We’ve all seen the headlines and read the deeply emotive and personal stories behind new drugs coming to the market after successful clinical trials, only for the cost of treatment to be so prohibitive that patients are unable to financially access the treatment that could potentially cure them. There are hundreds of drugs trials at various stages being conducted across the globe. They come with significant risk too, but in our constant zeal to reduce the impact of diseases and illnesses on the global population, without managed risks such as these, medicine would stand still.
But there is very much a real-life issue at stake here. New drugs come to market but with a prohibitive price tag. Who foots this risk? Who pays? The answer is Managed Entry Agreements, also known as MEAs.
Are MEAs the solutions?
Effectively, there needs to be a tool that manages the risks and uncertainties associated with marketing new drugs and treatment, no matter in which country the pharmaceuticals are to be sold.
The problem: essentially, when a new drug is developed and its success tested, there is pressure for rapid access to what is seen as a beneficial health technology. But there is a need to get the best value for money too. Ensuring affordability is key for health payers who wish to adopt a range of ‘innovative reimbursement approaches’. These are what have become known as Managed Entry Agreements.
The proposed solutions: essentially, MEAs are an attempt to deal with several key issues;
- Reduce uncertainty arising from incomplete information relating to the budget impact of a new drug or technology
- Use in real life
- Access to new therapies
- MEAs bring both benefits and limitation. Their uptake and use, for example, especially financial MEAs, has been significant in many European Union member states, and beyond too.
The use of MEAS has shown that they are able to satisfy a range of procedural issues and processes, whilst minimising the ‘normal ‘risks associated with buying and using new drugs and technologies.
They have also been significant in securing reasonable pricing structures, as well as addressing what many see as the uncertainties of these new technologies in real life.
However, despite all these benefits, there are limitations. MEAs should not be seen or used as quick-fix solutions, especially in addressing the risk and uncertainty of the introduction and use of new drugs and technologies. In essence, they too need to be integrated into the process of managed introductions of new medicines and therapies. There needs to be serious consideration still given to forecasting activities, as well as post-marketing studies and surveillance.
Why we need MEAs
Healthcare payers demand proof of the supposed superior outcomes of any new drugs or health technologies that a pharmaceutical company is bringing to market. They want to have a higher level of confidence that the money they invest in any new technology will deliver.
But there are budgets to consider and this is where financial MEAs have become widely used. There is no bottomless pit of cash. MEAs have been used to cover everything from evidence development set-ups to pay-for-performance deals and simple price-volume agreements.
MEAs do not directly determine a drug’s value but placing the focus on outcome-based MEAs is slightly trickier than those mentioned above. Likewise, determining the success of some MEAs can be tough too.
They do serve a purpose – and will continue to do so – but how MEAs are used now and in the future needs to be carefully considered.