It’s never too early to gather payer insights about a product under development. There can be a tendency in the pharma industry to focus on clinician insights to shape and support product decision-making. And that’s as it should be, because a product must be fit for purpose for clinicians and their patients.
However, before clinicians prescribe or use a product, it’s the payers who will decide on its accessibility and reimbursement. Therefore, incorporating their insights as early as possible, preferably ahead of phase 2 studies, can support decision-making.
Consider that phase 2, first-in-human efficacy studies can, if well planned, often flow into phase 3 studies and, therefore, for studies with small patient populations there is the potential to have longer-term safety and clinical data. To realise this possibility, sponsors need to make sure that those phase 2 studies are designed with the end outcomes in mind, including data to support health technology assessment (HTA) and reimbursement submissions.
That means considering not only outcomes, but also comparators, study type, patient inclusion and exclusions, groups and sub-groups and all the other factors that go into the study design. It needs to be as appropriate and relevant as possible for those decision-makers who are going to be evaluating your product on the data that you've generated.
It can prove invaluable to gather those insights to shape what your study design should look like or validate your study design with those key decision makers to ensure you’re not missing a critical element.
One way to gain those insights early on is to invest in market research. While companies have tended to leave market research until the later stages of development, beginning early on can provide you with the most valuable evidence to support market access and the value proposition for your product.
What does early market research look like?
A typical market research project for a new product would start with validating or understanding the current environment. How is diagnosis done? What are the standard treatment and disease management options? This can provide a better understanding of the unmet need, any bottlenecks to patient care or challenges with the existing treatment and management pathway.
The next stage in market research for a product under development is to look at the proposed new hypothetical, or product X, as we call it. That would include a brief profile and overview of the product (TPP), the indication, the target patient population, top line safety and clinical data, any adverse events reported, any contraindications and so on.
Good market research would delve deeper to uncover what is liked or disliked about the product profile, any gaps, concerns or action that would need to be taken to address issues with the unmet need. It would also look at a potential treatment pathway, including who might be considered appropriate to prescribe it.
Early research to inform phase 2 trial design may also take more time to explore details of the evidence that would be required or likely to be required by the time the new product is expected to reach the market. It can assess what may have changed in the treatment and management of the condition in future, and how trials can best future-proof the evidence generated to strengthen the proposition for the new product. For example, how much will efficacy impact decisions and positioning versus price? If entering a busy market, what will distinguish the new product from its competitors? What would need to be demonstrated to put a new product higher up the treatment pathway than older, established, potentially cheaper options? What data would help to provide the reassurance decision makers need to allow use of the new product with minimal restrictions on implementation?
Once a trial has been designed and is running it is incredibly difficult and costly to make changes. In fact, any changes would typically undermine the evidence being gathered. Therefore, investing in market research at this early point can be the best investment you make. Whether it steers your design in a different way, or validates and provides the confidence in your trial plans, it can help you ensure you are doing the best you can to optimise your product.
Defining pricing through market research
The next step would be to explore the potential access and the price points. What would payers expect the price to be, based on the product profile that's in front of them? What value do they consider it offers against current treatment options? What price would potentially provide fewer restrictions to patient access? And conversely, what price point would likely introduce patient restrictions and what might those restrictions look like? Would it mean prior authorisation is required? Or would it mean the clinician would need to fill out a form to justify that a particular patient has met the criteria, for example, that patient has already failed on other treatments and would therefore be appropriate for this next line product.
Market research questions would also consider what price would affect who was able to prescribe it. As prices increase, products are very often restricted to specialist initiation or use only. That impacts resources and the whole healthcare system, as well as cost to healthcare, but it also means fewer patients are likely to have access to that product, because they've got to go through those steps and be filtered through to a specialist.
Given the impact price has, it’s important to investigate or to validate if you are set on a price. Sometimes that can be a global price point set for a product, which can impact whether all markets are able to access that product. If affiliates in those markets can gather insights that present their case, it might be possible to push back within the company and argue for a different price, rebate or commercial agreement for that market.
The price a company sets for its product will affect patient access. Understanding that from the point of view of payers can help to inform decision-making.