Peter Burke (Longford-Westmeath, Fine Gael)
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819. To ask the Minister for Health the status of the licensing of patisiran for the effective treatment of nerve damage in view of the circumstances of a person (details supplied) and in further view of fact the drug is licensed in the UK and Northern Ireland. [14314/20]

Stephen Donnelly (Wicklow, Fianna Fail)
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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.

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 licensed indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority.

In making a relevant reimbursement decision, the HSE is required under the Act to have regard to a number of criteria including the health needs of the public, cost effectiveness, potential or actual budget impact and efficacy.

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.