Cassandra Rix | Article

Local activation of global market access strategy

How far does your Global Market Access Strategy go? How well is it implemented? How closely do the communicated key value messages resemble the original essence of the brand? Cassandra Rix and Oliver Leatham explain why global market access approaches must resonate with local stakeholders.

Pharma has historically been an industry that likes to put things in boxes, neatly organising different aspects of commercialisation into operational silos. Many analysts believe that Big Pharma will resist changing its traditional business model, even as the world of health care evolves around them. So when it comes to launching a new product, the multi-national pharmaceutical corporations will continue to think in global terms, rather than address the regional challenges across the array of emerging health economies, and the complexity of approval and reimbursement processes that it now faces.

Developing a new drug is an enormously expensive and time-consuming process, and so maximising speed to market and achieving maximum market share is vital to generate return on investment. This means that launching into as many markets as possible, as successfully as possible, is a key element to global level launch planning.

Unfortunately, whilst the science might be a constant, the way markets operate, and especially the willingness to accept new drugs (and importantly, achieving an optimum price for the product that can satisfy the shareholders) varies enormously from market to market – and in some markets, from region to region.

The challenge for those planning a new product launch is to create a market environment where there is sufficient access to the brand. This requires the development of an access strategy that maintains a consistent global brand strategy, whilst retaining the flexibility to implement this strategy within the different markets.

This need to ‘think global and be local’ represents a balancing act. Too specific, and the strategy will not be adaptable to local market drivers; too general and it becomes bland and meaningless – designed to work everywhere but in the end not working anywhere.

Actually, it is very unlikely that a single market access strategy will work everywhere, which is why the strategy needs to include an acknowledgement that it may be simply not worth launching in some markets – a difficult pill for many global teams to swallow.

Understanding the Drivers

Generally, the global strategy will be built on a commercial imperative, but that is not what drives the decision-making at national, sub-national or regional levels. A strategy will only work when it can align commercial objectives with the factors that will motivate payers, and, to a diminishing extent, clinicians, in the health economies where they continue to play a role in new drug appraisals or policy-making. To achieve this, the pharma company must first understand exactly what these ‘drivers’ are – and how they differ from market to market.

A key part of that is gaining a better focus and clarity about exactly which patients within a therapy area are best suited to your product’s profile. Whilst individual markets differ in their approach to product review, there is a move towards demanding specificity about the patient cohort who are most likely to respond to treatment, as well as the clear demonstrable benefit a product will bring within that group of patients..

Unfortunately, the focus and the decision-making processes are very different in each market, and often, within the same regional health economy (see sidebar). So, bearing this in mind, how can pharma build a consistent market access strategy that is future proof?

The first step is to gain a genuine and deep understanding of the key drivers of decision-making across all the target markets – and then examine which of these align with the evidence base and commercial objectives of the product. This marks a big change for pharma, as it is a total reverse to the traditional way of thinking. Inevitably this approach will highlight some markets where such an alignment does not exist; a robust market access strategy will recognise this and inform decisions about whether to try to enter that market or to approach it differently; rather than the pre-assumption that the product is right, the answer is ‘yes’ and that everyone will want to buy a slice of the pie…

The decision not to launch is a difficult one to make – particularly if you are a national level brand manager. No-one wants to recommend ‘not launching’ to the global team. The benefit of developing a global strategy based on local understanding of what drives each individual market is that you are able to ensure ‘buy-in’ from your global market strategy teams.

Early Engagement

Of course, it is no good trying to look at these very diverse sets of drivers, and then start engaging with decision makers at a late stage of formulating a global market access strategy. Unbelievably, we have seen many pharma companies trying to engage payers and carrying out advisory boards just a few months before launch – that is simply too late!

Ideally, if, as an organisation, you are aiming to build up a bank of knowledge about the markets you are wanting to enter, then you need to be thinking about that in your pre-clinical stages – in other words, at the time when you are thinking about whether there really is an unmet need in the disease area you are looking to get into, or at least an unmet need that is significant enough for a move into a particular market.

You need to be able to decide what outcomes you need to be demonstrating in your Phase 2b and Phase 3 studies, otherwise you won’t have the right value messages to be able to communicate at launch. It is self-evident that the earlier you start talking about the therapy area and priming the market, making payers aware of the unmet need, the better.

So engagement needs to start as early as possible, something which currently doesn’t happen enough. This is often because global teams are too far removed from the payers, and don’t necessarily understand the ‘drivers’ that influence their key decision-making.

Also to consider is the increasing influence patients have on decision-making and drug reimbursement. This is especially true in chronic disease areas, such as haemophilia, where the patients are often as informed as the clinicians, and will be monitoring clinical trial development with a vested interest.

Owning the Relationship

Given that one-step-removed nature of global teams – who should lead stakeholder engagement – and who should own the relationships?

The temptation is for global teams to keep a tight grip on the process, aiming to control as much of the plan as possible. That is understandable – given the global team’s job is to ensure a measure of consistency of approach across the world. However, this approach simply cannot work, which is why close co-operation between and communication amongst teams at each level is critical.

