Innovative Drug European Associates

Two in one go: Don’t shy away from joint consultation with EMA and HTAs

It’s understandable that companies tend to be focused first on getting their products approved. But that’s just part of the battle. The other part is getting your products paid for. In July 2017, EMA began offering consultations in parallel with the European Network for Health Technology Assessment (EUnetHTA).

The objective is to ensure that you not only have the data needed to approve your product for marketing authorisation, but also the economic effectiveness data to support reimbursement arguments.

To date, however, most companies have shied away from the joint consultation process. There are good reasons for this reticence. First, it’s a new process and many companies don’t know how to do it or what to expect. But perhaps a bigger barrier is that once you’ve had the parallel consultation, you can’t talk to the individual member states (to avoid potential for conflicting advice). This can feel like you’re shutting down your options. Another potential issue is if the regulatory and HTA recommendations conflict, which may sometimes be the case.

But by talking to both at the same time you can ensure you don’t just receive the green light to sell your product but also the support of the payers, and you are fully aware of any potential setbacks and problems. This allows you to plan your development strategy according to your priorities, with an understanding of where issues might arise in future. If you are entirely focused on getting MAA approval without considering reimbursement from early on, you could well spend precious years jumping through additional hoops to get it on the market post authorisation.

As with any process, any undesirable responses that arise during your conversations with EMA and the HTA representatives can be addressed if you start early enough. If your product is for a rare disease, you might be providing surrogate endpoints rather than the traditional pivotal endpoints. If that’s the case, you need to be looking at building patient-reported outcomes in your phase 2 trials, which will help with your economic analysis later. Having that conversation early and knowing what to expect may well improve your position later when it comes to the decision about reimbursement.

As I’ve stated before, the regulators want to get good products to patients – as do the HTA representatives. But they want to know that what they’re paying for will make a difference to patients compared with what is already on the market. And they need to understand how your product works. If you have a first-in-class molecule that requires HTA bodies to install new diagnostic equipment to diagnose the biomarker, they need to see the value of investing in your product. That’s a reasonable expectation. So, the sooner you discuss those needs with all the key stakeholders, the better your chances of getting your product on the market and starting to make money from it.

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