Dr. Máirín Ryan:

I thank the committee members for their questions. I will begin with Deputy O'Reilly's question on entitlement to the content of the basket of care. When we do a health technology assessment what we consider includes the ethical implications of adopting a particular technology, and one of the main areas of focus is equity of access. Tomorrow we will publish a health technology assessment on a groundbreaking treatment for the management of stroke, mechanical thrombectomy, which involves using a device to retrieve the clot from the blood vessel in the brain that is causing the stroke. It can only be provided at very specialised centres with neurosurgery and neurocritical care. The two centres are Beaumont and Cork. In our report we clearly raise an issue with regard to equity of access for patients who live at a distance from these two centres, particularly in a situation where the treatment needs to be provided within six to 12 hours of the onset of a stroke. We are very conscious of addressing equity of access issues, and this is a cornerstone of any programme of universal health care.

Deputy Madigan raised the very pertinent question of the quality of the data available to produce a health technology assessment. To explain how we tackle this particular challenge, the first aspect of the technology we look at is its clinical effectiveness and safety, because if it does not deliver a benefit for patients we do not progress any further. How we do this is on the basis of standard methods to assess the international evidence on clinical effectiveness and safety. It is on the basis of the literature. If there is no evidence of clinical effectiveness we cannot do a health technology assessment. It is a simple as that. If there is evidence we have standard methods to synthesise the data and translate it into benefits for people. Where it becomes a little more challenging with regard to data is when we move onto the next aspect. We construct a model to predict the clinical benefits for patients in Ireland and how much the technology would cost to implement here. This is not only takes account of the purchase price but also what other services are needed to implement the technology and the cost savings. As well as the budget impact we also need to look at the cost effectiveness and how it compares to how we would use the budget to fund other technologies in the Irish health care system.

The type of data we need there are the epidemiology data, in other words how many patients have the disease in Ireland and how is it currently treated in Ireland. Sometimes we have difficulties there and we must go to other jurisdictions with similar populations or health care systems to ourselves. We also need cost data from the Irish setting. We have relatively dependable cost data from the hospital setting but not such good data from the community care setting. How we deal with that is if we find that a particular datum is really important for the result of the model - we do that by testing through a sensitivity analysis - we then do extra work to try and get a handle on that cost. That might involve a micro-costing study, for example, to figure out what is the actual cost of a particular service. Any data that go into our model are varied around the plausible limits - how low or high can they possibly be - and what difference that makes to our final result with regard to predicting how many patients will benefit, how much it will cost and whether it is good value for money.

The other quality assurance mechanism we use is that we have an expert advisory group for every piece of work we do. This is made up of expert clinicians in the area, right across the divide of acute services, primary care if it is relevant, public health expertise if that is relevant, hospital managers with responsibility for the delivery of the service, patient representatives, international experts in whatever the clinical area is, and the health technology assessment, HTA, methodologies that have been used elsewhere for that area. We use all of those different quality assurance mechanisms to ensure that what we produce is the best available evidence to guide the final decision.