The cornucopia that is the Innovative Medicines Initiative never fails to keep on giving. Among the gems on offer within the IMI 2’s 6th Call and housed under the overarching Big Data for Better Outcomes (BD4BO) programme is “Real World Outcomes Across the AD (Alzheimer’s disease) Spectrum (ROADS) to Better Care”.
The really devastating march of Alzheimer’s across the globe is on display in the World Alzheimer Report 2015, led by King’s College London. It suggests that there are some 46.8 million people living with dementia – the disease group to which Alzheimer’s belongs – worldwide. This figure is predicted to double every 20 years, increasing to 74.7 million by 2030 and 131.5 million by 2050. It is further estimated that some 9.9 million new dementia cases emerge each year across the world – one new case every 3.2 seconds.
Given the devastating effects of Alzehimer’s not only on the individual patient, but also on families, friends and society at large, as well as the fact that this is a complex disease that is still not fully understood, the need for significant step towards a cure is undeniable. This is why IMI’s ROADS project is so important.
The fact is that significant investments are ongoing to accelerate drug development in AD care and prevention. Yet where we are falling down, is in our efforts to collect future prospective data collection that are relevant to access and reimbursement questions. So even if we come across therapies, we can’t drive forward access until these issues are addressed.
We do, though, have a great ally in this goal: the supportive framework of IMI – the world’s largest public-private partnership in the health sector. Within it, ROADS will promote the development and enhancement of public-private collaborative research programmes with specific aims.It will, for example, define a minimum set of measurable patient relevant real world outcomes.
At the same time, it wants to make certain that key are able to agree the value of these these outcomes to different areas within the medicines life-cycle paradigm. These areas could include: academic research; regulatory; HTA; funding and reimbursement; relative effectiveness assessment; clinical guidelines; and the optimisation of healthcare systems.
It will also seek to identify data sources and outline a data strategy so we can characterise the spectrum of AD across disease stages and multiple geographies and identify best practices in collecting real world clinical outcomes. Depending on the various data sources, this should help us to make recommendations concerning different approaches to model disease progression, which will in turn allow us to offer a better treatment selection and improved health care value for AD.
There is also a supremely collaborative aspect to ROADS, which will see companies working closely with national health authorities, health technology assessment (HTA), and regulatory agencies to develop recommendations on the appropriate AD-related cognitive, functional, and behavioural endpoints that can be used across various types of real-world research programs and data systems outside of clinical trials.
It is vital to understand that this type of high-level scientific and societal collaboration would be unachievable outside the framework of IMI. IMI, BD4BO and ultimately ROADS allow pharmaceutical companies to collaborate with academia, payer, regulatory and other important stakeholder partners to prepare health/social care and data systems for emerging new treatments that address the increasing societal burden of AD.