Dáil Éireann Debate, Tuesday - 5 July 2022
613. Deputy David Cullinane asked 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]
Amharc ar fhreagraThe 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.
