Brendan Smith
Question:198. Deputy Brendan Smith asked the Minister for Health the position regarding the availability of Orkambi for persons with cystic fibrosis; and if he will make a statement on the matter. [12455/17]
View answerMedicinal Products Reimbursement
Questions (198)
Written answers
The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.
Under Section 19 (4) of the 2013 Act, the HSE is prohibited from making a decision to reimburse a medicine, except in accordance with the criteria specified in Schedule 3 of the 2013 Act.
With regard to Orkambi for the treatment of cystic fibrosis patients aged 12 and older, an application to the HSE from the manufacturer was received in March 2016. The application was considered and not recommended for reimbursement at the submitted price by both the National Centre for Pharmacoeconomics (NCPE) and the HSE’s Drugs Committee. In December, the HSE Directorate took the decision not to reimburse at the submitted price. The HSE called on the company to re-enter negotiations, with a view to significantly reducing the cost of the treatment.
Further meetings were held with the manufacturer in December and early January. The discussions with the company have broadened to include Orkambi, Kalydeco and further treatments for cystic fibrosis patients. The matter is currently under consideration by the HSE Directorate and by officials in my Department.
I expect that this process will conclude in a period of weeks. However, given the scale of the investment, the potential benefits for Irish patients and the impact of this decision on the health service overall, I would call on all deputies to allow this statutory process to be concluded.
I am acutely aware that the last number of months have been a stressful and worrying time for cystic fibrosis patients and their families. However, the Government’s priority is to achieve the best outcome for Irish patients and the health system overall.
Services for People with Disabilities
Questions (199)
Michael D'Arcy
Question:199. Deputy Michael D'Arcy asked the Minister for Health when a person (details supplied) in County Wexford will receive full-time residential care suitable for their needs; his plans to build a new residence for persons with disabilities and to expand respite services in County Wexford; and if he will make a statement on the matter. [12459/17]
View answerWritten answers
The 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.
The Programme for Partnership Government states that the Government wishes to provide more accessible respite care to facilitate full support for people with a disability.
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.
Medical Card Reviews
Questions (200)
Bernard Durkan
Question:200. Deputy Bernard J. Durkan asked the Minister for Health if an interim card will issue or a previous card will be reactivated while awaiting a decision on a current review in the case of persons (details supplied); and if he will make a statement on the matter. [12460/17]
View answerWritten answers
Under 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 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.
Health Screening Programmes
Questions (201)
Carol Nolan
Question:201. Deputy Carol Nolan asked the Minister for Health if consideration will be given to reducing the age at which women are eligible for free smear tests; and if he will make a statement on the matter. [12462/17]
View answerWritten answers
CervicalCheck, the National Cervical Screening Programme, was introduced in 2008 and offers free smear tests to women aged 25-60. This is in line with international best practice.
Invasive cervical cancer is extremely rare in women aged under 25, with less than 5 women in this age group being diagnosed with this condition in Ireland each year. While changes in the cells of the cervix are very common for those under 25, in the vast majority of cases these changes will settle and return to normal without intervention. If the screening age was lowered to invite those under 25 for smear tests, young women could be subjected to unnecessary treatment that could have potential long-term negative effects on their health and fertility.
My Department encourages all women aged under 25 to be vigilant about their health and to consult their GP immediately if they have any symptoms which would raise the suspicion of cervical cancer. If necessary, their GP will refer them to a gynaecology clinic for further investigation. Similarly it is recommended that any woman concerned about cervical cancer on the basis of family history should discuss this with their GP.
Hospital Waiting Lists
Questions (202)
Carol Nolan
Question:202. Deputy Carol Nolan asked the Minister for Health the reason a person (details supplied) has been waiting over a year to see a dermatologist; and if he will make a statement on the matter. [12463/17]
View answerWritten answers
Under 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 scheduling of appointments for patients is a matter for the hospital to which the patient has been referred. Should a patient's general practitioner consider that the patient's condition warrants an earlier appointment, he or she should take the matter up with the consultant and the hospital involved. In relation to the specific case raised, I have asked the HSE to respond to you directly.
