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 licenced indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority.
Pertuzumab (Perjeta) has been granted marketing authorisation for a number of indications and is included on the HSE reimbursement list for one of those indications. In addition, a number of other indications are currently being assessed for reimbursement.
The HSE has approved reimbursement for the following licensed indication:
- Pertuzumab is indicated for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.
The HSE has received pricing and reimbursement applications in relation to this medicine for the treatment of early breast cancer in combination with trastuzumab and chemotherapy (both neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence and adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence).
These applications are under consideration are currently being processed by the HSE and the statutory assessment process is ongoing.
I am aware that 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 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.