Real-World Evidence and Access Europe 2018

Apr 24, 2018 - Apr 25, 2018, Berlin

See the future. Secure market access.

Overcoming The Access Hurdle

If pharma is to keep whizzing ahead, it needs to rethink its approach to market access



The pharma industry is a textbook example of how progress can be a double-edged sword. The breakneck pace of drug innovations, data crunching and the increasing focus on patient pathways are a cause for much fist-pumping, but they also make the challenges more pronounced.  

Amid this evolving landscape, payer expectations are mounting. Pharma must clearly demonstrate its value or face being stonewalled at the point of access.

What is the nature of this beast and what can the industry do to confront it?  

Earlier collaboration
“The old way of developing things was to do the basics, showing the drug worked and then throwing it over the fence for marketing to sell, hoping they could figure out how to introduce it. That simply doesn't work anymore,” says Steve Wooding, Head of Global Commercial and Market Access Strategy Organization, Janssen.

Only truly innovative compounds will meet unmet needs and “create sustainable business”, he says. The challenge for market access professionals is that the innovation bar has been raised just as industry is evolving to tackle more complex conditions. 

The question is how to influence and engage the R&D process to think about market access at a much earlier stage, which is not something that pharma has ingrained in R&D, but it is something that over time will be required, he says.

Greater collaboration with regulators at this stage offers an opportunity to license medicines with more relevant data, says Wooding.

“We do not necessarily always agree on everything, but more often than not we can agree on end points in the science. Increasingly, we need to move in that direction with market access.”

Concrete steps
So, what is Janssen doing to bring this about?

“We have implemented a program of access and evidence reviews for each compound in our pipeline, looking at and anticipating what the access environment will be when the potential medicine is launched.

With many competitors, it is also essential to look at factors such as the changing treatment landscape and other treatment modalities coming in or going out to ensure differentiation with the innovation and ultimately demonstrate value,” he says.

Janssen sees its global access approach as having three pillars. First, developed markets have relatively defined, if challenging, Health Technology Assessment processes; second, emerging healthcare systems, where the payer may not be the government or insurance, and there is a higher proportion of patients paying out of pocket; third is in global public health, where there simply isn't either the financial and treatment infrastructure to make the medicine available, which calls for partnerships with various organizations and partners.

The approaches to these three pillars are markedly different, both in terms of the data requirements and the access approach, says Wooding. 

“Different pricing approaches are needed to navigate these three pillars, and, in many cases, different end points and data are available, not for everything but certainly for a number of medicines. To play in those three spaces in an effective way, which is difficult to do, there is not a one-size-fits-all solution and developments need to recognize different stakeholders.” 

Walk a mile in someone’s shoes
Wooding urges the industry to pay closer attention to the changing role of stakeholders. Healthcare remains both a major political and economic challenge for governments around the world. Out of necessity, payers are now trying to become more engaged and to forecast ahead.

A little empathy and understanding can open the door to greater input and engagement from the payer side, but he also advises caution.  

“Be careful that you are not restricting innovation by just doing something everybody is familiar with; see that, not only are there different scientific approaches to innovation, there are other innovative approaches to how medicines demonstrate value and are paid for.”

The year of the patient
One of the biggest challenges in the early development phase is defining the role of the patient. Progress is afoot, however, and the industry’s most talked about topic is starting to have a significant impact on decisions, says Wooding. 

“We are looking at our target product profiles as they develop, asking: Where is the patient voice in this, have patients been engaged in discussions and are we building something that will ultimately meet patient needs?”

Patient-reported outcomes should also be discussed much earlier and should influence development more substantially because payers and regulators are clearly bringing that “totality of the patient view into the mix,” he says.

Shape-shifting
To truly innovate in the market access space, pharma companies need to adopt a more fluid and proactive approach, he says.

“To be able to feed what's happening locally on the ground back through the global organization produces more tailored solutions. A global organization can't do that everywhere and every time, but unless there is a degree of sensitivity and understanding of what is changing locally and how those markets are moving from an access perspective, it unfortunately becomes a kind of retrofit, procrustean approach with inevitable delays.”

The reality of Real World Evidence
RWE is often dubbed the industry’s ‘holy grail’ but it is not a sure-fire success, says Wooding. Pinning down a definition is the first stumbling block. “If you asked five people what RWE was, you'd get 10 definitions.”

Unlocking RWE’s potential comes down to recognizing the value it brings, the impact it has and the difference it makes to patients, he says. This may sound straightforward but demonstrating each component to a payer is an arduous task with unpredictable returns.     

Equally as unpredictable is payer uptake. Authorities have differing views on RWE; some have embraced it –  while others will shut you down if there is no controlled study to prop it up.

Other external factors will shape RWE’s success, he says. The influence of the local health economy, government, insurers and other regulatory bodies, who must make decisions on what they believe they can afford, is not going to yield a uniform response.

The RWE buzz does point to a promising future, however. “There is a fairly robust attempt to integrate it into development programs, thinking about how to move seamlessly between one and the other to provide a package of data that supports a medicine and the value it brings throughout the lifecycle.”

Onwards and Upwards
Market access is ultimately moving in the right direction, says Wooding.

“There is a general recognition of the need to develop things in a more access-friendly way; indeed, at Janssen we have just done a big strategic review and when we asked open ended questions from people from across the organization, we repeatedly heard access, access, access -  so it is clearly the priority. We need to look at the success of development in terms of technical, regulatory and reimbursement success.”

Wooding believes the reimbursement hurdle will eventually become a core part of every discussion around medicine development. This will require companies to rigorously analyze and anticipate future outcomes, which will occasionally throw up things that they don’t want to see, but this is the upshot of a value-based world.

Pharma and payers have more in common than meets the eye, he says.

“If you start with the patient and work back, our objectives are aligned. It is up to us to figure it out in a collaborative partnership because ultimately, we both want better medicines that provide patients better outcomes.” 

Steve Wooding will be weighing in on the conversation at the Real-World Evidence and Access Europe 2018 event in April. 


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Real-World Evidence and Access Europe 2018

Apr 24, 2018 - Apr 25, 2018, Berlin

See the future. Secure market access.

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