The evolution of personalised healthcare within oncology

Hannah Blake interviews Chris Teale

GfK Bridgehead

Chris Teale continues our personalised medicine theme by discussing the current situation in oncology and the factors that are contributing to the rise in targeted therapies.

The evolution of personalised healthcare has changed the diagnosis and prognosis of cancer patients. But in order to achieve success, you need to understand this evolution from various stakeholder perspectives – patients, physicians, payers, and industry. To find out a bit more on this theory, we spoke with Chris Teale, Principal Consultant at GfK Bridgehead.

Chris discusses how the introduction of personalised healthcare has changed the way pharma thinks about healthcare – as Hippocrates once said, “It?s far more important to know what person the disease has than what disease the person has.”

Speaking from an oncology point of view, Chris also shares his thoughts on the current situation in companion diagnostics and the barriers that need to be overcome in order to achieve success in this area.

Interview summary

HB: Hello Chris, thanks for taking part in this interview. Would you like to tell us a bit about how you became involved in personalised medicine, and what your current role entails please?

CT: Certainly, no problem. Basically my introduction to personalised medicine was about four or five years ago. At that time, I was director of global pricing and market access for oncology at AstraZeneca. They had a product called gefitinib or Iressa, and at the time of the regulatory assessment of that product the conclusion was that it actually worked much better in some patients. One of the requirements of the product licence was for use in patients with non-small cell lung cancer with a particular genetic mutation, the EGFR positive mutation. And as a result, all sorts of new challenges arose, because clearly physicians couldn’t use that product unless the EGFR mutation status had been correctly identified. So that was really my baptism by fire into personalised medicine. But that wasn’t a one off. One of the things that we are seeing now is that an awful lot of pharmaceutical companies are investing more and more of their R&amp,D pipeline in the direction of personalised healthcare.

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“…it was a very wasteful approach – not ideal from either patient’s or payer’s perspectives.”

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My current role is as Principal Consultant at GfK Bridgehead, where we’re doing a significant amount of work supporting clients in the personalised healthcare space, looking at things like the assessment of co-dependent value between a pharmaceutical (Rx) and a companion diagnostic (Dx), addressing market access, pricing and reimbursement challenges of both Rx and Dx, and looking at the hurdles that a companion diagnostic has to overcome in order to be funded, because of course unless you have funded access to the diagnostic you’re not going to get utilisation of the related personalised medicine. That’s really where I am today.

HB: How has the introduction of personalised medicine changed the way pharma thinks about healthcare?

CT: I think significantly. Historically, pharmaceuticals worked in very much a scattergun approach, they worked in some patients and failed to work in others, so it was a very wasteful approach – not ideal from either patient’s or payer’s perspectives. Science has evolved, with dependency between diagnostic and drug being driven by greater understanding of genetic profiles. This is a tremendous opportunity for the pharmaceutical industry in terms of better targeting (identifying the right patients) and consequently achieving better outcomes with the pharmaceuticals that are being developed.

HB: In what ways will personalised medicine benefit patients and physicians as well as payers?

CT: As I indicated earlier, it’s moving into a position of ensuring that the right drug goes to the right patient at the right time. Physician benefit lies in higher treatment success rates, with patients getting the most appropriate medicines, informed by their genetic profile. As a result, payers are seeing significantly less “wasted spend” (ie they are paying for less treatment failures).

HB: What’s the estimated growth in market size for targeted therapies over the next few years, and what factors are contributing to this growth?

CT: I can speak probably much more from an oncology perspective than I can from a general perspective to answer this question. Here are a couple of key points – 50% of pharmaceutical manufacturers are currently integrating personalised medicines into their development programmes to support product differentiation and market access. Back in 2006, the global revenue for molecular targeted therapies in oncology overtook cytotoxic therapies for the first time. About that time the global annual revenues for molecular targeted therapies were about $10.7 billion compared with $8.9 billion for the cytotoxic therapies. By 2016, the global market size for molecular targeted therapies in oncology is forecast to be in the order of about $40 billion. So huge growth is forecast in molecular targeted therapies in oncology compared with the classical cytotoxic and anti-hormonal therapies where sales are forecast to be flat or even declining slightly.

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“…a significant proportion of patients, in excess of 50%, have tumours that are driven by certain genetic mutations.”

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I think it’s also worth observing that there’s quite a big variation between cancer types, so if you’re looking at cancer types like melanoma, thyroid, colorectal cancer, then a significant proportion of patients, in excess of 50%, have tumours that are driven by certain genetic mutations. In lung cancer, it’s probably about 40% driven by genetic mutations of various types, and even for ovarian, head and neck, and other GI cancers tumours are being driven by genetic mutations in around 20% of patients.

HB: How has the evolution of personalised healthcare changed the diagnosis and prognosis of cancer patients in the UK?

CT: It has changed how we think of the disease, and the assessment of treatment. And this is evolving rapidly. Although we still talk very much about cancer type (breast cancer, non-small cell lung cancer, colorectal cancer etc.), we are probably moving to a time in the not too distant future when we will think and talk about biomarker defined diseases. So the disease will be less defined by where the tumours emanate from and more by the biomarkers that define the disease.

