Hogan Lovells has partnered with Demy-Colton to host a special three-part webinar series focused on US market access for life science companies, providing companies that are new to the US market or looking to get started in the United States, especially early-stage biotechnology companies, with basic rules from governments and commercial payers. The third panel in the series included Hogan Lovells partners Alice Valder Curran and Lowell M. Zeta, as well as Michael Rothrock, President, Allegheny Strategic Partners LLC, and Peter Rubin, Executive Director, No Patient Left Behind (NPLB). Together, they discussed how to future-proof a company’s value-based market access strategy. In short, what can companies do now to prepare a value-based marketing strategy for a product that is still in clinical trials?
In the article below, we summarize the main takeaways from this webinar. You can access the first and second parts of the series here:
Building on the foundational lessons provided in Parts One and Two of this year’s course Demy Colton U.S. Healthcare Market Access Webinar Series, Alice Valder Curran, a partner at health firm Hogan Lovells, stressed that pre-commercial companies should focus on their go-to-market strategies as early as their phase 1 trials to increase their likelihood of success. Market access is the most important factor for success in the U.S. market, noted Valder Curran, and must be a research and development imperative as well as a commercial imperative, not least because it impacts design and the execution of a company’s clinical trial strategies.
Panelist Michael Rothrock, president of Allegheny Strategic Partners LLC, provided the payer’s perspective from his experiences on behalf of national and regional health plans and pharmacy benefit managers (PBMs). Rothrock provided a timeline of best practices outlining how and when a manufacturer should engage with managed care payers, including key topics to cover at each stage of clinical trial development. Rothrock noted that the therapeutic class of the product could be relevant in determining when early engagement is most recommended. For example, orphan drugs, rare diseases, gene therapies and oncology therapies could benefit from phase 1 or even pre-phase 1 engagement with potential payers on topics such as “outcomes” in the assessment of trial evaluation criteria. Valder Curran posed the important question of how companies without a market access team could still engage with payers at this stage. According to Rothrock, even without an internal market access team, manufacturers could still reach out to medical directors, pharmacy managers, business managers at specific payers. Rothrock cautioned that while some payers or PBMs won’t commit at this point, others, depending on disease status, will want to think ahead about which drugs to include on their formulary. Continuing the product development timeline, Rothrock noted that for therapeutic categories where payers tend to have a better understanding of existing treatments and alternatives (for example, diabetes, cardiovascular or respiratory disease), engagement starting at the time of phase 2/3 trials may be appropriate. This would allow a manufacturer to help align with what might help differentiate their drug to make it more valuable for Pharmacy and Therapeutics (P&T) or formulary approval. After Phase 3, re-engagement with the payer tends to focus on a review and discussion of trial endpoints, focusing on the “patient journey” and alignment of the new medicine with d other possible therapies. Also at this stage, payers would expect to discuss specific pricing and distribution options in anticipation of an FDA approval date. Rothrock noted that the FDA approval date begins “zero P&T time” to review the label and package insert, as well as final distribution options.
Lowell M. Zeta, partner in pharmaceutical and biotech practice Hogan Lovells and former Senior Advisor to the Commissioner of the FDA, provided insight into the tools manufacturers can use when engaging with the FDA to support a strategy based on value for their products. Zeta has identified three key areas that management should incorporate into their strategic plans. First, Zeta discussed the use of patient-generated data and digital tools for data acquisition. “As payers increasingly focus on outcomes, the FDA and [industry have] focused more on patient-centric drug development,” Zeta noted, making sure the therapies work as intended. Early and meaningful engagement with the FDA is crucial to help the Agency assess the value of innovative tools, such as digital technologies or new biomarkers. Zeta also explained how the Agency tackled regulatory decision-making around real-world data/real-world evidence (RWD/RWE) and published several useful and relevant pieces of information. tips documents. Second, Zeta explained how companion diagnostics can impact strategic planning. Zeta noted that it is important to determine early on whether a companion diagnostic is essential for the safe and effective use of a corresponding therapy, and if so, whether it will be stipulated in the final labeling. Zeta shared that lab-developed tests (LDTs) can be used early in development, and stressed the need for manufacturers to consider what studies might be needed to bridge the gap between LDTs and companion diagnostics. Rothrock added that payers like to see companion diagnoses tied to a binary “yes or no” of a patient’s response to medication; more difficult from a payer’s perspective are companion diagnostics that only identify a “better or worse” responder. Third, Zeta discussed confirmatory trials, which can support, for example, the Accelerated Approval Program, which gives conditional approval based on a more limited data set. Manufacturers need to keep a close eye on these areas as regulatory frameworks evolve, including major proposed changes to industry user fee legislation.
Panelist Peter Rubin, Executive Director, No Patient Left Behind (NPLB) discussed how manufacturers can convey the value of their product to a wider audience ahead of launch. Rubin gave an overview of the ‘ISPOR flower of value’, which provides an enhanced societal view of the cost-effectiveness of a therapy, compared to the ‘simple math’ budget view of innovation adopted by many economists. of health. Rubin suggested that a traditional cost-effectiveness analysis (CEA) often undercuts the market price because economists overlook many of the benefits that drugs provide to society as a whole. Rubin encouraged manufacturers to highlight these “real-world values,” such as generification and less burden on caregivers, to better capture the societal value of the innovation and justify a likely market price. Rubin advised manufacturers to design studies to support a generalized cost-effectiveness analysis (GCEA) and be prepared to “frame the debate” by providing a broader rationale for innovative therapies to support patients and families. Adding to the prospect of regulatory approval, Zeta noted that confirmatory studies have focused on verifying safety and efficacy in the clinical setting. However, noted Zeta, there is also recent thinking about how to link this with RWD to support patient voice and quality of life, and potentially, expanded indications. Data generated to support the FDA regulatory process can also guide other decisions to support the overall value proposition.
Particularly for start-ups with a limited amount of resources and personal time to devote to product development, Valder Curran reiterated the importance of “starting early” and “making thoughtful decisions about what you focus on.” , when you commit, how you frame the product instead of being framed at the end because you didn’t think of it”.
The full webinar summarized above is available for viewing online here.
Our summaries of the first and second webinars in the series are available online here (part 1) and here (part 2). The first session,The basics: the basics of market access and their importance before phase III” addressed the key issues that new drug developers need to consider early on when planning their clinical and market access strategies. The second session,Making It Real: What does an early stage market access strategy look like?” ran through real-life hypotheses that incorporate key learnings from the first webinar.