Capturing outcomes and supporting patients after Managed Access Agreement (MAA) programmes is vital to the generation of real-world evidence and understanding quality of life. In light of the recent historic approval of crizanlizumab, also known as Adakveo, the need for this approach to gaining true and deep insights into therapeutic outcomes has been pushed to the forefront of many teams’ minds within the life science and technology sectors.
Indeed, Novartis has seen partnership with key organisations such as the National Haemoglobinopathy Registry, NICE, and NHS England in order to generate what is currently severely lacking real-world evidence in SCD, as a driving force to ensure regulators would be satisfied in approving the new medicine for patients for this MAA scheme.
So how do we get this right the first time for other pharmaceutical companies, biotech innovators, healthcare providers, and ultimately patients? Eleven Health, through the use of advanced clinically researched and FDA approved ethical data technology, Artificial Intelligence, and a large patient community, is changing the landscape for patients, research, and managed access.
A year of innovation
Sickle Cell Disease has seen an incredible trend in increasing awareness and therapeutic innovation over the past year. With no new therapies in over 20 years, the arrival of crizanlizumab feels much overdue, and is set to see more than 300 patients receive crizanlizumab each year through the MAA – a number only set to increase over the following years.
New medicines such as crizanlizumab hold the potential to truly transform patient care and support improved outcomes. However, not all patients may respond the same or see identical results in the context of any treatment.
In light of the recent recommendation of crizanlizumab, and as new therapies for Sickle Cell Disease and other chronic or rare conditions continue to make their way through the discovery pipeline, Eleven Health works to independently support patients in understanding the impact of new medicines at an individual level. Driven by patients through a patient-centric platform, CE marked and FDA approved wearables, and advanced AI/ML technology, Eleven’s ecosystem supports patients to track and capture these impacts in real-time.
The live tracking of automated quality of life linked biometrics and patient-reported measures creates an important timeline along which to track any variations in health, with the ability to link this to any changes in treatment or other lifestyle and healthcare factors.
Long-term impacts and improvements
Throughout the Sickle Cell community, patients have felt new hope for future innovation and improvements to their daily lives – crizanlizumab’s evidenced ability to reduce the number of painful sickle cell crises per year is a truly significant change to patient quality of life. However, its approval for full routine use across the NHS continues to be limited by reservations that impede its reach to the wider patient community.
Indeed, uncertainty around the treatment’s long-term efficacy and cost-effectiveness sees the necessity for additional clinical trials and evidence generation. The fight to meet, as stated by NICE, ‘the high unmet need for treatments for Sickle Cell Disease and NICE’s aim of reducing health inequalities’ will require robust, longitudinal, and in-depth collection of such data – and this is where technology can step in to help.
Each month, Eleven Health draws insights from vital Hospital Episode Statistics (HES) data, which provides an individual look at each patient’s contact with healthcare, as well as the incidence of clinical events such as vaso-occlusive pain crises. With the ability to match this to specific events in the patient care and wellbeing journey through this episodic data, the next complementing part of Eleven’s ecosystem incorporates the direct patient experience into all insights.
Real-time outcomes mapping – a case study in crisis intervention
Each patient’s experience is unique, and a crucial part of understanding the true impact of new medicines and care pathways upon those that are most significantly impacted is by building a full, day-to-day picture of their wellbeing. Therefore, Eleven combines the automated collection of real-time wearable biometrics such as heart rate, activity, and sleep quality with patient-reported outcomes that range from more traditional, validated EQ-5D measures, to basic 0-10 pain and wellbeing scoring.
Already, Eleven has applied this methodology to supporting patient self-management of their disease, creating a timeline of retrospective, daily, and predictive insights that enable live tracking of any variations to each patient’s individual baseline. Arming patients with this level of understanding of their own disease has supported those in the Eleven community to make informed decisions around the next steps in their care in the face of potential challenges.
Case studies run by Eleven have proven the vast impact their predictions have on an individual level. Using elevated pain levels as a proxy for potential upcoming vaso-occlusive crises (VOCs), Eleven is able to warn patients of potential upcoming VOCs, enabling patients to take preventative action. Built from live, remote monitoring of biometrics, this risk stratification and early warning system has played an important part in ensuring the patient has been able to take steps that have curbed the progression to pain crises, with no VOCs or hospital admissions since joining Eleven – despite these periods of high pain and complication risk.
By mapping this against the intervention taken and resulting changes to patient biometrics and wellbeing, this has created an important insight into the treatments that truly work in preventing health deterioration, with real-world evidence of its benefits to patient quality of life and healthcare utilisation.
Applying technology to the monitoring of new therapies
Each therapeutic innovation in the sickle cell landscape holds the potential to bring incredible changes to patient lives, and it is vital that this is supported in every way possible. Eleven’s goal is to help patients in understanding their day-to-day wellbeing, as well as the real-time impacts of any treatments and changes to their care – while simultaneously building a powerful base of real-world data and evidence that can help to support the acceleration and approval of new medicines to reach the patients that need them most.
Visit Eleven Health to find out more about how daily and treatment-focused decisions truly impact your health.
Recommended for you
Interoperability has been widely heralded as vital for the future of healthcare, so what’s stopping it from becoming common practice?
Through their innovative tech, Swedish company Minesto leverages the power generated from underwater ‘kites’ as a source of renewable energy.
Google’s parent company Alphabet launches an AI-powered drug discovery firm. Isomorphic Labs reimagines the entire drug discovery process.
Priorities of workers have shifted and the future of work is uncertain. A new report examines the five key factors in our new work lives.