Written Answers Nos. 194-208
194. Deputy David Cullinane asked the Minister for Health the daily running cost of running a fully staffed mobile catheterisation laboratory; the daily cost of running a fully staffed permanent catheterisation laboratory; and if he will make a statement on the matter. [2230/17]
View answerIn relation to this particular query, as this is a service matter, I have asked the HSE to respond to you directly.
195. Deputy Billy Kelleher asked the Minister for Health the status of the drug Nusinersen for the treatment of spinal muscular atrophy, including timeframes; if there is any possibility of the drug being allowed on compassionate grounds (details supplied); and if he will make a statement on the matter. [2241/17]
View answerThe Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicinal products under the community drug schemes in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013. The decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds by the HSE.
Prior to a medicine being marketed, made available to patients and/or submitted for assessment under the 2013 Act, it must have a market authorisation from the European Medicine Agency (EMA).
The European Medicines Agency provides independent recommendations on medicines for human and veterinary use, based on a comprehensive scientific evaluation of data.
The EMA’s evaluations of marketing-authorisation applications provide the basis for the authorisation of medicines in Europe. This is separate to the Statutory Assessment process conducted by the HSE.
I understand from the HSE that Biogen have applied to the European Medicines Agency (EMA) for market authorisation in the EU for the drug Nusinersen (Spinraza). The application to the EMA was submitted in Autumn 2016. The EMA assessment process generally takes around one year.
Should Nusinersen receive European marketing authorisation, the manufacturer would then be open to make an application to the HSE to have the product reimbursed under the community drug schemes.
The operation of patient access schemes is at the discretion of manufacturers. There is no provision in Irish legislation for the approval of compassionate use programmes for specific groups of patients with an unmet medical need. I have previously asked manufacturers to show compassion and to provide access to patients, separate to the statutory assessment process. I understand that following an application from Dr Declan O'Rourke, a consultant paediatric neurologist at Temple Street hospital, the company has extended their early access programme to two of his patients with SMA Type 1. I further understand that the patients' families were informed.
196. Deputy Clare Daly asked the Minister for Health when draft designation regulations to regulate counsellors and psychotherapists under the Health and Social Care Professionals Act will be brought before the Houses of the Oireachtas for approval. [2244/17]
View answerPsychotherapists and counsellors are not currently regulated under the Health and Social Care Professionals Act 2005. However, the Act provides that the Minister may, by regulation, designate a health and social care profession not already designated if he or she considers that it is appropriate and in the public interest to do so and if specified criteria have been met.
The regulation of a new profession under the Act involves a consultation process and the making of a number of statutory instruments by the Minister for Health and by the relevant registration board.
My Department has engaged in a consultation process in which interested persons and organisations were invited to formally submit their views on how the statutory regulation of the profession(s) should proceed. A total of 84 submissions were received on foot of the consultation process which concluded on 30th November 2016.
I am undertaking an examination of these submissions which will inform the approach to be adopted in progressing the statutory regulation of psychotherapists and counsellors.
I envisage that the next steps in the statutory regulation of the profession(s) under the Act will commence in the coming months with the submission of draft designation regulations to the Houses of the Oireachtas.
197. Deputy Robert Troy asked the Minister for Health his views on whether a person prescribed three different dosages of a thyroid medicine should be charged three prescription charges (details supplied). [2250/17]
View answerUnder the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for the administration of the community drug schemes; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.
198. Deputy Billy Kelleher asked the Minister for Health if he will sanction an independent clinical review of scoliosis services here; when this can take place; and if he will make a statement on the matter. [2254/17]
View answerLong waiting times for scoliosis surgery are not acceptable, and my Department has been working closely with the HSE to address services pressures, particularly in Our Lady's Children's Hospital Crumlin, which is the largest provider of scoliosis surgery for children and young people.
Additional funding of €1.042m was allocated under the 2015 Service Plan to increase capacity at Crumlin, and further resources of €0.987m have been allocated under the 2016 Service Plan for Orthopaedics and Trauma to address service needs in Crumlin which will have a positive effect on access for scoliosis patients. The HSE Winter Initiative 2016/2017 includes €2m provided specifically for scoliosis patients to provide for scoliosis surgeries. 78 scoliosis patients were reviewed under this initiative. To date, 54 have been treated and 4 have received appointments for treatment in February, due to clinical age restrictions for procedures.
The construction of a new orthopaedic theatre in Crumlin has been completed and is commissioned. This will provide for additional scoliosis activity in 2017 but is dependent on the recruitment of additional theatre nurses. The Children's Hospital Group is proactively working on nurse recruitment to support the opening of the new theatre. I met with a number of scoliosis advocacy groups to discuss their concerns following which the Children’s Hospital Group has begun a process of engagement with advocacy groups on developing a partnership approach to the design and planning of services for children with scoliosis. Therefore, an independent clinical review of scoliosis services is not required at this time.
