Written Answers Nos. 188-199
188. Deputy Robert Troy asked the Minister for Health if he will expedite an appointment for nasal surgery for a person (details supplied) based on an additional referral submitted by the person's general practitioner; and if he will make a statement on the matter. [8901/17]
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.
189. Deputy Louise O'Reilly asked the Minister for Health the reason a decision was made not to reimburse Respreeza; the grounds on which this decision was made; if the HSE will be re-entering negotiations with the drug company (details supplied); the outcome for those persons who had been on a compassionate based programme of this drug; his plans to assist those persons; and if he will make a statement on the matter. [8916/17]
Amharc ar fhreagra196. Deputy Clare Daly asked the Minister for Health further to the decision by the HSE new drugs group not to reimburse Respreeza, if he will intervene such that persons suffering with alpha-1 antitrypsin deficiency do not lose access to this life-changing drug. [8944/17]
Amharc ar fhreagraI propose to take Questions Nos. 189 and 196 together.
The 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: 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. This decision will be made on objective, scientific and economic grounds by the HSE in line with the 2013 Act.
In keeping with the drug assessment process, the recommendation of the HSE Drugs Group regarding the reimbursement of Respreeza was considered by the HSE Leadership team. The HSE has informed that the statutory assessment process is ongoing.
190. Deputy Barry Cowen asked the Minister for Health the status of a hospital appointment for a person (details supplied); and when the person can expect an appointment at the Midland Regional Hospital, Tullamore. [8920/17]
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.
191. Deputy Barry Cowen asked the Minister for Health the status of an orthodontic appointment for a person (details supplied); and when the person can expect an appointment for orthodontic treatment under the Health Service Executive in view of the fact that they have been on the waiting list for five years. [8921/17]
Amharc ar fhreagraAs this is a service matter it has been referred to the HSE for reply to the Deputy.
192. Deputy John McGuinness asked the Minister for Health if a medical card review for a person (details supplied) will be expedited. [8927/17]
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 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.
193. Deputy Lisa Chambers asked the Minister for Health the number of persons who attended the emergency department of Mayo University Hospital in 2016. [8939/17]
Amharc ar fhreagraIn relation to the particular query raised, as this is a service matter, I have asked the HSE to respond to you directly.
194. Deputy Richard Boyd Barrett asked the Minister for Health if it is the policy of his Department to replace staff as they leave the HSE; if so, when the consultant orthodontist in Loughlinstown hospital will be replaced; if not, the location to which persons requiring orthodontic surgery in the catchment area of Loughlinstown hospital can be referred; and if he will make a statement on the matter. [8940/17]
Amharc ar fhreagraAs this is a service matter it has been referred to the HSE for reply to the Deputy.
195. Deputy Robert Troy asked the Minister for Health if he will schedule an appointment for hip replacement surgery for a person (details supplied); and if he will make a statement on the matter. [8942/17]
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.
197. Deputy Joan Collins asked the Minister for Health if the HSE high level officials group has made a recommendation on the reimbursement of Orkambi and the extension of Kalydeco for the two to five age group and the R117h group of persons with cystic fibrosis eligible for these vital drugs; and if he will make a statement on the matter. [8974/17]
Amharc ar fhreagra198. Deputy Joan Collins asked the Minister for Health if the HSE's approval of the reimbursement of Orkambi and the extension of Kalydeco for the two to five age group and the R117h group is contingent on additional funding being provided by the Government to the HSE. [8975/17]
Amharc ar fhreagra199. Deputy Joan Collins asked the Minister for Health if the Cabinet will be making the final decision relating to the reimbursement of Orkambi and the extension of Kalydeco for the two-to-five age group and the R117h group; if so, when; and if not, the body that is making the final decision. [8976/17]
Amharc ar fhreagraI propose to take Questions Nos. 197 to 199, inclusive, together.
The 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 and Kalydeco. 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 or Kalydeco.
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 the current price offered by the company.
The HSE has since re-entered into negotiations with Vertex, the manufacturer of Orkambi and Kalydeco, with a view to significantly reducing the cost of both drugs. A meeting was held in December and again in early January. Following completion of the negotiation process, I am advised that the HSE’s Drugs Committee met at the end of January and considered the manufacturer's latest price offerings. No decision has been reached regarding Orkambi and discussions are ongoing with regard to Kalydeco. The matter is currently under consideration by the HSE Directorate.
I understand how patients and their families must feel in these circumstances, as they await the decisions by the HSE in relation to reimbursement. However, as with all new drugs developed, the HSE must follow a statutory process, as set out in the 2013 Act.
