Dáil Éireann Debate, Thursday - 21 June 2018
197. Deputy Brendan Smith asked the Minister for Health when he plans to make the drug Pembrolizumab available through the HSE in view of the comments of leading oncologists of the value and importance of this medication; and if he will make a statement on the matter. [27317/18]
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.
The Minister for Health does not have any statutory power in relation to the reimbursement of medicines.
In line with the 2013 Act and the Framework Agreement with industry, if a company would like a medicine to be reimbursed by the HSE, the company must first submit an application to the HSE to have the new medicine added to the reimbursement list.
Reimbursement applications are made for indications which have been granted market authorisation by either the European Medicines Agency or the Health Products Regulatory Authority.
As outlined in the Framework Agreement, and in line with the 2013 Act, the HSE will decide, within 180 days of receiving the application (or a longer period if further information is sought from the company), to either add the medicine to the reimbursement list or refuse to reimburse the medicine.
HSE decisions on which medicines are reimbursed 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.
The HSE strives to reach a decision in as timely a manner as possible. However, because of the significant moneys involved, it must ensure that the best price is achieved, as these commitments are often multi-million euro investments on an on-going basis. This can lead to a protracted deliberation process.
Pembrolizumab is currently reimbursed for the following indications:
- KEYTRUDA as monotherapy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults.
- KEYTRUDA as monotherapy is indicated for the 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 they are currently deliberating on the following indications for reimbursement:
- Pembrolizumab (Keytruda) as a 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.
- KEYTRUDA as a 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 KEYTRUDA.
The National Centre for Pharmacoeconomics (NCPE) completed a health technology assessment on 28 May 2018 for the latter indication. They recommended that pembrolizumab (Keytruda) 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 have commissioned HTAs on the following indications:
- Pembrolizumab (Keytruda) for the first-line treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy.
- Pembrolizumab (Keytruda) 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.