My Department will continue to work with the HSE and the relevant hospitals to ensure improvements in access to spinal surgery.
199. Deputy Bernard J. Durkan asked the Minister for Health the basis on which it was determined that there had been a change in circumstance and subsequently a medical card review form for persons aged 70 or over issued in the case of a person (details supplied); if this matter will be rectified as soon as possible; and if he will make a statement on the matter. [2263/17]
View answerThe Health Service Executive has been asked to examine this matter and to reply to the Deputy as soon as possible.
The Health Service Executive operates the General Medical Services scheme, which includes medical cards and GP visit cards, under the Health Act 1970, as amended. It has established a dedicated contact service for members of the Oireachtas specifically for queries relating to medical cards and GP visit cards, which the Deputy may wish to use for an earlier response. Contact information was issued to Oireachtas members.
200. Deputy Brendan Smith asked the Minister for Health the position regarding negotiations between the HSE, the National Centre for Pharmacoeconomics and the manufacturer of Orkambi; if this drug will be made available for patients with cystic fibrosis; and if he will make a statement on the matter. [2277/17]
View answerThe HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.
In reaching its decision, the HSE examines all the evidence which may be relevant in its view for the decision (including the information /dossier submitted by the Company) and will take into account such expert opinions and recommendations which may have been sought by the HSE at its sole discretion (for example, from the National Centre for Pharmacoeconomics).
In considering an application, the HSE will also have regard to Part 1 and Part 3 of Schedule 3 of the 2013 Act. Part 3 requires the HSE to have regard to the following criteria:
1. the health needs of the public;
2. the cost-effectiveness of meeting health needs by supplying the item concerned rather than providing other health services;
3. the availability and suitability of items for supply or reimbursement;
4. the proposed costs, benefits and risks of the item or listed item relative to therapeutically similar items or listed items provided in other health service settings and the level of certainty in relation to the evidence of those costs, benefits and risks;
5. the potential or actual budget impact of the item or listed item;
6. the clinical need for the item or listed item;
7. the appropriate level of clinical supervision required in relation to the item to ensure patient safety;
8. the efficacy (performance in trial), effectiveness (performance in real situations) and added therapeutic benefit against existing standards of treatment (how much better it treats a condition than existing therapies); and
9. the resources available to the HSE.
I am informed that, following a request from the HSE, the NCPE carried out an assessment of the manufacturer's economic dossier submitted in March 2016 on the cost effectiveness of Orkambi. This dossier included details on all relevant costs and relevant cost offsets including those associated with hospitalisation, disease management costs, intravenous antibiotics, adverse events and any additional costs arising in patients not taking Orkambi.
The NCPE has completed its Health Technology Assessment and this is available on its website. It was submitted to the HSE in June 2016. The NCPE determined, following an evaluation of the economic dossier, that the manufacturer failed to demonstrate cost-effectiveness or value for money from using the drug. The NCPE have confirmed that all relevant costs were included in the analysis. In line with the HSE's assessment process, the HSE Drugs Committee considered the NCPE recommendation, the manufacturers submissions and commercial offer and other information. Following this consideration the Drugs Committee did not recommend reimbursement at the current price. The HSE Directorate considered the Drugs Committee’s recommendation in December and the Directorate took the decision not to reimburse at current price offered by the company.
The HSE has since re-entered into negotiations with Vertex, the manufacturer of Orkambi, with a view to significantly reducing the cost of Orkambi. This process is on-going. A meeting was held in December and again in early January. Following completion of this process the HSE’s Drugs Committee will make a recommendation on the cost-effectiveness of Orkambi to the HSE Directorate for a decision, taking into consideration the manufacturer's latest price offerings. Again, this decision will be made on objective, scientific and economic grounds in line with the 2013 Act.
I fully support the HSE in its efforts to reduce the price of this medicine and I would call on all public representatives, including the members of this house, to do the same.
201. Deputy Brendan Smith asked the Minister for Health the additional support to be provided for the primary care sector in 2017; and if he will make a statement on the matter. [2278/17]
View answerThe development of primary care is central to the Government's objective to deliver a high-quality, integrated and cost-effective health care system. The Programme for a Partnership Government commits to a decisive shift within the health service towards primary care in order to deliver better care close to home in communities across the country. The Programme emphasises the need and focus on enhancing primary health care services including the building-up of GP capacity, increasing the number of therapists and other health professionals in primary care and continuing to expand the development of primary care infrastructure.
