Interview with Anke Holtorf, Managing Director, Health Outcomes Strategies, GmbH on the subject of patient involvement in pharmaceutical market access.
Patients are playing an increasingly powerful part in market access, and this was recently explored within a chapter in the newly-published book Pharmaceutical Market Access in Developed Countries.
Both co-authors are well-positioned to pen such a piece from the industry perspective; Anke-Peggy Holtorf works with the company Health Outcomes Strategies, which aims to help pharmaceutical companies and medical devices companies to highlight the value of their products or to make decisions about technical developments as relating to the potential value of the product. Holtorf is also actively involved in the International Society For Pharmacoeconomics and Outcomes Research (ISPOR) and the Health Technology Assessment International Society. Nigel Cook works with Novartis.
The book chapter explores the concept of patients as active partners in healthcare delivery and drug development in an industry that is not necessarily prepared for this major shift in approach. It also aims to provide some insights into potential best practices for pharma, which has been struggling to master patient engagement.
Holtorf explains to PFMD that while the idea of patient-centricity has been a “huge development”, it is still a relatively new concept for an industry that has historically been product-focused.
“That makes sense; there is so much work and expertise involved in developing these products,” she admits. Yet Holtorf points out that like in many other sectors, such as the car industry, they have recognised that today’s customers are much more informed, they want to be part of the decision and design process to ensure that future products are better and to improve the success rate of clinical studies. She adds that other stakeholders in healthcare, such as the regulatory authorities, have also changed their attitude; “They listen much more to patients, not just the EMA but also on the reimbursement side – some payers are listening much more to the patient.”
Although the industry is under increasing pressure to listen to patients and gather their insights, historic barriers often prevent this – while some are regulatory or compliance issues, cultural and practical problems also abound. Holtorf says, in her experience, only a few companies have progressed to the level where collection of patient insights is fully integrated into their highly regulated clinical development processes.
“It is very challenging because these processes are sensitive and you cannot open them too much because the regulatory path is so clearly defined in terms of what you can and cannot do, then all of a sudden there is a patient who says what you do is not relevant, we want it done differently. For many companies they have not figured out how to address this.”
Indeed, the patient perspective is often considered too late by industry.
“They start the development project and at some stage someone says we have to listen to the patient, but at that point they’ve already finalised their clinical trial protocols and it is too late to adapt anything.”
Unsurprisingly within this new field, there is significant experimentation taking place. While best practice has not been established yet, models are emerging which look extremely promising, according to Holtorf.
“The IMI projects such as PREFER or PARADIGM are very good examples; that for me make sense as there is a consortium of industry partners working together with all other stakeholders to develop these methodologies collaboratively – you need to test them in practice and refine them based on the experience. ”
In their chapter, Holtorf and Cook also discuss the commercial attractiveness of such an approach, saying the evidence shows that a significant return on investment is possible when companies engage in patient-centric drug development.
“I believe so,” she tells PFMD. “We see companies that did not involve patients and then failed because their products did not meet the needs of patients either due to burdensome properties or to a lack of the expected outcome. If you develop products that directly meet the needs of whoever is supposed to use them, then you achieve a better fit to the market and there is a higher demand and that’s where the commercial advantage comes.”
This will be a core component of innovation in the future, she adds.
“Innovation will come about from biomolecular research, and understanding healthcare data better, but it will also result from understanding what is important to patients and what their values are, and how we can improve therapies to make them more valuable to the patient.”
The chapter concludes by stating that whereas patient-focused drug development may once have been considered a ‘nice to have’, it has since moved on to a point where patient involvement and partnership is now an “essential and necessary component” of the drug development process.
Holtorf likens this change to when industry was forced to become aware of health economics and cost-effectiveness a couple of decades ago – nowadays there is no product developed without this being considered throughout the process. Eventually, the same will happen with patient engagement, she believes.
“Companies who do refine their processes to take into account the patient perspective will be more likely to succeed. This is not only about industry but also about the way we interact with each other in the healthcare process and the patient’s role in it – we are moving towards health-care where the patient assumes more responsibility for her or his health and everyone else supports them to make good decisions.”