James Browne
Question:388. Deputy James Browne asked the Minister for Health the position regarding the creation of the rare disease technology review committee; and if he will make a statement on the matter. [46871/18]
View answerTuesday, 13 November 2018
Questions (388)
Written answers
In June 2018, the HSE Leadership agreed to the appointment of a Technology Review Committee for Rare Diseases which is now operational and has already completed work in relation to orphan products.
The Technology Review Committee for Rare Diseases is responsible 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 Orphan Medicinal Products are not intended to replace any part of the existing medicines appraisal or reimbursement process. The recommendations will be informed by a Health Technology Assessment (HTA) submission, or similar, by the National Centre for Pharmacoeconomic Evaluation (NCPE) or other body, Committee discussion, and guidelines developed by the relevant clinical group/Clinical Lead of Centre of Expertise.
The recommendations of this Committee will be based on the degree of unmet clinical need, clinical effectiveness, alternative therapies available, toxicity (where relevant) and the cost effectiveness of the proposed technology. These criteria are based on Schedule 3, Part 3 of the Health (Pricing and Supply of Medical Goods) Act 2013.
The creation of the Technology Review Committee for Rare Diseases is intended to provide a greater balance and transparency to the assessment process. The inclusion of two public/patient representatives from a selected panel of three is in recognition of the concept that there is a value of opportunity to have representation on the Committee from this cohort. As well as examining the methodologies for assessing orphan drugs, it will also consider the views of patients, caregivers and at the wider issues that go into health technology assessments.