admedicum recently attended the HTAi 2019 meeting in Cologne, Germany entitled, “HTA beyond 2020: Ready for the New Decade?” At admedicum, we believe patient involvement in HTA is crucial for making the right decisions because health technology is FOR THE PATIENTS.
We took the opportunity of other stakeholders being in Cologne to co-host a PEGASUS Networking Event to discuss the same topic as this blog with a group of diverse stakeholders including patient-representatives from several different disease-areas.
Patient expertise is equally relevant to decision making and offers further insights beyond fundamental medical or methodological knowledge. Patient empowerment starts in the development phase of any new health technology, not when the product has already reached the market.
Patients may have a drastically different view of what is relevant for them in terms of risk/benefit and quality of life. They need health technology and treatment options that help them cope with their disease and adhere to therapies in alignment with personal goals and attitudes.
Earlier patient involvement means more robust data
From the very beginning of developing any new therapy, industry needs to begin a dialogue with patients openly and transparently. As this relationship builds and trust is established, patient-relevant evidence is collected from clinical trials, natural history studies, registries, and real-world data from places like patient organization surveys or social listening. This genuine and robust data assists everyone involved, as well as the larger disease community and others with similar conditions. While this is essential for all life-threatening or disabling diseases, in particular HTA in rare diseases will benefit as here the evidence base is still often quite limited.
To draw a clear distinction, patient input into HTA content, processes, methods and outcome is not equivalent to Patient-Based-Evidence. When patients are included from the beginning, they are partners in generating Patient-Based-Evidence, e.g. from wearables or sensors years before the product has reached the HTA.
What makes patient involvement in HTA challenging?
While advocating for patient involvement in HTA, it is necessary to acknowledges the challenges that go along with it.
- Finding the right patients or patient representatives at the right time
- Involving traditional patient organization advocacy, informal social-media based patient communities and individual patients in appropriate ways
- Communication: Technical jargon vs. laypersons’ language
- Time-constraints: process may not fit into patients’ schedule
- Managing expectations of all parties involved (HTA-bodies, industry, patients): quality and quantity of input, speed, representativeness of opinions expressed
- Transparency and respect of independence and confidentiality
- Paying “lip-service” to patient involvement rather than gaining meaningful input
- Patient-relevant evidence at time of evaluation is often still limited, ways to enhance body of evidence may still need to be defined at time of dossier submission (e.g. routine-therapy accompanying continuous evidence generation, further RCTs, patient-registries)
How can HTA-bodies, learned-societies and industry equally benefit from early involvement of patients along the health-technology’s life cycle?
- Co-creating clinical trial design
- Including meaningful patient-reported and patient-relevant physical outcome parameters
- Efficient recruitment and retention in clinical trials
- Fair and balanced communication of trial results
- Establishing and maintaining well-governed and scientifically sound clinical trial registries and other forms of evidence generation
How we can help
Read through the cases in our Patient Engagement Guide to read real world case studies of how we work with patients and industry to overcome some of these challenges. And get in contact with us if you want to discuss the topic further. Let’s co-create solutions where everyone benefits.
Healthcare-system will have its “Greta Thunberg Moment” – get prepared
The healthcare-system will soon have its “Greta Thunberg Moment” because patients have immediate access to a plethora of information, can report on how they are doing and share data from sensors and wearables instantly. Most importantly, as citizens they are no longer prepared to wait until the system is slowly adapting to new ways of generating and evaluating evidence. While all this can be seen as challenging, it is first and foremost a great opportunity to improve health-technology-assessment and decisions based on it. It’s all about involving the patient.