US Launch Readiness Assessments: Preparing for a Successful Triple Aim Product Launch

By Ellen Brett
Man looking up thinking, looking up at plans

Health Information technology is enabling the US market to evolve from a fee-for-service, disease treatment market to a patient-centered, value-based, real-world outcomes market. Yet, many life sciences companies are failing to anticipate the needs of a US market that is solving for the Triple Aim of improving population health, reducing per capita costs, and improving patient experience – a framework for measuring overall health system performance.

Triple Aim

Improve Population Health

Reduce per capita costs

improve patient experience

There have been significant investments to build market access and health economic functions while evolving commercial models to engage more successfully with integrated health systems and consolidated, powerful payers. There have also been highly sophisticated patient support efforts, reputation efforts, transformations to digital, countless reorganizations and large management consulting projects. Yet analyses of biopharma launches show that 40-70% of launches are still failing to meet analyst expectations. In addition, there has been a plethora of failed customer engagement and access strategies with minimal or declining ROIs. So, why haven’t significant efforts to address a changing US market yielded better results?

Patient-Centered Commercialization

The evolution of the market to a more interconnected ecosystem of stakeholders focused on Triple Aim requires a new perspective, viewing patients as THE customer and a more focused examination of all the influences on patient experience and behavior. The fundamental decision around what patient populations within a label to focus on are often not well-informed pre-launch, nor are the decisions about which partnerships and services need to be built pre-launch to ensure these patients get to the desired outcomes in a real-world setting. A patient-centered lens helps leaders to illuminate and fully characterize patient populations and their barriers to get to valued outcomes in order to design an optimal patient experience, while also aligning with key US stakeholders’ perspectives:

  • Policymakers’ drive to the Triple Aim
  • Payers’ and Organized Providers’ need to identify well-defined treatment populations and to realize desired outcomes
  • Physicians’ and other HCPs’ tendency to consider treatment decisions by patient-type

To compete successfully in a real-world outcomes market that is solving for the Triple Aim, organizations need to build a deeper, more holistic understanding of the full ecosystem of influences affecting physician and patient behavior (and thus patient outcomes) earlier in the product development and commercialization process.

Assessing Launch Readiness

A Launch Readiness Assessment, ideally conducted at least 18-24 months prior to launch, can help to ensure that brand teams have more fully integrated pre-launch plans that take all of these influences and stakeholders into account.

Among many other alignment issues, a structured Launch Readiness Assessment addresses issues such as:

  • Will Payers be willing to invest in this population given competing priorities?
  • Will Policymakers align payment and delivery reforms and policies to measures of value?
  • Will Providers, such as integrated delivery networks (IDNs), hospitals, and healthcare professionals under value-based payment schemes be willing and able to identify, treat and engage the right patients for your brand?
  • How will KOLs and Advocacy groups shape policy agendas?
  • Will shared decision making among the HCP and patient take place? What is the shape of the dialogue among HCPs and patients?
  • Will Patients be willing and able to access the healthcare system, pay OOP costs, and adhere to treatment?

A Launch Readiness Assessment provides a third-party perspective free from inherent organizational biases, identifies blind spots in market understanding, and further illuminates the risks and opportunities in strategy decisions already made. Done well, the Launch Readiness Assessment will help organizations to better anticipate market needs and improve results by:

  • Identifying the key barriers of well-defined patient populations to real-world outcomes, as well as the risks in contracting around outcomes
  • Building the narrative, tools, education, customer engagements and collaborations needed to deliver an optimal patient experience and bring about improved real-world outcomes
  • Informing decisions for Phase IV clinical trial planning and health economic analyses

Leaders will have the additional benefit of simplifying complexity internally to drive alignment, focus, and resources to well-defined patient population needs. Every part of the launch organization will have a shared understanding of the desired patient experience and a line of sight into the ways that each functional team can ultimately affect the patient experience and desired outcomes, while also being better prepared to sense and respond to a dynamic and changing US market.