David Cullinane (Waterford, Sinn Fein)
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611. To ask the Minister for Health the total spend by the HSE on the reimbursement of medicines, and by each medicine, in each of the years 2016 to 2021 and to date in 2022; and if he will make a statement on the matter. [35332/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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As this is a service matter, I have asked the Health Service Executive to respond to the deputy directly, as soon as possible. 

David Cullinane (Waterford, Sinn Fein)
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612. To ask the Minister for Health the number of new medicines added to the reimbursement scheme from 2016 to 2021 and to date in 2022, broken down by year and the cost for each new medicine; and if he will make a statement on the matter. [35333/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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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.

David Cullinane (Waterford, Sinn Fein)
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613. To ask the Minister for Health the formal processes in place which govern applications for the pricing and reimbursement of medicines and new uses of existing medicines to be funded and-or reimbursed; and if he will make a statement on the matter. [35334/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.

In line with the 2013 Health Act and the national framework agreed with industry, a company must submit an application to the HSE to have a new medicine added to the reimbursement list.

Reimbursement is for licenced indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority.

In making a relevant reimbursement decision, the HSE is required under the Act to have regard to a number of criteria including efficacy, the health needs of the public, cost-effectiveness and potential or actual budget impact.

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 a drug's clinical and cost effectiveness as a health intervention.

To facilitate increased patient involvement during the HTA process, the NCPE promotes a patient submission which provides an opportunity for the views and experience of patients, carers and their families to be considered as part of the assessment of a particular medicine. The NCPE provides the full patient submission to the CPU as part of the documentation for consideration by the HSE Drugs Group. 

In 2018, the Technology Review Committee for Rare Diseases (RDTRC) was introduced by HSE Leadership (as recommended by the National Rare Disease Plan for Ireland) with responsibility for:  

1. 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 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 to complement it.

The Rare Diseases Technology Review Committee also facilitates the input of patient and clinician perspectives to assist the Drugs Group in its reimbursement recommendations to the HSE Executive Management Team (EMT). 

The HSE Drugs Group is the national committee which the HSE has in place to make recommendations on the pricing and reimbursement of medicines. The membership of the HSE Drugs Group includes public interest members and clinicians.

The Drugs Group considers the NCPE assessment, the outputs from commercial engagements, patient interest group submissions, and any other pertinent information in advance of providing its recommendation to the HSE EMT.

The HSE EMT is the decision-making body for the reimbursement of medicines under the Health Act 2013 and it will, following receipt of the outcome of the Drugs Group's deliberations, make the decision on whether a given medicine will be approved for reimbursement. The HSE EMT decides on the basis of all the demands with which it is faced (across all services) whether it can fund a new medicine, or new uses of an existing medicine, from the resources that have been provided to it in line with the 2013 Health Act.

David Cullinane (Waterford, Sinn Fein)
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614. To ask the Minister for Health if he or his Department has carried out any review of the processes in place which govern applications for the pricing and reimbursement of medicines and new uses of existing medicines to be funded and-or reimbursed since 2016; and if he will make a statement on the matter. [35335/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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Following a tender by the Office of Government Procurement, Mazars conducted a review of the governance structures around the HSE's drug reimbursement process. The report was submitted to my Department in January 2020.

The review made recommendations in respect of the HSE’s systems, structures, processes, governance arrangements and use of specialist resources in respect of the drug reimbursement process.

The report was under consideration by officials, however the focus of the Department of Health changed to the immediate public health considerations of the COVID-19 pandemic and the preservation of life. This meant that this work stream was suspended to reallocate resources to support essential services.

My Department aims to complete its consideration of the report’s recommendations when resources permit.

David Cullinane (Waterford, Sinn Fein)
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615. To ask the Minister for Health the number of rapid review dossiers submitted to the HSE from 2016 to date, broken down by the number of dossiers presented that were successful and unsuccessful in the medicines contained in the dossiers being added to the reimbursement scheme; and if he will make a statement on the matter. [35336/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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The 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.