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This is the first in a series of articles in which we’ll explore how biopharma companies — no matter their size — can accelerate the launch of their new products. The following blog post is an abbreviated version of a more in-depth article that was published in the February 2016 issue of PharmaVoice. 
 

As new drug launches proliferate in the increasingly complex specialty therapeutic space, biopharma is finding that success is often pre-determined by actions that take place very early in the development and commercialization cycle. In many cases commercial input is often overlooked. A vital driver of success is the quality and depth of interactions with key influencers including clinicians, patients and equally as important, payers. Done right, this preparation can help a new medicine outperform at market launch as well as facilitate prompt uptake by healthcare professionals and payers.

Since cracking the human genome code 15 years ago, life-science companies have been working on innovative ways to apply genomics to drug development for personalized medicines. While highly specialized drugs produce better outcomes for patients, they present a tougher challenge for marketers, which must be considered early on.

Personalized drugs also require a fundamentally different pricing model. Companies’ commercial teams must convince both payers and healthcare providers that their product not only produces better outcomes but also reduces the cost of treatment. The education and messaging required to communicate the value of precision medicines is significantly more complicated. Further, the market landscape today is incredibly diverse, replacing the traditional physician relationship with a vast, interconnected network of stakeholders who can each influence product success differently.

A recent benchmarking survey by Quintiles aimed to understand how companies are integrating the payer voice into clinical development, and then validated these insights with payers. Three key themes emerged:

  1. Secure leadership buy-in for reimbursement and regulatory approval success. Top performing manufacturers have switched to a business of creating drug products that are both reimbursable and approvable, not just ones that meet regulatory requirements. It is critical for senior leadership to understand the potential financial downside of launching a poorly differentiated product that fails to demonstrate value to a broader set of stakeholders, particularly payers. As payer controls continue to increase, successful product development will require a cross-functional approach starting as early as pre-clinical research.  
     
  2. Develop and maintain transparent internal processes. Early and integrated market access input is critical to evidence-based decisions and evidence-informed trials. Companies should move from the traditional, siloed functional groups addressing stakeholder needs separately, to an aligned system with cross-functional collaboration. New functions that have input to both clinical and commercial decisions can help improve cross-functional collaboration and set the stage to demonstrate value to broad sets of stakeholders.    

  3. Link incentives to financial success of products. Clinical and commercial teams together should be accountable for product approvability and reimbursement. All functional areas should hold some accountability for manufacturer profitability, but should also have a say in investment decisions. The most successful approach involves an evolution from the typical incentive approach, where clinical and commercial incentives may not have been historically aligned, to linked functional area incentives.

In conclusion, companies must recognize that the world has changed and adjust their commercialization plans accordingly by starting early and taking an integrated, holistic approach. A product launch plan must be comprehensive, extending beyond commercialization to consider manufacturing capabilities, clinical expectations, economic impact, and more. This launch planning process should start as early as possible, sometimes three years ahead of the anticipated launch enabling executives to take necessary time to “measure twice” (or thrice) and cut just once. Launch excellence — the culmination of an iterative process that unifies clinical and commercial teams along with key stakeholder objectives — is needed to deliver an optimized launch in an increasingly complex healthcare marketplace.