Local Enterprise Offices Data

Ceisteanna (155, 156)

Billy Kelleher

Ceist:

155. Deputy Billy Kelleher asked the Minister for Business, Enterprise and Innovation the number of local enterprise office clients by county and, in the case of Dublin, by Dublin city, Dún Laoghaire-Rathdown, Fingal and south Dublin in each of the years 2016 to 2018, in tabular form; and if she will make a statement on the matter. [1989/19]

Amharc ar fhreagra

Billy Kelleher

Ceist:

156. Deputy Billy Kelleher asked the Minister for Business, Enterprise and Innovation the number of local enterprise office supported jobs by county and, in the case of Dublin, by Dublin city, Dún Laoghaire-Rathdown, Fingal and south Dublin in each of the years 2016 to 2018, in tabular form; and if she will make a statement on the matter. [1990/19]

Amharc ar fhreagra

Freagraí scríofa (Ceist ar Business)

I propose to take Questions Nos. 155 and 156 together.

The Local Enterprise Offices (LEOs) are the ‘first-stop-shop’ for providing advice and guidance, financial assistance and other supports to those wishing to start or grow their own business.

Details of the number of LEO supported clients and of the number of jobs in micro-enterprises supported by the LEOs for 2016 and 2017 is shown in the following tables on a county basis, including the four LEOs in Dublin.

Please note that the relevant details for 2018 will not be available until the results of the annual employment survey of LEO clients is completed in Q1 2019.

LEO

No of LEO Clients 2016

No of LEO Clients 2017

Carlow

221

216

Cavan

208

206

Clare

197

224

Cork City

122

156

Cork South

188

261

Cork W / N

240

203

Donegal

183

200

Dublin City

349

397

DLR

229

256

Fingal

192

211

Dublin South

261

285

Galway

243

254

Kerry

437

425

Kildare

152

171

Kilkenny

266

254

Laois

102

115

Leitrim

162

155

Limerick

302

299

Longford

242

243

Louth

231

235

Mayo

220

207

Meath

207

242

Monaghan

153

152

Offaly

202

196

Roscommon

155

167

Sligo

215

231

Tipperary

295

297

Waterford

304

319

WestMeath

265

265

Wexford

187

213

Wicklow

116

127

Grand Total

6846

7182

LEO

Total Jobs 2016(FT + PT)

Total Jobs 2017 (FT + PT)

Carlow

1092

1128

Cavan

1162

1252

Clare

1110

1339

Cork City

633

739

Cork South

977

1487

Cork W / N

1393

1098

Donegal

1358

1193

Dublin City

1670

1947

DLR

1308

1561

Fingal

831

970

Dublin South

1230

1410

Galway

962

1039

Kerry

1962

2067

Kildare

881

967

Kilkenny

1500

1361

Laois

485

568

Leitrim

422

454

Limerick

1856

1907

Longford

1061

1154

Louth

780

906

Mayo

1239

1224

Meath

927

1112

Monaghan

903

1052

Offaly

921

995

Roscommon

704

794

Sligo

1095

969

Tipperary

1437

1595

Waterford

1469

1620

WestMeath

1375

1497

Wexford

1192

1348

Wicklow

699

732

Grand Total

34634

37485

Departmental Staff Recruitment

Ceisteanna (157)

Billy Kelleher

Ceist:

157. Deputy Billy Kelleher asked the Minister for Business, Enterprise and Innovation the number of additional staff to be appointed in her Department and in State agencies and bodies under the aegis of her Department in 2019; the estimated cost of hiring additional staff in her Department and in each State agency and body, in tabular form; and if she will make a statement on the matter. [1991/19]

Amharc ar fhreagra

Freagraí scríofa (Ceist ar Business)

My Department considers its overall allocation and resource needs on an ongoing basis and through a workforce planning process. The need for additional posts in 2019 was considered in conjunction with Budget 2019 and the Revised Estimates and taking account of the delivery of urgent business priorities that cannot be met with current staff resources.

This exercise was undertaken in the context of the expansion of responsibilities across the Department, in light of Brexit and other global challenges, the growing number of priorities facing the Department in 2019, including the significant increase in the number of employment permit applications.

