Dáil Éireann Debate, Tuesday - 22 September 2020
813. Deputy Pádraig Mac Lochlainn asked the Minister for Health if his attention has been drawn to calls by persons living with amyloidosis to take actions (details supplied) with reference to the HSE amyloidosis working group; and if he will make a statement on the matter. [25384/20]
View answerThe 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. The HSE continues to receive and process pricing and reimbursing applications during the COVID-19 crisis.
In line with the 2013 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.
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 whether a drug is cost-effective as a health intervention.
I am advised by the HSE that it has received an application for the reimbursement of patisiran (Onpattro®) for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.
In January 2019, a full HTA was commissioned by the HSE. This assessment was completed in February 2020, with the NCPE recommending that patisiran not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments.
The HSE Drugs Group is the national committee in place to make recommendations on the pricing and reimbursement of medicines. The decision-making authority in the HSE is the HSE Executive Management Team (EMT).
The HTA report with respect to patisiran was reviewed by the HSE Drugs Group, along with the outputs of commercial discussions with the applicant which took place in May 2020, and the patient group submission received during the HTA process.
The HSE Drugs Group have requested Patient and Clinician Engagement input via the Rare Diseases Technology Review Committee (RDTRC) to assist the group in making its recommendation to the HSE EMT regarding reimbursement of patisiran. The application for patisiran remains under consideration with the HSE and is being assessed in line with the 2013 Health Act.
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, taking account of a range of objective factors and expert opinion as appropriate.
The 2013 Act requires the HSE to have regard to both the clinical benefits and cost effectiveness. While the 2013 Health Act does not include provision for a different ruleset when assessing orphan drugs, the HSE seeks as far as possible to take into account issues such as the small patient numbers and the nature of the condition to be treated when evaluating these medicines. The criteria that apply to the evaluation process allow sufficient scope for the HSE to take on board the particular circumstances that pertain to orphan drugs.
I am pleased to report that there has been a number of key changes in the HSE assessment process of medicines within the confines of the 2013 Health Act. These have included changes to the HSE Drugs Group, whose membership has been expanded to include two representatives from the National Patients Forum and more clinical expertise in the area of rare diseases.
In June 2018, the HSE Leadership appointed a Technology Review Committee for Rare Diseases (RDTRC) which is responsible for:
1) reviewing proposals received from industry or expert groups in Ireland for funding of new products for rare diseases including orphan drugs, 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 HSE has advised that, due to COVID-19 pressures, the RDTRC has not met in recent months. However, meetings are planned for in quarter 3 of 2020 at which time the Committee’s terms of reference will be reviewed. The updating of membership is currently underway.
Regarding a national programme or model of care for Irish patients with amyloidosis as mentioned by the Deputy, I have referred the question to the HSE for direct response, as the HSE would have operational responsibility for any such programme.
