Tuesday, 24 Sep 2019

Written Answers Nos. 320-339

Mental Health Services Staff

Questions (320)

James Browne

Question:

320. Deputy James Browne asked the Minister for Health the position regarding the transfer of staff from one facility to another (details supplied). [38513/19]

Written answers

Minister of State at the Department of 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 Reimbursement

Questions (321, 366)

Michael Moynihan

Question:

321. Deputy Michael Moynihan asked the Minister for Health if his Department has received a request for funding from the HSE for the reimbursement of the drug Tagrisso for the treatment of adult patients with locally advanced or metastatic EGRF T790M mutative-positive NSCLC; when he expects funding to be made available for same; and if he will make a statement on the matter. [38520/19]

John Curran

Question:

366. Deputy John Curran asked the Minister for Health further to Parliamentary Question No. 1309 of 6 September 2019, when the HSE received the further information from the manufacturer regarding Tagrisso; the length of time reimbursement has been under consideration by the HSE; when the HSE will make a final decision regarding reimbursement; and if he will make a statement on the matter. [38787/19]

Written answers

Minister for Health

I propose to take Questions Nos. 321 and 366 together.

The HSE has statutory responsibility for medicine pricing and reimbursement decisions, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. The Act specifies the criteria for decisions on the reimbursement of medicines. The Minister for Health has no role in relation to reimbursement decisions.

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).

The current application for the reimbursement of Osimertinib (Tagrisso) for the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC was received on 16 January 2018.

Following the NCPE’s assessment and after a number of rounds of commercial negotiations and HSE reviews, the HSE notified the applicant in February 2019 that it was minded not to approve reimbursement for this indication.

The 2013 Act provides for a period of representations after such notifications, before the HSE can make its final decision. The HSE have received representations from the manufacturer and they are under consideration by the HSE leadership team in advance of a final reimbursement decision.

Cancer Screening Programmes

Questions (322, 323)

Bríd Smith

Question:

322. Deputy Bríd Smith asked the Minister for Health further to Parliamentary Question Nos. 1190, 1191 and 1197 of 6 September 2019, if a direct response will issue on the specific question regarding a patient having to fund an independent review of her smears if she has been diagnosed with cervical cancer. [38526/19]

Bríd Smith

Question:

323. Deputy Bríd Smith asked the Minister for Health further to Parliamentary Question Nos. 1190, 1191 and 1197 of 6 September 2019, if a response will issue on whether the financial burden on patients with cervical cancer will be removed; and if the HSE will fund an independent review of smears if requested. [38527/19]

Written answers

Minister for Health

I propose to take Questions Nos. 322 and 323 together.

As previously outlined to the Deputy, in response to a recommendation from Dr Gabriel Scally, the HSE has established an Expert Group to review clinical audit of interval cancers in the three cancer screening programmes. This work, which incorporates consideration of international best practice, is expected to be complete by the end of this year, following which the recommendations will be implemented.

In relation to the issue of funding private smear reviews, this matter remains under consideration. However, in that context it is important to again re-emphasise the limitations of cervical screening, and the fact that false negative results are an inherent part of any cervical screening programme. Cervical screening will not prevent all cases of cervical cancer and unfortunately some women will still develop cervical cancer despite regular screening. The HPV test is a more accurate testing mechanism than liquid-based cytology, which is the current testing mechanism. I have asked the HSE to introduce HPV testing as the primary screening method for the prevention of cervical cancer as soon as possible and have approved a draft project plan for the HPV primary screening project. Its use will result in fewer false negative results, though it is important to be clear they will continue to occur.

Medicinal Products Reimbursement

Questions (324)

Eugene Murphy

Question:

324. Deputy Eugene Murphy asked the Minister for Health if the reimbursement dataset specifically covers only current HSE-funded users of the FreeStyle Libre device; if the health technology assessment group review will compare total blood glucose strip usage spend year on year; and if he will make a statement on the matter. [38567/19]

Written answers

Minister for Health

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.

Medicinal Products Reimbursement

Questions (325)

Eugene Murphy

Question:

325. Deputy Eugene Murphy asked the Minister for Health the weighting percentages to be used as part of the upcoming HSE FreeStyle Libre review decision-making process that will be given to criteria (details supplied); and if he will make a statement on the matter. [38568/19]

Written answers

Minister for Health

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.

