Dáil Éireann Debate, Tuesday - 27 July 2021
2611. Deputy Pádraig O'Sullivan asked the Minister for Health the details of the recommendation made by the HSE drugs group in its May 2021 meeting regarding the reimbursement of patisiran; and if he will make a statement on the matter. [38387/21]
Amharc ar fhreagra2613. Deputy Pádraig O'Sullivan asked the Minister for Health when the HSE executive management team will meet to consider the recommendation of the drugs group regarding the reimbursement application of patisiran; when the treatment will be made available to patients in Ireland; and if he will make a statement on the matter. [38397/21]
Amharc ar fhreagraI propose to take Questions Nos. 2611 and 2613 together.
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 Health 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. 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 HSE has advised that it received an application in December 2018 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 (HTA) with respect to this indication 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 could be improved relative to existing treatments.
On 22 June 2021, following extensive engagement by the HSE with the applicant company, the HSE Executive Management Team considered the HSE Drugs Group recommendation with respect to Patisiran and have supported hospital pricing approval for the drug, subject to the implementation of a managed access programme.
The HSE further advises that they will now develop and implement the required managed access programme, in order for all eligible patients with hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) with stage 1 or stage 2 polyneuropathy to access treatment with Patisiran in the near future.