The example I like to give comes back to non-small cell lung cancer (NSCLC). It’s now recognised that NSCLC consists of a multitude of disparate molecular subsets. If you go back to the traditional view, lung cancer was split down into squamous and non-squamous, or squamous and adenocarcinoma. Then around about the 1990s it began to be discussed as KRAS and “unknown”. By early 2000 the thinking was KRAS, EGFR, and “other”. Now we’re in a situation where the lung cancer patient may be KRAS wild-type, or they may have a positive EGFR mutation, or they may have a certain level of HER2 expression, or an EMP4-ALK mutation, or may have a tumour identified by BRAF, MET, AKT1, MAP2K1, or “other”. Even EGFR mutations can be further broken down into mutations associated with drug sensitivity, primary drug resistance, and acquired drug resistance. All of these are factors that will increasingly be used to inform the treatment of the disease.

In summary you can say that traditionally treatment decisions for lung cancer were based solely on histology and stage of disease, and that clinically relevant molecular subsets can now be identified based on specific driving mutations in genes that encode signalling proteins involving cellular proliferation and survival. Recent therapeutic advances can adopt a personalised therapy approach enabling the targeted management of a wide range of oncology indications.

HB: What is the current situation in oncology companion diagnostics in the UK, and how does this situation compare to the rest of Europe?

CT: Personalised medicine holds a promise to help physicians and payers target resources more effectively. But that promise is not the same as delivery, and this is true for most EU countries not only the UK.

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“Personalised medicine holds a promise to help physicians and payers target resources more effectively.”

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There are certain barriers that exist out there in all markets to the development and access to personalised medicines and companion diagnostics. I think there are basically four types of barrier. Type 1 relates to “Assessment Disparity”. The assessment and the regulation of pharmaceuticals and diagnostics are in most cases still separate processes with no framework for drug and diagnostic manufacturers to harmonise Dx-Rx co-development. Type 2 relates to the “Complex Economic Ecosystems”. In most countries there are no explicit health technology assessment (HTA) criteria for the value based reimbursement of diagnostics, and there is a poor understanding between Rx and Dx manufacturers as to how the combined value of the Dx-Rx product should be shared. Type 3 relates to the “Speed at which science is advancing ahead of economics”, and Type 4 is the “Lack of direction from Policy makers”. Health systems are often not geared up to address Dx-Rx offerings (e.g. deficiencies in reimbursement coding systems, unacceptable “turn-around-times” ie time between test and test results, issues around enforcement of Intellectual Property, etc) and the challenge of launching the Rx and Dx simultaneously.

So there are quite a few barriers that can make the reality of personalised healthcare challenging, and we as a consultancy are working closely with clients advising them on the different ways they can overcome those barriers.

HB: Finally, in what ways do you see personalised medicine progressing in the future in your opinion?

CT: At the end of the day, a lot of it will come down to the reimbursement of both the Rx and the diagnostic, and that will come down to evidence, ensuring that the right evidence at the right time in the right population is delivered to the right decision and policy makers.

I think three key areas will need to be addressed in the future to ensure that personalised medicine can progress and grow. The first one is evidence development, the second one is evidence assessment, and the third one – perhaps the most important one – relates to collaboration between stakeholders. How, where, when, and why should pharmaceuticals companies collaborate or partner with diagnostic companies going forward, and how should the evidence of co-dependent value be developed and communicated?. I think that these are not only areas of future challenge but also opportunity.

I also think there are certain key questions which pharmaceutical companies must ask themselves going forward. The first one is: Is personalised healthcare an appropriate way forward for the particular drug that they’re developing? Are the patient population, the Rx and the Dx all suited to personalised healthcare with a clear understanding of the value drivers of a personalised approach for payers and patients. The second key question is: How should collaboration be managed between two independent parties (the Rx developer and the Dx developer)? How should revenue streams /royalty flows be divided as the basis for the collaboration? How should pricing and market access considerations be factored into the collaboration?

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“…I do feel personalised healthcare is certainly a critical element of any future jigsaw.”

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Finally, I think three conclusions can be drawn. Conclusion number one is: “Personalised healthcare, although it’s often attractive, it’s not a panacea”. Incremental clinical value doesn’t necessarily justify a significant incremental price to offset the smaller size of the patient population, or for the payer to fund diagnostic testing. However, I do feel personalised healthcare is certainly a critical element of any future jigsaw. Conclusion number 2 is: “Consideration of co-dependent value (Rx and Dx) is essential”.

My final conclusion relates to what I call “Futurenomics”. To make the future economics of personalised healthcare add up, success will depend on two factors: The ability to influence and change external regulatory and payer assessment and evaluation systems, and effective collaboration. That is collaboration between the pharmaceutical industry and payers, collaboration between pharmaceutical companies themselves, and collaboration between the pharmaceutical companies and diagnostic companies.

I believe these are going to be the key elements to consider going forward in personalised healthcare.

HB: Thank you for your thoughts today Chris.

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About the interviewee:

Chris Teale is Principal Consultant at GfK Bridgehead. He joined the company in 2011, bringing with him extensive practical and academic experience within the pharmaceutical industry, across both Marketing and R&amp,D, over a 30 year career.

He has held a number of leadership positions at both Global and European level, having previously been Director of Global Pricing and Market Access (Oncology) at Astra Zeneca, Director Health Economics, Pricing, Reimbursement and Access at Allergan, Commercial Planning Manager at Fisons, and Portfolio Planning Manager at Ciba-Geigy in Switzerland.

Chris gained a BSc degree in Mathematics from Newcastle University, and also studied at Loughborough University (Management Information Systems) and INSEAD Business School (Marketing for International Business). He is also an occasional lecturer on health economics and pricing and reimbursement on the Organisation for Professionals in Regulatory Affairs (TOPRA) MSc course at the University of Wales, a member of ISPOR and a German speaker.

You can contact Chris via his email – Chris.Teale@gfk.com.

How will personalised healthcare continue to improve in oncology?