Alzheimer's disease – is Europe ready if revolutionary treatment becomes available?

Recent clinical trials have given hope that a background treatment for Alzheimer's disease may soon be available. Such therapy would treat the disease at an early stage to prevent or delay progression to dementia.

However, a study commissioned by Biogen from RAND and the University of Southern California found that several European countries were not able to quickly switch Alzheimer's disease-modifying treatment from approval to widespread clinical use. This could significantly delay access to care and bring an additional one million people to develop Alzheimer's dementia on the waiting lists.

We have developed a simulation model to examine the state of readiness of health systems in France, Germany, Italy, Spain, Sweden and the United Kingdom. The model predicts what would happen if these countries were faced with an upsurge in patients seeking badessment and treatment, baduming that potential treatment became available by 2020. These six countries account for 65% of the population of the country. European Union.

Context

There is currently no treatment for Alzheimer's disease, but several treatments are under development. After encouraging results from preliminary clinical trials, there is cautious optimism about the forthcoming availability of treatment.

Based on the results of early-stage clinical trials, therapeutic development has focused on the badumption that Alzheimer's dementia should be prevented rather than cured, as treatment candidates did not reverse the disease. course of dementia. This is why current trials are targeting patients with early-stage Alzheimer's disease by first looking for signs of early-stage memory loss or mild cognitive impairment (MCI), in particular performing tests of the pathology of Alzheimer's disease, then treating patients or slowing the progression of MCI due to Alzheimer's disease towards Alzheimer's dementia.

If this treatment were to become available, 20 million Europeans would have to be screened for MCI, an Alzheimer's disease badessment, biomarkers (via cerebrospinal fluid dosages or brain imaging) and to be tested. treated by intravenous infusion.

Our model

In our model, we badume that people aged 55 and over could undergo cognitive screening via a short instrument in a primary care setting. Patients who test positive would be referred to a dementia specialist for neurocognitive testing and possible reference to Alzheimer's disease-related biomarker testing.

Patients who test positive would return to the dementia specialist for further evaluation to confirm whether treatment would be appropriate and appropriate. If so, they would be referred to treatment, which would reduce the risk of progression of IBD to overt dementia due to Alzheimer's disease.

This is the same model we used previously to badyze the US health care system's preparedness to cope with the potential number of cases if a disease-modifying treatment became available. In the US, we found that early visits to dementia specialists would be long, followed by long wait times for biomarker testing confirming the pathology of Alzheimer's disease and moderate expectations for infusion. treatment. It would eventually result in 2.1 million patients developing Alzheimer's dementia between 2020 and 2034 (about 13% of new potentially avoidable cases during this period) on waiting lists. While other countries may face similar infrastructure challenges in diagnosing and treating people with Alzheimer's disease, we have applied this model to six key European countries.

Europe is not prepared

Our study badumes that one therapy is approved for use from 2020 and estimates that in such a scenario, approximately 7.1 million people with MCI would need a quick diagnosis by a specialist. After follow-up badessments and biomarker testing, we estimate that 2.3 million people in the six countries could eventually be recommended for treatment. However, delays in the badessment process as well as delays in the intravenous infusion of treatment could result in more than one million patients developing Alzheimer's dementia pending evaluation and treatment between 2020 and 2050.

In France, 389,000 people may develop Alzheimer's dementia while waiting for evaluation and treatment. In Germany, it would be 55,000 people; in Italy, 146,000; in Spain, 171,000; in Sweden, 12,000; and in the United Kingdom, 260,000 (see chart).

The main capacity constraint is the lack of trained medical specialists to diagnose patients who may be showing the first signs of Alzheimer's disease and confirm that they would be eligible for treatment to prevent progression of the disease. Some countries have too few medical specialists and may require additional training of health care providers. There are also too few facilities that can provide infusion therapy to patients.

The waiting times for treatment vary from five months in Germany to 19 months for an badessment in France. The first year without waiting time would be 2030 in Germany, 2033 in France, 2036 in Sweden, 2040 in Italy, 2042 in the United Kingdom and 2044 in Spain.

We found that each country also had a unique set of capacity constraints. In Germany and Sweden, the main constraint of infrastructure would be the infusion capacity. In the other four countries, waiting times due to both the availability of specialists and the infusion capacity would delay the treatment of a larger number of patients. The capacity of specialists is the main limiting factor in France, the United Kingdom and Spain. In addition, innovation in the diagnosis and administration of treatment would create sufficient capacity to treat patients with Alzheimer's disease at an early stage.

The path to follow

Although many European countries are unprepared, promising efforts are underway. France has a national plan that aims to improve care pathways for patients with neurodegenerative disorders. Italy has launched a project to identify patients with the highest risk of developing Alzheimer's dementia to improve coordination and speed of care. Understanding of Pharmaceutical Market Europe January 2019, the characteristics of patients with early-stage Alzheimer's disease are essential to effectively identify patients likely to benefit from a new treatment.

A therapeutic agent would require visits almost every month to administer an intravenous infusion and most European countries might not be able to provide infusions to all eligible patients as soon as possible. However, there may be two relatively short-term solutions: the construction of dedicated infusion centers as extensions of existing facilities and the use of home infusions, if possible depending on the safety profile of the treatment. Outpatient infusion centers can be built in cooperation with hospitals, memory clinics and other health care facilities.

In the past, specialized infusion centers have been established to provide outpatient infusion therapy administered by nurses to multiple sclerosis patients in Germany. Similar centers could be set up for MCI patients if a new therapy became available, with specialized nurses trained in intravenous administration, to supervision by doctors and to educating patients.

It is crucial that European countries begin to discuss now how best to overcome these obstacles in order to be better prepared in case a breakthrough in Alzheimer's disease occurs.

Above all, nations should:

• Establish clinical pathways to detect cognitive disorders and develop better detection tools
• Use specialized outpatient clinics in collaboration with a hospital, memory clinics and other facilities
• Ensure proper reimbursement of services
• Create EU-wide guidance and best practices for coordinated and timely care.

This new study is an important warning for all actors in European health systems. Health leaders in the European Union should start preparing for a breakthrough now. Without prior planning, we can not guarantee that all EU citizens likely to benefit from evaluation and treatment can reap the benefits if such treatment becomes available.

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