Dáil Éireann Debate, Tuesday - 24 July 2018
1651. Deputy Brendan Smith asked the Minister for Health further to Parliamentary Question No. 197 of 21 June 2018, if there have been further developments in regard to the availability through the HSE of the drug Pembrolizumab in view of its potential benefits to patients; and if he will make a statement on the matter. [33964/18]
Amharc ar fhreagraThe HSE has statutory responsibility for medicine pricing and reimbursement decisions, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. The Act specifies the criteria for decisions on the reimbursement of medicines. As Minister for Health, I do not have any statutory power or function in relation to the reimbursement of medicines.
In line with the 2013 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 licenced 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).
Pembrolizumab is currently reimbursed for the following indications.
- As monotherapy for the treatment of advanced (unresectable or metastatic) melanoma in adults.
- As monotherapy for first-line treatment of metastatic non-small cell lung carcinoma (NSCLC) in adults whose tumours express PD-L1 with a 50% tumour proportion score (TPS) with no EGFR or ALK positive tumour mutations.
The Department has been informed by the HSE that it is currently deliberating on the following indications for reimbursement.
- As monotherapy for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma who have failed autologous stem cell transplant and brentuximab vedotin (BV), or who are transplant-ineligible and have failed BV.
- As monotherapy for the treatment of locally advanced or metastatic NSCLC in adults whose tumours express PD-L1 with a 1% TPS and who have received at least one prior chemotherapy regimen. Patients with EGFR or ALK positive tumour mutations should also have received targeted therapy before receiving pembrolizumab.
The National Centre for Pharmacoeconomics (NCPE) completed a health technology assessment on 28 May 2018 for this indication. It recommended that pembrolizumab be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments. The HSE will now evaluate this application for reimbursement in line with criteria laid out within the 2013 Act before making a final reimbursement decision.
In addition to this, the HSE has commissioned HTAs on the following indications.
- For first-line treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy.
- As monotherapy for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy.
There are no other indications for pembrolizumab approved in the European Union at this time. Clinical trials are ongoing globally in relation to a range of other possible indications which may receive marketing authorisation in the EU over the next number of years. Each of those indications will be considered for reimbursement as market authorisations are received.