In this regard, a total of 16 additional critical posts were identified to meet the Department’s priorities for 2019. The overall cost of approving the additional staffing requests associated with the priority areas identified for the Department is €572,354.18. This information is set out in the following table.

Grade

Number of Additional Posts

Principal Officer

1

Assistant Principal Officer

3

Administrative Officer

7

Executive Officer

2

Clerical Officer

3

Total Estimated Cost

€572,354.18

It should be noted that this position may need to be reviewed later this year when the next cycle of workforce planning is undertaken, particularly in respect of the demand for employment permits.

In relation to the Offices of the Department, an additional pay budget was allocated to the Office of the Director of Corporate Enforcement (ODCE) and the Workplace Relations Commission (WRC) for 2019.

The ODCE was allocated an additional pay budget of €740,000 to assist with the transition of the Office into a statutory agency. Identification of the specific posts that will be required are part of the ongoing work underway, to progress the transition of the ODCE to agency status.

The WRC was allocated an additional €640,000 for pay to provide for additional resources to support the extension of their functions to include other sectors of employees who will gain access to their services.

The Agencies that come within the remit of my Department, carry out their own workforce planning exercises and have at this early stage identified the following additional positions and costs associated with these for 2019.

Agency

Number of Additional Posts

Estimated Cost

Competition and Consumer Protection Commission

11

€553,170

Enterprise Ireland

14

€867,000

Health and Safety Authority

7

€412,000

IDA Ireland

14

€1,045,940

National Standards Authority of Ireland

5

€400,000

Economic Competitiveness

Ceisteanna (158)

Billy Kelleher

Ceist:

158. Deputy Billy Kelleher asked the Minister for Business, Enterprise and Innovation her views on the latest report of the National Competitiveness Council, Ireland’s Competitiveness Challenge 2017; and the timeline for implementation of recommendations in this publication. [1996/19]

Amharc ar fhreagra

Freagraí scríofa (Ceist ar Business)

Improving Ireland’s competitiveness and ensuring Ireland is an attractive location to do business is a key economic priority for this Government.

By highlighting the competitiveness challenges that the economy faces and identifying the actions to address those issues within our control, the National Competitiveness Council makes a valuable contribution in this regard, and I welcome the Council’s most recent report, Ireland’s Competitiveness Challenge 2018 .

In this report, the NCC’s message is clear. While Ireland’s overall competitiveness performance remains positive, as the risks to Ireland’s prosperity are increasing, there can be no room for complacency. The threats posed by Brexit, and the evolving global trading and tax landscape, mean we must enhance our competitiveness position and make the economy resilient to withstand external shocks.

I share the Council’s view that to further improve competitiveness, we need sustainable public finances, continued investment in infrastructure, and the talent to drive innovation and productivity across all sectors of the economy.

Moreover, several initiatives are in train across Government to enhance our competitiveness performance, including:

- The review of SME policy designed to assess the SME business ecosystem and the range of supports offered to SMEs undertaken by my Department in conjunction with the OECD;

- The development of an Industry 4.0 strategy to respond to the challenges and opportunities arising from the impact of digital technologies;

- The development of sectoral strategies for Enterprise Ireland’s client base;

- The Future Growth Loan Scheme that will allow businesses to borrow for up to 10 years to support capital investment and enhance their competitiveness.

My Department and the Department of the Taoiseach are also preparing the Future Jobs Programme, a cross-government initiative with a strong focus on improving productivity, that will be published in February. This initiative will propose concrete and ambitious actions to enhance our productivity and competitiveness and will ensure that we are well positioned to adapt to transformational changes the economy will face in the years ahead.

Alongside the Competitiveness Challenge, the NCC have made a submission to the Future Jobs initiative that highlights key actions for the Government. We will reflect on the findings of the Competitiveness Challenge – and the contents of the NCC’s submission - as the Future Jobs initiative is finalised.

