Written Answers Nos. 1130-1154
1130. Deputy Louise O'Reilly asked the Minister for Health the steps he has taken to implement the recommendations of the report by the Joint Oireachtas Committee on Health on evaluating orphan drugs; and if he will make a statement on the matter. [31809/19]
Amharc ar fhreagraIn March 2018, the Report on Evaluating Orphan Drugs published by the Joint Committee on Health, was received by my Department. The Committee’s report put forward a number of recommendations which were carefully considered by my Department, the Health Service Executive and the National Centre for Pharmacoeconomics.
I am satisfied that 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 all medicines, taking account of a range of objective factors and expert opinion as appropriate. This assessment process has delivered results for the State and Irish patients. In 2019, the HSE has approved 26 new medicines and 5 new uses of existing medicines, 17 of these medicines are for the treatment of rare diseases.
Since the publication of this Report, I am pleased to report that there has been substantial engagement between my Department, the HSE and the NCPE on each of the recommendations, which has resulted in a number of key changes in the HSE assessment process of medicines within the confines of the 2013 Health Act. These have included changes to the HSE Drugs Group, whose membership has now been expanded to include two representatives from the National Patients Forum and more clinical expertise in the area of rare diseases.
In June 2018, the HSE Leadership appointed a Technology Review Committee for Rare Diseases which is responsible for:
1) reviewing proposals received from industry or expert groups in Ireland for funding of new products for rare diseases including orphan drugs, or expanded indications for existing products for rare diseases and making recommendations as to the implementation of the relevant recommendations from the National Rare Diseases Plan 2011-2018; and
2) 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. The Committee’s recommendations for reimbursement of OMPs are not intended to replace any part of the existing medicines appraisal or reimbursement process but rather complement it.
The Committee also recommended the appointment of an independent academic with knowledge of pricing and reimbursement systems and orphan medicines, to conduct a review of the current process and its role in orphan drug availability in Ireland.
My Department has recently completed a tender process for a review of the HSE reimbursement and pricing decision-making process. Mazars has been appointed as the consultancy firm to complete this work. The review will make recommendations, as considered appropriate, in respect of any required improvements to the HSE's systems, structures, processes, governance arrangements or use of specialist resources in respect of the review.
The Committee in its report conveys it support for collaborating with other EU member states. A significant development since the publication of the Committee’s report was the joining of the Beneluxa Initiative on Pharmaceutical Policy in June 2018. This collaboration is supporting my objective of co-operating 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 patient is at the centre of this collaborative international approach. This is a long-term strategy but a strategy that we expect will complement existing domestic policy in this area.
1131. Deputy Louise O'Reilly asked the Minister for Health the new medicines reimbursed by the HSE in 2018, in tabular form; the date on which each medicine secured a positive reimbursement from the HSE drugs group and leadership team if applicable; the date on which each medicine became available for eligible patients here; and if he will make a statement on the matter. [31810/19]
Amharc ar fhreagraThe HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drug schemes, in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013; therefore, the matter has been referred to the HSE for reply to the Deputy.
1132. Deputy Louise O'Reilly asked the Minister for Health the new medicines reimbursed by the HSE in 2019, in tabular form; the date on which each medicine secured a positive reimbursement from the HSE Drugs Group and Leadership Team if applicable; the date on which each medicine became available for eligible patients here; and if he will make a statement on the matter. [31811/19]
Amharc ar fhreagraThe HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drug schemes, in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013; therefore, the matter has been referred to the HSE for reply to the Deputy.
1133. Deputy Louise O'Reilly asked the Minister for Health the status of the research being undertaken by the NCPE into the impact of expanding the criteria for health technology assessment, HTA, assessments for new orphan medicines; and if he will make a statement on the matter. [31812/19]
Amharc ar fhreagraI am advised that the National Centre for Pharmacoeconomics periodically conducts and publishes peer-reviewed research in the area of Health Technology Assessment. This research ensures the methods used are robust and are in line with best practice.
The research referred to is not yet published but has been presented at a recent international conference. The research concluded that broadening the economic perspective of the HTA did not alter the final NCPE reimbursement recommendations for Orphan Medicinal Products included in the study.
I am informed by the NCPE that it is happy to share the final abstract with the Deputy once the research has been published.
1134. Deputy Louise O'Reilly asked the Minister for Health if he or his officials are monitoring the average time taken for new medicines to become available here compared to other EU countries; if he has requested his officials to review whether the current reimbursement process here is a factor in delayed access for Irish patients; and if he will make a statement on the matter. [31813/19]
Amharc ar fhreagraMy Department does not collate data on the average time taken for new medicines to become available in Ireland compared to other European countries.