In a well-oiled pharma machine, the regional team will have a good picture of drivers within each market within a region on a real-time basis, and so there should be few surprises during the formulation of a market access strategy for a launch – but in reality, this is rarely the case. So at the very least, regional teams should be checking in (at an early, pre-clinical, stage) with national teams to make sure they understand each market. This will enable the global teams to work with each regional team to build up an understanding which should go on to shape and inform the global strategy.

Even if it is regional – or even global – teams carrying out research within a given market, it is important to make sure the national team knows what is going on. Believe it or not, most national healthcare bodies have the perception that the industry, for all its flaws, is actually quite business-like and professional; it makes it very difficult for them to want to engage with the industry if it looks like the left hand doesn’t know what the right hand is doing.

It is important that ultimately the relationship is owned at a local level, because throughout the lifecycle of a product, that is going to be the central relationship. If the local team doesn’t have the right relationships with the right people, the role of the global team building a market access strategy should be to help make that happen, rather than trying to take over.

A Global Strategy?

The fractured nature of the many different markets in which pharma operates, and the very different models of decision-making, not just across the world, but within regions and even within individual markets, does raise the question whether a global market access strategy is really possible.

This is different from a global brand strategy, which is about identifying the essence of the brand and ensuring that, however the message might be adapted at regional, national or local level, the essential core messages and tone remain the same. But is this really possible with a market access strategy, without it becoming so watered-down and general as to be meaningless?

The fact is that a ‘one size fits all’ approach will never work, even if you have a perfect understanding of the drivers at play in each market (and that in itself is pretty unlikely).

Instead, your critical success factors become about how you are going to make sure you are successful globally – whatever globally means. It probably won’t mean launching successfully in every single market – and in reality, it never has done,

The strategy can be truly global – but only if that means looking across the globe and identifying those markets where the product is going to meet the drivers for success, and just as importantly, recognising where your product doesn’t meet those drivers, and accepting that to try and launch in those markets would be a mistake.

Implementing a global market access strategy does not mean achieving access everywhere; it does mean gaining a true understanding of the access issues within each region, within each nation and even within each sub-national region – and above all it means being flexible enough to use that understanding to the best possible effect.

DIVERSE DRIVERS

Trying to get to grips with the different drivers in different parts of the world is a huge and complex task. Even within our own region – Europe – there are markets with very different priorities, and very different motivations for accepting a new drug. Looking at just three markets in one continent is very instructive in grasping just how diverse those drivers can be; multiply that complexity many times, and you start to realise the hurdles the global market access strategist has to overcome.

United Kingdom

In the UK, the drivers are cost-saving and efficiency (which itself is almost always about economic rather than clinical efficiency). The focus of a Head of Medicines Management and Commissioning is always about saving money, and usually in the short term. That means there is not as big a focus on prevention as we might like, because although that saves money in the long term, it doesn’t save money this year.

The most payers will are willing to look ahead is annually, and often it’s quarterly or even monthly. So if a new drug is being introduced, the question will always be: what other drug can be removed/what is it replacing? If the answer if nothing, then a new product will need a staunch clinical argument.

That said, the industry does need a better understanding of the payer networks, recognising that some payers do take an altruistic and slightly longer-term view, do think about how many lives are going to be saved, how many hospitalisations can be avoided and what impact that will have on the cost of healthcare five to ten years on.

France

France takes a slightly wider view, considering not just the drug budget implications, but the wider economic and social impact a given drug will have. So the impact on lives becomes more of a factor, both socially, but also on wider economic factors – so, for example, if an illness means a patient can’t work, the impact of that enforced economic inactivity will be taken into account.

After the initial hurdles of impact on the individual patients, and wider economic implications, there is a third driver: the incremental benefit that a given new drug offers.

Essentially, the value driver in France is much wider than in the UK, taking into account the value that a product will offer to the patient, to society and the economy as a whole – rather than simply the health service’s drug budget.

Germany

Germany is a highly complex market where there are almost two parallel streams co-existing. Because it is very much a cost-constrained environment, launching new drugs into the market is very much about demonstrating value over existing treatments.

There are essentially two ways of entering the market: the first is to allow pharma companies to choose the cohort of patients for whom they want to demonstrate value, and then to choose the comparator against which to demonstrate added value/differentiation. In turn, the system will agree to pay for the first 13 months, but if after those 13 months, you haven’t demonstrated in real life what your clinical data said you would, the system might decide no longer to reimburse – or worse, to reimburse at a centrally-fixed price.

If they do this, they can essentially decide to pay what they like; by which time you have 13 months’ worth of patients on your product, making withdrawal problematic and possibly, unethical.

The second way is to ensure you have the right comparator data in order to differentiate your product effectively and set the price from the outset. This has the advantage that you can predict long-term return on investment. That is one reason why Germany might be regarded as a risky market. But it is also a massive economy, and the fastest-growing market in Europe, so the opportunities are huge – providing you get your strategy right.