- All > Medicine Access and Rational Use > Financing
- All > Quality and Safety: Medicines > Regulatory Support
- Keywords > access - innovative medicines
- Keywords > access to new technologies/health products
- Keywords > adaptive pathways
- Keywords > early access - new, innovative medicinal products (not yet licensed)
- Keywords > marketing authorization
- Keywords > new medicines - efficacy and safety
- Keywords > pharmaceutical pricing and reimbursement policies
(2016; 36 pages)
Increasingly often, patients are asking for quicker access to new, innovative medicinal products that are not yet licensed or for which reimbursement via the health insurance system is not yet available. In order to meet this demand, the European Medicines Agency (EMA) has developed a new concept for market access of medicinal products, called ‘adaptive pathways’. This involves making more effective use of existing flexible marketing authorisation procedures, such as a Conditional Marketing Authorisation. In addition, it is intended that the procedures for marketing authorisation and reimbursement, which currently take place one after the other, should run in parallel as far as possible. Furthermore, patients and healthcare providers will be involved structurally and at an early stage in the processes of marketing authorisation and reimbursement.
The key instrument for making adaptive pathways possible is a brainstorming session organised at an early stage with manufacturers, marketing authorisation and reimbursement authorities, patients and healthcare providers. Together, these parties look at the clinical study design, the development pathway and the licensing and reimbursement route that is envisaged.
The National Institute for Public Health and the Environment (RIVM) is investigating the benefits and potential bottlenecks of the proposed authorisation concept. Research by the RIVM shows that the parties that would be involved with or affected by adaptive pathways in the Dutch situation do see added value in it. They expect that adaptive pathways will make it possible to match medicines better to patients’ demands and perhaps do so more cost-effectively.
At the same time, the parties interviewed point out that greater investment must be made in monitoring the safety and quality of medicinal products after they are licensed. This can, for instance, be done through suitable patient records and monitoring systems. In addition, they are of the opinion that bridging the time gap between (international) marketing authorisation and inclusion in the (national) reimbursement system is a very complex issue, which would require extensive agreements and cooperation at international level. Furthermore, they think that the flexible inclusion of medicinal products in the health insurance package demands clear agreements about whether medicines can be withdrawn from the market if they prove not to provide the added value anticipated.