Developing a new product and bringing it to market is a complex and expensive process. With so many phases to be completed, and with differing regulatory concerns in different markets, it is essential to guide the process with an eye on the final prize.
Utilising payer scientific advice can help shape trials, packaging and treatment regimes to ensure that your product will ultimately reach as many patients as possible. Market access consultants are ideally positioned to investigate the HTA landscape and feedback payer insights so that your teams can respond.
As your product nears market readiness, you need to be sure that the market is going to accept it. Taking advantage of payer scientific advice at an early stage enables you to plan what evidence you will need to gather to show efficacy, as well as to power a switch from existing treatments.
Regardless of the market, payers will not open purse strings unless there are provable to using your product over an established treatment. Even when you are bringing a completely new treatment to the table many payers have to balance the number of patients your product will help against their budget as a whole and will demand to see evidence. Incorporating payer insights and scientific advice into trial design will enable you to meet those evidence requirements
Clinical trials are some of the final stages of bringing a product to market and are essential to proving that the product is not only safe and effective but that it is cost effective. Seeking out payer scientific advice while designing trials will avoid wasting resources on trials which, while they may enable you to obtain market authorisation, will be worthless in convincing budget holders to fund treatments.
Lines of enquiry
In the very early stages of research and development, you often need to decide which ideas are likely to offer some sort of return. While some unpromising research turns out to be significant, it is usually the case that only some areas of study will appear promising, and even fewer will ever make a significant return.
Which is why paying attention to payer scientific advice is an essential part of focussing your research labs output. Understanding what treatments they are looking for, what evidence will be required, how likely a product is to gain market access and so forth can avoid the situation where your early stage research spends a lot of time and effort with very few marketable results. Ultimately if you don’t listen to the people with the money, you won’t get a share of the pie.
One-size doesn’t fit all
Different markets have a different focus on what they consider the most critical factors. Payer scientific advice will allow you to understand what factors the payers use in their decisions in each market and also enable you to provide them with the information they need.
For example, Germans generally prize comparative clinical effectiveness. If a new product is no more effective than existing treatments, it will be difficult to charge more than existing standard therapies. It is essential to consider this need to show an improvement throughout the research and trial phases.
In the UK market access can hinge on whether or not a product is subject to an HTA, and whether or not it obtains a positive review. Early payer scientific advice can allow you to gauge the likelihood of a positive HTA review, and how to ensure that your evidence is presented so that it will obtain one.