Ministerial Meetings

Questions (326)

Michael Fitzmaurice

Question:

326. Deputy Michael Fitzmaurice asked the Minister for Health the number of times he has formally met his UK counterpart to date in 2019, in tabular form; and if he will make a statement on the matter. [38569/19]

Written answers

Minister for Health

I engage regularly with my EU counterparts at the EPSCO (Employment, Social Policy, Health and Consumer Affairs) Council meeting of Health Ministers, as well as through bilateral meetings in capitals and on the margins of Council meetings.

I have met UK Parliamentary Under Secretary of State for Health, Baroness Blackwood at the EPSCO (Employment, Social Policy, Health and Consumer Affairs) Council meeting of Health Ministers in Luxembourg on 14 June 2019.

I had previously met Baroness Blackwood at the Informal meeting of Health Ministers in Budapest on the 15 April 2019.

There is ongoing liaison between my officials and colleagues in the Department of Health and Social Care, UK and other devolved administrations in the UK.

Autism Support Services

Questions (327)

Michael Healy-Rae

Question:

327. Deputy Michael Healy-Rae asked the Minister for Health the status of an autism assessment appointment for a person (details supplied); and if he will make a statement on the matter. [38572/19]

Written answers

Minister of State at the Department of Health

As the Deputy's question relates to a service issue it has been referred for direct reply.

Medicinal Products Reimbursement

Questions (328)

Niamh Smyth

Question:

328. Deputy Niamh Smyth asked the Minister for Health if the reimbursement dataset will specifically cover only current HSE-funded users of the FreeStyle Libre device; and if not, if the health technology assessment group review will compare total blood glucose strip usage spend year on year. [38573/19]

Written answers

Minister for Health

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.

Medicinal Products Reimbursement

Questions (329)

Michael Fitzmaurice

Question:

329. Deputy Michael Fitzmaurice asked the Minister for Health the weighting percentages to be used as part of the upcoming HSE FreeStyle Libre review decision-making process that will be given to criteria (details supplied); and if he will make a statement on the matter. [38574/19]

Written answers

Minister for Health

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.

Medicinal Products Reimbursement

Questions (330)

Michael Fitzmaurice

Question:

330. Deputy Michael Fitzmaurice asked the Minister for Health if the reimbursement dataset will specifically cover only current HSE-funded users of the FreeStyle Libre device; and if not, if the Health Technology Assessment Group review will compare total blood glucose strip usage spend year on year; and if he will make a statement on the matter. [38575/19]

Written answers

Minister for Health

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 (331)

Michael Healy-Rae

Question:

331. Deputy Michael Healy-Rae asked the Minister for Health the status of a procedure for a person (details supplied); and if he will make a statement on the matter. [38580/19]

Written answers

Minister for Health

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, since 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 the Deputy directly.

Medical Card Drugs Availability

Questions (332)

John Brady

Question:

332. Deputy John Brady asked the Minister for Health the reason a medication (details supplied) has been withdrawn and is no longer available under the medical card; if a replacement or substitution of another medication will be made available; and if he will make a statement on the matter. [38589/19]

Written answers

Minister for Health

Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for the pricing and reimbursement of medicines; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.

Disability Services Provision

Questions (333)

Niamh Smyth

Question:

333. Deputy Niamh Smyth asked the Minister for Health the measures he is taking regarding the crisis with the lack of resources in early intervention, adequate respite services and a lack of residential spaces for persons with disabilities in counties Cavan and Monaghan; and if he will make a statement on the matter. [38590/19]

Written answers

Minister of State at the Department of Health

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 service matters, I have arranged for the question to be referred to the Health Service Executive (HSE) for direct reply to the Deputy.

Medicinal Products Reimbursement

Questions (334)

Brendan Ryan

Question:

334. Deputy Brendan Ryan asked the Minister for Health the status of the rolling out of Plenadren as an alternative hydrocortisone therapy here under the HSE drugs schemes in view of the fact it has been approved in the UK, Spain and the United States of America; and if he will make a statement on the matter. [38591/19]

Written answers

Minister for Health

Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for the pricing and reimbursement of medicines; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.

Medicinal Products Reimbursement

Questions (335)

Kate O'Connell

Question:

335. Deputy Kate O'Connell asked the Minister for Health the weighting percentages to be used as part of the upcoming HSE FreeStyle Libre review decision making process that will be given to criteria (details supplied); and if he will make a statement on the matter. [38592/19]

Written answers

Minister for Health

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.

Medicinal Products Reimbursement

Questions (336)

Kate O'Connell

Question:

336. Deputy Kate O'Connell asked the Minister for Health if the reimbursement dataset will specifically cover only current HSE-funded users of the FreeStyle Libre device; and if the health technology assessment group review will compare just total blood glucose strip usage spend year on year. [38593/19]

Written answers

Minister for Health

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.

