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‘Levers and tools’ on biosimilar costs considered

27 Feb 2017

Possible legislative changes regarding biologic medicines are being considered by the Department of Health, the HSE and the Health Products Regulatory Authority (HPRA), according to the Minister for Health.

Department officials were developing a national biosimilar policy that would require consideration of a “range of regulatory, patient safety and health policy issues” as well as an examination of different “policy levers and tools” that might be implemented in order to increase the uptake of biosimilars, Minister Simon Harris told Social Democrats Deputy Róisín Shortall in the Dáil.

It was likely, he noted, that the use of biosimilar medicines would grow in the coming years as the patents on biological medicines expired, offering opportunities for the State to make further savings on the cost of medicines, adding that the Framework Agreement on the Supply and Pricing of Medicines 2016-2020 with the Irish Pharmaceutical Healthcare Association (IPHA) included a provision to take advantage of such new developments in the pharmaceutical industry.

Under the agreement the price of a biologic medicine will be reduced by 20 per cent and an additional rebate of 12.5 per cent provided upon entry into the market of a biosimilar.

Under the Heath (Pricing and Supply of Medical Goods) Act 2013, biosimilars are not considered to be interchangeable, and therefore cannot be substituted for biological medicines.

gary.culliton@imt.ie

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