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Tuesday, 20 Feb 2018

Written Answers Nos. 328-343

Medical Aids and Appliances Provision

Questions (328)

Patrick O'Donovan

Question:

328. Deputy Patrick O'Donovan asked the Minister for Health if a matter (details supplied) will be addressed regarding the FreeStyle Libre device; and if he will make a statement on the matter. [8244/18]

View answer

Written answers

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

Questions (329)

James Lawless

Question:

329. Deputy James Lawless asked the Minister for Health the status of an application by a person (details supplied); and if he will make a statement on the matter. [8246/18]

View answer

Written answers

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

Medicinal Products Availability

Questions (330)

James Browne

Question:

330. Deputy James Browne asked the Minister for Health the reason the eye medication Macushield has been withdrawn from medical card holders; if a substitute medication will be made available; and if he will make a statement on the matter. [8247/18]

View answer

Written answers

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)

Robert Troy

Question:

331. Deputy Robert Troy asked the Minister for Health if a date for surgery in the Royal Victoria Eye and Ear Hospital for a person (details supplied) will be expedited. [8248/18]

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Written answers

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, 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.

Hospital Appointments Status

Questions (332)

Barry Cowen

Question:

332. Deputy Barry Cowen asked the Minister for Health when a person (details supplied) will receive a hospital appointment. [8249/18]

View answer

Written answers

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, 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

Questions (333)

Mary Butler

Question:

333. Deputy Mary Butler asked the Minister for Health the circumstances that determined the decision to change the way in which Versatis patches can now be prescribed and approved; the steps he is taking to have the scheme clarified; the steps being taken to provide a replacement therapy when and as required; the associated costs of the patches in view of the fact that they vary based on need and or demographics; and if he will make a statement on the matter. [8250/18]

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Written answers

Medicines play a vital role in improving the health of Irish patients. Securing access to existing and new and innovative medicines is a key objective of the  health service. However, the challenge is to do this in an affordable and sustainable manner. The medicines bill for the community drugs schemes – primarily the GMS, Long Term Illness and Drugs Payment schemes and the High Tech Arrangement – was approximately €1.8 billion in 2017.

To ensure patients receive the highest quality care, resources invested in medicines must be used efficiently and effectively. This requires an integrated approach to secure best value for money for all treatments, greater efficiencies in the supply chain and the use of the most cost-effective treatments.

Lidocaine 5% medicated plaster is licensed for the symptomatic relief of neuropathic pain associated with previous herpes zoster (shingles) infection, known as post-herpetic neuralgia (PHN), in adults. It has been reimbursed in the community drugs schemes since 2010. The projected budget impact on introduction was low due to the specific licensed indication but total expenditure trebled between 2012 and 2016, from €9.4 million to over €30 million, mainly from off-license use for pain not associated with shingles.

An HSE Medicines Management Programme (MMP) review of this product highlighted that the clinical evidence for its use in PHN is limited due to lack of comparative data, and its value is uncertain for other types of pain. The National Centre for Pharmacoeconomics estimated that, in Ireland, only 5-10% of prescribing of this product has been for the licensed indication of PHN.

Following the MMP review, the HSE introduced a new reimbursement system for the product from 1 September 2017. This process supports its appropriate use, ensuring that PHN patients continue to receive this treatment.

Under the protocol, all patients who were receiving antivirals for shingles were automatically approved for the lidocaine medicated plaster. No action was required by GPs and the patient’s pharmacy was notified of his or her approval status.

However, since 1 December 2017, non-shingles patients no longer automatically receive this item under the community drugs schemes. In August 2017 the HSE advised GPs of the changes and of treatment alternatives.

It is possible for non-shingles patients to be approved for the patch through the community drug schemes. The patient's GP should apply to the Medicines Management Programme through the online system, and the MMP will review the application and inform the GP of its decision.

I am advised that the MMP has received over 4,500 applications from GPs, of which some 10% have been approved.  For many of the conditions applied for, prescribing of the patch was inappropriate, for example for conditions such as deep venous thrombosis, angina, gout and endometriosis.

Where a GP’s application is rejected, it may be appealed.  Of some 250 appeals to date, the HSE advises that over 60% have been accepted on clinical grounds.

