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Personalized Medicine – Challenges, Opportunities & Market Access
Industry Insight

Personalized Medicine – Challenges, Opportunities & Market Access

Personalized Medicine – Challenges, Opportunities & Market Access
Industry Insight

Personalized Medicine – Challenges, Opportunities & Market Access

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By enabling increasingly targeted diagnostics and therapies, personalized medicine offers great potential to improve patient outcomes. However, there are still a number of challenges to overcome before personalized medicine can become routinely adopted.
We spoke to Iain Miller, Founder, Healthcare Strategies Group, to learn more about some of the challenges in the commercial development of personalized medicine products, and what is needed for a successful market strategy. 

AM: Can you tell us a little about the Healthcare Strategies Group?

IM: Healthcare Strategies Group provides a blend of strategic advisory services and operational business development and general management support to the diagnostic, pharmaceutical and med-tech industries. The company’s advisory services are focused on commercial strategy development through to operational business development, market access and general management support. We have a particular focus area at the intersection of diagnostics and therapeutics.

AM: What does your role as a member of the NICE Technology Appraisal Committee involve?

IM: Within NICE, I sit on Technology Appraisal Committee C, which reviews the cost effectiveness of new drug and device/diagnostics technologies. The committee, which comprises a diverse group of external experts, looks carefully and objectively at the evidence base for the new technology and issues a recommendation as to whether the technology in questions should be available within the NHS. NICE is perhaps the world leading agency when it comes to the quantitative assessment of value of such new innovations and I am privileged to be a part of the process.

AM: Can you describe some of the criteria NICE uses to review new medicines and tests?

IM: NICE considers the patient benefit, as measured in Quality Adjusted Life Year gains and measures these benefits against the cost of the innovative technology. An assessment is then made as to whether the cost/QALY, also known as the Incremental Cost Effectiveness Ratio (ICER) exceeds a threshold generally in the range of £20-30k/QALY. While NICE guidance is often seen as controversial, it is important to recognize that, in so doing, NICE is looking at the opportunity cost associated with new innovations and thereby seeking to maximize the utility which the English health systems gets for its healthcare spend. The NICE criteria are objective and transparent and, in my view, a great contribution to the healthcare innovation economy. 
AM: You are also a board member of EPEMED. Can you tell us about the role EPEMED is playing in advancing personalized medicine in Europe?

IM: EPEMED, which I co-founded in 2009, brings together diverse constituencies interested in Personalized Medicine. These include pharmaceutical and device companies, and patient representatives. We work together to address important issues for personalized medicine, including how to improve patient access across the EU to such new technologies. These issues assume particular importance in the diverse and heterogeneous EU marketplace, and we seek to drive best practices across the EU. We sponsor conferences, working groups, and white papers, such as our recent white paper on market access to companion tests, which can be found at our website www.epemed.org. This white paper represented the culmination of a 2 year analytical project.

AM: What are some of the challenges in the commercial development of personalized medicine products?

IM: There are many commercial challenges. One such is ensuring recognition and apportionment of the value brought by the medicines and device developers. Absent such recognition, investment will not flow into these key programs. The problem is one of identifying appropriate Health Technology Assessment mechanisms, and translating these criteria to a reimbursement model which supports innovation. Other challenges relate to standardizing product quality, and finding optimal co-development paths for pharma and diagnostic companies. 
AM: What is needed for a successful market access strategy for diagnostic products?

IM: The innovator needs to consider the full path to demonstration of clinical utility, sometimes region by region. This is often more complex and costly than originally envisaged. It is also important to consider the competitive context and whether it makes sense to “go-it-alone” or find a collaborative route to market. The latter often includes collaboration with pharmaceutical companies. It is also obviously of critical importance to carefully identify your target market segment and refine your target product profile at an early stage. Sometimes a niche market can make most sense, especially for a small company. Business plan development is of course key, including addressing the foregoing issues, together with regulatory, reimbursement and exit strategy.

AM: Can you describe some of the new developments in the personalized medicine field?

IM: Some recent key developments are the new immunotherapy products, some of which may be highly personalized. Others will require patient stratification using a diverse toolkit of biomarker and assay technologies, which collectively will take us well beyond the one drug / one test paradigm. Other important developments relate to deployment models for next generation sequencing and other multi-parametric technologies.

Iain Miller was speaking to Anna-Marie MacDonald, Editor for Technology Networks.

Dr. Iain Miller, founder of the Healthcare Strategies Group, has extensive international experience, having split his career between the US and the EU. His client and broader experience base spans GE Healthcare, Biomerieux, J&J, Philips, Myriad Genetics and the UK Government Technology Strategy Board, in addition to various SMEs and investor groups. In addition to his 20-year US experience, Dr. Miller has worked extensively in the UK and EU marketplace, including major market access policy projects with European thought leaders. He is also a founding Board member of the European Personalized Medicine Association and has been very active in the UK stratified medicine and broader med-tech ecosystems. Within the UK Iain sits on the NICE Technology Appraisal Committee which reviews drugs and companion test products and is a member of the Oxford Bioscience Network Med-Tech Advisory Board. He also frequently serves as an assessor for the UK Technology Strategy Board (Innovate UK). Healthcare Strategies Group is based in London, where Dr. Miller and his associates frequently provide market bridging services between the US and the EU, including on-the-ground UK / EU market development for US companies and US market development support for UK-based companies.