How soon is too soon to consider market access strategies for my specialty drug?

Published: 5-Dec-2022

The answer is that it’s never too soon, advises Craig Caceci, Managing Director at Terebellum. In fact, he says, if you want to ensure your product is paid for, then the sooner the better

Market access and commercialisation strategies should always be considered as early as possible in the product development process to increase the likelihood of a successful drug launch.

This is even more important when developing treatments for rare or orphan diseases, for which having a patient doesn’t actually guarantee that your product will enter the market and be paid for.

There is a lot of work to be done to build disease state awareness, generate data to demonstrate value and develop brand positioning. You’ll be up against treatments for a whole range of diseases, all competing for the same budget or funding. To ensure your product has the best chance of entering the market, you’ll need to start planning early.

Why do I need to start early?
You need enough time to collect all the data required. Alongside the development of your drug, you should be accumulating data to increase your likelihood of success. It’s essential that you allow sufficient time, consideration and planning to gather enough, and most importantly, the right data. 

The data that payers want to see will most likely differ from what regulators are looking for. What’s more, the data you collect early on in the process can help to inform later-stage decisions such as strategy and pricing.

How soon is too soon to consider market access strategies for my specialty drug?

As an example, let’s look at epidemiology data. Initial thoughts on who will use your product may vary significantly from reality — owing to a reduction in the size of the suitable patient population or constraints introduced by regulators.

By allowing sufficient time for the appropriate clinical trials and regulatory applications to be done, you’ll have more scope to adapt accordingly and manage any impact on future revenue streams.

You may ask what the risk is of not implementing a market access strategy early enough is. You could spend many years and a significant amount of money developing a product that doesn’t get to launch or doesn’t get paid for. There are many examples of instances of when NICE has said no to a product … and often it’s to do with not having collected and analysed the right data at the right time.

When exactly is the right time to think about market access?
Would you be surprised if I said consider market access right from proof of concept? Although launching the product feels like a long way off, during the average 10-year process of developing a product, market access should be evaluated at every phase.

At the bare minimum, consider it prior to the clinical trial phase (4–6 years into development). However, from phase one is advised. You only need to start developing the strategy, not build the actual infrastructure. Seeking access to the market, appointing personnel and raising capital can all be done later — but it helps to understand what these might look like.   

Many make the mistake of squeezing a 10-year development process into a shorter period and, as a result, insufficient time is available to obtain the data needed, corners get cut and critical end points are skipped.

Yes, time and budgetary demands do mean that all data collection and regulatory stages inherently feature some level of risk. However, leaving market access considerations until after the clinical trial phase — with the aim of launching in 12 months — is certainly the riskiest of all strategies.

Another common pitfall is to focus too much on the research. Yes, it’s important; however, only having clinical trial data to fall back on will not be sufficient.

What else do I need to consider?
Start developing your strategy for all elements that could drive commercial success, such as

  • gathering the right clinical data and developing a safety profile
  • building a compelling value story
  • considering adherence and compliance
  • determining pricing and reimbursement
  • identifying the patient population size
  • discontinuation of therapy metrics.

Take “building a compelling value story” for instance. You’ll need to identify the unmet need, communicate the burden of the disease and showcase the effectiveness of the therapy. Doing so requires collecting data inside and outside of the clinical trial.

However, the benefits are that you’ll be able to adopt value-based pricing, attract broad reimbursement, secure prescribing/physician adoption and gain patient advocacy and adherence.

How soon is too soon to consider market access strategies for my specialty drug?

How do I make it happen?
First, take into consideration that it’s all scalable. Early on, it’s not necessary to have a full team working on market access and commercialisation. Just one individual/partner driving the plan will be sufficient. As you progress and confidence increases, you can build resources in this area accordingly.

And remember, you don’t need to do it all yourself. Seek the support of experts who understand the product development pathway. They’ll understand your challenges and opportunities and can provide guidance in terms of appropriate next steps.

If you’re developing a treatment for a rare/orphan disease, seek out a partner that specifically understands that market. There are many more — and different — considerations that come into play.

Above all, awareness of the importance of considering market access and commercialisation early is what matters most. When launching a product, you’ll want to know that if you build it, they will pay.

This is not a given. However, by allowing time to collect the data needed, you dramatically increase your chances of a successful launch for commercial success and improved patient access and outcomes. So, it’s never too soon to start. 

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