CHALLENGES IN OPTIMISING REAL WORLD EVIDENCE FOR ALZHEIMER’S DISEASE

Author(s)

Reed C1, de Reydet de Vulpillieres F2, Gallacher J3
1Eli Lilly and Company Ltd, Windlesham, UK, 2NOVARTIS PHARMA AG, Basel, Switzerland, 3Oxford University, Oxford, UK

Alzheimer’s disease (AD) is a gradually progressive condition with increasing humanistic and economic burden for patients, families and society. Due to the long term nature of the disease (up to 20 years) characterised by cognitive and functional decline, and behavioural changes, there are challenges in identifying meaningful clinical milestones along this continuum and in demonstrating the value of slowing disease progression within clinical trials and beyond. Societal costs of AD, including those of informal caregiving costs, are well recognised when considering the totality of the disease, but when new treatments enter the market, the potential impact on future healthcare costs for providers and payers is anticipated to be considerable. The methods for determining how HTA and payer agencies value developments in AD must be put in the context of health and medical care policy while balancing this potential high budget impact. Real World Outcomes across the AD spectrum for better care: Multi-modal data Access Platform (ROADMAP) is a public-private consortium funded by the Innovative Medicines Initiative’s Big Data for Better Outcomes programme to evaluate the validity of linking RCT and real world data to demonstrate the benefit of new AD therapies. Using pilot studies, ROADMAP will develop scalable and transferable tools and methods to support disease progression and economic modelling relevant for national and regional HTA bodies, payers, and regulators, with concomitant patient advocacy engagement. Feedback from these key stakeholders will set new standards for the collation and evaluation of real world evidence in AD to support demonstrating the value of new AD treatments. ROADMAP will play a role in challenging current paradigms in the assessment of novel treatments by decision makers and describe innovations for assessing new therapies to treat AD. Funding: This work has received support from the EU/EFPIA Innovative Medicines Initiative Joint Undertaking (ROADMAP grant n° 116020).

Conference/Value in Health Info

2017-11, ISPOR Europe 2017, Glasgow, Scotland

Value in Health, Vol. 20, No. 9 (October 2017)

Code

CP4

Topic

Health Policy & Regulatory

Disease

Neurological Disorders

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