JEAN-LUC HAROUSSEAU (NANTES)
ACCESS TO DRUGS
Hôpital Privé du Confluent, Nantes, France
In the past 10 years 8 new myeloma drugs have been approved in Europe. They are being used both in
relapse and in newly diagnosed patients. But due to their high price, there are huge inequalities in access
to these drugs across European countries.
There are two steps:
- Authorization: a European market authorization is granted when the European Medicine Agency
(EMA) positively evaluated (centralized process) the pharmaceutical quality, the safety and the
efficacy –benefit/risk ratio) of the new drug
- Market access (reimbursement and pricing) is decided at the national (and sometimes regional)
level, usually on the basis of evidence-based analysis of available clinical trials by Health
Technology Assessment (HTA) agencies. The proportion of authorized drugs that receive a positive
reimbursement decision ranges from 7% in Latvia to 98% in Germany. The time to Market Access
varies from 3 months to 2.5 years (average 462 days)
These differences are obviously related to the national economic context and to health-care
policies, because of the high cost of new agents and of their combinations. But they are also
explained by decision-making levels and by criteria used to define value-based pricing.
The main criteria are clinical-added value compared to existing drugs, cost-effectiveness
(incremental cost-effectiveness ratio) and budget impact. While some countries mostly use
clinical assessment (Germany), others use exclusively medico-economic assessment (UK), and a
large number use a mix of criteria.
Moreover, even if the assessment methods are comparable, appraisal of the added-value may
vary across HTA agencies.
Therefore, while final pricing decisions will remain the national government responsibility,
harmonisation of assessment processes are necessary at the European level. Several initiatives
have already been proposed by the European HTA network (EUnetHTA) : early dialogs with
pharmaceutical companies, methodologic guidelines, plot joint assessments , post-launch data
collection. One can hope the European Commission will obtain consensus of member states to
organize joint assessments at the European level.