I propose to take Questions Nos. 424 and 606 together.
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.
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 licensed indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority.
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 the 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.
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).
I am advised by the HSE that it has received a number of applications for the reimbursement of Nivolumab (Opdivo). Some of these have already been approved for reimbursement, including applications for the following indications:
- As monotherapy for the treatment of advanced (unresectable or metastatic) melanoma in adults
- In combination with ipilimumab, indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults
The HSE has received an application for the reimbursement of Nivolumab as monotherapy for the adjuvant treatment of adults with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.
In respect of this indication, a health technology assessment was completed on 13 October 2019 with the NCPE recommending that Nivolumab be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments. The HSE will assess this application for reimbursement in line with the 2013 Health Act.
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 has 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 is 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 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.