The role for health service research in the life sciences industry

Health systems are mindboggling complicated things. The word “system” somewhat implies that these are planned and well organised but in reality they are evolving ecosystems made up people, technology, buildings, support services and information systems… all brought together in a web of billing programmes, financial incentives, regulatory scrutiny and politics. At the centre of all this are patients trying to navigate and work through their own journeys of health and illness, each bringing their own needs and perspectives.

The challenge of adoption

To become part of regular clinical practice, innovations such as new medicines and medical devices need to find their place in these healthcare ecosystems. However given the complexity of health systems, it is not surprising that some innovations and medicines struggle to be adopted, even after receiving positive recommendations from health authorities and payers.

Adoption challenges are not the same for all new medicines and innovations. Generally speaking, the further away a new medicine is from being “just another pill in a blister pack”, the greater the challenge. Adoption is often particularly challenging for advanced therapy medical products such as cell and gene therapies which often require very sophisticated administration techniques, medicines requiring companion diagnostics or complex monitoring, and treatments in therapy areas where existing clinical pathways and care systems are underdeveloped or fragmented (e.g. dementia care).

How health service research can help

Understanding all this is the discipline of health service research (HSR). HSR brings science and rigor to the understanding of health systems, and aims to generate evidence for how to design, deliver and transform health systems to improve the quality, safety and efficiency of healthcare. For example, HSR might consider questions such as “Does the implementation of a new diagnosis and treatment pathway improve survival for people with lung cancer?” or “What are the effects on patients’ quality of life, outcomes and costs of treating people with pneumonia at home instead of as inpatients?”.

Whilst there are pockets of teams across pharmaceutical companies exploring the importance of health system transformation along with new therapy introduction, the industry has not traditionally focussed a great deal on HSR. Relatively few evidence generation plans and market access strategies for new product launches consider how health services research could contribute to local market access and post launch success. There are a few potential reasons for this – health system factors were perhaps less of an issue for previous generations of medicines, and how life sciences companies engage with and support health systems is a complicated and sometimes sensitive area.

I would argue that this is a missed opportunity, and that the life sciences industry could make better use of health services research evidence to actively support the adoption of new treatments and technologies into clinical practice, improve the safety profile of new treatments and potentially reduce the costs of bringing new treatments into clinical practice.

HSR is a diverse field and spans trials, real world studies and qualitative research. Trials provide the most robust evidence for the effect of health system transformation but are complex to do and there are specific methodological considerations, such as often needing to use cluster designs rather than person level randomisation. Many HSR studies make use of real world data such as electronic healthcare records, registries and claims databases, leveraging variation in clinical practice and natural experiments (e.g. policy changes). Qualitative research methods such as ethnography have an important role in HSR, helping to explain and understand health systems and the findings from trials and real world studies. As always in research, it is critical to match the evidence need and research question to the appropriate research methods and study design.

In summary, making better use of HSR offers an opportunity for the life sciences industry to address the adoption and access challenges that many new medicines face, and engage with health systems in evidence-based transformation and service design. This is going to be particularly important for the wave of cell and gene therapies and precision medicines likely to be launched over the next few years, where adoption may be challenging in some markets and local health systems.