Medicinal Products Prices

Questions (1280, 1296)

John Brassil

Question:

1280. Deputy John Brassil asked the Minister for Health the status of the involvement of Ireland in the BeNeLuxA initiative on pharmaceutical policy; if Ireland will automatically reimburse drugs reviewed as part of this process and unilaterally reimbursed by Belgium, the Netherlands, Luxembourg and Austria; and if he will make a statement on the matter. [32470/19]

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John Brassil

Question:

1296. Deputy John Brassil asked the Minister for Health the involvement by Ireland in the BeNeLuxA initiative on pharmaceutical policy; if Ireland will automatically reimburse drugs reviewed as part of the process and unilaterally reimbursed by Belgium, the Netherlands, Luxembourg and Austria; and if he will make a statement on the matter. [32490/19]

View answer

Written answers (Question to Health)

I propose to take Questions Nos. 1280 and 1296 together.

The challenge of securing affordable access to innovate medicines is not unique to Ireland. Over the past two years, I and officials have been engaging with a number of voluntary EU forums in an effort to identifying solutions to issues of medicine pricing, sustainability and supply.

In June 2018, I signed the Beneluxa Initiative on Pharmaceutical Policy to work with Austria, Belgium, the Netherlands and Luxembourg. 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 Initiative is a voluntary collaboration between nation states and allows for whatever level of participation that is deemed appropriate by each member state. The Initiative has accord to domestic legal frameworks on drug pricing and crucially respects the fact that pricing and reimbursement decisions remain a national competency.

This Initiative is well established, with clear goals and a pragmatic approach to delivering on its objectives. Four areas of collaboration has been identified: horizon scanning, health technology assessment, information sharing and policy exchange and joint price negotiations.

Members of the Beneluxa Initiative are working closely across the four domains to create opportunities to create greater access to new medicines. In this context, a project is on-going on the development of an International Horizon Scanning Initiative (IHSI), which seeks to build a permanent horizon scanning system that can support countries and institutions in policy planning and their decision making regarding the reimbursement of new pharmaceuticals. In addition, the Beneluxa partners conduct joint health technology assessments and share data and policies.

The Beneluxa Initiative on Pharmaceutical Policy will have an important role to play in securing faster access to innovative medicines and provide important platforms in which to strengthen the policy mix and deliver on the shared objective of securing access to high cost, innovative treatments at affordable prices. The patients is at the centre of this collaborative international approach.

Cancer Services Funding

Questions (1281)

John Brassil

Question:

1281. Deputy John Brassil asked the Minister for Health if he will request the creation of a cancer drugs fund to increase access to the latest cancer therapies in view of concerns raised by clinicians and patient groups that Ireland will fail to meet its five-year survival rate improvement targets for cancer as set out in the National Cancer Strategy 2017-2026; and if he will make a statement on the matter. [32473/19]

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Written answers (Question to Health)

The HSE has a standard assessment process in place for the approval of the reimbursement of new drugs and new indications for existing drugs. The aim is to arrive at decisions on the funding of drugs that are clinically appropriate, fair, consistent and sustainable. All cancer drugs that have been approved for reimbursement since 2012 have gone through this process. Funding for cancer drugs is considered on an annual basis as part of the Estimates process.

A key aim of the National Cancer Strategy 2017-2026 is for Ireland's cancer survival rates to be within the top quartile of European countries by 2026.

The National Cancer Registry Annual Report 2018 shows that there have been significant improvements in 5-year net survival rates in Ireland. Also, the CONCORD-3 Project, which examined data from over 37.5m people across 71 countries and territories from 2000-2014, showed that Ireland is currently ranked around mid-table for survival rates amongst our European counterparts.

It is acknowledged that there will be a need for on-going improvements in survival rates over the period of the Strategy to ensure that the aim for the top quartile of European countries is achieved.