While Industry likes to quote "league tables" comparing speed of reimbursement in Ireland with other countries, the fact of the matter is that several countries have quite different and often less rigorous statutory assessment arrangements then Ireland. Furthermore, many of the newer products being licensed are falling well short of cost-effectiveness thresholds, with limited clinical benefits.
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.
In line with the 2013 Act, if a company would like a medicine to be reimbursed by the HSE pursuant to the Community Drugs scheme, the company must first submit an application to the HSE to have the new medicine added to the Reimbursement List.
As outlined in the IPHA agreement, and in line with the 2013 Act, the HSE will decide, within 180 days of receiving the application (or a longer period if further information is sought from the company), to either add the medicine to the reimbursement list or agree to reimburse it as a hospital medicine, or refuse to reimburse the medicine.
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 NCPE conducts health technology assessments (HTAs) for the HSE, and makes recommendations on reimbursement to assist HSE decisions. The NCPE uses a decision framework to systematically assess whether a drug is cost-effective as a health intervention.
The process for assessing applications works very well where the new medicines have strong evidence of clinical effectiveness and are priced in a cost effective manner. Delays in reimbursement decisions for new products do occur in cases where the evidence of clinical effectiveness is weak, and where prices are set well outside of cost effectiveness parameters. The HSE strives to reach a decision in as timely a manner as possible. However, because of the significant monies involved in many of these applications, it must ensure the best price is achieved, as these commitments are often multi-million euro investments on an ongoing basis. This can lead to a protracted deliberation process.
In line with the 2013 Health Act, the HSE is obliged to ensure that any new drug has sufficient clinical benefit to justify using it and that it is affordable and the best use of finite health resources. In 2019 to date, the HSE has approved 26 new medicines and 5 new uses of existing medicines. 17 of these medicines are for the treatment of rare diseases. As the Deputy will be aware, It is extremely rare for a medicine to be refused reimbursement in Ireland.
My Department and the HSE are working on making greater efficiencies in medicines usage through a range of initiatives internationally and domestically to ensure the greatest possible access to new treatments for patients in Ireland. In June 2019, Ireland became a Founding Member of the International Horizon Scanning Initiative which is being established as part of the work programme of the Beneluxa Initiative on Pharmaceutical Policy.
1135. Deputy Louise O'Reilly asked the Minister for Health the terms of reference for decision making by the HSE’s enzyme replacement therapy committee; the frequency with which the committee meets; the funding available for providing therapies to eligible patients; and if he will make a statement on the matter. [31814/19]
Amharc ar fhreagraAs the HSE has responsibility for this matter, I have asked the HSE to respond directly to the Deputy on this issue.
1136. Deputy Louise O'Reilly asked the Minister for Health the budget available to severe asthma centres for the provision of anti-IL5 inhibitor treatment to eligible patients that meet the criteria of the national severe asthma network; if he is satisfied a sufficient budget has been provided to meet the full eligible patient population; and if he will make a statement on the matter. [31815/19]
Amharc ar fhreagraAs this is a service matter, it has been referred to the Health Service Executive for attention and direct reply to the Deputy.
1137. Deputy Louise O'Reilly asked the Minister for Health the funding streams available for an organisation (details supplied). [31816/19]
Amharc ar fhreagraAs this is a service matter, it has been referred to the Health Service Executive for attention and direct reply to the Deputy.
1138. Deputy Louise O'Reilly asked the Minister for Health if an organisation (details supplied) can access funding under the Healthy Ireland fund. [31817/19]
Amharc ar fhreagraThe primary aim of the Healthy Ireland Fund is to support innovative, cross-sectoral, evidence-based projects and initiatives that support the implementation of key national policies in areas such as obesity, smoking, alcohol, physical activity and sexual health. The Fund has focused on the creation of partnerships and to mobilise action at local level across nationally supported thematic areas.
The process to allocate the third round of the Healthy Ireland Fund is currently underway. The Fund will be distributed via two strands. Strand one is allocated through Local Community Development Committees (LCDCs) and Children and Young People’s Services Committees (CYPSCs). At present each LCDC and CYPSC will be in the process of locally agreeing a programme of work to be finalised in September. Strand two is a closed call for funding and the Department has identified and invited statutory agencies to apply to implement discrete and specific actions that align with Healthy Ireland.
I would encourage the organisation identified to contact the various CYPSC and LCDC to see if they can collaborate with them to realise actions at local level.
1139. Deputy Margaret Murphy O'Mahony asked the Minister for Health the number of children’s disability network teams now established by CHO. [31825/19]
Amharc ar fhreagraThe Government is committed to providing services and supports for people with disabilities which will empower them to live independent lives, provide greater independence in accessing the services they choose, and enhance their ability to tailor the supports required to meet their needs and plan their lives. This commitment is outlined in the Programme for Partnership Government, which is guided by two principles: equality of opportunity and improving the quality of life for people with disabilities.
