Dr. Tony O'Connell:

I thank the committee for the invitation to speak about the current arrangements regarding the provision of deep brain stimulation treatment under the treatment abroad scheme. I would like to introduce my colleagues, Ms Angela Fitzgerald and Dr. Áine Carroll from the HSE. In my statement I want to provide the committee with what I hope will be helpful background information on the current arrangements for treating patients with deep brain stimulation and the key considerations in terms of shaping future provision.

Deep brain stimulation, DBS, is a neurosurgical intervention for the management of movement disorders such as Parkinson's disease, dystonia and essential tremor. DBS is an established technology that uses a surgically implanted pulse generator device, called a neurostimulator, similar to a cardiac pacemaker, to deliver controlled electrical stimulation to precisely targeted areas in the brain. Stimulation aims to interrupt faulty communication between the brain and the muscles that result in involuntary muscle movements. DBS is targeted at those patients with movement disorders whose conditions are no longer adequately controlled by drug therapy. Currently, DBS treatment is not available in Ireland and patients requiring treatment are referred overseas under the treatment abroad scheme.

The treatment abroad scheme, TAS, is operated by the HSE and allows patients access to proven treatments not available in Ireland in another EU-EEA country or Switzerland. The funding for the treatment is approved under the TAS in accordance with the provisions of the relevant EU regulation. Under the terms of the scheme, a hospital consultant must provide medical evidence of the details of the patient’s condition and must certify that the treatment concerned is not available in this country; there is urgent medical necessity for the treatment; there is a reasonable medical prognosis; the treatment is regarded as a proven form of medical treatment; and the treatment abroad is in a recognised hospital or other institution and is under the control of a registered medical practitioner. DBS treatment satisfies the treatment abroad scheme criteria in terms of the treatment not being available in this jurisdiction and the efficacy of the treatment. However, there is still a requirement for patients to be assessed on an individual patient basis to ensure that the other criteria are satisfied consistently and there is equity in the application of TAS across all patient cohorts.

In the absence of a DBS service in Ireland, patients are currently referred to DBS centres abroad for assessment, surgery and follow-up care. At present, DBS patients are referred to two centres in the UK, Oxford and Newcastle. Recently, three patients have gone to Belfast for treatment. The HSE has agreed costs with Oxford and, more recently, Belfast, but such arrangements do not preclude a doctor in Ireland referring a patient to any other centre in the EU or EEA under EU Directive 883/2004.

Over the period 2012 to 2014, the total number of patients seeking to access DBS abroad increased by 182%, from 50 to 170, with a corresponding increase in the cost, of the order of €1,117,950. Therefore, the overall cost increased from approximately €400,000 to €1.5 million. Over the same period, the number of new patients remained relatively static with an average of 25 new patients per annum. The total cost of the whole treatment abroad scheme in the current year for all treatments is estimated at approximately €9 million.

In October 2012, HIQA published a health technology assessment, HTA, into the provision of DBS services via the TAS versus the feasibility of providing the service here in Ireland. The HTA conclusions are important in terms of informing future decisions about the organisation and delivery of the DBS service for the future. Results of an economic analysis comparing the current TAS service delivery to a prospective national DBS service show that the current median cost per patient for the existing TAS-funded service is €44,700 over ten years. Providing DBS services in Ireland would cost the HSE an additional €20,900 per patient over ten years. Over five years, the incremental budget impact of a national DBS service is €1.84 million more than the estimated €4.29 million to treat the same number of patients through the TAS over the same period.

The assessment also highlighted the importance of ensuring that there is adequate planning for the establishment of a DBS service in Ireland, including the development of appropriate and consistent theatre access and additional neurosurgical services. The report acknowledged that while a national DBS service may address the existing equity issues that exist in regard to those patients that are unable to travel for DBS care, it may give rise to new ethical issues due to the diversion of resources from other effective treatments or from the overall health care fund.

The TAS continues to offer timely access to deep brain stimulation treatment, as evidenced by the increase in referrals of 182% over the period 2012 to 2014. In the past 12 months alone, the numbers have increased by 60%. Furthermore, in order to improve timeliness of access, the TAS has implemented initiatives to streamline the application process.

The HSE appreciates that there are challenges for movement disorder patients in terms of accessing this service abroad and therefore the recent option whereby patients can avail of the service in the North of Ireland is welcome. The referral of patients to Queen's University Hospital, Belfast and The Belfast Trust means that, with immediate effect, DBS surgery will now be available to movement disorder patients without the requirement for overseas travel. This will ameliorate some of the financial and logistical burden on the patient and should also enable improved access for those patients who were precluded from availing of the service under the TAS. For 2014, it is expected that ten patients will be treated in Belfast.

It is acknowledged that proximity to the service will also potentially increase the demand. It is expected that the additional costs will be partially offset by the reduction in the cost per case from availing of the service in Belfast. The indicative savings are of the order of €7, 200 per case, with further savings envisaged over time particularly with the potential development of outpatient follow-up in the Irish system. It is expected there will be further savings in regard to the reduction in pharmaceutical costs associated with DBS as a result of the patients availing of the surgery. It is also anticipated that in time this service will be developed further, with the possibility that multidisciplinary out-patient follow-up clinics could be conducted in the South providing further convenience for the patients.

The option of developing a DBS service in the Irish health system will be kept under continual review within the context of the overall Estimates process and other competing priorities. It is not possible to consider this service for 2015, as the funding is already fully committed to meeting existing service priorities. It is important to state that the TAS is a demand-led scheme and as such the funding arrangements do not enable a transfer of funding to support the development of the service on a continual basis. We are confident that in the short term the combined access to the UK and Northern Ireland will allow patients timely access to the service.

This concludes my statement. I and my colleagues will be happy to answer any questions.