Work Permits Data

Ceisteanna (159, 160)

Billy Kelleher

Ceist:

159. Deputy Billy Kelleher asked the Minister for Business, Enterprise and Innovation the number of employment permits granted for non-EEA workers in each of the years 2010 to 2018, by occupation and sector, in tabular form. [1997/19]

Amharc ar fhreagra

Billy Kelleher

Ceist:

160. Deputy Billy Kelleher asked the Minister for Business, Enterprise and Innovation the number of applications for work permits received in each of the years 2015 to 2018; and the number of applications that remained to be processed by 31 December in each year, in tabular form. [1998/19]

Amharc ar fhreagra

Freagraí scríofa (Ceist ar Business)

I propose to take Questions Nos. 159 and 160 together.

The information requested by the Deputy regarding the number of employment permits granted for non-EEA workers in each of the years 2010 to 2108, listed by occupation and sector, is set out in tabular form.

The Employment Permits Section of my Department has used the international Standard Occupational Classification (SOC Codes) system to classify workers into occupational categories for the purpose of collecting, calculating, or disseminating data since 2013.

The following table sets out the information requested by the Deputy in regard to the number of applications accepted in each of the years 2015 to 2018, and the number of applications that remained to be processed by 31 December in each year in tabular form.

2015

2016

2017

2018

Applications Accepted

9,021

11,317

13,217

16,735

Applications that remained to be processed by 31 December

*1,134

*1,140

1,192

2,630

* The figures for applications that remain to be processed at 31 December 2015 and 2016 are approximates.

Occupation and Sector

Work Permits Eligibility

Ceisteanna (161)

Billy Kelleher

Ceist:

161. Deputy Billy Kelleher asked the Minister for Business, Enterprise and Innovation the occupations and sectors on the highly skilled eligible occupations list and the ineligible categories of employment list, respectively, in tabular form. [2000/19]

Amharc ar fhreagra

Freagraí scríofa (Ceist ar Business)

The employment permits system is managed through the operation of the Highly Skilled Eligible Occupations List (HSEOL) and the Ineligible Categories of Employment List (ICEL).

Occupations listed on the HSEOL are highly skilled jobs such as professional positions in medicine, ICT, sciences, finance and business. Occupations listed on the ICEL are generally occupations with lower skills requirements, e.g. personal services, trades, operatives and there is evidence that there are more than enough Irish/EEA workers to fill such vacancies. Every other job in the labour market, where an employer cannot find a worker, may be eligible for an employment permit.

In order to ensure that the employment permits schemes are responsive to changes in economic circumstances and labour market conditions, these occupations lists are reviewed twice yearly to keep pace with rapid labour market changes and to be proactively identifying and addressing shortages as they arise.

Ireland is a leader EU -wide in linking labour market intelligence to economic migration policy and is guided by research undertaken by Solas, the Expert group of Future Skills Needs, Government Strategies as well as through a public consultation process

A Review of these lists is underway at present and is expected to be finalised before the end of January 2019. The review commenced with a public call for submissions from stakeholders and interest groups requesting changes to the lists. Submissions have been received in respect of a range of occupations and those submissions and other relevant research and data are now being examined.

Comprehensive information on the employment permit system is available on my Department's website www.dbei.gov.ie

Attachment No: 1

HSEOL

Attachment No: 2

ICEL

Personal Injury Claims

Ceisteanna (162)

Billy Kelleher

Ceist:

162. Deputy Billy Kelleher asked the Minister for Business, Enterprise and Innovation if she will provide data (details supplied) for the period 2011 to 2018. [2001/19]

Amharc ar fhreagra

Freagraí scríofa (Ceist ar Business)

The detail requested by the Deputy is an operational matter for the Personal Injuries Assessment Board (PIAB). PIAB is an independent statutory agency and I, as Minister, am not permitted in my executive function to interfere in any way with the day to day operations and functions of PIAB.

However, in order to assist the Deputy, I have set out in the following tables the relevant information published in the PIAB Annual Reports for the years 2011-17, the Annual Report for 2018 has not been published yet.

