Decoding the complexity: How value and access is changing

By James Whitehouse, Joint Managing Director

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Some time ago, when I started in the NHS, I had an idyllic view of the world. I worked in one of our greatest national institutions, providing health care, free at the point of use. As an economist my understanding of a market is simple, strike a fair balance between supply and demand and you have equilibrium. Healthcare is not a normal good, we tend not to want to acquire it, and it is probably underutilised (think public health), hence why we determine health as a merit good, underestimating its long-term value. We pass our rights (in most markets) to purchase health to our practitioner. My overly simplified views in the NHS rapidly started to shift as I realised money was involved, somewhere. On the one hand we had the Commissioners (or Primary Care Trusts back in those days) who on paper need to maximise health for their economy, but in practice need to save money. On the other hand, we had the provider, who in practice should balance the books, but in reality, wants to maximise their income. When you throw private enterprise into the mix, this complicates matters slightly, as now a non-normal good is exposed to all the workings of a free-market environment.

In reality, the flow of money within the healthcare industry supports accessible services and future innovations in global markets not just the UK. When we focus on the pharmaceutical industry, the idea is that innovation should be rewarded, but in the last 10 years that bar keeps rising. As therapies become more targeted, regulatory assessment processes are accelerated and the cost of development rises, it is increasingly difficult for value and access teams to keep pace. My own experience has been that the once “fourth hurdle” (i.e. reimbursed patient access) after development and regulatory is becoming increasingly intertwined in earlier decision making, and with the recent geopolitical climate interlocking global trade and pricing under the US Most Favoured Nation policy, value and access expertise is being elevated to the C-Suite level.

But are things becoming overly complex? Health Technology Assessment (HTA) was started to assess what is worth adopting, limiting waste and focusing on improving health for a fair allocation of resource. The process needs to answer a few grounded questions regarding comparative effectiveness, safety and value for money, but in reality, this is far more complex. What if we cannot provide comparative evidence? What if the relevant comparator changes in the time between starting a clinical trial and the HTA submission? The realms of clinical development, time pressures and cost constraints dictate that a ‘full’ dataset cannot always be produced at that specific point in time.

More recently, additional layers of policy and academic methods have been stacked on top of HTA systems, with various factors adjusting how we address a decision problem. This adds additional complexity within national level assessment processes, attempting to adjust for how the industry landscape has evolved from small molecule therapies treating broad diseases to highly targeted complex therapies. Often the process can get caught in the weeds of analysis, rather than taking a step back to answer the most fundamental questions above.  Recently the introduction of the Joint Clinical Assessment (JCA) adds another step for European level evaluation of new therapies/indication, before national level pricing and reimbursement decisions. The intention is to streamline the process, the reality is that almost every possible angle of academic analysis across the Population, Intervention, Comparator and Outcome needs to be addressed within the framework. This, coupled with policy makers requesting shorter delays between regulatory and access with a launch everywhere push on the industry, has led to the almost impossible task of value and access functions attempting to do the most with the data they have, in a time period that is untenable. What has failed to be recognised is that decisions regarding evidence generation are often years before the final scope is agreed, by which time no level of academic analysis, however complex, can address inevitable data haps. Have we made launch too difficult? Is it becoming an increasing problem that we are not prioritising our investments, disinvesting in areas that do not add value, and reallocating those disinvestments to true innovation?

Our role as value and access professionals is to maximise access, but to provide a fair balance with investment. In this new world of increasing complexity and interconnection with macro level policy, traditional methods of strategy, evidence generation and execution simply cannot keep pace. I am a firm believer that Artificial Intelligence (AI) can unlock some the complexities we face now in the industry. As an agency founder this is incredibly important as we often ask ourselves how we can provide the best possible service in such a fluid industry.  As HTA continues to expand and evolve, so do the learnings for our sector. We have a vast data network of hundreds of thousands of decisions, each mapped against a playbook of guidance and methodologies. With the technology we possess today, instead of trawling through that data for weeks or months to provide a hypothesis on how a product might perform in the eyes of HTA, or what evidence generation needs are required, we have a significant opportunity to streamline activities and try, at best, to keep pace with how the policy landscape evolves.

This however does not mean we should simply rely on AI for all decision making. At Lightning Health, we constantly shape how we develop hypotheses, especially within disease areas that does not have a precedent to leverage. At the same time expert leadership throughout any AI methodology, be it predictive or retrospective, is critical to assess the nuances in value and access challenges and take ownership of the strategy. This also supports optimising engagement and research with external stakeholders, such as ex-payers and clinicians, who are a vital part of validating the strategies we build every day.

We should be pushing science so we can improve health and ensure the right patient at the right time receives that innovation. All the time ensuring we can invest into the next one. The question on our increasingly complex role as value and access professionals is not simply ‘increase complexity for the sake of it’, but do we need overly complicated decision making in the first place. Is there a better use of technology that can meet our evolving industry needs? It starts with the relevant data we present. That alone, in most cases, should speak for itself.

If it’s worth investing in at that point, the rest should follow. Wasting resources and finances in areas that do not push innovation forward limits capacity and funding across the sector, whilst we shape technology advancements in AI to augment once difficult or time-consuming activities in shaping strategy, led by human ownership and accountability.