Written answers

Thursday, 3 May 2018

Department of Health

Medicinal Products Availability

Photo of Catherine MurphyCatherine Murphy (Kildare North, Social Democrats)
Link to this: Individually | In context | Oireachtas source

139. To ask the Minister for Health the approval status with respect to the provision of a drug in the treatment of cancer; if his attention has been drawn to the fact that it is being used in both the NHS in the UK and in the US; if it is awaiting evaluation or approval; if options for persons such as a person (details supplied) will be considered in situations in which there are no further treatment options; if not, the reason therefore; and if he will make a statement on the matter. [19321/18]

Photo of Simon HarrisSimon Harris (Wicklow, Fine Gael)
Link to this: Individually | In context | Oireachtas source

The HSE has statutory responsibility for decisions on medicine pricing and reimbursement in the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. Before deciding whether to reimburse a medicine, the HSE considers a range of statutory criteria, including clinical need, cost-effectiveness and the resources available.

The decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds by the HSE, on the advice of the National Centre for Pharmacoeconomics (NCPE). The NCPE conducts health technology assessments (HTAs) of medicinal products for the HSE, and makes recommendations on reimbursement to assist the HSE in its decision-making process. The NCPE uses a decision framework to systematically assess whether a drug is cost-effective as a health intervention.

The NCPE is currently conducting an HTA on Osimertinib (Tagrisso). When completed, a report will be sent to the HSE for consideration.

The HSE will decide, within 180 days of receiving the application (or a longer period if further information is sought from the company), to add the medicine to the reimbursement list, agree to reimburse it as a hospital medicine or refuse to reimburse it.

The HSE strives to reach a decision in as timely a manner as possible. However, because of the significant monies involved, it must ensure that the best price is achieved, as these commitments can be ongoing multi-million euro investments. Successful price negotiations also allow for more products to be approved within the finite budget available.

Comments

No comments

Log in or join to post a public comment.