Full details of the review are available on the HSE website at http://hse.ie/eng/about/Who/clinical/natclinprog/medicinemanagementprogramme/yourmedicines/lidocaine-plaster/lidocaine-medicated-plaster.html.

This decision is a matter for the HSE. However, I fully support the objectives of the HSE Medicines Management Programme.

Primary Medical Certificates Applications

Questions (334)

Bernard Durkan

Question:

334. Deputy Bernard J. Durkan asked the Minister for Health when a primary medical certificate will issue to a person (details supplied); and if he will make a statement on the matter. [8255/18]

View answer

Written answers

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

Prescriptions Charges

Questions (335)

Catherine Connolly

Question:

335. Deputy Catherine Connolly asked the Minister for Health his plans to address issues in regard to persons overpaying prescription charges (details supplied) whereby multiple prescription charges are applied to various strengths of the same product; and if he will make a statement on the matter. [8263/18]

View answer

Written answers

My Department is aware of the issues raised by the Deputy, and has been considering the position in relation to the possible need for legislative change to address potential anomalies in the application of the prescription charge.

Question No. 336 answered with Question No. 300.

Hospital Appointments Status

Questions (337)

Eugene Murphy

Question:

337. Deputy Eugene Murphy 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. [8291/18]

View answer

Written answers

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, 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.

Health Services Access

Questions (338)

Niamh Smyth

Question:

338. Deputy Niamh Smyth asked the Minister for Health the reason a person (details supplied) cannot receive an appointment in their local health centre; and if he will make a statement on the matter. [8293/18]

View answer

Written answers

As this question relates to a service matter, I have arranged for the question to be referred to the Health Service Executive for direct reply to the Deputy.

Speech and Language Therapy Provision

Questions (339)

Tony McLoughlin

Question:

339. Deputy Tony McLoughlin asked the Minister for Health if consideration will be given to granting a school (details supplied) in County Sligo additional speech and language therapy resources; and if he will make a statement on the matter. [8295/18]

View answer

Written answers

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.

Orthodontic Services Waiting Lists

Questions (340)

Niamh Smyth

Question:

340. Deputy Niamh Smyth asked the Minister for Health the reason a person (details supplied) is waiting over a year for orthodontic treatment in a Drogheda hospital. [8315/18]

View answer

Written answers

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

Hospital Appointments Status

Questions (341)

Martin Ferris

Question:

341. Deputy Martin Ferris 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. [8316/18]

View answer

Written answers

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, 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 Aids and Appliances Provision

Questions (342)

Tony McLoughlin

Question:

342. Deputy Tony McLoughlin asked the Minister for Health his plans to ensure persons with type 1 diabetes are entitled to obtain free access to a device (details supplied); if his attention has been drawn to the fact that all type 1 diabetics in the UK are entitled to this device; and if he will make a statement on the matter. [8318/18]

View answer

Written answers

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

Questions (343)

Bobby Aylward

Question:

343. Deputy Bobby Aylward asked the Minister for Health if his attention has been drawn to reports emerging of potential health risks in regard to the use of an enzyme (details supplied) in the manufacturing of a vaccine. [8322/18]

View answer

Written answers

The Health Products Regulatory Authority (HPRA) is responsible for monitoring the safety and quality of all medicines including vaccines that are licensed in Ireland. I am informed by the HPRA that the enzyme thiaminase is not added during the manufacture of Gardasil HPV vaccine and is not used as an ingredient in the final medicine. Like all other medicines manufactured using cell technologies, trace amounts of residual proteins from these cells, which would include any residual thiaminase, may be present in the final Gardasil product. Gardasil meets EU regulatory requirements by limiting these proteins to microgram amounts at which level they have no discernible effect. Prior to each batch being placed on the market, testing is carried out to confirm that the level of residual proteins is less than the specified limit.

Other medicinal products manufactured using such cells, including some insulin products, are used daily and over a long duration (often years), compared to Gardasil which is administered once or a maximum of three times.

Gardasil is approved centrally by the European Commission, acting on the recommendation of the European Medicines Agency, for all EU Member States.

Most instances of thiamine deficiency appear to be as a result of lack of dietary intake and/or in instances of intake of foods rich in thiaminase. Neither scenario applies to Gardasil or other medicines manufactured using similar cell technology.

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