Table 1 – Applications to PIAB*

Year

Applications Received

Total Motor Claims Received

Total Public Liability Claims Received

Total Employer Liability Claims Received

2011

27,669

16,351

7,452

3,866

2012

29,603

17,443

8,602

3,828

2013

31,311

18,877

8,394

4,040

2014

31,576

18,994

8,214

4,368

2015

33,561

19,812

8,906

4,843

2016

34,056

19,633

9,182

5,241

2017

33,114

18,623

5,634

8,857

*source data from PIAB Annual Reports 2011-17

Table 2 – Awards Made and Awards Accepted*

Year

Awards Made

Number of Accepted Awards

2011

9,833

5,875

2012

10,136

6,124

2013

10,656

6,476

2014

12,420

7,519

2015

11,734

6,716

2016

12,966

7,071

2017

12,663

6,788

*source data from PIAB Annual Reports 2011-17

Medical Aids and Appliances Provision

Ceisteanna (163)

Billy Kelleher

Ceist:

163. Deputy Billy Kelleher asked the Minister for Health when a person (details supplied) will receive a new wheelchair; and if he will make a statement on the matter. [1822/19]

Amharc ar fhreagra

Freagraí scríofa (Ceist ar Health)

As this is a service matter it has been referred to the HSE for direct reply to the Deputy.

Home Help Service Provision

Ceisteanna (164)

Billy Kelleher

Ceist:

164. Deputy Billy Kelleher asked the Minister for Health if he is satisfied with the level and quality of service being provided by a home care company (details supplied) on behalf of the HSE; his plans to ensure that action is taken immediately to resolve the care issues being experienced by a person; and if he will make a statement on the matter. [1824/19]

Amharc ar fhreagra

Freagraí scríofa (Ceist ar Health)

As this is a service matter I have asked the Health Service Executive to respond directly to the Deputy as soon as possible.

Medicinal Products Availability

Ceisteanna (165)

Billy Kelleher

Ceist:

165. Deputy Billy Kelleher asked the Minister for Health if the decision to refuse a person (details supplied) with allergies preventing other forms of pain relief from obtaining Lidocaine patches will be reviewed as a matter of urgency; and if he will make a statement on the matter. [1835/19]

Amharc ar fhreagra

Freagraí scríofa (Ceist ar Health)

Medicines play a vital role in improving the health of Irish patients. Securing access to existing and new and innovative medicines is a key health service objective. However, the challenge is to do this in a safe and sustainable manner. Treatment must be appropriate and proportionate and clinical decision-making, such as prescribing, should be based on both patient needs and sound medical evidence.

Lidocaine 5% medicated plasters are licensed for localised relief of post-shingles pain in adults. This is the patch's only licensed use in Ireland. It has been reimbursed in the community drug schemes since 2010.

Clinical concern arose as usage increased significantly, to the point where more plasters were being used in Ireland than in the entire UK National Health Service. In such situations, it is important and appropriate for clinicians to review usage and, in 2016, the HSE Medicines Management Programme (MMP) reviewed the use of the plasters. The review estimated that only 5-10% of prescribing was for the licensed indication.

From September 2017, following the clinical review, the HSE introduced a new reimbursement approval system for the patches, to support appropriate use and patient care. Under these arrangements, the patient's GP or consultant applies to the MMP for reimbursement approval on behalf of the patient. If an application is refused, the clinician may submit an appeal to the MMP, making a clear clinical case for the patient. Information for patients and practitioners is on the HSE MMP website at: hse.ie/yourmedicines.

The outcome of an application or an appeal for reimbursement of lidocaine patches is a matter between the MMP and the treating clinician. The Deputy will appreciate that, as Minister for Health, I cannot intervene in individual cases.

The decision to introduce a new reimbursement approval process for a particular treatment is a matter for the HSE. However, I fully support the objectives of the HSE Medicines Management Programme.

Hospital Groups

Ceisteanna (166)

Michael McGrath

Ceist:

166. Deputy Michael McGrath asked the Minister for Health the position in relation to the spending or revenue allocation for 2019 to the maternity directorate in the South/Southwest Hospital Group; and if he will make a statement on the matter. [1845/19]

Amharc ar fhreagra

Freagraí scríofa (Ceist ar Health)

As this is a service matter, I have asked the Health Service Executive to respond to you directly as soon as possible

Hospital Groups

Ceisteanna (167)

Michael McGrath

Ceist:

167. Deputy Michael McGrath asked the Minister for Health his views on the request for a capital budget of €7.5 million in 2019 for the maternity directorate in the South/Southwest Hospital Group to enable the second operating theatre to open at Cork University Maternity Hospital and deal with other service improvements; and if he will make a statement on the matter. [1846/19]

Amharc ar fhreagra

Freagraí scríofa (Ceist ar Health)

As the Health Service Executive is responsible for the delivery of healthcare infrastructure projects, I have asked the HSE to respond to you directly in relation to this matter.