Medicinal Products Reimbursement
Questions (203)
Brendan Griffin
Question:203. Deputy Brendan Griffin asked the Minister for Health his views on a matter (details supplied) regarding the drug Respreeza; and if he will make a statement on the matter. [12464/17]
View answerWritten answers
The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines in 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 information submitted by the company) and will take into account such expert opinions and recommendations which it may have sought at its sole discretion, for example from the National Centre for Pharmacoeconomics (NCPE).
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 eats a condition than existing therapies).
9. The resources available to the HSE.
I am informed that the HSE received a request and economic dossier from the manufacturer of Respreeza, for reimbursement of maintenance treatment of emphysema in adults with documented severe alpha1-proteinase inhibitor deficiency.
In June last year, the HSE asked the NCPE to carry out a health technology assessment on the cost effectiveness of this treatment. The NCPE completed its assessment and made a recommendation on 9 December 2016. The NCPE determined that the manufacturer failed to demonstrate cost-effectiveness of the drug and did not recommend it for reimbursement.
A summary of the health technology assessment has been published on the NCPE website and is available at: http://www.ncpe.ie/wp-content/uploads/2016/02/NCPE-website-summary_Final.pdf.
The HSE considers the NCPE assessment, and other expert advice, as part of its decision-making process for reimbursement, which is made on objective, scientific and economic grounds by the HSE in line with the 2013 Act.
The HSE has confirmed that the drug Respreeza was considered by the HSE Drugs Group, which did not make a recommendation for reimbursement on clinical grounds. The HSE Leadership team has accepted the Drugs Group recommendation of non-reimbursement.
Under the HSE statutory assessment process, the HSE is required to set out a notice of any proposed decision to an applicant company. The HSE is legally required to provide at least a 28 day period (from the formal written notice of proposal), to enable the company to consider any such proposal not to reimburse and to make representations to the HSE if it wishes to do so. The HSE is required to consider any such representations in advance of a formal decision.
Therefore, as the statutory process is still ongoing, the company has an opportunity to have further discussions with the HSE.
In relation to the compassionate access scheme operated by the manufacturer I note its decision to extend the scheme by a further two months. However it is important to point out that the operation of compassionate schemes is at the discretion of manufacturers. As Minister for Health I have no role in the operation of these schemes. 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 said that any attempts by manufacturers to link continued access, for patients already being treated with a new medicine, with decisions under the statutory reimbursement process is both inappropriate and unethical. Manufacturers should operate such schemes in a compassionate and not a commercially-motivated manner. There should be no link between compassionate use schemes and reimbursement decisions and manufacturers should be open with patients and clinicians from the outset.
Mental Health Services Provision
Questions (204)
Michael McGrath
Question:204. Deputy Michael McGrath asked the Minister for Health if the HSE national counselling service (details supplied) has plans to recruit counsellors and persons qualified in psychotherapy for the provision of services in the Cork area; if so, the details; and if he will make a statement on the matter. [12482/17]
View answerWritten answers
As this is a service issue, this question has been referred to the HSE for direct reply.
Long-Term Illness Scheme Coverage
Questions (205)
Mary Butler
Question:205. Deputy Mary Butler asked the Minister for Health his plans to make available the FreeStyle Libre device to children with diabetes that currently hold a long-term illness card; and if he will make a statement on the matter. [12487/17]
View answerWritten answers
Under 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.
Hospital Appointments Status
Questions (206)
Michael Healy-Rae
Question:206. Deputy Michael Healy-Rae asked the Minister for Health the status of a hospital appointment in respect of a person (details supplied); and if he will make a statement on the matter. [12488/17]
View answerWritten answers
Under 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 scheduling of appointments for patients is a matter for the hospital to which the patient has been referred. Should a patient's general practitioner consider that the patient's condition warrants an earlier appointment, he or she should take the matter up with the consultant and the hospital involved. In relation to the specific case raised, I have asked the HSE to respond to you directly.
