Peadar Tóibín
Ceist:617. Deputy Peadar Tóibín asked the Minister for Health if a drug will be released to a person (details supplied); and if he will make a statement on the matter. [4596/20]
Amharc ar fhreagraWednesday, 13 May 2020
Ceisteanna (617)
Freagraí scríofa
The HSE has statutory responsibility for medicine pricing and reimbursement decisions in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013 which specifies the criteria for decisions on the reimbursement of medicines. The 2013 Act does not give the Minister for Health any powers in this regard. The HSE does not require approval or consent from the Minister or Government when making a reimbursement decision. As Minister for Health, it would be inappropriate for me to comment on individual cases.
In line with the 2013 Health Act and the national framework agreed with industry, if a company would like a medicine to be reimbursed by the HSE, the company must submit an application to the HSE to have the 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.
I am advised by the HSE that it has received two applications for the reimbursement of Osimertinib (Tagrisso):
1) The treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive non-small cell lung cancer (NSCLC). In May 2018, the NCPE recommended that osimertinib not be considered for reimbursement for this indication unless cost-effectiveness can be improved relative to existing treatments. The application has had a positive recommendation from the HSE Drugs Committee and is currently under consideration by the HSE in line with the 2013 Health Act.
2) The first-line treatment of adult patients with locally advanced or metastatic NSCLC with activating epidermal growth factor receptor (EGFR) mutations.
In respect of this indication, a health technology assessment was completed on 6 August 2019 with the NCPE recommending that Osimertinib not be considered for reimbursement unless cost effectiveness can be improved relative to existing treatments. The HSE will assess this application for reimbursement in line with the 2013 Health Act.