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It started with a miss

Is pharma finally heading for launch excellence?

Feb PME cover

Chris Ross examines pharma’s never-ending journey to launch excellence and explores what companies can do to ensure their product launches don’t miss the mark.

There’s an old adage in journalism that if a headline ends with a question mark, the answer is probably ‘no’. Check out the UK media’s Brexit coverage over the past four years and you’ll soon conclude that the principle has merit. The theory can certainly be applied to the pharma press, where headline-writers (including me) have spent the last decade describing an industry on a sure- fire journey to ‘launch excellence’. The facts tell a different story.

Seven years after McKinsey’s much- quoted claim that around two-thirds of all new drugs fail to meet pre-launch sales expectations in their first year, IQVIA’s most recent analysis reveals that fewer than 10% of pharma’s launches can be categorised as ‘excellent’. It’s a staggering statistic that, in the case of this article, confirms ‘Betteridge’s law of headlines’. ‘Is pharma finally heading for launch excellence?’ The answer, emphatically, is no.

The devil, of course, is in the detail. Studies routinely show that the first six to 12 months of a product’s commercial life significantly shape its long-term trajectory. IQVIA says that more than 80% of launches don’t improve on their first six months, with less than 10% improving between six months and five years.

McKinsey agrees, claiming 75% of launches that underperform against forecast in year one maintain below par performance in the second year. It all serves to underline the point: launch excellence matters – it’s important to start with a bang. However, for far too many recent launches – to misquote Hot Chocolate – it’s started with a miss.

The stakes are high and getting higher. A recent report from EvaluatePharma forecasts that pharma is on the brink of a second patent cliff, with worldwide drug sales of over $198bn at risk due to patent expiries between 2019-2024. Replacing those lost revenues is mission critical, but as healthcare budgets get tighter and therapeutic innovation becomes more expensive, pharma companies must truly maximise the launch window if they’re to have any chance of succeeding.

So how can organisations get there? In a world of complexity – with multiple stakeholders, numerous routes to market and countless influences on everyday behaviours – how can companies finally complete the journey to launch excellence?

Definitions of launch are wide-ranging, with the most obvious focusing on the early phase of a product’s commercial life in-market. However, some companies extend that definition to include processes that occur far earlier in the development life cycle.

Ultimately, launch excellence is about aligning R&D and commercial activities to ensure patients can benefit from breakthrough medicines as safely and quickly as possible. It’s a complex puzzle with multiple pieces. I spoke to thought leaders from across the sector to get their perspectives on the core components of launch excellence.

Establishing a framework

One common theme was the importance of companies having their own launch protocols – and fine-tuning them to suit individual therapy areas and markets. Although many companies have developed launch excellence codes, their diffusion and adoption across global organisations seem to be variable.

“There are two key questions companies should ask themselves when they’re preparing to introduce a new product: do they have a launch framework, and is the company empowered to use it?”, said Suzie Denton, Managing Director, Consulting at McCann Health.

“The most successful organisations establish their own codes of practice to ensure there’s a standardised approach to launching across the company. Then within that framework, they’ll define clear launch archetypes; what type of launch is it? What level of investment does it require? What is the size and scale of expectation? Who needs to be involved? And what is the protocol for becoming ‘launch ready’ from global to local? Secondly, empowering teams to use a framework is as important as establishing one.

"Everybody involved in the launch preparation phase must both understand and be able to implement the launch excellence approach the company believes in. It has to be cohesive, joined up and embedded across regions – because, whatever the market nuances are, consistency in global and local delivery is essential.”

Customer-focused

A second core component is the need to be customer-focused rather than brand-led. This philosophy underpins all successful launches throughout the brand life cycle. “Launch excellence is about prioritising what matters for the launch brand. Every product is different, so you can’t launch everything in the same way,” said Denton.

“The complexities of today’s marketplace mean we really need to get beneath the surface of the brand and the opportunity, and take a bespoke approach to every launch. Running through all of this is the need to be customer-centric. Companies can sometimes become so focused on the data and the science that they forget to think about what matters to the doctor, the patient or the payer.

"What are the critical things that drive their behaviour now? What shift in behaviour is required to take them to where you want them to be? And how can you create meaningful engagement to help that transition? You won’t change that belief state by focusing solely on the data – you need to get closer to customers to help them along that journey. Customer-centricity is arguably the most important aspect of launch excellence. Without it, a brand cannot hope to succeed.”

Sustainable healthcare: a key driver

Emma Gorton, Director, Hanover Communications, believes that advances in medicine are rewriting the rules of healthcare and changing the nature of pharmaceutical launches. “The essence of what a launch is has changed,” said Gorton.

“We’ve been through an era where we had incremental increases in innovation – delivering blockbuster treatments for prevalent long-term conditions and headline diseases. However, we’re now moving into areas like immunotherapy and are on the edge of amazing innovations that will deliver great outcomes for patients.

"These advances are putting huge pressure on healthcare budgets. The debate has shifted; previously it was all around access to innovation – but now there’s a greater focus on the need for sustainability in healthcare systems.That has affected how launches work because people are looking for, and are now able to measure, different things from treatments – cost- effectiveness, societal value, whole system costs.

“There are huge implications for communications. Take gene editing, for example. We’re going to get to the point where treatments like gene therapies will be ubiquitous – so we need to set ourselves up for them now and embrace the ethical debate so that we bring the public along with us.

"We don’t want to be in a situation where the public only understands the complex access challenges we will face for potentially curative medicines when people are being denied them due to cost. We need to get ahead of it. That means thinking about the things that might affect a launch as early as possible and shaping those communications proactively. As things get more complex, we need more time to explain them, to prepare the market.”