As the Deputy's question relates to service matters, I have arranged for the question to be referred to the Health Service Executive (HSE) for direct reply to the Deputy.
1140. Deputy Margaret Murphy O'Mahony asked the Minister for Health the number of new persons with disabilities who commenced respite services for intellectual disability, autism, physical and sensory disability to date in 2019. [31826/19]
Amharc ar fhreagra1141. Deputy Margaret Murphy O'Mahony asked the Minister for Health the number of persons with a disability formally discharged from respite services for intellectual disability, autism, physical and sensory disability to date in 2019. [31827/19]
Amharc ar fhreagraI propose to take Questions Nos. 1140 and 1141 together.
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.
The Programme for Partnership Government states that the Government wishes to provide more accessible respite care to facilitate full support for people with a disability.
As the Deputy's questions relate to service matters, I have arranged for the questions to be referred to the Health Service Executive (HSE) for direct reply to the Deputy.
1142. Deputy Margaret Murphy O'Mahony asked the Minister for Health the number of persons with disabilities who have been accepted for rehabilitative training but will not now receive the rehabilitative training allowance by CHO in tabular form. [31828/19]
Amharc ar fhreagraThe Government is committed to providing services and supports for people with disabilities which will empower them to live independent lives, provide greater independence in accessing the services they choose, and enhance their ability to tailor the supports required to meet their needs and plan their lives. This commitment is outlined in the Programme for Partnership Government, which is guided by two principles: equality of opportunity and improving the quality of life for people with disabilities.
As the Deputy's question relates to service matters, I have arranged for the question to be referred to the Health Service Executive (HSE) for direct reply to the Deputy.
1143. Deputy Margaret Murphy O'Mahony asked the Minister for Health the estimated savings in 2019 from the abolition of the rehabilitative training allowance; and the estimated full-year cost of excluding new entrants from it in 2019. [31829/19]
Amharc ar fhreagraThe HSE’s New Directions policy seeks to reconfigure and personalise HSE funded adult day services to offer a flexible and individualised set of supports to enable each person to live a life of their choosing in accordance with their own wishes and needs.
Rehabilitative Training (RT) Programmes are designed to equip participants with basic personal, social and work-related skills. Approximately 2,300 people attend RT programmes, with 400 new attendees due to start this coming September. Payable in addition to Disability Allowance, the RT Bonus payment is currently payable at a rate of €31.80 per week to attendees of these RT Programmes, who can attend for a period of up to 4 years. The RT Bonus was introduced in 2001, aligned with a similar FÁS Training Bonus. This FÁS Training Bonus later became the Solas Vocational Training Programme payment, which was reduced in 2011 and discontinued in 2012.
Over the next four years, from September 2019, the RT Bonus will not apply to new attendees. The money that would have been spent on the bonus, estimated at approximately €3.7 million over the four years, will be redirected to address unmet need in day service provision for people with disabilities. This measure will have no impact on current participants as their payments will continue until they complete their 4 year programme. Importantly, the phasing out of the RT Bonus will mean that HSE Community Healthcare Organisations will have some funding to reallocate towards increasing the number of days per week available to those who did not receive a full service during the recession, or who are on a waiting list for a day service.
The phasing out of this Bonus payment by the HSE will ensure more people have access to a day service on an equitable basis, consistency in treatment of all day service users and maximise the use of finite resources.
1144. Deputy Margaret Murphy O'Mahony asked the Minister for Health when he was informed of the decision to close the rehabilitative training allowance for persons with disabilities due to start rehabilitative training in 2019; if he approved the decision; and if he will make a statement on the matter. [31830/19]
Amharc ar fhreagraThe HSE provide Day Services, including Rehabilitative Training, to over 27,000 people. Presently, approximately 2,300 of these people attend Rehabilitative Training for a period of 4 years and can receive a weekly bonus of up to €31.80 per week while participating. This bonus payment was introduced in 2001, aligned with a similar FÁS Training Bonus, which has since been discontinued.
There was minimal or no investment in Day Services during the recession, which resulted in a number of people receiving a part time Day Service or no Day Service at all. From 2015 onwards, there has been annual investment in Day Services for school leavers and those exiting RT programmes, but no investment to support those who had received a reduced level of Day Services in earlier years.
Government’s priority is to provide access to high quality day services to as many people with disabilities as possible. As Minister for Persons with Disabilities, I approved the discontinuing of the RT Bonus Payment for new entrants from September 2019 on 12th March 2019. Savings from the RT Bonus payment are to be used to invest in Day Services and supports for people with disabilities who currently have a partial Day Service or no Day Service. The current recipients of the RT Bonus will not be affected and their payments will continue until they complete their 4 year programme.
