When the Rx is Not Enough

Over the past 15 years, we have all experienced firsthand the explosion in data being made available to the pharmaceutical industry.  Claims, HECON, RWE, APLD, Reimbursement and even anonymized EMR/EHR have become more accessible.  But there has always been one constant, the prescription (Rx). 

Which makes sense.  Pharmaceutical companies stay in business and are able to innovate because HCPs prescribe their products to patients who need them.  The Rx pays the bills.  Therefore, Rx data has been the foundation on which pharmaceutical commercial planning was built.  Mega-brands like NEXIUM and LIPITOR were able to take advantage of large chronic disease states that effected millions of patients.  Their manufactures understood their markets incredibly well, differentiation was clear and the success that followed their launches fueled future product development and commercialization in other therapeutic areas such as oncology and diabetes.  And every step of the way the available Rx data informed them.  Where they were successful, where they struggled, which tactics worked and how many resources they needed.  The markets they launched into were well established and the existing data was rich and detailed.  But something has started to change and the foundational data of the industry won’t provide enough insight alone to support the next generation of products

The mega-brand launches of the late 1990’s and early 2000’s were in an era of chronic disease state focus for the pharmaceutical industry.  Yes, some companies – Genentech for example – had begun to execute a specialty product strategy, but most of the top 20 were looking for the billion dollar launch product and large market success.  But those days are gone.  Today the top 20 – which looks a little different that 15 years ago – is pivoting towards a specialty future as well.  With a few exceptions, like diabetes, most of the chronic markets are firmly generic, well served and contain limited mass market opportunity.  Instead, specialty products are the future.  Targeted therapies, genetic markers and oncology rule the pipelines.  All the innovation we have been hearing about is almost here.  But will commercial success follow?

It seems slightly insulting to ask if success will follow.  Clearly the pharmaceutical industry knows how to commercialize products.  But let’s look at an example of what challenges lie ahead.  Let’s say you are a company launching a promising new therapy for Acute Myeloid Leukemia (AML).  One that specifically targets a genetic mutation that is present within ~25% of all AML patients.  You are first in class, a novel therapy with no direct competitors, a favorable clinical profile and successful clinical trials.  Everything that a company would want in a pre-launch product.  But now it is time to begin commercial planning and start asking some important questions of your insight team and your data. 

  1. How many patients are there?
    • Epidemiological data can answer the national level question.  About 21k new AML patients next year with ~25% of these patients having the mutation.  But national level data won’t provide enough insight to satisfy the needs of a commercial launch.  More detail is required to develop sales and marketing plans.
  2. Where are these patients?
    • In the past, with chronic markets, we would use competitor products to provide guidance or proxy models based on “similar” product launches to tell us where. But this is a novel therapy, targeting a specific mutation and has no competitors.  And while you can certainly expect to find them at your clinical trial sites, things could and will have changed between the trials and time of launch. 
  3. Who treats these patients?
    • This can be simpler, especially if you are targeting Hematologists.  But how many test for the mutation that is part of your indication?  If they don’t, how can you be sure your patient type will resonate with the physician?  If launch success is dependent on early trial success with the product, finding those HCPs who screen for and “see” the patient type is critical. 
  4. How much opportunity is in the market? 
    • This is different than the first question.  It’s not simply how many patients, but how much built up unmet need is there in the market?  How many patients and physicians will try this new therapy when made available? 

These critical questions need to be answered, but using the traditional Rx and HCP data won’t provide you with the insights you need.  Forecasts, resourcing, production timelines and marketing plans will be heavily informed by these answers. The stakes are high if these foundational assumptions turn out to be incomplete or wrong.

As the pharmaceutical industry turns its focus to specialty products with very specific patient populations, patients, and their new and emerging data, will become the foundation of future product launches and commercial planning.  Tradecraft Analytics was founded to help companies tackle the challenges and opportunities that come with the realization that things need to change and to help companies answer critical questions by leveraging new and emerging sources of patient data.  At Tradecraft Analytics we see data differently and we believe that the emergence of patient centered data will allow the industry to ensure they deliver on the promise of their pipelines and provide physicians the options they need to continue to improve patient care.

Rx data has served the industry well as the “one version of the truth”, and this isn’t to say that the industry should retire Rx data or that is isn’t valued. But instead, companies need to ask themselves, “Do I know everything I should about my market(s) and my target patient population(s)?”  If Rx data still gives you everything you need, great.  But I am betting that for most companies and their upcoming specialty product launches, the answer will be no.  That is a good place to start and Tradecraft is here to help.

Categorized As Uncategorized