John Brassil (Kerry, Fianna Fail)
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214. To ask the Minister for Health the status of the implementation of the HSE’s best-value biologics process; if the HSE has plans to review this process to drive greater adoption of the designated best-value biological drug; if the HSE will expand this programme to further therapy areas in which a biosimilar drug is available here; and if he will make a statement on the matter. [48231/19]

Simon Harris (Wicklow, Fine Gael)
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The Health Service Executive has operational responsibility for best-value biological medicines, thus the matter has been referred to the HSE for their attention and direct reply to the Deputy.

John Brassil (Kerry, Fianna Fail)
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215. To ask the Minister for Health the status of the planned development of a national biosimilar medicines policy statement; and if he will make a statement on the matter. [48232/19]

Simon Harris (Wicklow, Fine Gael)
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Since 2017, my Department has been engaged in public consultation activities and in the exploration and implementation of a number of operational policy levers to both increase awareness and to facilitate the use of biosimilar medicines.

At an operational level, the HSE's Acute Hospitals Drugs Management Programme has a biosimilar strategy in place since 2017, which is making considerable progress using a collaborative approach with hospital pharmacists and clinical teams to bring about changes in prescribing practice. Hospitals are working towards a HSE targeted minimum prescribing rate for biosimilars of 50%.

The HSE is also working on identifying barriers to the prescribing of biosimilars, with a specific focus on education and support. It is seeking to increase understanding of biosimilars through targeted presentations to clinicians and hospitals.  This is proving promising, for example the prescribing rate for the biosimilar drug Infliximab increased from 5% in 2017 to 40% in 2018.

In May 2019, the HSE Medicines Management Programme completed the evaluation process for the identification of the best-value biological (BVB) medicines for TNF-α inhibitors on the High-Tech Drug arrangements. In June 2019 the HSE introduced a system of gain-share to encourage the prescribing of the BVB medicines.

Drawing together all of these  initiatives  my Department, in collaboration with a number of agencies, is currently developing a National Biosimilar Medicines Policy Statement. The aim of the statement and supporting documentation is to highlight and endorse the many initiatives that are already underway in Ireland and thereby to promote confidence in biosimilar use among healthcare professionals.