Occupational Therapy
Questions (207)
Michael McGrath
Question:207. Deputy Michael McGrath asked the Minister for Health when a person (details supplied) in County Cork will have an occupational therapy assessment carried out; and if he will make a statement on the matter. [12489/17]
View answerWritten answers
As this question relates to service matters, I have arranged for the question to be referred to the Health Service Executive (HSE) for direct reply.
Long-Term Illness Scheme Coverage
Questions (208)
Mary Butler
Question:208. Deputy Mary Butler asked the Minister for Health if he will implement the roll-out of the FreeStyle Libre device for children under 18 years of age with diabetes; and if he will make a statement on the matter. [12490/17]
View answerWritten answers
Under 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.
Long-Term Illness Scheme Coverage
Questions (209)
Mary Butler
Question:209. Deputy Mary Butler asked the Minister for Health his plans for the roll-out of the FreeStyle Libre device for adults with diabetes; if this will be made available to medical card holders; and if he will make a statement on the matter. [12491/17]
View answerWritten answers
Under 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.
Hospital Waiting Lists
Questions (210)
Michael Healy-Rae
Question:210. Deputy Michael Healy-Rae asked the Minister for Health the status of a cataract operation in respect of a person (details supplied); and if he will make a statement on the matter. [12494/17]
View answerWritten answers
Under 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.
Hospital Appointments Administration
Questions (211)
John Brassil
Question:211. Deputy John Brassil asked the Minister for Health if he will expedite an orthopaedic appointment at Kerry University Hospital for a person (details supplied); and if he will make a statement on the matter. [12507/17]
View answerWritten answers
Under 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.
In relation to the specific case raised, I have asked the HSE to respond to you directly.
Medicinal Products Availability
Questions (212, 243, 244)
Bobby Aylward
Question:212. Deputy Bobby Aylward asked the Minister for Health when the necessary legislative amendments will be made in order to facilitate the implementation of the cannabis access programme; if he will expedite this process; if he will consider granting a licence to an Irish registered doctor to authorise access to medicinal cannabis for named patients with conditions such as Dravet syndrome, rare forms of epilepsy and other such conditions in the meantime; and if he will make a statement on the matter. [12508/17]
View answer
Róisín Shortall
Question:243. Deputy Róisín Shortall asked the Minister for Health the precise criteria which must be met in order for cannabis-based medicine to be prescribed under the present regulatory framework. [12641/17]
View answerRóisín Shortall
Question:244. Deputy Róisín Shortall asked the Minister for Health his plans to give effect to the report of the Health Products Regulatory Authority in respect of establishing a compassionate access programme for cannabis-based treatments; and the timeframe proposed. [12642/17]
View answerWritten answers
I propose to take Questions Nos. 212, 243 and 244 together.
On 3 November 2016 I asked the Health Products Regulatory Authority to examine the issue of medicinal cannabis and provide me with a report on the matter. I received the Authority's report ‘Cannabis for Medical Use – A Scientific Review’ on 31 January last.
On 10 February, I published the report and announced that I would establish an access programme for cannabis-based treatments for the following conditions;
- Spasticity associated with multiple sclerosis resistant to all standard therapies and interventions;
- Intractable nausea and vomiting associated with chemotherapy, despite the use of standard anti-emetic regimes;
- Severe, refractory (treatment-resistant) epilepsy that has failed to respond to standard anticonvulsant medications.
- Patients accessing cannabis through the programme are required to be under the care of a medical consultant.
The report has been referred to the Joint Oireachtas Committee on Health for consideration. Meanwhile officials from my Department and the Health Products Regulatory Authority will consult with stakeholders on how the access programme will operate. It will be particularly important to engage with the clinical community in the development of a framework. Officials are also examining legislative changes that will be required to underpin the access programme.
