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Is real-world data a market access hurdle or facilitator?

08 April 2014 Gaelle Marinoni

The IHS Life Sciences team is currently undertaking research on the concept of flexible pricing. Introduced notably in the UK Pharmaceutical Price Regulation Scheme (PPRS), the idea behind the concept is that manufacturers may apply for a price increase sometime after initial funding recommendation, in the hopes that significant new evidence will mean that the product is still determined to be cost effective. One aspect that particularly interests us is the nature of that potential evidence. In theory, given that the concept would apply to already funded products, this evidence could include real-world data. As such, flexible pricing is one means by which real-world outcomes - the subject of much debate within the healthcare space - could increasingly influence key decision makers in future.

The traditional route that pharmaceutical products take to market by and large precludes the use of real-world data in initial decision-making. For licensing purposes, the double-blind, randomised clinical trial remains the bedrock of decision-making. However, even in the regulatory sphere, there are ways in which real-world use of medicines is increasingly relevant. With benefit-risk assessment now solidified as an ongoing, continuous process under the European pharmacovigilance reforms, real-world experience can increasingly impact the regulatory fate of a medicine well after licensing. What is more, just recently the EMA announced its piloting of a novel adaptive licensing project - a scheme whose staggered approach could easily draw on real-world outcomes as the patient population is gradually expanded.

Meanwhile, when it comes to the pricing and reimbursement process, real-world data is usually not available at the time of initial decision-making. However, in case of uncertainty with regards to safety and/or efficacy, the collection of real-world data can become a prerequisite for access, notably as part of conditional reimbursement decisions or risk-sharing agreements. Interestingly, in the opinion of payers, real-world data isn't necessarily an attractive approach due to the delays and the costs (often to the national healthcare system) linked to collecting the relevant evidence. That said, based on the payer interviews we conducted as part of our upcoming flexible pricing research, payers are increasingly likely to leverage available real-world data to reassess their initial funding decisions and to develop treatment guidelines.

As real-world data can increasingly impact on the lifecycle and the commercial success of medicines, it is important for pharmaceutical companies to leverage the associated opportunities and plan for the potential challenges. As we prepare to attend the second annual Real World Data Europe Conference, we are looking forward to hearing even more about regulator and payer behaviour with regards to real-world data and will report back on the conference key points shortly.

By Gaelle Marinoni and Cameron Lockwood



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