It should be noted that most people with disabilities are now in receipt of the Disability Allowance paid through the Department of Social Protection. Historically, this allowance was not available to all persons attending RT. The removal of the RT Bonus will bring equity and consistency between people with a disability attending HSE RT schemes and trainees, including those with a disability, in other State schemes such as further education and training schemes and importantly provide a service to individuals who have reduced or no service.
1145. Deputy Charlie McConalogue asked the Minister for Health the status of the assessment of Acarizax under the provision of the community drugs scheme; and if he will make a statement on the matter. [31837/19]
Amharc ar fhreagraUnder 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.
1146. Deputy Louise O'Reilly asked the Minister for Health further to Parliamentary Question No. 870 of 8 May 2019, the specific cost of the building of the private clinic at the new national children’s hospital; and the way in which it is intended that the State will recuperate this money. [31851/19]
Amharc ar fhreagraThe presence of a private suite allows Children’s Health Ireland to meet the contractual obligations of the consultants who are working on public/private contracts as per national healthcare policy.
There are private clinics currently located on the grounds of each the existing three children’s hospitals.
The private outpatient clinic at the new children’s hospital represents circa 0.25% of the clinical space within the new children’s hospital. There are a total of 129 outpatient clinical exam rooms primarily accessed off the main concourse on the ground and lower ground floor of the new children’s hospital, each of which are identical in design and fit out. There are 8 clinical exam rooms in the private outpatient clinic.
The private outpatients clinic is located adjacent to the south entrance (Rialto Luas Stop) on the ground floor of the hospital. Patients for all clinics will check in to the same reception areas in the main concourse and will be directed to a number of shared outpatient main wait areas. Once called to be seen, the patient will access the private outpatient clinic via a doorway from the shared outpatient main wait area. Patients will access the private outpatient clinic from the concourse, as outlined above, and not from a separate external entrance. There will not be an independent, external entrance/exit to the clinic.
Ultimately, the proposal is for consultants to pay a fee for use of the rooms and other operational costs. The proposed level of fee has not been determined yet.
1147. Deputy Shane Cassells asked the Minister for Health his plans to extend the availability of a device (details supplied) to diabetes patients over 21 years of age on the long-term illness scheme. [31853/19]
Amharc ar fhreagraUnder 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.
1148. Deputy Michael Healy-Rae asked the Minister for Health if a hoist will be provided for a person (details supplied); and if he will make a statement on the matter. [31878/19]
Amharc ar fhreagraAs this is a service matter it has been referred to the HSE for reply to the Deputy.
1149. Deputy Michael Healy-Rae asked the Minister for Health the status of the supply of medical equipment for a person (details supplied); and if he will make a statement on the matter. [31879/19]
Amharc ar fhreagraAs this is a service matter it has been referred to the HSE for reply to the Deputy.
1150. Deputy Timmy Dooley asked the Minister for Health when a person (details supplied) in County Clare will receive a confirmation date of when treatment will commence; and if he will make a statement on the matter. [31880/19]
Amharc ar fhreagraUnder 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.
1151. Deputy Robert Troy asked the Minister for Health if an appointment will be scheduled for a person (details supplied) through the National Treatment Purchase Fund. [31882/19]
Amharc ar fhreagraThe National Treatment Purchase Fund (NTPF) works with public hospitals, as opposed to with patients directly, to offer and provide the funding for treatment to clinically suitable long waiting patients who are on an inpatient/day case waiting list for surgery, having been referred on to such a list following clinical assessment by a consultant/specialist at an outpatient clinic.
The key criteria of the NTPF is the prioritisation of the longest waiting patients first. While the NTPF identifies patients eligible for NTPF treatment, it is solely on the basis of their time spent on the Inpatient/Daycase Waiting List. The clinical suitability of the patient to avail of NTPF-funded treatment is determined by the public hospital.
In relation to the patient's appointment in Midlands Regional Hospital Tullamore, as this is a service matter, I have asked the HSE to respond to the Deputy directly.
1152. Deputy Eoin Ó Broin asked the Minister for Health the waiting lists for CAMHS in CHO 7 by wait times of three, six, nine, 12, 18 and 24 months, respectively. [31913/19]
Amharc ar fhreagraAs this is a service matter I have asked the Health Service Executive to respond directly to the Deputy as soon as possible.
1153. Deputy Eoin Ó Broin asked the Minister for Health the staffing levels for CAMHS in CHO 7 compared with recommended levels in A Vision for Change. [31914/19]
Amharc ar fhreagraAs this is a service matter I have asked the Health Service Executive to respond directly to the Deputy as soon as possible.
1154. Deputy Eoin Ó Broin asked the Minister for Health the amount spent by the HSE on taxis in CHO 7 in each of the years 2016 to 2018 and to date in 2019. [31915/19]
Amharc ar fhreagraAs this is a service matter I have asked the HSE to respond directly to the Deputy as soon as possible.
