Pharma must get in the ‘real world’ to prove value of medicines

 

The pharmaceutical industry is entering a ‘prove it works’ era that will rely increasingly on collaboration and partnership with the NHS, the ABPI has said.

Its new CEO, Stephen Whitehead, has said that the industry’s imperative to demonstrate the value of its medicines will rely on developing and using ‘real world data’.

But observers have warned pharma companies that if they want to use real word data, they must first ensure they ask customers ‘real world questions’, rather than rush out to provide data that suits their own agendas.

In his first address since becoming CEO, Whitehead said that for working partnerships to progress, the industry must show it is ‘part of the solution, not the problem’.

“For a number of years, the industry has worked in partnership with parts of the NHS to help redesign pathways,” he said. “We have moved beyond purchaser and seller transactional relationships; this next era will be based on partnerships and collaboration. And by using real world data we can, for the first time, provide evidence of value – we can prove it works.”

In line with this, the ABPI has published ‘The Vision for Real World Data – Harnessing the Opportunities in the UK’, which outlines how the UK industry can become a centre of excellence for the collection and analysis of Real World data (RW). It defines RW as data “that are collected outside the normal constraints of conventional randomised clinical trials to evaluate what is happening in normal clinical practice.”

The ABPI says that the collection of such data will lead to a better understanding of conditions and treatments in a wider population, help improve the management of chronic conditions, and the avoidance of preventable hospitalizations.

“Real World data will provide us with the means for assessing the true value of a medicine – it will provide us with the opportunity to improve patient quality of life while reducing NHS costs,” said Whitehead. “But to make the best possible use of Real World data we must have seamless collaboration between the NHS and the industry.”

The ABPI report makes a number of recommendations as to how the industry can make the transition towards RW data collection. These include the development of a toolkit for companies to present the case to global colleagues, and the need to engage at local, national and European level to streamline the regulatory environment for the conduct of RW data studies.

It also advocates increasing efforts to facilitate NHS partnerships with the industry in the collection and interpretation of RW data and further engagement with the wider medical community to ensure it is published in respected medical journals alongside traditional clinical trial findings.

The push for more Real World thinking has been widely applauded, but some commentators believe that much of what is needed to propel the new approach is already present in the system.

Andy Lee, Commissioning and NHS Partnerships Director, WG Group, said: “A lot of the data for RW studies is already there, it just needs a systematic approach to joining it up. The most important issue, however, is to demonstrate true partnership, not pay lip-service to it: if pharma is going to use real world data, it needs to make sure it asks the real world questions – and those are the questions that commissioners and medicines management leads will be asking, not necessarily those that pharma companies might like to try to prove. The two sides need to talk and agree the outcomes data that will really enable decisions to be made, and changes to actually happen.”