I propose to take Questions Nos. 1011, 1220 and 1222 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, a company must submit an application to the HSE to have a 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.
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).
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 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 2019 and 2020, the Vhi decided to extend 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.
A number of the medicines, or indications (which includes pembrolizumab and nivolumab), which the Vhi has now decided to cover, are in process with the HSE with a view to making them available in the public hospital system.
I am advised by the HSE that it has received pricing and reimbursement applications for the indications listed below:
- Nivolumab (Opdivo®) as monotherapy is indicated for the adjuvant treatment of adults with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.
- Pembrolizumab (Keytruda®) as monotherapy is indicated for the adjuvant treatment of adults with Stage III melanoma and lymph node involvement who have undergone complete resection.
The HSE has confirmed that health technology assessments have been completed by the NCPE for both these indications. These applications for reimbursement are now been assessed by the HSE in line with the 2013 Health Act.