Written answers

Wednesday, 21 April 2021

Department of Health

Medicinal Products

Photo of John LahartJohn Lahart (Dublin South West, Fianna Fail)
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2089. To ask the Minister for Health if he plans to publish a national biosimilars policy; and if he will make a statement on the matter. [19796/21]

Photo of Stephen DonnellyStephen Donnelly (Wicklow, Fianna Fail)
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I am pleased to inform the Deputy that the prescribing of Best Value Biologic medicines is leading to significant savings for the health service, which is assisting us in facilitating access to new, innovative medicines for patients.

The HSE is actively engaged in implementing effective policy levers across a number of domains and under several initiatives, including the Acute Hospitals Drugs Management Programme, the Medicines Management Programme, and within the Primary Care Eligibility & Reimbursement Service.

The HSE Medicines Management Programme published recommendations in May 2019 in relation to two high tech drugs, adalimumab and etanercept. That year, the HSE also introduced the Gainshare Initiative, which provides a financial incentive to public hospitals and clinics to pursue biosimilar treatment switching programmes. By December 2020, almost 12,000 patients have switched to a best-value-biologic (BvB), almost 57% of the claims submitted to PCRS for payment was for the BvB alternative to the originator biologic and associated annual savings in excess of €46 million has been achieved.

While progress has been positive, the Department of Health and HSE are continuously monitoring and evaluating the effectiveness of current levers to ensure that the State can capitalise on the most efficient policy approach.

There is value and savings to be gained from the adoption of biosimilars technology. However, progress in this area has to be carefully planned and implemented, with patient’s confidence and assurance at the forefront of any new initiatives and developments.

Despite the impediment of Covid-19, the HSE are progressing well in achieving savings in this area whilst maintaining the engagement of clinicians and the confidence of patients in the safety and efficacy of this technology.

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