At the 2018 Financial Times Pharmaceutical and Biotechnology Conference, there was a lot of buzz around ‘patient centricity’ and all of the big pharma companies were determined to broadcast their goals of having patients at front and centre throughout their business.
Over the past decade, we have seen a dramatic shift of power in favour of patient advocacy groups throughout the healthcare and life sciences sectors and pharma is catching on as companies are starting to realise the value in patient input especially in the areas of R&D and regulation.
During the panel entitled ‘Patient-Centred Care and Patient-Centred Outcomes — Hope or Hype?’, a number of speakers referred to the dawn of the 80s HIV crisis and the birth of the first highly effective patient group that was responsible for propelling treatment development for the much-stigmatised disease.
Long gone are the days of Dr knows best. The value of real-world data and patient experiences are beginning to wield power in all areas of the value chain.
The driving force behind this move to patient centricity is clearly the patients themselves as they have begun to put pressure on governments and multinational companies.
So, has patient involvement helped or hindered R&D? What are pharma companies doing to become more patient centric? And, what are the challenges of collecting real-world data?
Global President, Internal Medicine, Pfizer
The one thing that is being lost is the voice of the patient. Ironically on a panel about patient centricity there is not a single patient advocate.
This shows how difficult it is to put patients at front and centre. We have to work harder than ever to do this.
We are trying to put patients first in every area of our organisation. When we engrain patient centricity into the culture we always get a lot of new creative ideas.
Pain patients have a very difficult time expressing their condition. A grip test for monitoring a muscle waste disorder does not say much about that patient’s life. With digital tech, we have taken a different approach. What about their mobility? How do they move around the house? What can they eat? This information is infinitely more valuable than looking at some static measure.
Chief Patient Officer, MSD
We are in a new era where patients have access to information and data. They have expectations and demands, they are funding research and becoming increasingly organised.
This patient empowerment is certainly having an effect on the regulatory environment.
However, patient recorded outcomes require a different methodology when approaching vital statistics. It is much more social behaviour research. The risk in bringing this sort of data into the regulatory environment is that it could create regulatory uncertainty.
As a doctor, my patients were my best teachers. I trained during the early days of aids before anti-viral meds. In areas of extreme ambiguity you need to make decisions together – things such as orchestrating a good death for a patient can only be done with a collaborative spirit.
I think we should have more flexibility in the regulatory environment. It is important to understand safety but we must broaden the ability for doctors and patients to negotiate decisions together. We are not there yet but we are moving in that direction
Senior Medical Officer, European Medicines Agency (EMA)
Patients have emancipated themselves. 10 years ago there were very few well organised, outspoken patient groups. Now disease area by disease area we see how one eloquent group after another is popping up and we are seeing great change which then triggers change in other players like us as regulators.
A regulator wants to see endpoints, clinical trial outcomes and data that is measurable, this is changing as patient groups apply pressure on regulatory bodies to include human data. We need to find out how to get there but the rethink has already happened.
In the majority of our consultations, we have patient representation. And do they move the needle? The answer is very often yes.
Where we really need more patient input is trade-offs. When you have a product that does some good and bad, we need patients help to find the appropriate trade-off between benefit and risk.
A huge challenge is the difference between patient-level decisions and public level decisions. One patient may get up every morning and cry, whilst another with the same disease may not. As regulators, payers and industry we have to see how we can distil these individual patient stories and turn them into a metric to make public level decisions. How do we turn an anecdote into a metric? We are still not there yet.
Chief Medical Officer, Johnson & Johnson
This year Johnson & Johnson (J&J) celebrated the 75th anniversary of the crede General Johnson put out before going public. At the top was, ‘the people who use our products.
When we started we aimed to be patient-centric in our decision making. Now we see being patient-centric as being a partner with patients in decision making. We work with patients to co-design our R&D programme and get their advice on everything we do that is important to them.
We had some safety issues in an ongoing Alzheimers study. After conducting patient preference studies we found that they were willing to accept quite a bit of risk for the chance of a few years of extra cognition which helped us reach a decision quicker than we would have in the past.
I think patient centricity will help us improve R&D productivity – especially in ensuring we are working on products that we know are meaningful for people. Also, patient input can dramatically decrease the number of patients who drop out of our studies.
Including patients all along the spectrum is a benefit – even if there is added cost.
However, getting input from one patient group does not have the breadth to be of real value, but diversity of input adds value. Although it makes things more complex it is still a positive, diversity is our friend. When doing patient preference studies it’s important to do them across a wide range of different people with different backgrounds. We are doing this now in a more quantitative way and hope that this will help make our decision making more patient centred and value-based
Exec VP & Chief Commercial Officer, Bristol-Myers Squibb
Bristol-Meyers Squibb’s (BMS) programme, “who are we working for?” helps to remind our employers about how they operate as a business.
BMS, being a leader in combating HIV has a lot of experience in engaging patient advocacy groups. We are now trying to take a much more holistic viewpoint. Rather than just focusing on the patient-physician relationship we are looking more at understanding patients — the burden of disease, the caregivers role, access decisions, the healthcare systems and leveraging patient data.
What has really worked for us is broad-based collaborations. We have worked very closely with the Oncology Nursing Society (ONS) in the US.
If you think about how chemo patients were taught to manage their disease in the past – they were taught to bear with it and get to the next treatment cycle. Now it is very different, we want patients to call if they have a cough or any symptoms.
We worked with ONS to redifine how they train their staff and engage with patients.
When it comes to statistics, median overall survival/landmark survival rates are all important metrics. The new intellectual challenge is coming up with a metric that will capture what life is like for patients post survival.
This panel discussion took place on Tuesday 6 November 2018 and was moderated by Greg Reh, global life sciences and healthcare industry leader at Deloitte.