Hospital Procedures

Ceisteanna (168, 169, 170)

Gerry Adams

Ceist:

168. Deputy Gerry Adams asked the Minister for Health the number of persons that have undergone cataract surgery in each of the years 2016 to 2018; and the cost of this surgery in each of these years. [1848/19]

Amharc ar fhreagra

Gerry Adams

Ceist:

169. Deputy Gerry Adams asked the Minister for Health the HSE locations at which cataract surgery is performed. [1849/19]

Amharc ar fhreagra

Gerry Adams

Ceist:

170. Deputy Gerry Adams asked the Minister for Health the number of persons in each county awaiting cataract surgery; and the length of time they have been waiting. [1850/19]

Amharc ar fhreagra

Freagraí scríofa (Ceist ar Health)

I propose to take Questions Nos. 168 to 170, inclusive, together.

Improving access to hospital treatment is a key priority for Government.

Waiting list figures for December 2018, published last week by the NTPF show that considerable improvements have been made to the number of patients waiting for an Inpatient or Day case procedure which have fallen to 70,204 from the peak of 86,100 in July 2017. This represents a reduction of over 18% in the overall number of patients waiting for a procedure. Over the same period, the waiting lists for Cataracts has reduced from over 10,000 to 6,440 representing a reduction of 36%.

Furthermore, the number of patients waiting over 9 months has almost halved since July 2017 from 28,100 to 14,900. The impact is particularly noteworthy when one considers the improvements to the Waiting Lists for those particular specialties which were the focus of the Inpatient/Daycase Action Plan in 2018 including the numbers waiting over 9 months for a Cataract procedure which have fallen by 87% since July 2017.

My Department is working closely with the NTPF and the HSE to finalise a Scheduled Care Access Plan for inpatients/daycase and outpatients for 2019. In this regard, the NTPF and HSE will continue to work closely with Hospital Groups, inviting proposals to improve access for patients waiting for hospital procedures. .

The number of persons treated for Cataracts in 2017 was 2,983 and in 2018 was 6,764. The NTPF did not have a direct role in the commissioning of patient treatments in 2016. At that time, the procurement of treatments was carried out by the HSE and the role of the NTPF was in the administration of the payments to the hospitals. The expenditure on Ophthalmology was €5.7m in 2017 while the 2018 Annual Financial Statements have not been finalised.

The HSE locations at which cataract surgery is performed are:

- Children’s University Hospital Temple Street;

- Galway University Hospital;

- Letterkenny General Hospital;

- Mater Misericordiae University Hospital;

- Royal Victoria Eye and Ear Hospital;

- Sligo Regional Hospital;

- South Infirmary-Victoria University Hospital;

- St. Vincent s University Hospital;

- University Hospital Limerick;

- University Hospital Waterford;

- Nenagh Hospital; and

- Louth County Hospital.

The information requested by the Deputy regarding the number of persons in each county awaiting cataract surgery, is set out in the document in the following link.

Cataracts

Vaccination Programme

Ceisteanna (171, 179, 180, 181, 183, 190)

John Curran

Ceist:

171. Deputy John Curran asked the Minister for Health the age children who may not have been previously vaccinated for the meningococcal B disease are now entitled to vaccination from the HSE; and if he will make a statement on the matter. [1853/19]

Amharc ar fhreagra

John Brassil

Ceist:

179. Deputy John Brassil asked the Minister for Health if the HSE has undertaken a cost analysis for the provision of the meningitis B vaccine to all children born before October 2016; if he will consider same; and if he will make a statement on the matter. [1934/19]

Amharc ar fhreagra

John Brassil

Ceist:

180. Deputy John Brassil asked the Minister for Health if the HSE has established the number of persons affected by the meningitis B strain in relation to the recent meningitis outbreak; the number of persons that recently died due to the meningitis that were affected by the meningitis B strain; and if he will make a statement on the matter. [1935/19]

Amharc ar fhreagra

John Brassil

Ceist:

