Dáil Éireann Debate, Thursday - 16 July 2020
186. Deputy Jennifer Murnane O'Connor asked the Minister for Health when funding and approval for the immunotherapy drug pembrolizumab will become available for persons with bladder cancer which has migrated to their lungs; and if he will make a statement on the matter. [16442/20]
Amharc ar fhreagraThe 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.
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 pembrolizumab (Keytruda®) for two indications related to urothelial carcinoma:
1) Pembrolizumab (Keytruda®) indicated for the first-line treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumours express PD-L1 with a combined positive score (CPS) 10.
2) Pembrolizumab (Keytruda®) indicated as monotherapy for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy.
The application for the reimbursement of pembrolizumab with respect to the above indications has been assessed by the NCPE and the HSE Drugs Group, in line with the 2013 Act. The Drugs Group has given a positive recommendation for the application which has been progressed to the HSE Executive Management Team (EMT).
The application remains under consideration with the HSE. The HSE will make a final decision with respect to this application in line with the 2013 Health Act.
