In an ideal world, the approval of a drug should automatically mean the ability to market it using a comprehensive pharma marketing approach. When it comes to European countries, however, we do not live in an ideal world.The advantage of the European Union is the centralised authorisation process, which approves drugs across the entire union in a single stroke. The disadvantage, as far as pharma market access is concerned, is that individual countries still control their own prices and decide which drugs to fund via social security systems. This slows distribution down across the board, but in some countries more than others.
The Waiting to Access Innovative Therapies (WAIT) indicator has been drawn by EFPIA (European Federation of Pharmaceutical Industries and Associations), and displays the average ‘waiting’ time (between authorisation and access) of EU member countries:
As we can see in the graph from EFPIA, countries have been facing long ‘wait’ times (over a year for Portugal in 2011 and Belgium in 2008), which are causing problems for pharma brand strategies and patients alike. Yet although Germany and the UK have the ability to distribute drugs as soon as they are approved for marketing, they too experience long delays – due to health technology assessment (which checks drug effectiveness and the impact of health interventions). The question, then, is how can member states – and the EU leadership itself – shorten the pharma market access process?
Emphasis on pharma action, not the EU
In 2013, the EU launched the Transparency Directive (89/105/EEC), with the intention of making the pricing and reimbursement process more efficient (and therefore speedy). The proposals were abandoned, however, and so waiting times have remained largely unimproved across member countries.
Pharma professionals, however, would be pessimistic to think that the EU is the only potential driving force behind change. Countries have decided that extensive measures must be taken before any drug goes to market, but who is to say that pharma cannot play an active part in fulfilling these measures? A wealth of expertise has gone into producing the drugs in the first place, so surely the same expertise can be applied to the assessments which make them fit for pharma market access?
By doing some of the assessors’ work for them, the process can be shortened and, therefore, patients will not have to wait as long to access drugs. Some positive steps include:
- COLLECTING REAL-WORLD DATA: Besides clinical trials (which have limitations), testing of drugs in the day-to-day lives of patients provides a large chunk of the assessments. It can be collated via trials, registries, and monitoring of community groups
- REAL-WORLD EVIDENCE FROM SOCIAL MEDIA: There is a vast array of human stories, expressed on social media, which aren’t as quantifiable as standard test results. Pharma experts can translate these stories into hard facts, and pass on to assessors.
- REACH OUT TO ASSESSORS: Pricing and reimbursement teams need to qualify the safety, effectiveness, cost and cost-savings of each drug, and pharma experts will in many cases have made these qualifications – but only to themselves. Again, it’s about doing some of the assessors’ work on their behalf, and sharing knowledge of the overall worth of particular drugs. In other words, the ‘picture’ of each drug should be painted and presented to assessors, and this will guide them towards the finer details with greater speed.
If someone knows what to look for, they have a greater chance of finding it. In the case of pharma market access, regulators and assessors need to do a thorough job of making sure drugs are worthy of the target market. Pharma companies already know the answers to many of the questions they have, so it’s both helpful to them – and valuable to patients – to provide these answers.