Healthcare decisions are life changing. In today’s value-based healthcare environment, it’s important to take an integrated, multi-perspective approach to value demonstration.
What do the following have in common? The choice to advance or kill a molecule in development, a split-second prescribing preference, the selection of products for reimbursement, and the option a patient has whether to take a medicine or not. One answer is that they’re all potentially life-changing decisions. That’s quite a significant statement. In a complex world of conflicting priorities across clinical development, HEOR, HTA’s, payers, policy makers, commercial realities, regulations, mergers, and functional silos it’s often easy to forget that simple fact. Decisions in healthcare change lives - so too then does the information used to inform them.
It’s important therefore that we all take responsibility for those decisions and the information used to make them ‘right’. The next question of course is what exactly constitutes ‘right’ when it comes to healthcare decisions – and that’s where the second realisation comes in, healthcare decisions these days are predominantly based on value. A good healthcare decision is probably one from which as many people as possible get the best possible value. Value is a big, multi-faceted word, but it’s quite a simple concept really.
Whilst value is a multi-perspective thing, with the perception of value depending totally on one’s position at a particular time, we can all conceptualise it to some degree – putting ourselves in others’ shoes where necessary. The challenge with healthcare today is that patients, caregivers, employers, manufacturers, and society as a whole want valuable interventions from each and every perspective, in reality they demand it.
"Decisions in healthcare change lives - so too then does the information used to inform them…"
In the context of the healthcare industry it’s probably fair to assume that whilst we may have personal perspectives, most of us really do want fair value for everyone involved – manufacturer, regulator, prescriber, payer, and patient. However internally, within the companies that innovate and make medical products, there will naturally be unique sub-perspectives as to what constitutes value. Classically the clinical, commercial and regulatory agendas differ, being at best broadly aligned, and now with the necessary advent of ‘market access’ departments the payer needs have also been added more and more into the mix.
So what’s the point of all this introspection you might ask? Well, with resource pressures on healthcare businesses more acute than ever, the rising cost of innovation and development, and the challenge of differentiation in today’s patient-empowered world, making value demonstration multi-faceted, mutually acceptable, and as efficient as possible throughout development is no longer fantasy, it’s a necessity. Even more so when you remember that those numerous decisions we’re making or informing, change lives.
Going back then to the assumption that the ‘right’ decision is a fair, appropriate, and well-informed one, that is mutually beneficial wherever possible – it’s clear that what healthcare businesses need to be doing is developing value evidence from every perspective right from the outset. In fact in the current environment, nothing less will do. The concept of value needs to permeate everything – not be something done by one department or tacked onto the end of a clinical development plan. Just as strapping a beautiful body to a flawed chassis doesn’t make a useable sports car, a clever economic model and a creative value dossier can’t make a medical product what it’s not.
By the time a development plan is being designed, the potential value of the product should be clear regardless of which perspective you take. Target claims and target profiles should be complemented by, or replaced with, target value claims and target value propositions in today’s world.
"Value is a big, multi-faceted word, but it’s quite a simple concept really…"
To some extent market access has a lot of parallels with digital marketing. The latter starting life as a separate function and skill set to address an acute need, but something now so integral to everything, that it cannot and should not stand alone. Just as marketing agencies without an integrated digital marketing capability or mind-set cannot succeed, nor in my view, can healthcare companies that do not have multi-perspective value demonstration in their DNA.
So what might a great approach to the demonstration of value look like? In my experience (good and bad), the following attributes are typical best practice:
• Start early
There’s nothing worse than trying to rescue a product from its own development plan, nor realising too late that the endpoints and study population are the wrong ones, so the value proposition needs to drive the research – not the other way around. The right outcomes to measure need to be considered early, and built into development plans.
• Multi-perspective from the outset
A strong value proposition openly acknowledges the multiple internal and external perspectives (clinical, regulatory, commercial, patient, prescriber, payer etc.), explicitly considers each one, and does not pretend that the perspectives are always perfectly aligned.
