Please login to the form below

RWE Blog 4: The place of real-world evidence in the market access strategy

The fourth and final blog in our latest series focuses on market access strategy. This follows our evaluation of the role of real-world data (RWD) and real-world evidence (RWE) in Real-world challenges and real-world data, understanding the payer's perspective, in Payers use real-world data cautiously, and seeing the views of both advocates and opponents of RWE in Is real-world evidence the holy grail: Finding the balance.

Understanding the opportunities and risks that RWD offers to both payers and industry is improving. Observational studies provide an important source of information not given by randomised controlled trials, with the data gathered, analysed, and interpreted with special attention to bias and data quality.

Valid criteria for RWE include:

  • Effectiveness in daily practice
  • Long-term safety and clinical outcomes data
  • Data on utilisation in vulnerable patient groups
  • Use of economic resources

However, for comparing effectiveness of a new entrant to older or competitive drugs, there are strong concerns and calls for caution.

There is a strong drive to capture and analyse RWD on the effectiveness and safety of products. The regulatory authorities often request the capture of post-launch data, and in some cases it’s mandatory. But what are the practical consequences for market access and commercial functions for companies planning to develop and use RWE?

  • For markets with 'normal' timelines for marketing authorisation, RWE arrives too late to support initial pricing and reimbursement discussions. Putting in place an early access programme can deliver some early RWE that may be of use, but it’s important to remember that these patients may not represent the larger population that will use the therapeutic after launch
  • Studies that compare effectiveness between your product and your competitors’ will be scrutinised by payers that have an awareness of possible selection bias and confounding. Because of this, RWE may not be the best way to demonstrate efficacy
  • Be aware of selection bias and confounding issues during study design and analysis, and demonstrate, where possible, that patients in both cohorts are fully comparable. Remember that a pure statistical correction is less likely to be accepted by the payer audience
  • Remain focused on statistical and quality issues
  • When dealing with a sceptical payer audience, avoid phrases like 'real-world evidence' and 'data dredging'.

Before conducting a real-world review of a product, it's vital to study the existing product and competitor data to see whether it’s likely that your product will perform better or worse in the real world. This should be done as early as possible and includes consulting with experts who can evaluate and predict the channelling and other confounding factors that are expected to arise when your product enters the market.

In conclusion, a plan for RWE is needed to support market access and pricing. It should not only consider benefits, but also take possible risks of real-world effectiveness into account, and have plans to mitigate the impact of potentially biased outcomes.

If you’re interested in finding out more information on how to use payer-relevant evidence to best support your product value, the Valid Insight team can help, so call us: +44 (0) 20 3750 9833 or email us:

18th November 2019



Company Details

Valid Insight

+44 (0) 20 3750 9833

Contact Website

152-160 City Road
Kemp House
United Kingdom

Latest content on this profile

Webinar: How to develop an optimal value story for your product
This webinar is part of the ongoing expert insights series run by Valid Insight
Valid Insight
Last chance to register - Webinar: How to price a pharmaceutical product during a global economic recession
How can you ensure your product achieves optimal market access during a global economic recession?
Valid Insight
Are biobetters a market access opportunity?
Biobetters are biologics that have been improved compared to the marketed originator, for example in efficacy, safety, tolerability or dosing regimen.
Valid Insight
Why are new medicinal products denied reimbursement in France?
Many medicinal products looking to launch are rejected for reimbursement in France. A manufacturer must convince the Transparency Committee that their product is safe, effective and offers added value relative to alternative treatments for successful market access. In this blog, we summarise the reasons for negative reimbursement decisions in 2017 and discuss common pitfalls manufacturers should avoid.
Valid Insight
Using TRAVELLESS™ to provide tailored pharmaceutical training
In May 2020, Valid Insight were scheduled to travel to Grenoble to deliver the market access modules as part of the Advanced Master’s in Biotechnology & Pharmaceutical Management programme with Grenoble Ecole de Management, a French graduate business school. The course has participants from varied backgrounds, but all from roles within the pharmaceutical industry.
Valid Insight
The vicious circle of pharmaceutical tendering
Pharmaceutical tendering and contracting has long been common in healthcare for medical devices and diagnostics; the Gulf Cooperation Council and the Jamaica Commodity Trading Company have been using pharmaceutical tendering since the 1970s. In the 1990s, international institutions such as the World Health Organisation and the World Bank endorsed tendering as the preferred procurement process for drugs.
Valid Insight