Written Answers Nos. 251 - 263
251. Deputy Bernard J. Durkan asked the Minister for Health if reconsideration will be given to making the drug Respreeza available through the HSE with particular reference to the fact that it is a life changing therapy for the treatment of emphysema due to alpha-1; and if he will make a statement on the matter. [10551/17]
Amharc ar fhreagraThe 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 the HSE received a request and economic dossier from the manufacturer of Respreeza for maintenance treatment of emphysema in adults with documented severe alpha1-proteinase inhibitor deficiency.
In June of 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 and 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 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 days period (from the formal written notice of proposal) to enable the pharmaceutical 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 legally required to consider any such representations in advance of a formal decision.
Therefore as the statutory process is still on-going the Company has an opportunity to have further discussions with the HSE.
In relation to the compassionate access scheme operated by the manufacturer, CSL Behring, I note and welcome the decision of the Company to extend the scheme by a further two months. However it is important to point out that the operation of such compassionate schemes is at the discretion of manufacturers. I as Minister for Health 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 and that manufacturers should operate such schemes in a compassionate and not a commercially-motivated manner.
252. Deputy Thomas Byrne asked the Minister for Health when a home care package will be put in place for a person (details supplied). [10552/17]
Amharc ar fhreagraAs the Deputy's question relates to service matters, I have arranged for the question to be referred to the Health Service Executive for direct reply to the Deputy.
253. 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. [10553/17]
Amharc ar fhreagraUnder 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.
254. Deputy Kevin O'Keeffe asked the Minister for Health if he will arrange to have an application for a specific item (details supplied) reconsidered. [10554/17]
Amharc ar fhreagraAs this is a service matter, it has been referred to the HSE for reply to the Deputy.
255. Deputy Kevin O'Keeffe asked the Minister for Health if he will expedite an admission to hospital in respect of a person (details supplied). [10557/17]
Amharc ar fhreagraUnder 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.
256. Deputy Pearse Doherty asked the Minister for Health if he will provide the individual scores recorded by each child who was formally assessed as part of the service user evaluation with regard to the paediatric clinical assessment test conducted in the latter part of 2016 to assess the individual care needs of children with complex needs and life limiting conditions resident in County Donegal; if he will provide this data while withholding the names, addresses and other such personal details held in respect of each child; and if he will make a statement on the matter. [10569/17]
Amharc ar fhreagraThe 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.
257. Deputy Pearse Doherty asked the Minister for Health the number of surgical procedures performed by each consultant breast surgeon at every hospital here during 2016, in tabular form; and if he will make a statement on the matter. [10571/17]
Amharc ar fhreagraThe Deputy's questions relate to service delivery matters and accordingly I have asked the HSE to respond directly to him.
258. Deputy Robert Troy asked the Minister for Health the status of reinstating the tablet MacuShield for older persons suffering from macular degeneration on the medical card. [10584/17]
Amharc ar fhreagraUnder 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.
259. Deputy Louise O'Reilly asked the Minister for Health the detail of the distribution of specialist registrars to every hospital across the State for each of the years 2006 to 2016 and to date in 2017, in tabular form. [10585/17]
Amharc ar fhreagraI have asked the HSE to respond to the Deputy directly on this matter.
260. Deputy Kevin O'Keeffe asked the Minister for Health the timeframe for the introduction of the Cannabis for Medicinal Use Regulation Bill; and if he will make a statement on the matter. [10587/17]
Amharc ar fhreagraAs you will be aware, the Cannabis for Medicinal Use Regulation Bill 2016 is a private members bill and not a Government Bill. All such questions related to the Bill should be addressed to either Deputy Gino Kenny T.D. or Deputy Bríd Smith T.D.
261. Deputy Martin Kenny asked the Minister for Health the reason the early intervention team could not provide a person (details supplied) with occupational therapy; and if he will make a statement on the matter. [10604/17]
Amharc ar fhreagra262. Deputy Martin Kenny asked the Minister for Health the reason the parents of a person (details supplied) were not permitted to employ a private occupational therapist and avail of the early intervention team's services at the same time, when the early intervention team was unable to provide occupational therapy. [10605/17]
Amharc ar fhreagra263. Deputy Martin Kenny asked the Minister for Health when a person (details supplied) will receive an autism service worker. [10606/17]
Amharc ar fhreagraI propose to take Questions Nos. 261 to 263, inclusive, together.
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.
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.
