Written Answers Nos 172-190
173. Deputy Willie O'Dea asked the Minister for Health when negotiations will take place between the HSE and a company (details supplied) regarding the drug Kalydeco; and if he will make a statement on the matter. [40256/16]
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 line with the 2013 Act, if a company would like a medicine to be reimbursed by the HSE pursuant to the community drug schemes or as a hospital medicine, the company must first submit an application to the HSE to have the new medicine added to the reimbursement list or to be priced as a hospital medicine. The company must submit a separate application to extend a treatment to a new cohort of patients. Each application is considered separately on its merits and in line with the 2013 Act.
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 Ivacaftor, brand name Kalydeco, for the treatment of cystic fibrosis patients aged 2 years and older and weighing less than 25kg. In March of this year, the HSE asked the NCPE to carry out a health technology assessment of the applicant’s economic dossier on the cost effectiveness of this treatment.
The NCPE completed its assessment and made a recommendation in October 2016. The NCPE determined that the manufacturer failed to demonstrate cost-effectiveness of the drug for its intended cohort of patients and did not recommend that it should be reimbursed for this indication at the submitted price. In the economic dossier submitted to the NCPE, the manufacturer estimates that there are 18 patients who may be eligible for early ivacaftor treatment.
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/2015/12/Ivacaftor-2-5-years-web-summary.pdf.
As the HSE is responsible for negotiations with manufacturers, I have asked it to reply to the Deputy directly in relation to the status of negotiations with the manufacturer.
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.
174. Deputy Róisín Shortall asked the Minister for Health his plans regarding the prevention and public awareness with respect to Lyme disease in view of recent developments in the United States (details supplied); and if he will make a statement on the matter. [40262/16]
Amharc ar fhreagraI am pleased to set out for the Deputy the ongoing work on prevention and public awareness with respect to Lyme disease.
Lyme disease (also known as Lyme borreliosis or LB) is an infection caused by a spiral-shaped bacterium called Borrelia burgdorferi that is transmitted to humans by bites from ticks infected with the bacteria. The infection is generally mild affecting only the skin, but can occasionally be more severe. Lyme disease is the commonest cause of tick-borne infection in Europe.
The Health Protection Surveillance Centre (HPSC) of the HSE collects and collates surveillance data on notifiable infectious diseases. Lyme borreliosis is notifiable in Ireland since 2012; the notifiable entity being the more severe neurological form of LB: Lyme neuroborreliosis.
The number of annual neuroborreliosis notifications over the last few years is as follows:
- 2012 - 8 cases;
- 2013 - 13 cases;
- 2014 - 18 cases;
- 2015 - 12 cases.
The Weekly Infectious Disease Report for week 48, covering the period 27 November - 3 December, issued by the HPSC on 7 December 2016 indicates that 19 cases of neuroborreliosis have been notified so far this year. This gives an average annual incidence rate of neuroborreliosis in Ireland of about 2.7 neuroborreliosis cases per million population.
Since 2013, the HPSC has held an annual ‘Lyme Awareness Week’ at the beginning of the tick biting season, the purpose of which is to draw attention - particularly in the media - to Lyme disease and the ticks that can spread this disease. The week beginning May 2nd was designated as Lyme Awareness Week this year.
The literature on the HPSC website points out that campers, walkers and certain occupational groups such as forestry workers, conservation workers, deer cullers and farmers are at particular risk of exposure to ticks (and therefore LB). That said, anyone walking or hiking in the countryside is at risk of biting ticks. The ticks responsible for LB are generally hard-bodied ticks (Ixodidae). Ixodes ticks are hosted by a wide range of mammals including deer, sheep and cows, and occasionally birds; their tiny size (less than 2mm unfed) means they can remain undetected for long periods.
Ixodes ticks are most likely to be found in:
- Shady and humid woodland clearings with grass;
- Open grassland, walking paths (especially those bordered by long grasses);
- Wooded and forested areas;
- Vegetation close to lakes and seaside beaches;
- Parkland areas; and
- Open fields and bushes.
They are present in both urban and rural environments and are active from spring to autumn. Lyme cases tend to appear in Ireland with greater frequency after April, hence the choice of this time of year for Lyme Awareness Week.
Both the Health Protection Surveillance Centre and Tick Talk Ireland provide guidance on protection against contracting Lyme borelliosis. The best protection is to prevent tick bites, when walking in grassy, bushy or woodland areas, particularly between May and October:
- Arms and legs should be covered; wearing long trousers tucked into socks or boots, and long-sleeved shirts with cuffs fastened is advised. Shoes or boots should be worn rather than open-toed sandals;
- The use of insect repellent on clothes is recommended, or on limbs if it is not practicable to cover up. DEET or permethrin (insect repellents) can be used – advice can be obtained from pharmacies;
- Skin and clothing should be inspected for ticks every three to four hours and children's skin and clothes checked frequently.
