How groupH can assist in developing Market Access strategies
The importance of planning market access strategies at an early stage.
There is an ever-increasing influence of payers in treatment decision-making processes. The commercial success of new pharmaceutical agents will therefore be heavily dependent on their market access position.
In the past it was the norm to engage with regulators at an early stage of drug development, but leave payer discussion to much later on in the process. Now though, it is becoming critical to evaluate the market access position of early-stage candidates right from the outset – the objectives being to reduce the overall go-to-market risk, achieve significant savings, and increase speed and magnitude of return on development dollars. One should never forget that any product that is denied reimbursement or provided only limited coverage is a product that has been approved by regulatory authorities. This illustrates the different perception of value across various stakeholders.
However, few drug-developers or investors are as yet dealing with payer value uncertainty in their clinical development plans and commercial strategies from this early stage.
How to tackle payer value uncertainty.
The task at first sight seems difficult if not impossible. Especially when trying to predict future uncertainty across several geographies. But actually, payer decisions on a new treatment are based on answers to four key questions:
- Can the product increase survival?
- Can it reduce symptoms?
- Can it increase patient quality of life?
- Can it reduce health resource utilization?
Nicolas Touchot, who heads up groupH’s newly formed Market Access practice, brings his insights from working with payers over many years to the task. With Nicolas’s expertise to enhance groupH’s offerings, we can help enable our customers to develop and refine their market access strategies and integrate these considerations into key product and therapeutic area decisions along the full pharma value chain: from allocation of R&D resources to product life cycle management.
For instance, we can help integrate market access considerations into Opportunity Assessments. Target product profiles, even at early stage, should include well-defined Payer Value Elements (PVEs). GroupH can aid in the identification of theoretical PVEs (clinical and/or economical), help express those PVEs compared to expected standard of care at launch, and identify approaches for demonstration of these PVEs.
We believe we achieve more from our payer work than other organisations, because only experienced and dedicated market access experts interact with carefully selected senior payers. Also, our payers can rely on comprehensive and detailed briefing materials prior to a discussion, which greatly enhances their ability to make meaningful comments in particular in orphan and other rarer indications. All this of course, is complemented by our proven track record in in-depth primary KOL and secondary research.
As an easy first step, Nicolas has developed a simple scoring system based on the four key questions above, answered by payers across many geographies with disparate health care systems. This provides a global view and allows characterization of the market access potential of early-stage assets. The algorithm, known as MAPPI (Market Access Potential and Pricing Index) has been validated by investors and research executives.
- Step 1: scores the product’s ability to generate realistic benefits that are highly valued by payers
- Step 2: assesses whether the payer value elements described in Step 1 can be demonstrated as part of the regulatory development process or require investment into additional trials
- Step 3: evaluates the product’s ability to generate economic arguments supporting the clinical value, and translates this clinical value into a pricing premium
Results are then combined through a series of scores and matrixes to define a market access environment score and to evaluate the impact on investment decisions and modelling assumptions.
Figure 1: Example MAPPI output
Get in touch for more information on how groupH can help.
Nicolas has addressed many other issues facing the industry with respect to market access in articles he has written recently (see below for details). He is also very happy to provide additional information and support, so please feel free to drop him a line!
Want to Dig Deeper?
Maximizing the Value of Early Engagement Between Manufacturers, Payers and Regulators in Europe – Key Lessons Learned From TCA’s Experience. TCA Viewpoints. November 2013.
Projecting Market Access Success For Early-Stage Pharma Assets: Getting Past The Hurdles. Nicolas Touchot, Lynn Nishida, Mathias Flume. In Vivo. February 2013.
Pharma strategies for development of payor evidence programs. Marie Cassese and Nicolas Touchot. In Vivo. February 2012.
The New Role of Payer Advisory Boards in Shaping Clinical Development Preparation, Structure, Outcomes and Key Success Factors. TCA Viewpoints. February 2012.
Integrating payor requirements into phase III clinical trials. Nicolas Touchot and Marie Cassese. In Vivo. June 2011.