The biggest challenge perceived by stakeholders is demonstrating the ‘right’ evidence. Specifically, evidence generation, demonstrating value and insufficient internal experience are the biggest factors playing into this.
This mainly stems from demonstrating value in a way that is meaningful to
payers. This is best summed up by a Brand Director that participated in the
survey: “Showing value (is the biggest challenge). Is value based pricing a
reality? I’m not convinced yet myself.”
Add to that a lack of experience and expertise internally, which was the
largest output from the people category, and the headache turns into a
migraine. These two factors play into each other, as in order to generate the
right evidence, you need the right resources to plan and execute.
Results – Part 1
Nearly half of the KSFs from the survey respondents relate to the process
and people category. More specifically external and internal communication
and alignment are considered most important. This implies that having a
truly innovative offering/product is not enough on its own to optimize
Surprisingly, having an innovative product does not even score high on the
KSF list, only 11%. Does this mean that pharma accepts that revolutionary
product changes are truly rare, and it’s the expertise of their resources that
truly make the difference?
Having evidence to justify the value of the drug in a format that
stakeholders want is what is important, and this requires the internal
expertise to demonstrate that value. Once again, this is best summed up by
a respondent from the survey. The Head of Global HEOR from one of the
companies said, “Clinical data that truly differentiates your drug from its
competition (is the most important KSF). That is still #1”.
What makes a successful launch is a robust understanding of your internal
and external stakeholders. Connecting directly with your customer is
considered essential. Having the experience to efficiently ‘sift through the
weeds’ and find what is truly meaningful to stakeholders’ matters, and
communication internally is as important as externally.
Based on the results we tabulated the top 3 learnings that enable
transformational market access:
- Know your customer: You must identify and prioritize your
customers. You must understand their values and beliefs.
Understand their constraints and limitations. Understand what
motivates them to take action.
- Develop your evidence: What truly makes an impact on their
values and beliefs? What trial design and endpoints will help them
move into action? What data design and evaluations best support
the evidence? What format should the data be in to be most
relevant to them?
- Be crystal clear internally on strategy and execution: What is
your plan? Who has the experience to execute them? When will they do it? How will they do it? What’s the contingency plan when something goes wrong?
Looking back at the Sovaldi case, how do those success factors apply to Gilead? The company confirmed sales for the first half of the year have exceeded expectations at $5.75bn, which now accounts for nearly 50% of the company’s turnover. These sales suggest the company clearly understood the market environment, and indeed the differential pricing in emerging markets, such as India. Furthermore, the evidence generation was certainly strong enough to warrant access without excessive restrictions. Perhaps a clear internal process and experienced staff also helped drive the process. So despite the continuing political debate over pharmaceutical manufacturers’ profitability, Sovaldi is a clear example of how Gilead has transformed market access.
In summary, market access is a complicated process with many moving parts and many obstacles to consider along the way. Understanding the strengths and shortcomings in your people, processes and evidence are going to be the keys to your success. Planning around these key factors will enable increased market share and ultimately enhanced revenue for your organization.