The process for applying for joint scientific advice from EMA and Health Technology Assessment bodies has been simplified by the establishment of European Network for Health Technology Assessment (EUnetHTA) and the development of a new IT platform.
There is currently a two-step process for patients to access medicines. Firstly a regulatory agency assesses the benefits against the risks of the medicine and grants a marketing authorisation if the balance is favourable. Then, the Heath Technology Assessment (HTA) bodies in each member state considers the value of the new medicine against treatments already available in accordance with national practices and legislative requirements. This enables them to make a decision regarding reimbursement and the price of the medicines at a national level.
In order to speed up this process, it has been possible for medicines developers to seek parallel scientific advice from the European Medicines Agency (EMA) and HTA bodies. However, this required the medicines developer to contact each Member State’s HTA body individually.
A body called European Network for Health Technology Assessment (EUnetHTA) was set up to facilitate the transfer of information between HTAs across Europe and various pilot schemes have been in operation to refine procedures
Now to request parallel scientific advice, medicines developers only need to notify EMA and EUnetHTA, who will coordinate the HTAs that the developer wishes to take part in the parallel scientific advice.
In addition, the EMA and EUnetHTA have set up a joint platform which allow them to share information, communicate more easily and streamlines logistics for industry. The aim is that coordinated advice can be provided to medicines developers on their plans, particularly the structure of pivotal phase III studies and post-authorisation safety and efficacy studies. This should help ensure that one set of data is generated by the medicines developer which meets the differing requirements of the regulatory agency and the HTAs.
The first requests for parallel consultations will be processed in September 2017.
To access the guidance document which has been produced jointly by EMA and EUnetHTA about parallel consultation, click here.