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Medicinal Products

Dáil Éireann Debate, Tuesday - 8 September 2020

Tuesday, 8 September 2020

Ceisteanna (1131)

Duncan Smith

Ceist:

1131. Deputy Duncan Smith asked the Minister for Health the reason his Department has failed to fund treatment for the hereditary blood disease amyloidosis in the form of patisiran or other relevant treatments which has been utilised as treatment for the disease by the NHS in the UK; and if he will make a statement on the matter. [21422/20]

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Freagraí scríofa

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®) not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments. The HSE engaged in commercial discussions with the company in May 2020 regarding this application. The 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. Patisiran was considered at the additional meeting of the Drugs Group in July 2020. The final HTA report was reviewed by the HSE Drugs Group, along with the outputs of commercial discussions, and the patient group submission received during the HTA processThe decision-making authority in the HSE is the HSE Executive Management Team (EMT). The HSE EMT decides on the basis of all the demands it is faced with (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 Health (Pricing and Supply of Medical Goods) Act 2013The application remains under consideration and will be decided upon in line with the 2013 Act.

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