Rare Diseases Strategy

Questions (1282)

John Brassil

Question:

1282. Deputy John Brassil asked the Minister for Health the status of the development of a new national plan for rare diseases; if the plan will have clear targets for increasing the availability of orphan drugs here; if the plan will establish clear targets for timely diagnosis of a rare disease; and if he will make a statement on the matter. [32474/19]

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Written answers (Question to Health)

The National Rare Disease Plan was launched in 2014 and a report on the implementation of the Plan's recommendations was published in 2017. Both are publicly available on the Department of Health website.

We are now at the point where the operationalisation of the Rare Disease Plan is firmly embedded in the work of the HSE Clinical Programme for Rare Diseases and the HSE Rare Disease Office. As part of the oversight of the implementation of the National Rare Disease Plan my Department has a quarterly engagement with the Rare Disease Taskforce, comprising of Rare Diseases Ireland (RDI), Medical Research Charities Group (MRCG), The Irish Platform for Patient Organisations, Science and Industry (IPPOSI) and Cystic Fibrosis Ireland.

Work this year to date has identified the following key priority areas for the next phase of implementation; raising awareness; expansion of our participation in European Reference Networks; enhancing research and access to medicines and services.

This is a significant body of work that must also be aligned with the objectives of our healthcare system as set out in the SláinteCare Implementation Plan. Irrespective of disease or condition all patients must have access to the same level of preventative, early detection, diagnostic and treatment services. An important next step in this regard will be the publication of a model of care for rare diseases by the HSE Clinical Programme.

With particular reference to Orphan Drugs, The Oireachtas has put in place a robust legal framework in the Health (Pricing and Supply of Medical Goods) Act 2013, which gives full statutory powers to the HSE to assess and make decisions on the reimbursement of medicines, taking account of a range of objective factors and expert opinion as appropriate.

The 2013 Act requires the HSE to have regard to both the clinical benefits and cost effectiveness but it does not include provision for a different ruleset when assessing orphan drugs. However, both the National Centre of Pharmacoeconomics (NCPE) and HSE are mindful of the differences and challenges in terms of patient numbers when assessing this type of medicine.

In 2019, the HSE has approved 26 new medicines and 5 new uses of existing medicines, 17 of these medicines are for rare diseases.

Medicinal Products Availability

Questions (1283, 1301)

John Brassil

Question:

1283. Deputy John Brassil asked the Minister for Health if he will consider the creation of a national medicines strategy containing clear steps to improve the availability of medicines here; and if he will make a statement on the matter. [32475/19]

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Robert Troy

Question:

1301. Deputy Robert Troy asked the Minister for Health if the creation of a national medicines strategy containing clear steps to improve the availability of medicines here will be considered; and if he will make a statement on the matter. [32498/19]

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Written answers (Question to Health)

I propose to take Questions Nos. 1283 and 1301 together.

The timely and sustainable access to new medicines is a priority for Government. As the Deputy is aware, the Oireachtas put in place a robust legal framework, in the Health (Pricing and Supply of Medical Goods) Act 2013, to give full statutory powers to the HSE to assess and make decisions on reimbursement of medicines, taking account of a range of objective factors and expert opinion as appropriate. These include the clinical and cost effectiveness of the product, the opportunity cost, the potential or actual budget impact, and the impact on resources that are available to the HSE.

By assessing medicines in this manner, we help ensure that the finite resources of our heath service are used most effectively. This process can lead to protracted negotiation processes with pharmaceutical companies but this is necessary to ensure that the HSE can provide access to as many new innovative treatments as possible to patients in Ireland.

The legislative underpinning of the Health Act is backed up by the Framework Agreement on the Supply of Medicines 2016-2020 signed between the State and the Irish Pharmaceutical Healthcare Association (IPHA). It is expected to deliver approximately €600 million in savings from IPHA companies over the four year lifetime of the Agreement and €150 million in savings from non-IPHA companies.

This Agreement contains a number of measures intended to increase sustainable drug access and supply, including setting prices relative to those in over half of EU member states, reviewing prices annually against the reference countries to achieve better value for money over a product’s lifetime and formal health technology assessment of new treatments to inform reimbursement decision making.

