James Browne
Question:389. Deputy James Browne asked the Minister for Health his plans to change the assessment criteria of orphan drugs; and if he will make a statement on the matter. [46872/18]
View answerTuesday, 13 November 2018
Questions (389)
Written answers
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 medicines. The Act specifies the criteria for decisions on the reimbursement of medicines.
The 2013 Act requires the HSE to have regard to both the clinical benefits and cost effectiveness but it does not include provision for a different ruleset when assessing orphan drugs. It would take an act of the Oireachtas to change the current assessment process for medicines. However, both the National Centre of Pharmacoeconomics (NCPE) and the HSE are mindful of the differences and challenges in terms of patient numbers when assessing this type of medicine.
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.
There has been substantial engagement between the Department, the HSE and the NCPE over the last number of months which has resulted in a number of key changes in the HSE assessment process of medicines within the confines of the 2013 Health Act.
Technology Review Committee for 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, 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 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 patient representation on the Committee. As well as examining the methodologies for assessing orphan drugs, it will also consider the views of patients, caregivers and the wider issues that go into health technology assessments.
This Committee is operational and has already completed work in relation to orphan products.
HSE Drugs Group
The composition of the HSE Drugs Group has recently been expanded to include two representatives from the National Patients Forum and more clinical expertise in the area of rare diseases.
In all of the above circumstances, I do not purpose to bring forward proposals to change the assessment criteria for orphan drugs, which would require the approval of the Oireachtas.