Written Answers Nos. 276-289
276. Deputy Clare Daly asked the Minister for Health if the healthcare assessment and needs of children suspected of having foetal valproate syndrome will be prioritised; and if there will be no delay in diagnosis and service provision [20330/19]
View answerThe 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.
278. Deputy Clare Daly asked the Minister for Health the clinical trials conducted on sodium valproate here prior to its licensing in 1975; and if no clinical trials were conducted, the international clinical trial data used as the basis for its approval. [20332/19]
View answerThe Health Products Regulatory Authority (HPRA) has advised my Department that it will take some time to compile the information requested by the Deputy. Therefore, I have asked the HPRA to reply directly to the Deputy on this occasion.
279. Deputy Brian Stanley asked the Minister for Health the position regarding the recruitment of physiotherapists in counties Laois and Offaly; if there is a freeze on recruitment or a freeze on appointing those that have successfully gone through the recruitment process; and if he will make a statement on the matter. [20339/19]
View answerI have asked the HSE to respond directly to the Deputy on this matter.
280. Deputy Kevin O'Keeffe asked the Minister for Health if a person (details supplied) will be assisted in being assessed for home help. [20347/19]
View answerAs this is a service matter I have asked the Health Service Executive to respond directly to the Deputy as soon as possible.
281. Deputy Clare Daly asked the Minister for Health further to Parliamentary Question No. 189 of 18 April 2019, if he will amend his response that all protected disclosures received by his Department are given due attention in keeping with the policies and procedures of his Department in accordance with the Act in view of the fact that it has failed to make a decision in regard to whether or not to investigate at least one protected disclosure (details supplied) in its possession within the 21 days as laid out in its policy and procedures. [20348/19]
View answerThe Department’s Policies and Procedures document in relation to protected disclosures sets out timeframes for certain steps in the process for dealing with protected disclosures. These timeframes are not statutory but, rather, reflect the Department's overall policy in dealing with these matters. In relation to the initial assessment of a protected disclosure, the Deputy correctly refers to the timeframe of 21 days within which the person who has made the disclosure should be advised as to whether the matter requires an investigation. The specific case referred to relates to a body under the aegis of the Department of Health. Regrettably, in this case it was not possible to meet this timeline, given the extensive nature and complexity of the disclosure made.
I can confirm that this protected disclosure has been given significant attention by the Department. Given the nature of this protected disclosure and its overlap with other matters, it was decided that it would be more appropriate to make arrangements for an external review. This is in keeping with the Policies and Procedures document. A procurement process has been completed to source an appropriate reviewer. The Department is currently engaged in finalising the terms of reference for the review. To assist in the process I understand that the Department has been in contact with the person who made this protected disclosure and that, most recently, a significant amount of additional information has been provided which is currently being examined by the Department. These papers will be passed to the external investigator to assist in finalising the terms of reference of the investigation. It is intended that the person who made this protected disclosure will also have sight of the terms of reference of the investigation prior to its commencement. The Department fully appreciates the desire on the part of the person making the disclosure to have the matter concluded and the delay in doing so is regretted. The person who made the disclosure has been updated on specific developments and the Department's plans and this will continue.
In relation to the carrying out of the review, the policy states that an investigation should be carried out ‘without delay’. It is also clear that the investigation should be consistent with investigatory procedures and should embody principles of natural justice. There is no precise timescale or steps required for investigations under the policy as it is recognised that this will depend on the nature and extent of the issues raised.
In light of the above, I do not believe it is necessary to amend the record. While it was not possible to meet the suggested timelines in this policy, the necessary steps have been complied with and arrangements are underway to conduct an external review.
282. Deputy Sean Fleming asked the Minister for Health if he will provide information relating to maternity units (details supplied); and if he will make a statement on the matter. [20392/19]
View answerAs this is a service issue, I have asked the HSE to reply to you directly.
283. Deputy Pearse Doherty asked the Minister for Health if funding has been sanctioned for planned refurbishment and upgrade works at St. Joseph's and Ramelton community hospitals; and if so, when works will commence [20409/19]
View answerAs the Health Service Executive is responsible for the delivery of public healthcare infrastructure projects, I have asked the HSE to respond directly to you in relation to this matter.
284. Deputy John McGuinness asked the Minister for Health if an MRI scan will be arranged for a person (details supplied); and if the matter will be expedited. [20412/19]
View answerUnder 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.
