Patient Reported Outcomes: Strategies for market access

Publication Date:
May 2016
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Harness the power of Patient-reported outcomes

Patient-reported outcomes (PRO) can refine research design, support new product applications and build powerful evidence of your brand’s value with payers.  But how do you create effective PRO instruments, in what settings do they bring greatest value and what developments are on the horizon?

Get our new report, Patient Reported Outcomes: Strategies for market access.

Informed by expert opinion, this report examines the emerging science of PROs and identifies how you can practically build the tools, and apply the techniques, that will harness the power of the patients’ experience for your brand. 

“It benefits everybody. It benefits government. It benefits people who pay for the drugs, it benefits insurance companies, industry as well as physicians, because imagine, if patients are cured they won't be coming again and again to the doctor” 
Ashok Bhaseen
Global President of Thyroid Federation International

Answering key questions:

  • Could do better:  Pharma is not fully benefitting from PROs – in what areas could they do better?
  • Expanding use: In what conditions and therapy areas are PROs playing a key role? 
  • Market Access: How can PRO data be used to enhance market access?
  • Key PRO ingredients: How can you define a PRO measure and what patient and operational issues do you need to consider when designing a study?
  • Measuring up:  What different types of PRO measures currently available and how might they develop in the future?
  • Improving research: In what ways can PRO measures be added into clinical trial design to deliver more valuable outcomes? 
  • Payer influence: What PRO data can be persuasive to payers and support pricing?
  • Guidance: What guidance is available from the FDA, EMA and PRO Consortium on the selection and use of PRO instruments?


Key Topics Explored

  • PRO measures articulate the patients’ experiences in a structured manner for application across a range of pharma’s activities, but it is essential to design studies that deliver insights not just data.
  • PRO data is no longer just a “nice to have”.  Regulators and payers are increasingly demanding PRO data to support their evaluations.
  • While traditionally used in pre-marketing settings, PROs are now positively impacting drug applications and post-marketing assessments 
  • Incyte’s Jakafi (ruxolitinib) is seen as a model application of a PRO strategy – what benefits did the company accrue and what lessons can be learnt? 


Expert Contributors

  • Dr Hendrik-Tobias Arkenau, MD, PhD, Founding Medical Director of the Sarah Cannon Research Institute UK, and Fellow of the Royal College of Physicians.
  • Ashok Bhaseen, Global President of Thyroid Federation International.
  • Claire Burbridge. Senior Director of Clinical Outcomes Assessment at Clinical Outcomes Solutions Ltd. 
  • Dr Diego Cadavid, Senior Medical Director, Biogen. 
  • Dr Stephen Joel Coons, PhD, Executive Director, Patient-Reported Outcome Consortium, Critical Path Institute, US.
  • Dr Gordon Crawford, MD, Director and co-founder of Patients Direct. 
  • Linda Deal, Patient-Centered Outcomes Assessment (PCOA) Lead, Global Health & Value, Pfizer. 
  • Matt Reaney, Head of Patient-Reported Outcomes, Global Health Economics and Outcomes Research, Sanofi.
  • Sue Vallow, Senior Director and Head of Patient Focused Outcomes at GlaxoSmithKline. 

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