Medical Products

Questions (337, 338, 339, 343)

James Browne

Question:

337. Deputy James Browne asked the Minister for Health the position regarding the Chief Medical Officer's report on mesh implants carried out here; and if he will make a statement on the matter. [38598/19]

James Browne

Question:

338. Deputy James Browne asked the Minister for Health the number of women that received mesh implants here; and if he will make a statement on the matter. [38599/19]

James Browne

Question:

339. Deputy James Browne asked the Minister for Health the steps he is taking to address the concerns of women who had mesh implant procedures carried out here; and if he will make a statement on the matter. [38600/19]

James Browne

Question:

343. Deputy James Browne asked the Minister for Health when an aftercare service pathway will be in place for those living with complications arising from vaginal mesh implant surgery; and if he will make a statement on the matter. [38634/19]

Written answers

Minister for Health

I propose to take Questions Nos. 337 to 339, inclusive, and 343 together.

As Minister for Health, I requested Dr Tony Holohan, Chief Medical Officer (CMO) to draft a report on the use of Uro-Gynaecological Mesh in the surgical treatment of stress urinary incontinence (SUI) and pelvic organ prolapse (POP) in women. The report covers the clinical and technical issues involved in ensuring both:

1. the safe and effective provision of mesh procedures in urogynaecology and

2. an appropriate response to women who suffer complications as a result of undergoing such procedures.

This report was published on the Department of Health website on 21 November 2018.

The CMO’s Report identifies that for many women, surgical procedures using synthetic mesh devices have provided a more effective and less invasive form of treatment than traditional SUI and POP procedures. However, mesh devices are associated with significant and severe complications in a minority of women. These are of concern given the difficulties of mesh implant removal.

The Report makes 19 recommendations including:

- the development of patient information and informed consent materials;

- surgical professional training and multidisciplinary expertise in units carrying out mesh procedures;

- the development of clinical guidance;

- the development of information systems to monitor the ongoing use of mesh devices;

- ensuring the reporting of mesh related complications; and

- ensuring timely, appropriate and accessible care pathways for the management of women with complications.

In advance of the report’s completion, the HSE was requested in May 2018 to begin work immediately on the development of national standardised patient information and informed consent materials and the clarification and development of treatment pathways and appropriate referral services for women suffering serious complications.

The HSE was also asked by the Chief Medical Officer on 24 July 2018 to pause all mesh procedures where clinically safe to do so, pending confirmation by the HSE of the implementation of recommendations relating to (i) professional training requirements, (ii) patient information and consent and (iii) the development and maintenance of a national data set for all mesh procedures carried out in HSE funded hospitals.

A central finding of the CMO’s report is that there are significant gaps in knowledge about current practice in Ireland concerning the use of mesh implants. Routinely collected clinical activity data does not identify the number of women who have received mesh implants in HSE funded hospitals. This is being addressed through ongoing work to implement recommendation (iii) above.

A Synthetic Mesh Devices Advisory Group was convened by the HSE, to advise on and progress all of the recommendations which included three patient representatives, as well as representatives of the HPRA, the IOG, the RCSI, the CFI and all Hospital Groups to advise on and action all of the recommendations above.

I am informed that an ongoing work programme for the clarification and development of treatment pathways and appropriate referral services for women suffering from mesh-related complications is being progressed by the HSE. This work includes identifying the appropriate specialist clinical expertise and facilities required at hospital group level and nationally to provide comprehensive aftercare services.

Pending the completion of this work, the HSE is also examining options to address service requirements for patients with immediate or urgent needs.

As was requested by the Secretary General of my Department in November 2018, the HSE has prepared an Implementation Plan for the complete set of recommendations set out in the CMO’s Report, which was approved by the Leadership Team in the HSE and published on the HSE website on 26 April 2019, which I hope provides further clarity on this issue.

I am informed that the HSE has advised that a detailed progress report on implementation of the recommendations will be provided to my Department and this report is awaited.

The HSE has published a dedicated webpage about vaginal mesh implants, including contact information for women suffering complications, which I hope is a useful resource. This can be found on the HSE website.

I would strongly encourage all women affected by mesh to engage with the relevant HSE contact points provided, to ensure that their service needs can be identified and provided for.

At my meeting with the Mesh Survivors Ireland Group on 7 March 2019 I agreed to continue engagement with them on a pathway forward, to ensure that the ongoing clinical management of this patient group is in line with international best practice and emerging evidence. It is my intention to meet again with the Mesh Survivors Ireland group in the coming weeks.