Dáil Éireann Debate, Wednesday - 23 October 2019
150. Deputy Thomas P. Broughan asked the Minister for Health his policy for the approval of new drugs in 2019; if a cost neutral or cost saving approach will be pursued in 2020; and if he will make a statement on the matter. [43736/19]
Amharc ar fhreagraAs the Deputy is aware, the Oireachtas put in place a robust legal framework, in the Health (Pricing and Supply of Medical Goods) Act 2013, to give full statutory powers to the HSE to assess and make decisions on reimbursement of medicines, taking account of a range of objective factors and expert opinion as appropriate. These include the clinical and cost effectiveness of the product, the opportunity cost, the potential or actual budget impact, and the impact on resources that are available to the HSE.
In line with the 2013 Act, if a company would like a medicine to be reimbursed by the HSE pursuant to the Community Drugs scheme, the company must first submit an application to the HSE to have the new medicine added to the Reimbursement List.
As outlined in the IPHA agreement, 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). The NCPE conducts health technology assessments (HTAs) for the HSE and makes recommendations on reimbursement to assist HSE decisions.
The HSE National Service Plan 2019 included a provision of €10m for new drugs enabled by an “invest to save” programme. To assist the HSE in creating this financial headroom, the National Service Plan 2019 included a provision of €3m for the establishment of an HSE dedicated pharmaceutical value improvement programme, to bring about greater efficiencies in medicines management and to promote changes in prescribing behaviour in favour of more clinically efficient and cost-effective products in both community and hospital settings.
These new measures are expected to complement existing cost control initiatives which are being undertaken by the HSE under the auspices of the Medicines Management Programme. Among the initiatives already being pursued are improvement in practices for the procurement of drugs in hospitals and the designation of preferred products, with a focus on high cost prescribing areas.
I and officials have also been engaging over the past number of years with a number of voluntary EU forums. In June 2018, I signed the Beneluxa Initiative on Pharmaceutical Policy. This Agreement is in line with my objective to work with other European countries to identify workable solutions, in an increasingly challenging environment, to secure timely access for patients to new medicines in an affordable and sustainable way. In June 2019, Ireland became a Founding Member of the International Horizon Scanning Initiative (IHSI) which is being established as part of the work programme of Beneluxa.
These domestic and international measures are being taken to ensure the greatest possible access to new treatments for patients in Ireland. In 2019 to date, the HSE has approved 29 new medicines and 5 new uses of existing medicines representing a significant investment by the HSE to provide access to new and innovative treatment for Irish patients. It is expected that over 3,000 patients will benefit from access to these new medicines over the next five years.
With regards to 2020, funding is provided to the HSE for health services in accordance with the letter of determination which sets out the approved level of overall HSE expenditure for the year. The letter of determination issued from my Department on 11 October 2019. The NSP which must, under legislation, set out the type and volume of health and personal social services, to be provided during the year in question within the funding allocated.
The HSE is at present working on the development of the National Service Plan 2020 in line with the provisions of its governing legislation.
