Increasing Launch Success: Medimix’s New Syndicated Trackers

 The pharmaceutical market continues to evolve rapidly with a record year of drug introductions and an acceleration of fast track approvals, in particular in oncology.

When preparing the launch of a new drug, market and prescription information is traditionally tracked by the business analytics team after the filing date. Trackers are developed to follow prescription and main KPIs and to help the marketing team monitor the launch. However, traditional techniques of interviews and quarterly reports provide a slow tracking mechanism no longer adapted to the current pace of the market. Furthermore, a lot of information and knowledge is lost during the product handshake between the R&D team, the marketing team and eventually the commercial teams. Medimix proposes a radically new approach to respond to this new paradigm and to increase launch success for new drugs or new indications .

The acceleration of drug launches

After the dramatic 2012 patent cliff (figure 1), the pharmaceutical industry is now benefitting from a period of very moderate patent expiration. The total revenue of drugs going off-patent during the period 2016-2020 is relatively low ($18.3 billion), a figure dwarfed by the $ 28.3 billion that went off-patent in 2012 alone

Figure 1: The 2012 Patent Cliff and the subsequent moderate period of patent expiration

2012-patent-cliff

At the same time, the pace of drug approvals in recent years has again picked up, and 2015 closed with an unprecedented number of 45 novel drugs approved by the FDA, of which 27 (60% of the approvals) were designated in one or more expedited categories of Fast Track, Breakthrough, Priority Review, and/or Accelerated Approval. This means that 60% of the drugs approved benefited from an expedited speed of development and/or approval process in order to bring these important medications to the market as quickly as possible (figure 2).

Figure 2: New Molecular Entity (NME) and New Biologic License Application (BLA) filing and approval

new-molecular-entity-new-biologic-application-filing-and-approval

Consequently, there is even more pressure on manufacturers to launch their products successfully into an increasingly competitive market, and the speed of uptake of pharmaceutical launches has increased considerably over the last 10 years (figure 3). Most recent launches, such as Solvaldi (Gilead), show a faster uptake than traditional launches.

Figure 3 – Top drug launches of all time (Forbes)

top-drug-launches-of-all-times

Similarly, a few years ago a typical big pharma would launch 1 or 2 drugs per year and maintain a portfolio of half a dozen major brands with a focus on primary care, whereas today it manages a larger number of brands, with multiple launches across different indications in specialty medicine.

The first six months of launch are critical

This, combined with the emergence of new treatment paradigms, such as immunotherapies or genetic profiling in oncology, accelerates the speed at which market landscapes change. More than ever the first six months of a pharmaceutical launch are critical and determine the difference between a success and failure. As shown in a retrospective analysis of 15 years of drug approvals, while only 15% of launches start well in the first six months and continue well, out of the remaining 85%, less than 20% make significant improvements in the market share trajectory after the first six months.

Therefore, it is imperative to carefully prepare and monitor the early phases of the launch. To do so, a pharmaceutical company has a variety of data at its disposal. As can be seen in figure 4, it already benefits from a wealth of information collected during launch preparedness by different stakeholders, including the business development team, the medical team, market research and forecasting teams.  The Marketing Analytics budget is in fact spread between different functions. All these teams share a finite budget that varies along the development phases and peaks in filing phase.

Figure 4 – Market Analytics budget and associated projects throughout the product Lifecycle

market-analytics-budget-and-associated-projects-thru-out-product-lifecycle

In a perfect world, some information collected for the needs of one department could benefit others (e.g., epidemiology data, market share analysis, patient profiling). But the lack of harmonization of many information tools (e.g., share trackers, patient record analysis, electronic records…) makes it very difficult to consolidate data that is collected by different entities within the organization, and all too often the information remains siloed. As a result, it is not uncommon to see the exact same information collected multiple times at the country, regional and global levels, and millions of $/€ wasted in contacting healthcare professionals for the same data over and over again.

Different stakeholders, different frequency

Also, the frequency at which this information is needed varies according to stakeholders. For example, in Phase II and III, BD and R&D teams primarily need epidemiology data, market information, patient profiling and drug sequencing. Once a year measuring is enough. Closer to launch, in addition to the foregoing information, marketing teams want to understand market shares of competitors, patient profile, treatment sequencing, yearly to bi-yearly information is generally the norm.

 Figure 5 – Typical data needs and frequency, by stakeholders

Typical Data Needs & Frequency by Stkaeholders

At filing, the marketing budget and commercial activities increase. Quarterly trackers are set up, and marketing and commercial teams follow ATU metrics, adoption rate, market shares, treatment sequencing, patient profiles, duration of therapy, new versus renewal rate, messaging, positioning, and other KPIs.  To do so, typically 3- 6 months before launch, the business analytics team establishes its own tracker to obtain the best and most detailed information on the evolution of market share, positioning and other strategic KPIs. The main role of this tracker is to monitor the product launch during the critical first 6-12 months period. These trackers are traditionally performed in “waves”:  3 months before launch (base), 3 months after launch (M+3) and then M+ 6 and M+12.

If, thanks to technology, near to real-time reporting of sales and reps activity has now become the norm, the ATU and KPI trackers have remained to a great extent a relatively slow process with information traditionally obtained 4-6 weeks after the end of quarterly waves.

But this traditional approach is becoming unsustainable with the shorter, faster and more frequent launch of pharmaceutical products. With fast track approvals there is often no time to prepare and perform a “base” measure. With faster uptakes, two measures only during the first six months of the product life prove more and more to be insufficient, and the 4-6 weeks needed to report the information make the data old before it is even reported.

The traditional “Base, M+3, M+6, M+12” ATU trackers delivered as PowerPoint reports are not efficient anymore and need to be replaced by more technologically advanced platforms.

The emergence of an alternative tracking model ……

 

the-emergence-of-an-alternative-tracking-model

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 About the Authors

Henry Gazay, MSC- CEO and founder of Medimix International

After a Master of Science in Statistics and Computer Science, Henry founded Medimix International. For 25 years he has been working exclusively in market analytics for the pharmaceutical industry and has provided services to all the TOP 10 pharma companies. Henry has served on the board of PBIRG, PMRG and MRII. He is also long time member of EphMRA, ESOMAR, and AMA. In August 2011, the publication PharmaVoice recognized Henry among the TOP 100 most inspirational people in the pharmaceutical industry. Trilingual English/French/Spanish, he is fluent in Portuguese, conversant in German.

Dr. Robert Siegmund, PhD, MBA -Business Development Partner

Internationally recognized expert with an award-winning track record maximizing the global performance of pharma and biotech companies, Robert began his career as a research scientist for Boehringer, later moving into strategic planning, business planning and analytics with Amgen, Actelion and Roche.  He holds degrees in biochemistry (Univ. Zurich), a doctorate in molecular biology and genetics (univ. Wien), and a MBA in Finance and Corporate Strategy (London Business School). Member of EphMRA Ethics Committee, Advisory Board Member of the Pharma CI Conference, fluent in English and German.