A national assessment system for new drugs has recommended for the first time that a pharmaceutical company should only be reimbursed if the treatment works.
The assessment by the National Centre for Pharmacoeconomics at St James's Hospital said a new cystic fibrosis treatment, at its current cost of over €234,000 a year per patient, is too expensive to recommend.
In a New Health Technology Assessment, the centre said the drug at that price is not cost-effective and should not be paid for by the State.
However, it suggests that the drug company, Vertex Pharmaceuticals, reduce the price and, for the first time, engages in a risk-sharing scheme whereby the company is not paid for the medicine if the drug does not work in patients.
Ivacaftor is regarded as a breakthrough chronic therapy treatment for people with a certain genetic mutation, which results in cystic fibrosis.
The drug, taken twice daily, reduces shortness of breath, exacerbations and improves quality of life.
However, at €234,000 per year per patient, its annual cost would be around €28m, 40% of the funding for all new drug treatments.
The drug has been made available in England and would possibly help up to 14% of patients in Ireland with a certain cystic fibrosis gene called G551D.
The Cystic Fibrosis Association of Ireland has said the HSE should negotiate a fair price with the company that makes the drug.
Philip Watt said there should be no delay in making Ivacaftor available to around 120 patients who would potentially benefit from it.
Mr Watt described the drug as probably the most important cystic fibrosis drug ever developed.
He said it would impact on more people with the condition in Ireland than anywhere else in the world.
Mr Watt said the price of the drug was high, but this was because the research and development costs were high as only a small number of people would benefit from it.