Will the NHS ever fund the next generation of dementia drugs?

The NHS has said it will not pay for the first drug to slow brain destruction in Alzheimer’s disease.

The decision to fund lecanemab has caused dismay and disappointment among those who had hoped the drug could help combat a horrible and devastating disease.

But the decision is not a surprise either.

Lecanemab is not a “miracle drug”. The European Medicines Agency reviewed the same data as the UK and concluded that the drug should not be prescribed to anyone outside of a clinical trial.

But what would it take for a drug that slows Alzheimer’s disease to be covered by the NHS?

The National Institute for Health and Care Excellence is tasked with determining what constitutes good value for taxpayers’ money. This is where emotion, desperate need and lobbying for therapies collide with cold, hard calculations of cost-effectiveness.

Dementia drugs that help manage symptoms, such as confusion, have been approved in the past.

But this is the first time that a drug capable of modifying the course of a disease has been evaluated. This is an experience more common in other diseases. Earlier this summer, the cancer drug Enhertu, which can extend the lives of some people with incurable breast cancer, was rejected because it was too expensive.

But even very expensive drugs – I did a report on one point gene therapy which is officially costing £2.6m, may be approved if the benefits are sufficiently significant.

Lecanemab has issues with efficacy, cost, and safety.

It was hailed as the first drug to do something, anything, to slow the progression of Alzheimer’s disease. For a field that had suffered repeated failures, it was a truly significant moment when the data were published in 2022. written at the timethe effect is weak.

Lecanemab does not cure, reverse or stop Alzheimer’s disease. It slows the rate of decline.

In the trials, the disease continued to rob patients of their brain power, but this decline was slowed by about a quarter over the 18 months of treatment. On an 18-point scale, ranging from normal to severe dementia, patients on treatment improved by 0.45 points.

The significance of these effects is still hotly debated among researchers.

Some argue that they allow patients to maintain vital independence for longer. Others argue that the effects are so small that a doctor would be unable to tell the difference between a patient receiving lecanemab for 18 months and one receiving a placebo (a fake treatment). Still others argue that patients should be allowed to make an informed choice about what is important to them.

Drug data comes from a large-scale trial The study involved 1,795 volunteers with early-stage Alzheimer’s. But those enrolled were healthier and younger than people with a typical diagnosis. It raises questions about the drug’s “real-world” effectiveness in frail, elderly people with multiple health problems, or even “mixed” dementia, which could be partly Alzheimer’s and partly another disease.

A more powerful drug, with a clearer impact on the progression of Alzheimer’s disease, could tip the balance in favor of this cost-effectiveness ratio.

It could still potentially be lecanemab. It is possible that starting treatment even earlier in the disease or continuing it for longer would have greater effects. This has not yet been proven.

It may also be that lecanemab is leading the way, and that a future drug that follows in its footsteps could provide the greatest benefit. Medical research often needs an initial breakthrough that others can build on. The first HIV drugs eventually paved the way for modern antiretroviral therapy, which gives people with HIV a near-normal life expectancy.

Costs are the other side of the equation. A cheaper drug must be less effective to meet that value-for-money threshold.

Lecanemab is expensive. The drug itself costs about £20,000 per patient per year (based on US prices). But the care that goes with it doubles that cost in the NHS (and private costs are probably even higher).

An expensive positron emission tomography (PET) scan or a spinal tap to take a sample of spinal fluid is needed to confirm that patients actually have Alzheimer’s disease – because there are many types of dementia – before treatment can begin.

It then requires an infusion into a vein every two weeks to administer it and other expensive brain tests to monitor for known side effects.

One option is to negotiate a better price, and with other drugs on the horizon like donanemab, there will be competition that could drive prices down.

There is still time to achieve this. NICE published its draft decision on Thursday, which will be finalised later this year.

However, pharmaceutical companies want to recoup the costs of their years of research and development, and the sector has produced many costly misfires and dead ends.

Lecanemab and donanemab are also very expensive drugs called monoclonal antibodies. These are lab-made versions of the antibodies your immune system makes naturally to fight disease.

For Alzheimer’s, these antibodies were designed to target a sticky protein called amyloid, which clogs the spaces between brain cells. Amyloid is a key feature of Alzheimer’s, and the antibodies clear it away.

But these drugs are difficult to design and manufacture, which inevitably makes them expensive. You can’t get monoclonal antibodies for the price of aspirin.

The drug is also not approved for use in people with certain genetic mutations that actually increase their risk of developing Alzheimer’s disease, so genetic testing is necessary.

These drugs carry risks of brain swelling, bleeding or brain hemorrhage, and some can be fatal. So monitoring adds costs.

Blood tests for Alzheimer’s disease, drugs that require fewer infusions or produce fewer side effects, or better ways to predict who is at risk for side effects could also theoretically reduce the cost of care around these drugs.

But as things stand, treating the 70,000 people who would technically be eligible for the drug in England could cost around £1.4bn a year, and a similar sum for NHS care. This has been assessed as a poor use of taxpayers’ money for a drug whose impact is widely considered to be “low”.

This is a historic week. For the first time, a drug capable of slowing the progression of Alzheimer’s disease has been approved.

For decades, dementia was considered an inevitable consequence of aging. Then it became clear that it was a disease. Today, we are optimistic that we are on the verge of doing something about it.