The 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 has no role in this statutory process.
In line with the 2013 Act, if a company would like a medicine to be reimbursed by the HSE pursuant to the community drugs schemes, the company must first submit an application to the HSE to have the new medicine added to the reimbursement list.
As outlined in the Framework Agreement on the Supply and Pricing of Medicines, and in line with the 2013 Act, the HSE will decide, within 180 days of receiving an application (or a longer period if further information is sought from the company), to either add the medicine to the reimbursement list or agree to reimburse it as a hospital medicine, or refuse to reimburse the medicine.
The HSE at all times ensures that the systems that it has in place are designed to provide equitable access to all medicines across all therapeutic areas, cancer and non-cancer, from the resources provided to it.
In March 2019, the VHI sent a circular to Oncologists advising them that it was extending cover to a number of new cancer medicines. The decision by the VHI applies only to private care to private VHI patients in private hospitals. It will have no impact on the availability and use of medicines in public hospitals, where there is no distinction between public and private patients.
The effect of the VHI decision will be that VHI private patients in private hospitals may have access to a medicine that is not yet available in the public hospital system. However, a number of the medicines, or indications (which includes pembrolizumab and nivolumab), which the VHI has now decided to cover, are at various stages of the HSE assessment and reimbursement process with a view to making them available in the public hospital system.