Oireachtas Joint and Select Committees

Wednesday, 12 July 2017

Joint Oireachtas Committee on Health

Evaluating Orphan Drugs: Discussion

9:00 am

Professor Michael Barry:

Germany essentially has free pricing. One goes in with the price that one nominates and, as Deputy Brassil rightly said, that price lasts for a certain period, in this instance at least 12 months. There is a negotiation around the pricing. From our point of view, it is not a model to be followed. This is due to the significant budgetary issue with which it would leave us. For example, if we did not assess any medication in 2016, it would have added €1 billion over five years to the drugs budget. There are implications in following those patterns. There is heterogeneity throughout Europe in respect of assessments.

Regarding the NCPE, our rapid reviews are always done in under four weeks. We consider a drug, assess it and determine whether we are happy to recommend that it go through. No one could do it faster than that when one is examining upwards of 70 products.

As to full assessments, Entresto was done in four months, for example. The full assessment is a complicated procedure when large dossiers that are complex to analyse are received from the industry. Full assessments are usually done within six months. That is the approximate average. The process from market authorisation to the patient getting the drug slows down, and we take approximately six months out of that.

Regarding resources, we have three additional staff members compared with when I joined 19 years ago. A recent review suggests that we need nine additional staff members, particularly in technical areas because this work has grown quite scientific, with a great deal of mathematical modelling, statistical analysis and data analysis. These are the types of people that we want and we need more of them.