Joan Collins
Ceist:666. Deputy Joan Collins asked the Minister for Health when the drug kaftrio for cystic fibrosis patients will be approved for funding for use in Ireland. [23256/21]
Amharc ar fhreagraWednesday, 5 May 2021
Ceisteanna (666)
Freagraí scríofa
The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes and for the administration of the community drug schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.
Reimbursement is for licensed indications which have been granted market authorisation by the European Medicines Agency (EMA) or the Health Products Regulatory Authority.
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.
The HSE has advised that reimbursement under the High-Tech Drug Arrangements was approved in October 2020 for Ivacaftor/ Tezacaftor/ Elexacaftor (Kaftrio) in a combination regimen with ivacaftor 150 mg tablets for the treatment of cystic fibrosis (CF) in patients aged 12 years and older who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or heterozygous for F508del in the CFTR gene with a minimal function (MF) mutation. This reimbursement approval is fully aligned with the initial EMA market authorisation which issued on 21 August 2020.
The HSE advises that, the week beginning 26 April 2021, the European Commission approved the EMA's recommended licence extension of Kaftrio for patients aged 12 years and older with Cystic Fibrosis who have at least one F508del mutation.
In line with agreed formal processes governing the reimbursement of new medicines or new indications of existing medicines in Ireland, the assessment process commences when the applicant company submits a rapid review dossier of evidence to the HSE. The HSE has confirmed that it has received a rapid review dossier for the extended indication of Kaftrio from the applicant company.
The application remains under consideration with the HSE and a decision will be made in line with the 2013 Act.