HSE may miss out on €37m savings as costly drug Humira comes off patent

Policy of switching to biosimilar drugs never adopted

The HSE stands to save an estimated €37 million after its most costly drug went off patent in the EU this week.

However, the savings may not be realised due to a failure of the health service to bring forward a policy on switching to cheaper off-patent drugs known as biosimilars.

The HSE spent €123 million on Humira (adalimumab) in 2016, more than on any other drug. Originally developed to treat rheumatoid arthritis, Humira is now used by about 10,000 patients for a variety of conditions, including ulcerative colitis and Crohn’s disease.

Manufactured by AbbVie, it costs about €1,080 per month per patient, or almost €13,000 a year. The cost of the drug is reimbursed for patients under the State’s high-tech drug scheme.


Humira is a complex biologic drug containing living organisms. A “generic” version, known as a biosimilar, will shortly be available for 30 per cent less, offering a potential saving of up to €37 million.

Patented drugs

In recent years, the HSE has made significant strides in encouraging prescribers to switch from patented drugs to cheaper, generic alternatives.

However, little progress has been made in developing a similar policy for biologics/biosimilars.

Minister for Health Simon Harris promised a National Biosimilar Medicines Policy in February 2017 and a consultation was held later in the year, but no policy has been announced.

The department said it was considering responses to the consultation “and other possible policy levers” with a view to developing a national policy.

The Irish approach contrasts with the National Health Service in the UK, which is targeting €150 million in savings from a switch to biosimilar drugs. Under a new policy supporting a switch to biosimilars, 90 per cent of all newly presenting patients, and 80 per cent of current patients, will switch to the cheaper alternative.

A number of biosimilar alternatives to Humira are already available in Europe. Drugs manufacturer Mylan plans to launch its version in Ireland in the coming months.

“Biosimilars represent a huge opportunity for Irish patients to access high quality, more affordable medicines while also supporting our health services deliver excellent care in the face of aging populations and increasingly stretched resources,”the company said.

Paul Cullen

Paul Cullen

Paul Cullen is Health Editor of The Irish Times