181. Deputy John Brassil asked the Minister for Health his plans to extend the meningitis B vaccine to all children born before October 2016; and if he will make a statement on the matter. [1936/19]

Amharc ar fhreagra

John Brassil

Ceist:

183. Deputy John Brassil asked the Minister for Health his plans to establish a public awareness campaign to encourage the uptake of the meningitis B vaccine and the booster programme; and if he will make a statement on the matter. [1938/19]

Amharc ar fhreagra

Róisín Shortall

Ceist:

190. Deputy Róisín Shortall asked the Minister for Health if a catch-up meningitis B programme will be provided for all children; the estimated cost of providing such a programme; and if he will make a statement on the matter. [1971/19]

Amharc ar fhreagra

Freagraí scríofa (Ceist ar Health)

I propose to take Questions Nos. 171, 179 to 181, inclusive, 183 and 190 together.

The National Immunisation Advisory Committee (NIAC) is an independent committee of the Royal College of Physicians of Ireland which is comprised of experts in a number of specialties, including infectious diseases, paediatrics, and public health, which makes recommendations on vaccination policy in Ireland. Its recommendations are based on the prevalence of the relevant disease in Ireland and international best practice in relation to immunisation. All relevant and appropriate information is taken into account when deciding to make changes to the State's immunisation programmes. NIAC submits its recommendations to my Department for consideration.

On foot of a recommendation by NIAC, the Primary Childhood Immunisation Schedule was amended in 2016 to include the introduction of the Meningitis B vaccine for all babies born on or after 1 October 2016. This change to the immunisation schedule took effect from 1 December 2016. The first dose of the vaccine is administered to children when they reach two months of age; a second dose is administered at four months and a third and final dose at twelve months. Meningitis B disease is most common in babies under the age of 1 year old and the timing of the administration of the vaccine under the immunisation programme takes account of this.

All vaccines administered through the Primary Childhood Immunisation Schedule are provided free of charge. Ireland is the second country in Europe to make the Men B vaccine available free of charge as part of its national immunisation programme. A vaccine that protects against meningococcal C disease (Men C vaccine) is given at 6 months and at 13. It should also be noted that adolescents are routinely offered the Men C vaccine in the first year of secondary school. Parents are strongly advised to ensure that their children are immunised according to the vaccination programme. Other vaccines that protect against other forms of meningitis and septicaemia are included in the routine child vaccination programme (Hib vaccine and pneumococcal vaccine (PCV)).

There are no plans to introduce a catch-up programme for the Men B vaccine to older children. Those who have a medical card are eligible to have the vaccine administered by their GP free of charge. However, the purchase of the vaccine is not covered by the medical card scheme.

Eleven cases of meningococcal disease have been notified to the Health Protection Surveillance Centre (HPSC) since the last week in December. Three deaths were among these cases. This is due to an increase in incidents of meningococcal disease over the last two weeks. The eleven cases notified compares to 5 cases for the same time period last year. In 2018 a total of 89 meningococcal cases were notified compared to 76 in 2017. Provisional data on the strain types identified indicate that different strains of the organism are circulating. All age groups have been affected, ranging from infants to the elderly. Two of the 11 cases notified were related to the Meningitis B but none of the three deaths have been attributed to this strain of the disease.

Members of the public are advised that, if they (including those already vaccinated) have any concerns or are showing symptoms, they should contact their GP in the first instance and ensure that medical expertise is sought.

Medicinal Products Availability

Ceisteanna (172)

John Curran

Ceist:

172. Deputy John Curran asked the Minister for Health his plans to ensure the drug Pembrolizumab is made available for a person (details supplied); and if he will make a statement on the matter. [1854/19]

Amharc ar fhreagra

Freagraí scríofa (Ceist ar Health)

The HSE has statutory responsibility for medicine pricing and reimbursement decisions, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. As Minister for Health, I do not have any statutory power or function in relation to the reimbursement of medicines. In addition, Section 10 of the Health Act 2004 precludes me from directing the HSE to provide a treatment or a personal service to any individual or to confer eligibility on any individual. It would be inappropriate for me to comment on the particular circumstances of any individual patient.

