Minister launches consultation on biosimilar medicines

Minister for Health Simon Harris has launched a consultation document on a new biosimilars medicines policy as the HSE struggles to stretch its budget to accommodate new medicines coming to market.

Biosimilars are biological medicines that have no clinically meaningful difference from the original patented biologic medication but, like generics, cost less because they require lower research and development costs.

The consultation paper says Ireland’s medicines bill has been “relatively stable” at around €1.7 billion for the past five years. This is despite the State’s ageing demographics and the arrival of many new, often expensive, medicines, especially for the treatment of rare diseases or disease for which no treatment is currently available.

This surface stability masks a growing challenge for the health system, however. While the bill for the HSE has not risen generally there has been strong growth in the proportion of the budget accounted for by newer biologic medicines covered by the High Tech Arrangement. Spending under this heading has risen 35per cent – from €442 million to €597 million – between 2013 and 2016.

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Cost savings

Over €200 million is spent currently by the HSE on biologic medicines that will have a biosimilar available some time next year, the paper says. It wants to have a policy in place to ensure potential cost savings are secured.

For the moment, the paper says, “despite the opportunities presented by biosimilars, uptake in Ireland remains low in comparison to many member states”.

Medicines for Ireland, an industry group that represents drug companies manufacturing generic drugs and biosimilars, says the “most significant obstacle currently to increased uptake of biosimilars is the State itself”.

This, it says, is due to a biosimilars “blocker clause” in the Framework Agreement on the Supply and Pricing of Medicine, which the Minister and the research-based pharma sector signed last year.

Original producers

The clause at issue lays down that original producers of a biologic medicine must cut their price by 30 per cent only when a biosimilar enters the market. The biosimilar producers say the 30 per cent threshold makes it uneconomic for them to compete. And if they don’t the price of the drug does not come down at all.

Sandra Gannon, the country head of generics giant Teva and joint chairperson of Medicines for Ireland, welcomed the consultation paper but said that "meaningful action must follow...if Irish patients are to have access to more affordable and equally effective biosimilar medicines".

The consultation process will run until September 22nd.