I intend to progress the establishment of this access programme as a priority. However, to be clear, patients accessing cannabis through the cannabis access programme will need to be recommended for cannabis treatment by a medical consultant involved in the patient's care. This recognises the relevance of such treatment for overall case planning and management of the underlying medical condition.
For the period during which this access programme is being established, it remains open to me as the Minister for Health to grant a licence under the Misuse of Drugs Act for access to cannabis for medical purposes in individual cases. Such applications will be considered on a case by case basis. The granting of a licence must, however, be premised on an appropriate application being submitted to the Department of Health, which is endorsed by a consultant who is responsible for the management of the patient and who is prepared to monitor the effects of the treatment over time.
The main elements of a licence application are expected to include:
- An outline of the treatment the patient has received to date and justification from the doctor as to why it is appropriate in their patient’s specific circumstances to prescribe a Schedule 1 drug.
- If the patient’s consultant is not the applicant, the views, if any, of the consultant in relation to the application.
- Details of the cannabis-based product which it is proposed to prescribe and administer to the patient.
- The source of the cannabis-based product.
The appropriateness of any particular treatment is a matter between the patient and their doctor, I have no role in this process.
This information has been provided to the Oireachtas and is also contained in a recent Department of Health Press Release which outlines the advice provided by the Chief Medical Officer to me in relation to the use of cannabis for medical reasons.
Hospital Waiting Lists
Questions (213)
Robert Troy
Question:213. Deputy Robert Troy asked the Minister for Health if he will expedite cataract surgery in the Adelaide hospital Dublin in respect of a person (details supplied). [12510/17]
View answerWritten answers
Under 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 scheduling of appointments for patients is a matter for the hospital to which the patient has been referred. Should a patient's general practitioner consider that the patient's condition warrants an earlier appointment, he or she should take the matter up with the consultant and the hospital involved. In relation to the specific case raised, I have asked the HSE to respond to you directly.
Hospital Staff
Questions (214)
Charlie McConalogue
Question:214. Deputy Charlie McConalogue asked the Minister for Health the status of the staffing of a community hospital (details supplied); and if he will make a statement on the matter. [12512/17]
View answerWritten answers
As this is a service matter it has been referred to the Health Service Executive for direct reply.
Hospital Services
Questions (215)
Noel Grealish
Question:215. Deputy Noel Grealish asked the Minister for Health if, following the commitment given in Dáil Éireann by the Taoiseach on 29 November 2016, he will review the possibility of moving some services out of University Hospital Galway to Merlin Park University Hospital; the services that will be moved; the precise timeframe that is likely to be involved; if he will establish a minor injuries unit at Merlin Park to relieve chronic overcrowding in the emergency department at UHG; the timeframe for this; and if he will make a statement on the matter. [12522/17]
View answerWritten answers
Galway University Hospitals (GUH) comprises University Hospital Galway and Merlin Park University Hospital. This administrative structure was established with a view to delivering a co-ordinated service across both sites.
The Saolta University Healthcare Group advise that there are a number of future plans for the Merlin Park site at present. In general, further development of services on the site are planned, and the development control plan is currently being updated.
Planning permission has been obtained for a Day Services/Endoscopy Unit as Phase 1 of the Hospital’s development plan. A proposal for a temporary unit housing two Theatres and a Day Unit is to be resubmitted for consideration by HSE at corporate level. Other services planned on the site include, the replacement of existing long stay elderly care residential units, the building of a Hospice Unit, the development of Intensive Care Rehabilitation Unit, Mental Health Services.
Finally, tenders are currently under evaluation for a Permanent Ambulance Base and a new entrance to the site is planned.
Future investment in individual hospitals must be considered within the overall acute hospital infrastructure programme and establishment of hospital groups.
GUH will be asked to further update their Development Control Plan to develop plans for the optimal use of both sites. Meanwhile, funding has been allocated to progress the design phase of a new ED. Winter Initiative and New Development funding has been allocated to enable the opening of the new ward block at UHG. 28 beds in this facility are already operational.
As this is a service matter, I have asked the HSE to respond to you directly.