Tuesday, 28 July 2020
Department of Health
Cross-Border Health Initiatives
1045. To ask the Minister for Health if he will consider the EU cross border health directive as a vehicle in the short term for funding of amyloidosis; the time frame for the ultimate funding of amyloidosis; and if he will make a statement on the matter. [18906/20]
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. The Act specifies the criteria for decisions on the reimbursement of medicines.
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 health technology assessment was commissioned by the HSE. This assessment was completed in February 2020 with the NCPE recommending that patisiran (Onpattro®) is not considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments.
The HTA report will be an important input into the decision making processes of the HSE. The HSE is currently reviewing the report received and has recently met with the applicant company to discuss this.
Once negotiations between the HSE and the applicant company are complete, this application must then be formally considered by the HSE Drugs Group. 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 decision making authority in the HSE is the HSE Executive Management Team.
In general, the HSE's Treatment Abroad Scheme (TAS) does not provide access to drug therapies which are not provided (funded) by the public healthcare system in Ireland. However, I am advised by the HSE that in the case of treatments provided by the National Amyloidosis Centre at the Royal Free Hospital in London a patient can make an application to the TAS. Each application is dealt with by the HSE on an individual basis and subject to independent medical advice.