Launch excellence in a disrupted world

The accelerating speed of change within the pharmaceutical launch environment raises considerable challenges for launch excellence, as companies grapple with a complex and ever-changing world.

Today’s commercial returns from new, innovative prescription medicines are heavily concentrated within a small number of major developed markets, and specialty drugs are much more commercially dominant than those in primary care.

Just as markets are becoming more complicated, so too are individual products, as a new generation of gene therapies, cell therapies and digital therapeutics line up alongside established classes of biologic and small molecule-based medicines.

To assess the challenges and opportunities pharmaceutical companies face in this disrupted world pharmaphorum, in association with IQVIA, convened a panel of experts to discuss the past, present and future of pharma launches.

Drawing from the sixth instalment of IQVIA’s Launch Excellence report series, the webinar began by putting the current situation into context.

“We are no longer in a situation where major commercial launches are dominated by the top 20 pharma. Smaller companies can and do launch products themselves and make a success of it”
Sarah Rickwood

Major launches are no longer dominated by big pharma

“The launch environment has been changing increasingly rapidly in the last few years. While the lessons of big launches like Lipitor or Seretide from the early 2000s and late 1990s are interesting, they are not relevant to today’s launch environment,” said Sarah Rickwood, vice president of European Thought Leadership at IQVIA.

Promotional investment has changed considerably, with successful application of multichannel marketing principles. There’s more complexity in terms of market segmentation and payer demands. The nature of the products being launched, and the companies behind them, are also changing rapidly.

Sarah explained: “We are no longer in a situation where major commercial launches are dominated by the top 20 pharmaceutical companies. Smaller companies, both emerging biopharma and mid-sized companies, can and do launch products themselves and make a success of it.”

But, as IQVIA’s Launch Excellence VI report shows, it’s tough for companies of all sizes to have a consistent approach, either for one launch across multiple countries or for multiple product launches. That’s a real challenge, given that companies are often required to launch multiple products in a short space of time.

Few launches are ‘excellent’

The Launch Excellence VI report covers the seven most important pharmaceutical markets. Between them, the US, EU5 (Germany, France, the UK, Italy and Spain) and Japan account for over 85% of global new active substance sales in both the first two years and the first five years after launch.

Using its unique audit sales data IQVIA analysed 282 new substances launched in these ‘must-win’ markets between 2010 and 2016 to define and quantify three measures of commercial success. The launches were judged on their sales and performance improvement over time, with the number of direct competitors they faced also taken into account.

The pharmaceutical sales analysis provided an illuminating picture of how hard it is for pharma companies to achieve launch excellence – with less than 10% of new products across speciality and primary care doing so.

Alexandra Smith, consultant, European thought leadership at IQVIA, said: “The bar for excellence is still set very high and it is actually extremely difficult to achieve this.”

A crucial early window of opportunity

There are multiple factors that will influence a product’s sales trajectory. New indications can add incremental opportunities, market access decisions may help or hinder and, though it’s rare, a change of strategy might turn a slow starter into a rising star.

But the IQVIA data shows that one of the consistent issues with achieving launch excellence is that it is very difficult to change a product’s trajectory if it has got off to a slow start. Since the 1990s, 80% of launches have failed to improve on the trajectory set between the first six months and two years post-launch- if the launch starts on a great trajectory, that’s not a problem; but if it does not, it undoubtedly is.

Rickwood explained: “There’s a small percentage that make an improvement but it is not a majority. What we are seeing is the early uptake performance is set very early and is difficult to move.

“If you start well, you are likely to continue well. If you start with a low uptake you can improve, but you will be in a minority and there is no substitute for effective pre-launch preparation.”

She added that the launch environment, already altered over the last decade, will change still more radically. The new forms of products being launched will create their own sub-markets in prescription medicine, with structural, cultural and perceptual barriers that ‘mainstream Rx’ whether in the form of specialty care, orphan medicines or other areas, may not be able to address.

Real-world insights for pharma launches

The rise in the availability of real-world evidence, partly driven by the digitisation of healthcare, has significant implications for launches from the perspective of both regulators and payers, as Markus Gores, IQVIA’s vice president for real-world insights, explained.

“Generally speaking, regulators are becoming more comfortable with uncertainty and a lot more accommodating of balancing access with high unmet medical need, while still ensuring new products are safe.

“As a result of that, we see a lot of products approved on the basis of less mature data, often from phase 2 or single-arm trials, but that creates a huge problem for payers.”

That produces a large degree of uncertainty about clinical outcomes, whether a product will deliver the value that limited data promised and, crucially for healthcare systems, what the budget impact will be.

Many payers are still “reeling” from the budgeting problems caused by hepatitis C drugs, Gores said, adding that they are looking for reassurance about whether they will get a return on their investment in a new drug.

“That very much pushes the need from payers for much, much greater levels of evidence and real-world evidence,” he said.

Alongside the rise in real-world evidence is the need for it to be communicated effectively, which is where the medical affairs function has become increasingly important.

“Somebody needs to take those messages out to payers and healthcare professionals, who are very much looking for peer-to-peer discussions that are not clouded by any commercial overlay. So medical affairs needs to play a much, much more strategic role, early on, in shaping the evidence strategy for the company,” Gores said.

Pharma launch strategies

Giving practical advice about how to negotiate these problems, William McClellan, who leads IQVIA’s Center of Excellence for Launch in the US, said that it all starts with whether you have the right strategy.

“One of the things that is key is to align on a couple of different terms. First is patient types, making sure that you can very clearly point to the patient type that has most value for your product.

“The second piece that becomes incredibly important is how you define ‘efficacy’. Certain markets have various challenges around this and each stakeholder may define it differently.

“Most importantly, the third element is to know who you are competing against and what the standard of care is. Those three elements fundamentally feed your product positioning statement.”

With that in place, a solid marketing strategy based around the latest ‘omnichannel’ techniques will significantly improve the chances of a successful launch, particularly in the US. “The omnichannel in the US market is incredibly important. It’s not only about the investment, but it’s also about linking your marketing messages across those channels,” McClellan said.

As new forms of products come to the market and the speed of change in the launch environment increases, pharma companies are presented with significant challenges during the crucial launch stage in a new product’s life cycle.

The companies that will have the greatest chances of launch success will be those that can keep pace with market dynamics and ensure launch consistency across multiple geographical regions during the all-important window of opportunity that exists immediately after launch.