New product launches – maximise your chance of success
pharmafile | September 6, 2012 | Feature | Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing | MSI, Paul Stuart Kregor, Paul Stuart-Kregor, marketing, product launch
You don’t have to look very far to see that the pharma industry business model is under increased pressure, and many of these growing pressures have chipped away at the odds of making a success of bringing a new product to market.
The pressures are many: pricing and constrained healthcare budgets, an increasing need to demonstrate cost effectiveness; increasing generic competition and restrictive market access, and diminishing access to physicians.
Finally in some markets, there is a declining ability of patients to pay for their treatment.
A fast start across multiple markets is now a must, given that performance in the first year tends to predict peak sales, and after that you are rushing headlong towards the end of an ever-contracting competitive product life cycle. The consequence of these internal and external pressures is that pharma companies have to get product launches right first time.
And whilst the industry has plenty of experience in successful launches, historical approaches to launch can only help so much, given the ever-changing environment. In the same vein, relying on launch ‘processes’ is risky, as they are only as good as the information you put into them.
The key to success is to ensure you have joined-up, good quality thinking preceding co-ordinated and timely action. This will ensure that the market is properly primed to receive the new product; to create a powerful brand, and to make sure that that the organisation itself is in the right shape and prepared to act quickly to seize the launch opportunity, during the brief time envelope in which it exists.
Priming the market
To get to the point where the various external stakeholders – payers, clinicians and patients – see the benefit your brand brings, and your new product is actually going to be prescribed, first you have to ensure they understand the problem that your new product addresses. Vitally, they must believe the evidence you put forward: that the problem exists, that it needs to be taken seriously, and that your product actually provides something different and better in solving that problem.
The starting point for this process is setting up the problem your brand will solve, whether that is a clinical, health economic or purely financial problem. You need to establish clearly where your brand will fit into current and, perhaps more importantly, future treatment pathways. To do this in a way which shows added value, you need to identify any shortcomings in the current treatment pathways, and then provide evidence about how your brand will overcome these shortcomings. Alternatively, you need to show how to re-engineer the treatment pathway in a way that meets your external stakeholders’ needs and drivers.
Of course, this will be as much about the cost benefit as the clinical. Your evidence will need to show the economic outcomes as well as the health outcomes. So when we talk about evidence, it’s not just the clinical trial evidence, but the bigger picture. And that evidence must go beyond the ‘givens’ (efficacy, safety, tolerability) and show how your new brand will actually fit in practice, and what the consequences of its use will be.
That is because regulatory acceptance of any new drug is only a ‘ticket to play’ – it does not mean that that drug will necessarily be used (see the payer reaction to tofacitinib in the US) – although increasingly it appears that to get approval you need to demonstrate ‘value’. Real usage is an area where most unsuccessful launches fall down: there is too often an assumption that the evidence needed to gain approval is sufficient. A successful launch is not about approval, it’s about access and usage.
Generally, when a new product does not get used, it is because local healthcare economies cannot see the value in sacrificing something else to fund the new treatment (and in reality, that is what it boils down to – for your new product to be used, the funding must be found by not using something else). So driving usage, and priming the market, has to be done at a local level.
That means gaining insight into each market or healthcare economy archetype to understand what the drivers are at a local level; you cannot expect your Global Value Dossier to provide everything needed.
It will contain the key elements of the overarching value proposition, but these will need to be translated to the local healthcare economy in which you are operating.
There are various factors that differ between individual markets: how information flows, the depth and type of information you need to provide, and who you have to talk to, and when.
For example, in the UK market, you need to be providing information to decision-makers 12 months before the financial year in which you are planning to launch, otherwise there is little chance that they will find budget for your product, no matter how much extra clinical and/or health economic benefit it brings.
Couple that with an inherently slow uptake of new medicines in the UK, and you are looking at below par performance from the off!
Building a powerful brand
If priming the market is about helping stakeholders understand where there might be a gap in current treatment pathways and demonstrating the value your brand brings, then building a powerful brand is all about creating and communicating a Brand Value Proposition (BVP) that encompasses that value for all key stakeholders – the BVP has to sit right at the centre of any successful launch.
