The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drug schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.
In reaching a decision, the HSE examines all the evidence which may be relevant in its view for the decision and will take into account such expert opinions and recommendations which may have been sought by the HSE, including, for example, advice from the National Centre for Pharmacoeconomics (NCPE).
This process ensures that only treatments that are clinical and cost effective are reimbursed. In circumstances where the company has failed to demonstrate the clinical benefit to support the price they are seeking for their treatment, the HSE reaches a decision not to reimburse the medicine.
The NCPE Health Technology Assessment of Pembrolizumab (Keytruda®) for the treatment of locally advanced or metastatic non-small cell lung carcinoma (NSCLC) was completed in October 2017. The NCPE did not recommend Pembrolizumab for reimbursement as it was not deemed cost effective.
Until such time as the process has concluded and a formal decision has been communicated to the manufacturer, the application for reimbursement remains under consideration.