Unless a product is a complete breakthrough in a market, upon launch most new products will face the following questions.
- How much better is this new product vs what is being done today?
- What is the clinical or patient reported outcomes evidence supporting that?
- What is the value of the new product?
- How accessible should this new product be to physicians and patients?
The time to address these questions is prior to a drug’s entering Phase III, because the clinical endpoints drive the label and data with which a product goes to market. And this sets a new product’s adoption trajectory.
Many argue that the first 18 months post-launch is the most critical period and that even if new data or claims become available later, it is rare that those will dramatically significantly alter the perceptions of payers and usage by physicians.
Comparative value assessment is a research process
(both qualitative and quantitative).
All of the relevant stakeholders are identified and interviewed and the data is integrated and synthesized so a company can decide whether and how to best carry out Phase III trials. The process is future oriented, meaning it addresses the commercial challenges and competitive environment companies will face at the time of launch, and the results of this engagement allow companies to decide their Phase III, IIIB, or Phase IV strategy quickly and definitively.
Comparative Value Assessment Case Example
Assessing the Value of a New Drug for Stroke
The opportunity is large but the reality is that the therapeutic area has historically been a graveyard for new drugs. The client needed to identify clinically relevant stroke measure(s) for their development program.
The client had an oral product in early stage clinical development (phase I) for the treatment of stroke and needed help in identifying suitable stroke measures and secondary endpoints for evaluating a novel treatments’ efficacy.
Measures and endpoints required were:
- Acceptable by regulatory agencies in the U.S. and E.U.
- Practical for use in a clinical trial setting
- Easily understood and completed by clinicians, patients , caregivers, administrators and payers
- Commercially relevant and able to support market access, pricing and reimbursement
The Primary Objective
Delineate and understand optimal and meaningful patient outcomes for all relevant stakeholders.
- There is high inter-observer variability in adoption and use of current scales used causing the inconsistency in outcome measurement
- Current scales take a long time to administer
- Certifications are required to administer certain scales (NIH Stroke Scale)
- Current focus is often high-level and not detailed enough to capture smaller, but meaningful improvements in patients rehab
Implications for Our Client
We were able to clearly delineate:
- The role of each stakeholder
- The points at which they interacted with the patient (along the stroke timeline)
- The drug benefits that individual stakeholder groups desire
In addition, we were able to:
- Identify the significance of the role of the Rehab specialist and the impact they have on positive patient reported outcomes
- Establish a new scale that was broadly acceptable to all stakeholders that could be incorporated into our clients Phase III program
The Bottom Line
We identified a “new” influential stakeholder relative to our clients product in development and an associated PRO scale that was broadly accepted by all other stakeholders that could be incorporated into our clients clinical program.