The combination of the legislation and the Framework Agreement is in essence the national medicines strategy of the State.

The issue of access and affordability of new medicines is one shared by public health systems across the globe. Over the past number of years, my officials and I have been engaging with a number of voluntary EU forums in an effort to identifying solutions to these key issues.

In June 2018, I signed the Beneluxa Initiative on Pharmaceutical Policy to work with Austria, Belgium, the Netherlands and Luxembourg. 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.

Domestically my Department and the HSE are actively working on making greater efficiencies in medicines usage through a range of initiatives across the health service. This will free up existing resources to invest in new medicines in the future.

Medicinal Products Expenditure

Questions (1284)

John Brassil

Question:

1284. Deputy John Brassil asked the Minister for Health the cost-saving initiatives under way through the medicines management programme of the HSE; the estimated savings potential through each initiative; the planned initiatives to be commenced in 2019, in tabular form; and if he will make a statement on the matter. [32476/19]

View answer

Written answers (Question to Health)

The Health Service Executive has operational responsibility for medicines expenditure and cost saving measures, thus the matter has been referred to the HSE for their attention and direct reply to the Deputy.

Health Services Data

Questions (1285)

John Brassil

Question:

1285. Deputy John Brassil asked the Minister for Health the number of diabetes education programmes for blood glucose management carried out by the HSE or through HSE funding in each of the years 2015 to 2018 and to date in 2019; the average wait times for such education programmes; the number of persons on a waiting list to attend same in tabular form; and if he will make a statement on the matter. [32477/19]

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Written answers (Question to Health)

As this is a service matter, it has been referred to the Health Service Executive for attention and direct reply to the Deputy.

Health Services Data

Questions (1286)

John Brassil

Question:

1286. Deputy John Brassil asked the Minister for Health the percentage of HSE-funded or managed diabetes education programmes that seek to instruct on new technologies in the prevention and management of diabetes; the average wait times for such education programmes; the number of persons on a waiting list to attend same; and if he will make a statement on the matter. [32478/19]

View answer

Written answers (Question to Health)

As this is a service matter, it has been referred to the Health Service Executive for attention and direct reply to the Deputy.

Health Services Expenditure

Questions (1287, 1295)

John Brassil

Question:

1287. Deputy John Brassil asked the Minister for Health the estimated cost to the HSE attributed to the direct management and prevention of diabetes; the estimated indirect cost of complications associated with the disease; and if he will make a statement on the matter. [32479/19]

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John Brassil

Question:

1295. Deputy John Brassil asked the Minister for Health the estimated cost to the HSE attributed to the direct management and prevention of diabetes; the estimated indirect cost of complications associated with the disease; and if he will make a statement on the matter. [32488/19]

View answer

Written answers (Question to Health)

I propose to take Questions Nos. 1287 and 1295 together.

As this is a service matter, it has been referred to the Health Service Executive for attention and direct reply to the Deputy.

Hospital Appointments Status

Questions (1288)

John Curran

Question:

1288. Deputy John Curran asked the Minister for Health when a person (details supplied) will be given a date for an appointment to meet a consultant in Tallaght Hospital; and if he will make a statement on the matter. [32480/19]

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Written answers (Question to 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.

Medicinal Products Availability

Questions (1289)

Robert Troy

Question:

1289. Deputy Robert Troy asked the Minister for Health the status of the application for reimbursement for Spinraza for the treatment of spinal muscular atrophy; if he has engaged with the HSE in an effort to advance this process; and if he will make a statement on the matter. [32481/19]

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Written answers (Question to 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. The Act specifies the criteria to be applied in the making of reimbursement decisions which include the clinical and cost effectiveness of the product, the opportunity cost and the impact on resources that are available to the HSE.

As Minister for Health, I do not have any statutory power or function in relation to the reimbursement of medicines.

However, I can advise you that on 11 June 2019, the HSE Leadership Team approved access to the drug Nusinersen (Spinraza) for children with Spinal Muscular Atrophy (SMA) Type I, II or III on an exceptional and individualised basis.

