Personalised healthcare – are there still more questions than answers?

As part of our series on “personalised healthcare” (PHC) Chris Teale, Vice President Europe at GfK Bridgehead, provides his personal perspective – identifing some of the major issues requiring answers, plus his “top 5” key questions for companies to ask when considering adopting a personalised healthcare approach.

The evolution of personalised healthcare has changed the diagnosis and prognosis of cancer patients and is revolutionising the treatment oncology landscape. However, key market access obstacles still need to be removed in order for PHC to fully deliver on its promise of clinical and commercial success.

Physicians and payers are increasingly recognising the value of the PHC approach in terms of the economic, clinical and humanistic benefits delivered. Physicians wish to maximise the effectiveness of treatment through:

• Improved outcomes

• Avoidance of “trial-and-error” prescribing

• Avoidance of unnecessary side effects

Payers wish to leverage evidence of outcomes, costs and comparative effectiveness and they increasingly base their decisions on three efficiency strategies which are particularly well served by a PHC approach: value-based purchasing, pricing and reimbursement.

The common goal is “delivering the right drug to the right patient at the right time at the right price“.

 

“Physicians and payers are increasingly recognising the value of the PHC approach in terms of the economic, clinical and humanistic benefits delivered.”

 

A laudable objective, but it is not all “plain sailing”. Looking at real world utilisation and outcomes indicates that the number of patients benefiting from the PHC approach is dramatically reduced, unless the following issues are successfully addressed:

Testing demand – Will patients and physicians request a test?

Patient selection – Will the population tested be as broad as the licensed indication of the PHC medicine? Will clinicians de-select patients for testing for clinical or other reasons?

Treatment selection – Will clinicians prescribe other drugs despite a “positive” test result?

Test sensitivity & specificity – Will test be perceived as not sufficiently accurate or ambiguous?

Test “turnaround time” & complexity – Will physicians be unwilling to test due to complex, tedious or time-consuming testing processes?

Test funding – Will patients be denied testing due to a lack of funding?

Seen through pharma’s eyes, PHC is often quoted as “the answer” to the challenge of decreasing R&D productivity, industry sustainability, and a source of future growth. This should be seen however as “conditional”. There are “5 key questions“, each with several sub-questions, a company should ask to guide its PHC journey:

1. Is personalised healthcare an appropriate way forward for the drug?

Will it be ‘worth’ testing?

• Will the benefit / risk profile be positive? Ideally there should be no ‘risk of harm’ in testing, and the test outcome should inform the potential magnitude of treatment benefit

• Will the “co-dependent products” (test and drug) jump the regulatory (clinical efficacy and safety) AND the additional health technology assessment (cost effectiveness) hurdles?

 

“Seen through pharma’s eyes, PHC is often quoted as “the answer” to the challenge of decreasing R&D productivity…”

 

 

2. Will the reduction in available patient population for a PHC drug result in lower revenues compared to a non-PHC approach?

Will there be sufficient leverage in the following three key areas to result in higher revenues and / or profitability?

• Improved competitive position

• Premium pricing

• Earlier use in treatment pathway

3. How should two independent parties (drug developer and diagnostic developer) collaborate in a PHC strategy?

How should the investment and revenue streams be divided between the parties as the basis for the collaboration?

How should pricing, market access, and competition be factored into the collaboration?

4. Will there be a Willingness To Pay (WTP) for both the diagnostic test and the drug?

Payers, pharma companies and patients all have different WTP challenges:

The traditional payer’s WTP may depend on the incidence of the biomarker (genetic mutation), the cost of the diagnostic test, the price of the drug, and the magnitude of the incremental clinical benefit demonstrated in the biomarker population.

The drug company’s WTP (for diagnostic testing when the traditional payer is unwilling to pay) will depend on consideration of likely return on investment in the context of overall product strategy and resource allocation.

The patient’s WTP introduces questions of cost sensitivity and affordability, and the value the patient places on knowledge, risk, quality and quantity of life.

 

“Is personalised healthcare an appropriate way forward for the drug?”

 

5. Has appropriate and timely investment been made in other Critical Success Factors (CSFs)?

Future success in PHC will be driven by many factors. The three most important of these may be:

External change: The Industry’s ability to influence future regulatory, coding, payer assessment and evaluation systems, and healthcare policy

Effective collaboration: Collaboration between pharmaceutical companies; between pharmaceutical companies and diagnostic developers; and between companies and payers

Insight and foresight: Rigorous qualitative and quantitative analysis – from a multi-stakeholder perspective (physician, payer, patient, pathologist, and company – both pharmaceutical and diagnostic) – to provide a strong foundation for strategic decision-making and basis for a successful PHC market access strategy.

Companies would benefit from addressing these 5 questions when planning their journey towards personalised healthcare.

 

 

About the author:

Chris Teale is Vice President Europe 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&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 can pharma overcome the challenges involved in a personalised healthcare approach?