- Ticks should be removed as soon as they are seen attached to the skin. Further advice on tick removal can be obtained from the HPSC website;
- It is not recommended that antibiotics are given to prevent the transmission of Lyme disease following a tick bite. Only if the area becomes inflamed may treatment be required; and advice should be sought from a doctor; and
- People should see their doctor if they develop a rash or become unwell with other symptoms, letting the doctor know of exposure to ticks.
Further advice can be obtained from the HPSC website (www.hpsc.ie) and the HPSC produced a leaflet on “Protecting Yourself Against Tick Bites and Lyme Disease” which is available for the public to download.
In addition, a Lyme Borreliosis Subcommittee has been established to look at methods of raising awareness especially in those areas (including recreation areas) where Lyme carrying ticks can be most expected to be found.
175. Deputy Ruth Coppinger asked the Minister for Health his plans to develop and adopt a comprehensive sexual and reproductive health policy for adolescents that would ensure sexual and reproductive health information, supplies and services are physically accessible and freely available to all young persons who require them; and if he will make a statement on the matter. [40276/16]
Amharc ar fhreagraIreland’s first National Sexual Health Strategy 2015 – 2020 and Action Plan 2015 – 2016 was launched in October 2015. The National Sexual Health Strategy aims to improve sexual health and well-being, and reduce negative sexual health outcomes by ensuring that everyone living in Ireland has access to high quality sexual health information, education and services throughout their lives. It takes a life-course approach to sexual health and represents the first nationally coordinated approach to improving the population’s sexual health and well-being.
The Strategy contains 71 recommendations that address a wide spectrum of sexual health services, and places strong emphasis on access to information and education. It signals a change in sexual health services from current provision, which has its origins in regional responses to specific sexual health issues, to a national strategy to provide high quality sexual health services to the whole population as required.
‘Sexual health promotion, education and prevention’ represents one of the three overarching domains in the Strategy, and was a priority in the 2015-2016 Action Plan. The Plan contains specific actions to support parents in engaging with their children on sexual health issues, and includes actions that aim to improve young people’s experience of sexual health education in the education system by providing better training and resources for teachers and youth workers.
The HSE Sexual Health and Crisis Pregnancy Programme is charged with implementing most of the National Sexual Health Strategy 2015–2020, and with developing and implementing a national strategy to address the issue of crisis pregnancy in Ireland. It aims to improve the effectiveness and impact of sexual health services and prevention, as set out in the National Sexual Health Strategy.
176. Deputy Ruth Coppinger asked the Minister for Health if he will report on the implementation to date of the requirement in section 5(b)(iii) of the Regulation of Information (Services outside the State for Termination of Pregnancies) Act 1995 that crisis pregnancy information, counselling and advice are truthful and objective; the details with regard to his announcement of a review of that Act; and if he will make a statement on the matter. [40277/16]
Amharc ar fhreagraA wide range of service providers provide advice and information about pregnancy including health professionals, counsellors and crisis pregnancy agencies. The Regulation of Information (Services Outside the State for Termination of Pregnancies) Act, 1995 defines the conditions under which information relating to abortion services lawfully available in another state might be made available in Ireland. Sections (3) and (5) of the 1995 Act provide that information on termination of pregnancy must be "truthful and objective", section (10) provides that a breach of section (3) or section (5) is an offence. If an individual(s) considers that information provided under the Act is not truthful and objective then they may refer the matter to the Garda for investigation.
These provisions are already on the Statute Book and it is important that people with concerns about the veracity of information given out by service providers are aware that there is an existing basis for having their concerns investigated.
The review that my Department will undertake of the 1995 Act will examine if the provisions of the Act need to be strengthened or clarified.
177. Deputy Ruth Coppinger asked the Minister for Health if he will legislate against medical professionals and hospitals accepting money from pharmaceutical companies; and if he will make a statement on the matter. [40278/16]
Amharc ar fhreagraThe Ethics in Public Office Act and the Department of Public Expenditure and Reform's Code of Practice for the Governance of State Bodies set out legal obligations and best practice for public servants in this area. My Department wrote to the Health Service Executive on 16 November asking it to satisfy itself that health professionals and all relevant staff are familiar and operating in compliance with this legislation and to give consideration as to whether there is a need for any additional guidance in order to ensure that the public interest is safeguarded in all respects. I have also asked the HSE to undertake an assessment of existing protocols and procedures in relation to the receipt of funding or other benefits from pharmaceutical companies by its employees and the services for which it has responsibility.
