Professor Michael Barry:

Our assessment process has been in operation for approximately 19 years now. There is no doubt, however, that things have changed significantly in recent years. In 2012, we looked at about 20 products between rapid reviews and full HTAs. This year that figure will amount to 70 or more, which has been the case for the past three years. We are seeing an avalanche of newer, high-cost medicines. We are about to assess our first product to cost €1 million per patient per year. That gives the committee an idea of the challenges we face.

It is important to consider that, because of the NCPE process and the subsequent follow-up with the HSE, we are regularly able to achieve price reductions on products of between 20% and 50%. That is money that is now available to go into other areas in the health service.

Deputy O'Connell spoke about the cost of orphan drugs. As I mentioned, we are now facing our first drug to cost €1 million per patient per year. I do not know where these costs arise from so I cannot say if they are justified. That is what we are dealing with.

Orphan diseases are, by definition, rare but taken together they are not so rare. More than 50% of our current assessments are for orphan drugs, while a total of 80% are for orphan and cancer drugs. That should point to where the major areas lie. Matters are growing more complex because these are new biological medicines rather than the simple molecules we used to deal with before. Getting back to rare diseases, I am aware of the rare diseases plan and of recommendation No. 30 in particular, which highlights whether we can carry out the assessment process for orphan drugs in a better way. The answer to that is yes, we can always improve our processes. With that in mind, we are establishing a rare diseases technology review committee. I was asked to chair this and I agreed to do so in June of this year. The idea is that this committee would look not only at the methodologies for assessing orphan drugs but also at the views of patients, caregivers and at the wider societal issues that go into health technology assessment. We are only just in the process of establishing this committee but it is a welcome development.