“Wonderful” drugs for Alzheimer’s, refused! Why the UK says not to the latest treatments that promised to change everything.
The National Institute for Health and Excellence in Care (Nice) in the United Kingdom has decided not to recommend two new drugs for Alzheimer’s disease within the NHS (National Health) Service in England, according to Reuters.
Although this decision may seem disappointing for some families affected by dementia, it reflects a prudent, evidence -based approach, meant to protect patients and public funds.
What medicines is it about?
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The drugs in question are:
– Lecanemab, produced by the Japanese company Eisai;
– Donnemab, developed by the pharmaceutical giant Eli Lilly.
Both were intensely promoted in the press as revolutionary treatments or “wonderful drugs” for Alzheimer’s. However, Nice has a long tradition of rigorous analysis of new therapies for dementia and has reached, again, essential questions related to the real effectiveness of these treatments.
What effects do these drugs have?
According to data from clinical trials, both drugs can slow down the progression of Alzheimer’s disease by about 4 – 6 months, but only in patients in early stages. It is a real benefit, but far from being a spectacular progress, as suggested in some press titles.
Moreover, it is important to distinguish between the results of the clinical studies, carried out under controlled conditions and on groups selected by patients – and the efficiency of the treatments under the real conditions in the NHS system, where the diversity of patients is much higher.
Risks and limitations
In addition to modest efficiency, these drugs come with significant risks, including:
– inflammation and cerebral hemorrhages;
– the need for invasive tests, such as lumbar punctures or regular brain scans;
– Administration through hospital infusions for several months.
For some patients, these burdens could overcome the relatively modest benefit of treatment.
Another important aspect is the uncertainty regarding the long -term effects, it is not yet known whether the benefits persist beyond the period studied for 18 months.
Costs and equity
Cost is an essential factor in Nice assessment. In the US, these drugs can reach 25,000 pounds per patient per year. Even with any negotiated discounts for NHS, Nice must evaluate whether the same amount could not bring more value to other areas of the health system.
Professor Tom Dening, a specialist in dementia research at the University of Nottingham, described the benefits as “minimal” and warned that they can distract attention from other priorities, such as care and support to already diagnosed patients.
The Nice decision aroused heated controversy. Some pharmaceutical companies have criticized the British evaluation system, claiming that even the free drug would not ensure approval. But this ignores the fact that Nice analyzes not only the cost of the drug itself, but the whole therapeutic package: tests, infusions, monitoring, etc.
This is not the first time that companies are trying to exert public pressure on Nice, similar strategies have failed in the 2000s. In fact, the agency is known for its independence, and its decisions are generally supported by the Government.
What follows?
The current decision is still in the “final draft” stage. Companies involved can transmit observations or call until July 3. In the past, in 2007, the company Eisai sued and lost. This time, a call is more likely.
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