Real-World Evidence and Access Europe 2018

Apr 24, 2018 - Apr 25, 2018, Berlin

See the future. Secure market access.

It's Not You, It's Me

Despite its ups and downs, the relationship between pharma and payers is stronger than ever

Anyone in a long-term relationship will tell you it evolves over time. The honeymoon period gives way to a comfortable companionship, or perhaps the fabled seven-year itch. After years of acrimony, pharma and payers are getting on better than ever. Aided by the wider move towards patient-centricity across the entire industry, and galvanised by the new reality of health and technology assessments (HTA), pharma and payers are working together more closely than ever before, with the common goal of ensuring as many patients as possible have access to the drugs they need.

These last several years there has been a discernible change in the relationship between pharma, payers, patients and healthcare providers. All stakeholders are working in partnership, for better or for worse in closer collaboration and engagement

Enkeleida Nikaï, Director of RWE at Lilly, draws on her experience in market access roles where “early advice” from payers and HTA bodies plays a fundamental role in establishing a product’s clinical development plans. In recent years there has been a growing gap that could provide further support to pharma: for payer/HTA bodies to not only advise on randomised clinical trials but also input on real-world evidence. “We need to have early dialogue as well as late dialogue on this other type of evidence too,” she asserts.

Mata Charokopou, Patient Access and Value Lead, UCB, explains that as UCB focuses on severe chronic diseases, their interaction with the patients and healthcare systems’ stakeholders is crucial. “The process of access for certain disease areas and specific subpopulations is neither always clearly defined, nor is there one course or pathway that we need to follow. Hence, we reckon the need for flexibility in our holistic connectivity to eventually improve as many lives as possible. We all serve the same purpose: to improve mental and physical health and wellbeing.

“For years, there has been significant work by many to create value and put people and communities at the heart of their health. Arguably, we all define value a bit differently, depending on our perspective, but we, as UCB, value connectivity and try to align with the main stakeholders on what we mean by value to patients. That is our first priority – it is a patient value driven strategy and it’s not an easy feat to always infuse such a mindset.”

This flexibility and connectivity are critical – Charokopou explains that UCB will not “force” their healthcare solutions into a particular market if the patients and healthcare systems do not see a fit in their needs.

“We are always willing to listen to see if there is anything that will change our direction. It is not about deciding to position a holistic solution into the market, we first try to decide if the solution is actually needed in a certain market and by a specific population. We listen first to learn the benefits and experience the patient, the community, the health system within a country are looking for.”

The main challenge from Charokopou’s perspective is the heterogeneity of healthcare systems and payer archetypes across the globe: “The unmet needs are highly variable, so there is not just one unmet need to address with our solutions - one patient, one community or country may need something more than the other.”

Amanda Cunnington, Head of Patient Access, Bayer UK, works closely with NICE and NHS England as part of her role. She believes that while relationships have continually improved over the years, access remains hampered by an overarching focus on cost savings. “I think the ability to talk to each other and understand each other’s decisions has improved greatly in the UK, however, the actual processes themselves have become more convoluted, partly due to the austerity measures in place and partly due to the continual overlaying of different solutions.”

She explains to eyeforpharma that there are two important aspects to these relationships – getting access to the medicines in the first place, but, equally importantly, ensuring uptake of those medicines.

This means making sure the way the system works doesn’t adversely affect uptake. Cunnington gives the example of Bayer introducing one of the relatively new oral anticoagulants to the market some years ago; these had clear benefits over the standard of care , yet the healthcare system was designed to administer the older vitamin K antagonist, warfarin. “It’s all very well that the drugs are approved, but does this system adapt to take advantage of them?  Indeed, is there capacity within the NHS to give the drugs the way we know they have to be given to get the results that we want? We find that some parts of the country  really struggle so my team will work collaboratively with those areas to understand how patients move through the system so that they can use their available capacity more efficiently.” 

According to Cunnington, collaboration for the benefit of patients’ needs to happen at all levels to ensure both access and uptake. “The UK has problems with getting access and also with uptake, but the good thing about the healthcare system, especially NICE and the local healthcare system, is that they increasingly appreciate that industry are experts in their own medicines and in their data. Consequently they have been working more collaboratively with us, especially at a local level to solve some of the difficult, knotty problems.  It is fantastic to see Bayer alongside our NHS colleagues being publicly recognised for this work that improves patient outcomes.”

She agrees with Charokopou that while relationships have improved, pharma and payers will not necessarily see eye to eye. “Industry and NICE have always had the ability to have really good conversations and talk to each other about the process of how do medicines get approved – we may not always agree but I always think there is a good exchange of views and it’s not antagonistic.”

Cunnington is also quick to praise the ability of NICE to look at the value of medicines, and not simply the budget impact. “We might have debates about whether they look at the value in the right way, and this is not different to other countries across Europe. Budget impact and affordability questions increasingly dominate the public debate everywhere and we run a risk to lose the value focus and become more and more cost oriented.There are good things about the way NICE operates, but I would like to see them be more assertive in the public debate on why it’s important that the value of medicines is looked at - for them to say ‘yes, innovative medicines bring value to the healthcare system’ and recognise that it’s right to invest in innovation and not just balancing the books.”

The disconnect between regulators and payers when it comes to their advice was highlighted by Cunnington as a significant challenge going forward

“The EMA are very good at licensing medicines quickly, particularly in areas where there is unmet clinical need. What’s frustrating is that it might take a couple of years in the UK, or even longer in some other countries to get it through their reimbursement systems,” says Cunnington.

Aligned and streamlined input from key stakeholders would allow pharma to carry out better evidence planning; for example, there is sometimes a disconnect between regulators and payers, says Nikai. “A drug could get approved from the regulatory standpoint, of which the primary focus is safety, but then the payers will look at the value triangle of efficacy, safety, and price, and may request more long-term safety data when the regulators have not demanded this at all. This can be surprising.” Having that alignment at the time of launch would enable industry to develop a standard approach, she says.

Cunnington believes that at a country level companies are best placed to understand the requirements of their reimbursement and healthcare systems and should therefore control when to seek reimbursement.  “At the end of the day we need to be doing the best we can for patients now and in the future, and we need to have strong data to get us through both the regulatory and reimbursement environment. Given few reimbursement systems enable price increases when evidence improves, companies need to judge when this is the case so that patients not only benefit  from new innovations but further innovations can also be researched and developed,” she says.

Enkeleida Nikaï, Mata Charokopou and Amanda Cunnington will be joining our roster of keynote speakers at the eyeforpharma 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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