Health System Preparedness of Six EU Countries for a Future - PowerPoint PPT Presentation

Health System Preparedness of Six EU Countries for a Future Alzheimer’s Innovation AcademyHealth Annual Research Meeting 2019 Washington, D.C. June 2019 Jakub Hlávka, Soeren Mattke, Jodi Liu

Why focus on Alzheimer’s treatment now? • Currently no treatment, but therapies in clinical trials • Guarded optimism for new Alzheimer’s innovation currently being development • Shifting earlier (to the left) in the disease paradigm – Estimated 20 million people in the EU have mild cognitive impairment (MCI) Objective : Quantify the potential mismatch between supply and demand for the delivery of a future Alzheimer’s treatment in Europe. 2

Alzheimer’s disease progression and clinical pathway Assume intervention to reduce Screen the risk of transitioning from MCI to dementia Evaluate Test Treat 3

Limitations • Highly stylized clinical pathway that simplifies actual care patterns • Uncertainty about market entry, efficacy, and dosing of the therapy – Model assumes intravenous therapy, but same constraints can be applied to oral or subcutaneous therapies with the exception of treatment delivery – Published model assumed therapy available in 2020, screening would have started 2019 • Assumptions about start of screening and transition probabilities – Reliance on expert input for several assumptions related to patient uptake • Assumptions about theoretical capacity – Reliance on historical trends for capacity projections • Combination of data from different sources to implement model Results illustrate magnitude of the problem but may not predict actual numbers precisely 4

Conceptual framework Assume treatment reduces relative risk of progression by 50 percent

Snapshot of potential number of people in 2019 (millions) Constraint 1: dementia specialists Constraint 2: biomarker testing Constraint 3: infusion centers NOTE: The expected number of people at each step are from France, Germany, Italy, Spain, Sweden, and the United Kingdom. 6

Some EU countries have more specialists than others Geriatric or old- Specialists per Neurologists Geriatricians age psychiatrists 100,000 population France 2,571 1,756 - 6.7 Germany 6,607 2,149 10,943 24.0 Italy 6,508 1,415 1,578 16.0 Spain 2,719 970 735 9.5 Sweden - 450 1,349 18.2 United Kingdom 1,755 1,332 1,761 7.3 United States 17,408 7,560 1,953 8.0 Sources : Eurostat (2017), European Geriatric Medicine Society (2018), Liu et al. (2017) 7

We expect no wait for biomarker testing and varying waits for infusion delivery  Availability of CSF biomarker test in EU avoids most PET scans  Assume 10% of people with early‐stage AD require amyloid PET scan, mostly for anatomical reasons and anticoagulation  Assume (theoretical) capacity for lumbar punctures unconstrained  Infusion capacity is estimated to range between 54% (UK) and 137% (Germany) of U.S. capacity (Liu et al., 2017)  Based on a general health care system capacity index as no data were available for infusion capacity constraints in Europe 8

Projected average wait times in months, by country Dementia specialist visits Infusion therapy

Projected average wait times in months, by country 20 18 16 France 14 Germany 12 Italy 10 Spain 8 Sweden 6 United Kingdom United States 4 2 0 2019 2024 2029 2034 2039 2044 10

Wait times vary countries Potentially avoidable new Alzheimer’s dementia cases First year occurring while people wait, 2020-2044 (percent of Maximum waiting time, months with no wait potentially avoidable cases) times Scenario with specialist waits Biomarker Specialists Infusions Base case scenario but no infusion waits testing Germany None None <6 mo. 2030 55,000 (1%) 0 (0%) 2036 12,000 (2%) 1,000 (<1%) Sweden <6 mo. None 6-12 mo. Italy <6 mo. None 6-12 mo. 2040 146,000 (3%) 45,000 (1%) 2044 171,000 (5%) 88,000 (3%) Spain 6-12 mo. None 6-12 mo. United Kingdom >12 mo. None 6-12 mo. 2042 260,000 (7%) 171,000 (4%) France >12 mo. None <6 mo. 2033 389,000 (9%) 357,000 (8%) Total EU-6 1,033,000 (5%) 662,000 (3%) 2034 1,295,000 (13%) 756,000 (8%) United States >12 mo. 6-12 mo. <6 mo. 11

Action is urgently needed to reduce capacity constraints in time for potential treatments  Train more providers in dementia care and develop tools to make them more efficient  Utilize all options for infusion therapy, including the home setting  Ensure appropriate coverage of services and tests and limit scope and volume restrictions  Challenge that no individual stakeholder can solve alone  Professional societies, policymakers, industry, advocacy groups must be involved in the solution  Stakeholders must act today given the time it takes to build capacity 12

Summary • An Alzheimer’s therapy would be a significant breakthrough • Simulation suggests that EU countries are not prepared to handle the large number of prevalent cases, albeit to a different extent – Germany could clear the backlog by 2030, Spain by 2044 – As many as 1 million potentially avoidable Alzheimer’s dementia cases could occur because of delays in access to treatment • Increasing capacity will involve payment policy, regulatory requirements, workforce considerations, and capacity planning 13

Thank you! Other studies United States, Japan, Australia, Canada Report www.rand.org/t/RR2503 Contact jakub.hlavka@usc.edu @JakubHlavka Web sites.google.com/view/JakubHlavka Funding Biogen

Addendum

Infrastructure challenges to address • Specialist shortage is most urgent issue – Expedite development and deployment of screening tools – Qualify more providers in evaluation of MCI • Expansion of infusion clinics could lead to idle capacity later – Nature of treatment could allow home infusion – Home infusion delivery could increase capacity in the short run without fixed infrastructure • Reimbursement and regulation could create obstacles to access – Limited reimbursement could mean available capacity may not be devoted – Restrictions on allocation and growth of capacity can limit flexibility 16

Some encouraging activities have been launched Plan Maladies Neurodégénératives 2014‐2019 The Interceptor Project • • 5‐year strategic plan to improve care for neurodegenerative Project to help identify people at higher risk of developing AD disorders and thus the greatest likelihood of benefiting from treatment • • Emphasis on care pathways and need for screening and early Collects data on cognitive testing, CSF tests, and PET and MRI detection scans to inform design of nationwide screening program • • Calls for the development of better tools for screening and Goal to identify and prioritize for treatment for people at high diagnosis and creation of centers of excellence risk of progression Multiple sclerosis specialist nurses European Joint Action on Dementia • • Specially trained nurses to administer infusion treatment for Aim is to gather epidemiological data, improve the timeliness MS in outpatient clinics and reliability of diagnosis, and understand support systems for behavioral and psychological symptoms • Can also provide disease education and training for self‐ • administration Calls for better evidence on improving outcomes in people with dementia and caregivers through EU‐wide collaboration 17

United States

Model blueprint to reflect patient journey

Screening phase 80 percent of persons over 50 are screened 50 percent of screening- positive patients seek further evaluation

Diagnostic phase Confirmation of MCI, rule out of alternative explanations and contraindications Evaluation for treatment eligibility 80 percent of MCI patients with amyloid plaques assumed to be treatment-eligible 90 percent referred to biomarkers testing with CSF exam 45 percent assumed to have clinically relevant amyloid burden

Treatment phase Treatment is delivered by intravenous infusion every four weeks over one year

Outcomes phase Treatment reduces relative risk of progression by 50 percent Untreated disease progresses on waiting list