The HSE decision process in relation to Spinraza involved a full Health Technology Assessment followed by detailed consideration by the HSE expert groups on new drug therapies, including the Technology Review Group for Rare Diseases and the Drugs Committee. Evidence of the clinical effectiveness of this new drug therapy was also reviewed.

The recommendation is to approve access for children with genetically confirmed SMA Type I, II or III, in accordance with the controlled access criteria recommended by the Rare Diseases Technology Review Committee. The rare diseases committee recommendation was clearly targeted at the youngest and most severely affected SMA patients, and this group is the clear priority for the HSE. The actual patient assessment and approval process will be the means for determining access on an individual case by case basis.

Medical Aids and Appliances Provision

Questions (1290)

John Brassil

Question:

1290. Deputy John Brassil asked the Minister for Health if insulin pumps are available and reimbursed by the HSE for patients with type 1 diabetes of all age groups; and if he will make a statement on the matter. [32482/19]

View answer

Written answers (Question to 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 Conditions

Questions (1291)

John Brassil

Question:

1291. Deputy John Brassil asked the Minister for Health the estimated prevalence of type 1 diabetes here; the number of continuous glucose monitoring systems and insulin pumps, respectively, in use; and if he will make a statement on the matter. [32483/19]

View answer

Written answers (Question to Health)

As this is a service matter, it has been referred to the Health Service Executive for attention and direct reply to the Deputy.

Medical Aids and Appliances Provision

Questions (1292)

John Brassil

Question:

1292. Deputy John Brassil asked the Minister for Health if continuous glucose monitoring systems are available and reimbursed by the HSE for patients with type 1 diabetes of all age groups; and if he will make a statement on the matter. [32484/19]

View answer

Written answers (Question to 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.

Health Services Data

Questions (1293)

John Brassil

Question:

1293. Deputy John Brassil asked the Minister for Health the number of diabetes education programmes carried out by the HSE or through HSE funding in each of the years 2015 to 2018 and to date in 2019; the average wait times for these education programmes; the number of persons on a waiting list to attend these; and if he will make a statement on the matter. [32485/19]

View answer

Written answers (Question to Health)

As this is a service matter, it has been referred to the Health Service Executive for attention and direct reply to the Deputy.

Medicinal Products Availability

Question No. 1295 answered with Question No. 1287.

Question No. 1296 answered with Question No. 1280.

Questions (1294)

John Brassil

Question:

1294. Deputy John Brassil asked the Minister for Health if the patient and clinician contributions made on a medicine as part of the HSE rare diseases technology review committee work can be used by the National Centre for Pharmacoeconomics to inform the generation of a health technology assessment for the same drug; and if he will make a statement on the matter. [32487/19]

View answer

Written answers (Question to Health)

The Oireachtas has put in place a robust legal framework, in the Health (Pricing and Supply of Medical Goods) Act 2013, to give full statutory powers to the HSE to assess and make decisions on reimbursement of medicines, taking account of a range of objective factors and expert opinion as appropriate. These include the clinical and cost effectiveness of the product, the opportunity cost, the potential or actual budget impact, and the impact on resources that are available to the HSE.

The NCPE are commissioned to conduct a health technology assessment (HTA) by the HSE’s drugs group to inform its decision-making process. The NCPE’s recommendations address three of nine criteria outlined in the 2013 Act including the:

- Efficacy, effectiveness and added therapeutic benefit;

- Cost-effectiveness, and

- Budget impact.

The NCPE initiate patient input by inviting patient organisations to give input to the HTA process through the use of their Patient Organisations Submission of Evidence Template and supporting guide. This enables patient organisations to provide suitable patient and carer input to the assessment of a particular medicine. This information is passed to HSE Drugs Group as part of the HTA report.

