. The most crucial thing is that in the UK, there will also be disputes over funding decisions between local and central governments

If NICE is not involved, funding decisions will be made at the local level, which can lead to unequal access to treatment for patients - a "regional inequality" - and may increase costs, as multiple local negotiations with pharmaceutical companies may not be able to obtain optimal value for the NHS.

Overall, NICE emphasizes its role in the entire funding negotiation, believing that without their help, the outcome could be even worse.