In addition, the Medicinal Products (Control of Advertising) Regulations 2007 govern the advertising of medicines, and provide for a range of restrictions on gifts, hospitality and sponsorship of meetings. For example, a gift must be inexpensive and relevant to the practice of medicine or pharmacy. Hospitality must be reasonable in level, strictly limited to the main purpose or scientific objective of the event, and not extended to persons other than health professionals. Health professionals are also prohibited from soliciting or accepting any prohibited inducement, hospitality or sponsorship. Breaches of the Regulations may be prosecuted in the courts under section 32 of the Irish Medicines Board Acts 1996 and 2006.
Regulation of the medical profession is undertaken by the Medical Council, which updated its Guide to Professional Conduct and Ethics for Registered Medical Practitioners in May 2016. While the Guide is not a legal code, it sets out the principles of professional practice and conduct that all doctors registered with the Medical Council are expected to follow.
While I await the response of the HSE on the issues I outlined earlier, there are currently no plans to further legislate on this matter.
182. Deputy Brendan Griffin asked the Minister for Health his views on a matter (details supplied) regarding the drug Kalydeco; and if he will make a statement on the matter. [40291/16]
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 line with the 2013 Act, if a company would like a medicine to be reimbursed by the HSE pursuant to the community drug schemes or as a hospital medicine, the company must first submit an application to the HSE to have the new medicine added to the reimbursement list or to be priced as a hospital medicine. The company must submit a separate application to extend a treatment to a new cohort of patients. Each application is considered separately on its merits and in line with the 2013 Act.
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 Ivacaftor, brand name Kalydeco, for the treatment of cystic fibrosis patients aged 2 years and older and weighing less than 25kg. In March of this year, the HSE asked the NCPE to carry out a health technology assessment of the applicant’s economic dossier on the cost effectiveness of this treatment.
The NCPE completed its assessment and made a recommendation in October 2016. The NCPE determined that the manufacturer failed to demonstrate cost-effectiveness of the drug for its intended cohort of patients and did not recommend that it should be reimbursed for this indication at the submitted price. In the economic dossier submitted to the NCPE, the manufacturer estimates that there are 18 patients who may be eligible for early ivacaftor treatment.
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/2015/12/Ivacaftor-2-5-years-web-summary.pdf.
As the HSE is responsible for negotiations with manufacturers, I have asked it to reply to the Deputy directly in relation to the status of negotiations with the manufacturer.
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.
183. Deputy Brendan Griffin asked the Minister for Health his views on a matter (details supplied) regarding the metabolic condition phenylketonuria; and if he will make a statement on the matter. [40322/16]
Amharc ar fhreagra186. Deputy Michael Healy-Rae asked the Minister for Health his views on the case of a person (details supplied) with a medical condition; and if he will make a statement on the matter. [40327/16]
Amharc ar fhreagraI propose to take Questions Nos. 183 and 186 together.
The 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; therefore, the matter has been referred to the HSE for reply to the Deputy.
184. Deputy Kathleen Funchion asked the Minister for Health the status of funding for a project (details supplied) in County Kilkenny; and if the HSE will be forthcoming with the initially agreed funding for the project [40324/16]
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.
185. Deputy Peter Burke asked the Minister for Health the status of the provision of equipment for a hospital (details supplied). [40326/16]
Amharc ar fhreagraAs this is a service matter, I have asked the HSE to respond to you directly.
187. Deputy Jim O'Callaghan asked the Minister for Health if the clinical trial of the Respreeza drug which assists persons that suffer from emphysema will continue to be made available to persons who are currently in receipt of the drug; if not, if his Department will instruct the manufacturers (details supplied) to maintain compassionate access schemes to persons; and if he will make a statement on the matter. [40338/16]
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 this 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 will consider 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.
I understand that the NCPE is arranging to meet the patient representative group, the Alpha One Foundation, as soon as possible to provide them with an update in relation to the recommendation of the NCPE.
In relation to compassionate access schemes, I have previously asked manufacturers to show compassion and to maintain compassionate access schemes for patients during the assessment process by the HSE and this remains the position. However, the operation of these schemes is at the discretion of manufacturers. My Department has asked the NCPE to contact the company to seek clarification for those patients currently receiving this drug.
188. Deputy Martin Kenny asked the Minister for Health the number of persons outsourced at Sligo University Hospital for each of the years 2013 to date in 2016, in tabular form; and if he will make a statement on the matter. [40344/16]
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.
189. Deputy Martin Kenny asked the Minister for Health the number of emergency department attendances at Sligo University Hospital for each of the years 2013 to date in 2016, in tabular form; and if he will make a statement on the matter. [40345/16]
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.
190. Deputy Martin Kenny asked the Minister for Health the outpatient waiting times at Sligo University Hospital for each of the years 2011 to date in 2016, broken down by year and by specialty and in the wait time bands, up to three months, up to six months, up to 12 months, up to 15 months, up to 18 months, up to two years and more than two years; and if he will make a statement on the matter. [40346/16]
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.