The most powerful approach to building a true value proposition is an integrated one – where a variety of stakeholders (definitely internal, but ideally internal and external) meet regularly to share their thinking on value and build an integrated plan rather than running separate initiatives to address individual concerns.
• Insight-based and innovative
Often the gathering of insight comes too late and is seen as a ‘commercial’ activity, when in reality, actionable facts gathered early in (or even before) product development can inform end-point strategies, outcome measures, comparator selection, and optimise innovative positioning. Insight and unmet needs should drive development.
• Evidence-based and realistic
With the level of evidence required and the need for total transparency in developing healthcare claims, aspirational positioning and notional benefits need to give way to realism, niche positioning if required, and an acknowledgment that the nature of the data gathered along the way dictates and limits the creative possibilities for further analyses and writing.
"By the time a development plan is being designed, the potential value of the product should be clear regardless of which perspective you take."
It’s all well and good discussing ideals, but having developed and launched both pharmaceuticals and devices I can fully appreciate the very real barriers to taking such an approach. For a start there’s the challenge of the unknown in trying to plan a launch some ten to fifteen years hence. Then there’s the simple fact that healthcare products are complex and highly regulated, not to mention very expensive to develop. Add to that the hurdles, local requirements, multiple stakeholders, and internal silos – and it becomes a challenge even with the best will in the world. The truth is though that the world has moved on and there needs to be change. These are all things that can be addressed with the right approach and fresh ways of working.
I built my career at the clinical-commercial interface as a medic interested in bringing healthcare products to the market. It was an unusual world to many, in which I dared to frequent both brand and clinical development meetings – making it my business to ensure the two were not on wildly different trajectories. Such a role has its challenges for all the reasons one would expect, and on more than one occasion, it was clear that a divide existed – perhaps even a lack of respect for the differing perspectives. My personal opinion is that there’s no longer a place for that when there’s a need to efficiently realise value. What will win through is cross-functional development with the investigation and demonstration of value at the core. Such an approach requires teams of people with multiple perspectives and mutual respect, teams that can confidently inform and make life-changing decisions from every perspective.
In my current business that’s the approach we take to helping our global clients. We don’t speak from just one angle (technical, commercial, or regulatory), we don’t believe scientifically superior is necessarily the equivalent of more valuable, and we don’t sit in silos. In our quest to inform life-changing healthcare decisions effectively, we make the most of our cross-functional teams and integrated global practices, delivering truly strategic solutions with respect for the diversity of skills and perspectives. The integration of our practices (patient-reported outcomes, health economics, statistics and psychometrics, and value strategy and communication) is synergistic – catalytic even – and we insist on a combination of commercial acumen and scientific excellence in every one of our people.
In this new world the need for value evidence is not something to be viewed as additional or an extra hurdle. Economic models are not something to be produced and bolted on to overcome issues. Reimbursement submissions are not just a different way of writing about the clinical data.
To be frank, value isn’t the body of the car at all – it’s the chassis.
About the author:
Bruce Charlesworth has been Managing Director and Senior Vice President with Adelphi Values in the Manchester UK office since 2010. His client-side experience includes involvement across all phases of product development and launch, having been involved in the design, conduct, analysis and communication of numerous clinical trials in addition to holding senior leadership roles across Medical Affairs, Outcomes Research, Clinical Development, and in the FMCG sector. Bruce’s work, particularly in migraine, is widely published and he has appeared in the media as spokesperson on several key issues in relation to healthcare products. Bruce gained a medical degree from the University of Leeds, worked as a hospital doctor, and specialised in anaesthesia prior to embarking on a career in the healthcare products industry in 2000.
Adelphi Values is a global healthcare value consultancy combining strategic thinking with a reputation for excellence in outcomes research, health economics, and market access. Originally Mapi Values, the business was renamed following realignment with the Adelphi Group at the end of 2011. This evolution has further improved the service offer, and Adelphi Values continually develops and delivers client-focused services and solutions throughout clinical development and commercialization, with the clear aim of improving patients’ lives by informing healthcare decisions.
Tel: +44 (0)1625 576815
What do you think a strong value proposition needs?