MFI highlights that wait for national strategy on affordable biosmiliars goes on

Medicines for Ireland (MFI), the organisation which represents over 60% of medicines supplied to the HSE has called for the Government to stop dragging its feet on biosimilars and to create a dynamic environment for the supply of cost-effective medicines for patients.

MFI has highlighted that it is now more than two years since Minister for Health, Simon Harris TD, first announced Government plans to establish a National Biosimilars Policy for Ireland.

With a public consultation completed in September, 2017, MFI said there has been no proposals brought forward by the Minister since, adding “as medicines producers grow increasingly frustrated with the lack of competition in the market and the missed opportunity to increase patients access to life saving medicines”.

AN MFI statement continued: “Each year our health service spends over €280 M on biologic medicines, despite more affordable biosimilars available on the Irish market. Biosimilars are recognised globally as equally effective and safe but more affordable.

“Yet in Ireland biosimilars represent less than 6% of the market share with only €17 M spent on such medicines in 2018. This level of market penetration remains chronically low when compared with EU States where levels can be as high of 90%.

“One such example is the molecule Etanercept, used to treat conditions such as rheumatoid arthritis. In 2018, its biologic equivalent, Enbrel, dominated the market with a 98% share, while its biosimilar competitor, Benepali, secured only a 2% market share of all units sold. In monetary terms it equates to €41 million spend on the biologic and half a million euros spend on the biosimilar.

“Minister Harris recently suggested in response to a parliamentary question that ‘hospitals are working towards a targeted minimum prescribing rate for biosimilars of 50%’. However, there is no clarity around how this will be achieved, no engagement with biosimilar producers and the biggest barriers to increased uptake – a national medicine agreement between the Department of Health and biologic manufacturers and legislative restrictions on biosimilars, remain in place.”

MFI Chairperson Owen McKeon urged government and industry to start recognising the value of biosimilars to the Irish healthcare service and economy.

“Biosimilars are now a standard part of many treatment programmes worldwide and encouraged as an effective means to control medicine spend. Increased use of biosimilars are part of a critical, long-term approach needed to medicines in Ireland, to ensure sustained and enhanced patient access to quality medicines.

“Medicine shortages have only recently come to wider political and public attention because of Brexit but the reality is that shortages have long been a feature of our health landscape.

“Shortages are increasing each year, with the systemic failure in the way the State continues to procure medicines acerbating the problem.  The failure to develop and implement a National Biosimilars Policy is symptomatic of Ireland’s slow response to introducing innovation solutions, which are often the norm for many decades across comparable healthcare services.

“Ultimately, it is patients who suffer the consequences most, through a lack of or reduced access to the best treatments and medicines.  After two years of waiting, the Minister must now move to implement a roadmap for effective prescribing of biosimilars,” Mr McKeon said.