A separate expert body that feeds into the HSE’s decision making process, specifically for rare diseases, is the Rare Disease Technology Review Committee (RDTRC). This body meets after the completion of the NCPE’s HTA and is responsible for:

- reviewing proposals received from industry or expert groups in Ireland for funding of new products for rare diseases or expanded indications for existing products for rare diseases; and

- providing contributions to the development of clinical guidelines for relevant Orphan Medicinal Products (OMPs) and supporting the implementation of guidelines in conjunction with the National Drugs Management Programme Office where applicable.

As part of its assessment process the RDTRC provides a platform for patients, families and clinicians to give an input to HSE’s decision making process similarly to the patient input to the HTA process.

Both these independent bodies submit reports to the HSE Drugs Group which helps to inform the HSE’s deliberations on reimbursement decisions inline with the 2013 Act.

Question No. 1295 answered with Question No. 1287.
Question No. 1296 answered with Question No. 1280.

Services for People with Disabilities

Questions (1297)

Robert Troy

Question:

1297. Deputy Robert Troy asked the Minister for Health if the HSE will provide transport services for a person (details supplied). [32492/19]

View answer

Written answers (Question to 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.

Hospital Appointments Status

Questions (1298)

Michael Healy-Rae

Question:

1298. Deputy Michael Healy-Rae asked the Minister for Health the status of an operation for a person (details supplied); and if he will make a statement on the matter. [32493/19]

View answer

Written answers (Question to 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.

Medicinal Products Expenditure

Questions (1299)

Robert Troy

Question:

1299. Deputy Robert Troy asked the Minister for Health the cost-saving initiatives under way through the HSE medicines management programme; the estimated savings potential through each initiative; the planned initiatives to be commenced in 2019; and if he will make a statement on the matter. [32496/19]

View answer

Written answers (Question to Health)

The Health Service Executive has operational responsibility for medicines expenditure and cost saving measures, and so this matter has been referred to the HSE for their attention and direct reply to the Deputy.

Health Services Provision

Question No. 1301 answered with Question No. 1283.

Questions (1300)

Robert Troy

Question:

1300. Deputy Robert Troy asked the Minister for Health the number of diabetes education programmes for blood glucose management carried out by the HSE or through HSE funding in each of the years 2015 to 2018 and to date in 2019, in tabular form; the average wait times for the education programmes; the number of persons on a waiting list to attend same; and if he will make a statement on the matter. [32497/19]

View answer

Written answers (Question to Health)

As this is a service matter, it has been referred to the Health Service Executive for attention and direct reply to the Deputy.

Question No. 1301 answered with Question No. 1283.

Hospital Services

Questions (1302)

John Brady

Question:

1302. Deputy John Brady asked the Minister for Health the services provided at Portiuncula University Hospital, Ballinasloe, County Galway. [32534/19]

View answer

Written answers (Question to Health)

In relation to the particular query raised, as this is a service matter, I have asked the HSE to reply to the Deputy directly.

Hospital Staff Data

Questions (1303)

John Brady

Question:

1303. Deputy John Brady asked the Minister for Health the number of persons employed at Portiuncula University Hospital, Ballinasloe, County Galway. [32535/19]

View answer

Written answers (Question to Health)

In relation to the particular query raised, as this is a service matter, I have asked the HSE to reply to the Deputy directly.

Hospital Beds Data

Questions (1304)

John Brady

Question:

1304. Deputy John Brady asked the Minister for Health the number of beds in use at Portiuncula University Hospital, Ballinasloe, County Galway. [32536/19]

View answer

Written answers (Question to Health)

The number of patients attending Emergency Departments continues to increase year on year, with attendances in 2018 up by 3.5% on 2017. This reflects increasing demand for unscheduled care, especially by patients in the 75 and over age group.

The hospital system is currently operating at close to full capacity.

I am also conscious that waiting times are often unacceptably long and of the burden that this places on patients and their families. In this regard, the Government is committed to improving waiting times for hospital appointments and procedures. The NTPF advise that over recent months they have placed a particular focus on engaging with hospital groups and individual hospitals to identify outpatient waiting list proposals.

With specific regard to the number of beds occupied at Portiuncula Hospital, I have asked the HSE to respond to the Deputy with this information directly.