Given cell and gene therapies are typically personalized medicines, they come with outlier pricing and other unique commercialization challenges that differ from other large and small molecule therapies.
Roshawn Blunt, a respected biotech consultant, was inspired by President John Adams, who in 1798 signed an act authorizing the deduction of 20 cents per month from the wages of seamen for the purpose of funding medical care for sick and disabled seamen. Thus, she launched 1798 Consultants with a focus on developing market access strategies for groundbreaking new therapies. She and her team have earned accolades for their work creating game-changing market opportunities for advanced therapeutics like gene and cell therapy companies.
Roshawn says because each therapy is unique, her team starts by analyzing the specific industry landscape and competitive dynamics to uncover the data necessary for a successful market access program. She presents 10 questions that are critical to optimize the strategic plan:
1. What are the patients’ demographics, including payer mix?
2. What is the benefit category, and what are the most likely settings of care?
3. What are the implications of the distribution approach?
4. What is the marketing strategy?
5. What is the payer’s likely perception of the therapy and its ability to fulfill an unmet medical need?
6. What is the potential budget impact?
7. What are the political implications of the therapy, if any?
8. What is the advocacy landscape?
9. What are the requirements for patient affordability?
10. What is the gross-to-net objective?
“We then conduct primary market research with providers, payers, and patients to identify the strategic imperatives so we can define tactical plans," she says. “As the research evolves, we select the most appropriate methodology to test a hypothesis.
Quantitative surveys, for example, yield very different information than do healthcare claims analyses conducted by virtual advisory boards. By selecting the appropriate tool and rigorously developing the methodology, we acquire the targeted data we need to inform the development of a successful commercial strategy."
She cautions against getting too attached to a hypothesis, noting that a willingness to explore meaningful disparities uncovered during analysis is vital. “Past successes are only a starting point; future success requires new thinking," she says.
That success depends on plans’ ability to make appropriate coverage determinations for their patient population based on those data as a function of net price, so the data and the price must be credible.
“Finally, never underestimate the importance of the patient support team as a strategic lever," she says. “These are costly therapies that have a direct financial impact on patients and caregivers. Empower the patient support function to determine the best approach to support your access objectives by helping patients get and remain on therapy." (PV)