In Ireland the majority of patients access medicines through the publicly funded Community Drug Schemes.

In line with the 2013 Act and the national framework agreed with industry, if a company would like a medicine to be reimbursed by the HSE, it must apply to have the new medicine added to the reimbursement list.

Reimbursement is for licensed indications which have been granted market authorisation by the European Medicines Agency (EMA) or the Health Products Regulatory Authority (HPRA).

HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE).

Pembrolizumab has market authorisation in Ireland/the EU for a number of indications.

The HSE has approved the reimbursement of Pembrolizumab for the following indications:

- as monotherapy for the treatment of advanced (unresectable or metastatic) melanoma in adults;

- as monotherapy for the first-line treatment of metastatic non-small cell lung carcinoma (NSCLC) in adults whose tumours express PD-L1 with a 50% tumour proportion score (TPS) with no EGFR or ALK positive tumour mutations;

- as monotherapy for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) who have failed autologous stem cell transplant (ASCT) and brentuximab vedotin (BV), or who are transplant-ineligible and have failed BV.

It should be noted that the first part of the last indication is not reimbursed because the HSE is already reimbursing another immunotherapy with similar efficacy (nivolumab) at lower cost. Patients who are transplant-ineligible and have failed BV can receive reimbursement support for pembrolizumab, as nivolumab does not have market authorisation for this sub-group of patients.

The HSE Drugs Group are reviewing the indication below:

- as monotherapy for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy and whose tumours express PD-L1 with a combined positive score (CPS) 10.

The following indications are currently under health technology assessment with the NCPE:

- in combination with pemetrexed and platinum chemotherapy, for the first-line treatment of metastatic non-squamous NSCLC in adults whose tumours have no EGFR or ALK positive mutations;

- as monotherapy for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy.

No reimbursement application has been received to date for the following indication:

- as monotherapy for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) in adults whose tumours express PD-L1 with a 50% TPS and progressing on or after platinum-containing chemotherapy .

However, the HSE has approved reimbursement of nivolumab for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum-based therapy.

In October 2018, the Committee for Medicinal Products for Human Use (CHMP), which is the European Medicines Agency's committee responsible for human medicines, adopted a positive opinion recommending a change to the terms of the marketing authorisation for pembrolizumab to include a new indication as follows:

- as monotherapy for the adjuvant treatment of adults with stage III melanoma and lymph node involvement who have undergone complete resection.

The HSE has commissioned a rapid review assessment for this indication.

There are no other indications for pembrolizumab approved in the European Union at this time. Clinical trials for various immunotherapies, including pembrolizumab, are ongoing globally for a range of other possible indications, which may receive marketing authorisation in the EU over the next number of years. Each of those indications will be considered for reimbursement as market authorisations are granted and applications receive

Departmental Staff Data

Ceisteanna (173, 174)

Barry Cowen

Ceist:

173. Deputy Barry Cowen asked the Minister for Health the number of employees in his Department; the number professionally qualified with organisations (details supplied); the number with other relevant professional qualifications; and the number with no professional qualifications, in tabular form. [1890/19]

Amharc ar fhreagra

Barry Cowen

Ceist:

174. Deputy Barry Cowen asked the Minister for Health the number of employees in his Department authorised to engage in procurement; the number professionally qualified with organisations (details supplied); the number with other relevant professional qualifications; and the number with no professional qualifications, in tabular form. [1907/19]

Amharc ar fhreagra

Freagraí scríofa (Ceist ar Health)

I propose to take Questions Nos. 173 and 174 together.

The number of employees in my Department at the end of December 2018 was 498 in terms of headcount. My Department does not hold records of all of the professional qualifications held by its employees. Some employees may be members of professional organisations in a personal capacity and pay their own membership fees. The Department would have no record of such memberships.

The Department pays for corporate membership of the Institute of Public Administration. In 2018, three individual annual memberships of Chartered Accountants Ireland and one individual membership of the Chartered Institute of Management Accountants was reimbursed by the Department.

Various members of staff are engaged in procuring goods and services for the Department alongside their main duties. These staff abide by the procurement guidelines and procedures laid down by the Office of Government Procurement and act on its advice as appropriate. The staff involved would not require a professional qualification in procurement in order to undertake this work.