Timing is everything

When it comes to launching a new medicine, timeliness is key. “Essentially, a good launch is about getting breakthrough treatments to the people that need them as quickly as possible,” said Gorton.

“There are lots of stakeholders involved in that process – right across the ecosystem – and we’re all working towards that same goal. Progress is about developing relationships, creating collaborations and building long-term advocacy to ensure medicines get to the right people in the shortest possible time.

"Success requires being agile and responsive to fast-moving environments, and also being much more efficient. The rise of AI, along with better access to deep data, has the potential to reduce R&D time frames – making it easier to develop launch plans closer to launch when the environment is much clearer.”

Right customer, right time, right message

Stakeholder engagement is critical, but in an era characterised by significant pressure on costs – both among customers and companies – optimising resources is the name of the game. “Companies are striving to be more innovative in how they go to market,” said Sabine Dettwiler, Managing Director, Commercial Advisory Group, Syneos Health.

“It’s a huge ongoing challenge. How do you deploy your resources so you get to the right customer at the right time with the right messages – but, at the same time, minimise costs? There’s a real focus on customer-centricity, yet we still see launches where companies go after the wrong stakeholder or don’t tell the right story.

"Fundamentally, you need to develop a relevant, resonant story that differentiates your product and clearly conveys the value you bring to the patient and the healthcare system as a whole. Doing this means knowing your market and your stakeholders inside out, and understanding whether you can carve out a niche where you’re likely to get more traction.

"The best launch plans define how they’re going to target that niche. Many companies have moved away from one-size-fits-all messaging.They’re developing tight, customer-specific stories that align with an overarching message – and they’re leveraging market insight to create sound strategies for how they target them. The key is to engage early.”

Develop launch plans by purpose

One long-standing challenge in pharma launches is the engagement between R&D and commercial. “In most pharma companies, the owner of an asset until phase 3 is typically ‘development’,” said Dettwiler. “However, development people rarely have commercial backgrounds or even if they have, they are incentivised by ‘commercial metrics’.Too often, companies are late in considering the market potential of a compound.

"Those that leave those commercial considerations until phase 3 are invariably getting there too late. It’s improving, but it’s still an issue. The most progressive companies have shifted their approach; instead of developing launch plans ‘by function’, they’re designing them ‘by purpose’. They’re looking at their strategic objectives and working backwards.

"What are we trying to achieve? What do we need to get there? Do we need a cross-functional approach that involves input from market access, HEOR, marketing etc – and at what point do we get them on board? This approach is helping to tear down silos and develop a structured, cross- functional roadmap that helps get a product to market as efficiently as possible. Ultimately, all these functions have a shared purpose. Launch excellence is about understanding that purpose, as early as possible, and collaborating with the right people at the right time in order to deliver it.”

Trial and error: the danger of isolating clinical and commercial

One of the most frequently voiced theories on launch excellence is the importance of starting with the end in mind. In pharma’s case, this means configuring clinical development in line with identifiable customer needs. It’s a common sense principle – but it’s not yet become a default behaviour across the industry.

“The traditional approaches to launching a product still tend to sit in the commercial function,” said Chuck Stevens, Vice President and Global Head of Access, Commercialisation & Communications at ICON plc. “However, those approaches need to migrate out and begin to align with HEOR, medical affairs and clinical teams. Companies need to look at how they design their clinical trials and what their target regulatory approaches are in different markets around the globe – and start to overlay a commercial launch approach onto that regulatory sequencing.

“Often, the way clinical and regulatory teams configure clinical trials to meet local regulatory requirements is misaligned with how a drug needs to be introduced commercially in those markets. Similarly, commercial teams need to drill down and understand HTA requirements within the disease category to ensure trials are designed to capture the necessary data for modelling.

"When drugs don’t receive HTA regulatory support in major markets, it’s sometimes because companies haven’t modelled correctly – so when HTA bodies reverse engineer those models, they find that either information is omitted or things are included that skew the way they would normally assess a drug. These costly errors underline why the early alignment of R&D and commercial is essential at launch.”

Don’t forget the patient

Another area where there’s room for improvement is pharma’s understanding of the end user – the patient consumer. “Although every company says – and believes – that they’re patient-centric, their understanding of what constitutes value to a patient is often suboptimal,” said Stevens.

“Definitions of value will obviously differ from customer to customer – payers, patients, prescribers and providers will all have different views. In today’s marketplace, with the level of innovation coming through in areas like rare disease and genetic disorders, it’s incredibly difficult to model cost-effectiveness to determine value for the patient or caregiver. There’s also lots to do before we can define societal value for expensive curative treatments.”

So how does this translate into launch excellence? “Very early in development – as early as phase 1 and 2 – patient insight is critical,” said Stevens. “Pharma must move beyond traditional market research and engage patients, one-to-
one, to uncover their perspectives on everything from their disease experience and diagnostic pathways, to the things that prevent treatment and the real-world implications of taking a medicine.

"Understanding all these things is important – it will shape trial design, identify unmet need and help articulate the patient value that will drive adoption at launch. True patient insight and engagement is critical.”

The headline

Launching a new medicine is like crafting an article that captures attention: it’s how you start that matters. If pharma companies want to rewrite the headlines of launch excellence, they need to ensure that their planning, strategy and execution provide unambiguous answers – and leave no lingering question marks at all.

Chris Ross is a freelance journalist specialising in the pharmaceutical and healthcare industries

11th February 2020

Chris Ross is a freelance journalist specialising in the pharmaceutical and healthcare industries

11th February 2020

From: Marketing

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