Clinical trials have two main purposes, they produce data to show your device is regulatory compliant but they can also help you with your health technology assessment for commercialisation. We ask Paula Wittels, Programme Director at Translucency, a UK-based reimbursement consultancy, what you need to do to ensure you get the right clinical data for your target markets.
When you get to the clinical trial stage of your device development, you might be tempted to focus your data collection on CE-marking requirements, in your rush to ensure the next funding round. But when it comes to commercialising your device, you may find that your clinical data does not coincide with the requirements of a health technology assessment, which will give you clearance to sell in your market of choice.
‘One of the things that I would always recommend,’ Paula Wittels tells me, ‘is to at least understand what the data requirements are going to be for reimbursement and health technology assessments. That way, when you do the CE-marking it may be possible to extend the study a little bit or to at least be aware of what is needed so that you’re planning for the next stage.’ The data elements that are often missing from regulatory studies but are required for reimbursement and health technology assessment (HTA) are a comparison against the current standard of care and the full cost consequences. These costs not only refer to the device itself but also the costs of changing the care setting or care pathway.
‘The data needed for an HTA is normally going to be gathered from the care setting in which the device is going to be used,’ Wittels explains. Therefore, you need to identify your target patient group and be reasonably specific about it. If the device targets a broad patient group and will be increasing the cost of treatment, this will place an increased demand on the healthcare system, so the clinical data required to support it will be significant. But if the device is specifically suited to a niche group of patients and it replaces a less effective treatment, the data requirements for it will be less onerous.
‘A comparative study of your device against the current standard of care is very important,’ Wittels says. She also recommends talking to healthcare technology assessment bodies in your different markets as they may provide input on your plans and give your feedback on the study design and methodology.
‘I appreciate that this does cause problems for medical device companies because they do want to do one study that they can use right across Europe but it’s very likely that different markets will have different standards of care.’ In that case you will have to choose your entry market, study it and do a comparative study against the standard of care in that market.
The reason why there are various standards of care across Europe is because each country is responsible for its own healthcare. The doctors are all trained locally and have their own treatment pathways. So you do get variation across Europe in what people think is the best treatment.
The other data needed for the HTA is the resource data, which is often overlooked by device manufacturers. You might have an idea of how much your device will cost, but you will also need to research how much surgery and consultation time the device will require, whether the drugs currently being used can be reduced, and whether the hospital length of stay can be reduced. All these things affect how much it costs to provide the treatment, plus whether it can be carried out in an inpatient or outpatient environment or in a community setting.
‘As a rule, if you can demonstrate that your device is effective and reduces treatment costs, it is more likely to benefit from a positive HTA. If it’s a device that is used in the hospital in patient setting, the data is often transferrable across Europe. But if the device is adding costs to the standard of care and you want to show the clinical benefits, it’s much more likely that you’re going to have to go through an HTA in each market. If there isn’t a formal reimbursement or HTA requirement in an individual market, you may still have to make a business case to the payer, convincing them why they should be spending more money on this new treatment compared to what they were doing before,’ Wittels adds.
For a business case you need to be able to show the costs of the current and new pathway and the benefits of the new pathway for the defined patient group so that the payers can decide whether to fund the device.
‘In some countries, companies cannot apply for a health technology assessment – it’s the clinicians who make the applications for them. If you have had a KOL (Key Opinion Leader) involved in collecting clinical data from the device development phase, they will be able to support you through an HTA as well. Doing a health technology assessment is quite a big investment on the part of a country’s health authority so it’s always looking for technology that can clearly prove itself valuable and able to make a difference to the population. If this process is clinician-driven that means the technology is advanced enough to have clinician support because respected people in the field can see the value of it,’ Wittels concludes.
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