The HSE has statutory responsibility for medicine pricing and reimbursement decisions, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. As Minister for Health, I do not have any statutory power or function in relation to the reimbursement of medicines.
In Ireland the majority of patients access medicines through the publicly funded Community Drug Schemes.
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, it must apply 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 (EMA) or the Health Products Regulatory Authority (HPRA).
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 has market authorisation in Ireland/the EU for a number of indications.
The HSE has approved the reimbursement of Pembrolizumab for the following indications:
- as monotherapy for the treatment of advanced (unresectable or metastatic) melanoma in adults;
- as monotherapy for the first-line treatment of metastatic non-small cell lung carcinoma (NSCLC) in adults whose tumours express PD-L1 with a more than or equal to 50% tumour proportion score (TPS) with no EGFR or ALK positive tumour mutations;
- as monotherapy for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) who have failed autologous stem cell transplant (ASCT) and brentuximab vedotin (BV), or who are transplant-ineligible and have failed BV.
It should be noted that the first part of the last indication is not reimbursed because the HSE is already reimbursing another immunotherapy with similar efficacy (nivolumab) at lower cost. Patients who are transplant-ineligible and have failed BV can receive reimbursement support for pembrolizumab, as nivolumab does not have market authorisation for this sub-group of patients.
The HSE Drugs Group are reviewing the indication below:
- as monotherapy for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy and whose tumours express PD-L1 with a combined positive score (CPS) 10.
The following indications are currently under health technology assessment with the NCPE:
- in combination with pemetrexed and platinum chemotherapy, for the first-line treatment of metastatic non-squamous NSCLC in adults whose tumours have no EGFR or ALK positive mutations;
- as monotherapy for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy.
No reimbursement application has been received to date for the following indication:
- as monotherapy for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) in adults whose tumours express PD-L1 with a 50% TPS and progressing on or after platinum-containing chemotherapy .
However, the HSE has approved reimbursement of nivolumab for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum-based therapy.
In October 2018, the HSE commissioned a rapid review assessment for the indication below:
- as monotherapy for the adjuvant treatment of adults with stage III melanoma and lymph node involvement who have undergone complete resection.
The NCPE have recommended a full HTA to assess the clinical effectiveness and cost effectiveness of pembrolizumab compared with the current standard of care.
There are no other indications for pembrolizumab approved in the European Union at this time.
Clinical trials for various immunotherapies, including pembrolizumab, are ongoing globally for 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 granted and applications received.