Budget 2017 will deliver the highest health budget ever at €14.6 billion and, under primary care, provides for the commitment in the Programme for Government to provide a medical card to all children in respect of whom a Domiciliary Care Allowance (DCA) payment is made. In addition, legislation will be enacted to reduce the monthly cap on prescription charges for those over 70 years of age from €25 to €20. Additional funding of €18.5 million is also provided to support the development of primary care services, including enabling the support of complex paediatric cases at home, maintaining increased Community Intervention Team capacity and meeting lease costs of new Primary Care Centres. Preparations for the next phase of discussions on a new GP contract are under way and will be a key priority in the months ahead.
The quantum of service to be provided with the funding and the key service deliverables and priorities for the Primary Care Division are outlined in the HSE’s National Service Plan for 2017. Primary care services include primary care teams (PCTs), community healthcare network services, general practice, schemes reimbursement, social inclusion and palliative care services. The Plan can be sourced at www.hse.ie/eng/services/publications/serviceplans/Service-Plan-2017/2017-National-Service-Plan.pdf.
I am advised that the HSE Operational Plans for 2017 are in train and, when published, will provide further detail on the services to be provided.
202. Deputy Michael Healy-Rae asked the Minister for Health the status of a hospital appointment for a person (details supplied); and if he will make a statement on the matter. [2280/17]
View answerUnder the Health Act 2004, the Health Service Executive (HSE) is required to manage and deliver, or arrange to be delivered on its behalf, health and personal social services. Section 6 of the HSE Governance Act 2013 bars the Minister for Health from directing the HSE to provide a treatment or a personal service to any individual or to confer eligibility on any individual.
The National Waiting List Management Policy, A standardised approach to managing scheduled care treatment for in-patient, day case and planned procedures, January 2014, has been developed to ensure that all administrative, managerial and clinical staff follow an agreed national minimum standard for the management and administration of waiting lists for scheduled care. This policy, which has been adopted by the HSE, sets out the processes that hospitals are to implement to manage waiting lists.
In relation to the particular query raised, as this is a service matter, I have asked the HSE to respond to you directly.
203. Deputy Michael McGrath asked the Minister for Health when a person (details supplied) in County Cork will have an assessment of need under the Disability Act 2005; and if he will make a statement on the matter. [2288/17]
View answerThe Government is committed to providing services and supports for people with disabilities which will empower them to live independent lives, provide greater independence in accessing the services they choose, and enhance their ability to tailor the supports required to meet their needs and plan their lives. This commitment is outlined in the Programme for Partnership Government, which is guided by two principles: equality of opportunity and improving the quality of life for people with disabilities.
As the Deputy's question relates to an individual case, I have arranged for the question to be referred to the Health Service Executive (HSE) for direct reply to the Deputy.
204. Deputy Colm Brophy asked the Minister for Health his plans to include low protein products required by persons that suffer from phenylketonuria as part of the long-term illness scheme; and if he will make a statement on the matter. [2292/17]
View answerUnder the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for the administration of the primary care schemes; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.
205. Deputy Bernard J. Durkan asked the Minister for Health when previously available transport services will be restored in the case of a person (details supplied); and if he will make a statement on the matter. [2295/17]
View answerThe Government is committed to providing services and supports for people with disabilities which will empower them to live independent lives, provide greater independence in accessing the services they choose, and enhance their ability to tailor the supports required to meet their needs and plan their lives. This commitment is outlined in the Programme for Partnership Government, which is guided by two principles: equality of opportunity and improving the quality of life for people with disabilities.
As the Deputy's question relates to service matters, I have arranged for the question to be referred to the Health Service Executive (HSE) for direct reply to the Deputy.
206. Deputy Bernard J. Durkan asked the Minister for Health when appropriate footwear will be provided in the case of a person (details supplied); and if he will make a statement on the matter. [2296/17]
View answerAs this is a service matter, it has been referred to the HSE for reply to the Deputy.
207. Deputy Bernard J. Durkan asked the Minister for Health the reason scope facilities cannot be made available through the normal hospital services at weekends in the case of a person (details supplied); and if he will make a statement on the matter. [2297/17]
View answerIn relation to the query raised by the Deputy, as this is a service issue, I have asked the HSE to respond to you directly.
208. Deputy Bernard J. Durkan asked the Minister for Health the extent to which physiotherapy services can be restored to a person (details supplied); and if he will make a statement on the matter. [2298/17]
View answerThe Government is committed to providing services and supports for people with disabilities which will empower them to live independent lives, provide greater independence in accessing the services they choose, and enhance their ability to tailor the supports required to meet their needs and plan their lives. This commitment is outlined in the Programme for Partnership Government, which is guided by two principles: equality of opportunity and improving the quality of life for people with disabilities.
As the Deputy's question relates to an individual case, I have arranged for the question to be referred to the Health Service Executive (HSE) for direct reply to the Deputy.