Each stakeholder will look at this proposition from a different viewpoint. Healthcare professionals will be most interested in the clinical outcomes, whereas payers will be looking to add value from a health economic and population point of view. Where they are involved in the decision-making process, patients will bring a third viewpoint, with quality of life and social and individual economic factors coming into play. So the thinking behind the BVP can be complex, but the overall proposition needs to be as simple as you can make it.
It needs to encompass how the brand is both different and better than what is currently available. This can be clinical, financial, or, more likely, a combination of the two. If the new product does not have a big clinical differential, then it is going to have to be cheaper to demonstrate greater ‘value’ – unless we can find situations where that differential does offer value, perhaps in particular patient populations.
Even if the brand does have a clear clinical differential, you still have to show a strong value proposition; there is only so much that payers in tight economic situations will be prepared to pay for a clinical benefit, so you need to maximise the perception of the brand’s value in every way. Most launches in pharma will be on a global scale, and that presents its own problems in building a powerful brand. Any BVP has to have enough in it to motivate customer groups to change their (prescribing) behaviour.
The challenge for the global marketer is to understand how each market works so that you can help ensure launch success on a local basis at country level. For the local marketer the challenge is the obverse – to take the global BVP and make it meaningful within the local healthcare system while adhering to the global proposition.
Irrespective of the global local challenge, a strong, integrated Brand Value Proposition will join up external and internal stakeholder thinking and activity to gain not just approval, but reimbursement and, most importantly, usage.
Preparing the organisation
The third requirement for a launch to be successful is that the organisation behind the product must have the insight, processes and tools to deliver market access and brand usage immediately at launch.
A key factor is to prepare the organisation for launch early enough, so that the people working within it can work as efficiently as possible.
That means clarifying accountability, governance and decision-making rights at an early stage, because the whole process can otherwise grind to a halt through inertia or become incredibly inefficient, as different entities duplicate effort or start doing things before key strategic decisions have been reached.
Don’t underestimate how much of a challenge this is: getting a diverse international organisation to the same place, mentally and physically, at the same time is a significant task. Clear strategic leadership is vital, which includes providing opportunities to provide local input, discuss implications of findings and gain consensus.
It also means being clear about how and when decisions are actually made. Most people in the industry will know that if the Global team ‘talks at’ local teams in individual countries, this is seldom the best way to gain buy-in, understanding and motivation. At the same time, eventually someone has to take responsibility for pulling together all the varying views and make a decision.
Giving people the opportunity to input their views doesn’t mean the strategic leader can abrogate their responsibility to lead and take decisions; conversely, neither does a decisive style negate the need for flexibility.
Experience shows that senior management needs to have visibility on process and progress to avoid them getting too ‘involved’. Strong leadership can often mean allowing people with the right skills within your organisation to get on and do their job, avoiding temptation to meddle in the detail.
Good information systems should ensure that senior management is kept informed and can understand when their intervention is appropriate or necessary. In fact, information is key, because without the right information, it is impossible to make timely and accurate organisational decisions, such as changing resource levels.
Too often this information is delayed, inaccurate or simply not there, which both has a negative impact on effective decision-making, and will inevitably mean more management time spent involved in processes which would otherwise not require it.
When it comes to building the right organisation for a successful launch, one size can never fit all.
The amount of allowable local adaptation will depend on each organisation’s view and culture, but a common theme of the success launch organisation is an element of flexibility on local execution. How much flexibility will always vary, and it is vital that everyone is clear on what will be centrally determined, and what can be adapted at a local level.
Maximising your chances
Creating that vital successful launch is not a simple process; in fact, there are increasing numbers of strands to manage. That means it is not a task which can be undertaken late on in the process. You need to ask the hard questions early on, to give yourself time to have everything lined up to maximise your chances of success.
In practice, that means preparing your organisation and your processes in advance, so that the launch strategy is sufficiently defined to be influencing stakeholders as much as two years in advance – and that means the strategy itself will need to be in an advanced state as much as three years before the actual launch.
Considering the volume of work and number of work streams involved, it is too easy to get caught up in process and forget what is required to deliver fast access and usage. Process can only take you so far: quality of thinking and quality of output is becoming increasingly critical as the hurdles new brands face get tougher and tougher. That is where the value gets added.
Additional content: video interviews and some suggested further reading can be found here
Paul-Stuart-Kregor is director and founding partner as The MSI Consultancy. He can be contacted at pstuartkregor@msi.co.uk
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