285. Deputy John McGuinness asked the Minister for Health the date the HSE drugs group will meet to discuss the revised offer submitted by a company (details supplied); the date the HSE leadership team will meet to discuss a final decision on the matter; the reason Ireland signed up to the BeNeLuxA initiative in June 2018 along with the Netherlands, Belgium, Luxembourg and Austria; the benefits to Ireland of being in this group of countries; the reason Ireland did not approve the drug Spinraza when all of the other countries in the group did; his views on whether the BeNeLuxA initiative is now permanently damaged in view of the reluctance of Ireland to approve Spinraza; the reason he deems it inappropriate to meet a person (details supplied); if he will reconsider this invitation and meet the person; and if he will make a statement on the matter. [20414/19]
View answerThe HSE has statutory responsibility for medicine pricing and reimbursement, 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.
Following detailed consideration of an application for the reimbursement of Nusinersen (Spinraza) and lengthy engagement with the company, the HSE decided that it was unable to reimburse Nusinersen (Spinraza). The HSE concluded that the evidence for clinical effectiveness was still quite limited and that the price proposed by the manufacturer was not a cost-effective use of resources.
On 21 February 2019, the HSE wrote to the manufacturer involved and informed them of the proposal to refuse reimbursement at the current price offering. Under the requirements of the Health (Pricing and Supply of Medical Goods) Act 2013 the company had 28 days to respond or make representations to the HSE’s proposed decision.
I am advised by the HSE that the manufacturer submitted additional information and that the matter remains under consideration by the HSE. As the statutory process is ongoing, it would be inappropriate for me to meet with family members at this time.
As the Deputy is aware, in June 2018, I signed the BeNeLuxA Initiative on Pharmaceutical Policy to work with Austria, Belgium, the Netherlands and Luxembourg on drug pricing and supply. This Agreement is in line with my objective to work with other European countries to identify workable solutions, in an increasingly challenging environment, to secure timely access for patients to new medicines in an affordable and sustainable way.
The BeNeLuxA collaboration was established in 2015, with a view to taking a collective approach to pharmaceutical procurement and evaluation. This Initiative seeks to enhance patients' access to high quality and affordable treatments, improve the payers' position in the market through joint negotiations, increase transparency on pricing between the collaborating countries, share policy expertise and focus on knowledge building.
This Initiative is well established, with clear goals and a pragmatic approach to delivering on its objectives. Four areas of collaboration have been identified: horizon scanning, health technology assessment, information sharing and policy exchange and joint price negotiations.
The BeNeLuxA Initiative is an entirely voluntary process with a shared understanding that its workings and decisions have to accord to domestic legal frameworks.
In the case of Spinraza, two members of the BeNeLuxA Initiative (Belgium and the Netherlands) completed a joint negotiation for the reimbursement of Spinraza in July 2018. This process began before Ireland joined the collaboration and Ireland was not party to these negotiations.
286. Deputy Éamon Ó Cuív asked the Minister for Health the reason there are no CAMHS clinics held in Clifden, County Galway; the reason all persons who wish to avail of this service from the area must make a round trip of 200 km for an appointment; and if he will make a statement on the matter. [20417/19]
View answerAs this is a service matter I have asked the Health Service Executive to respond directly to the Deputy as soon as possible.
287. Deputy Éamon Ó Cuív asked the Minister for Health his plans to provide extra funding to the HSE western region for the provision of full-time residential care for persons with severe intellectual disabilities in view of the shortage of places in the region for such care and the burden being placed on families that require the service; and if he will make a statement on the matter. [20418/19]
View answerThe 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.
288. Deputy John McGuinness asked the Minister for Health if he will meet a person (details supplied); the progress made on the case of the person following his meeting with the person in County Kilkenny; if the approval of pembro for the person will be expedited without further delay; and if he will make a statement on the matter. [20419/19]
View answerThe 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 and 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. Therefore it would be inappropriate for me to meet with Mr Holmes, although obviously I have great sympathy for his situation.
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 HSE commissioned a rapid review assessment for the indication below:
- as monotherapy for the adjuvant treatment of adults with stage III melanoma and lymph node involvement who have undergone complete resection.
The NCPE have recommended a full HTA to assess the clinical effectiveness and cost effectiveness of pembrolizumab compared with the current standard of care.
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 received.
289. Deputy Niamh Smyth asked the Minister for Health the reason a person (details supplied) is waiting for a cataract operation; and if he will make a statement on the matter. [20433/19]
View answerUnder 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.
