Reilly approves costly CF drug
Minister for Health James Reilly has given his approval for a new cystic fibrosis drug despite concerns about the value, effect and strain on other services.
Minister for Health James Reilly has given his approval for a new cystic fibrosis drug despite concerns expressed by his officials about the claimed benefits of the treatment, the asking price and the effects on funding for other services.
The budget for Kalydeco, which will be used to treat 120 cystic fibrosis patients, is €220 million over 10 years, HSE director designate Tony O’Brien has told the Minister in a letter seen by The Irish Times.
Officials had also warned that approval for the drug might encourage the pharmaceutical industry to demand higher prices for new treatments. With a number of other new high-tech drugs in the approval pipeline, some costing more than €1 million for each patient, HSE sources say they fear this deal could set a precedent.
Mr O’Brien wrote to the Minister on Thursday seeking direction in view of the “profound ethical and financial issues” involved. He had warned that the HSE Drugs Group was concerned this decision “may have implications for the long-term affordability of new technologies and also for other services seeking funding”.
Drugs Group assessment
In its assessment, the group expressed considerable scepticism about the benefits claimed for the drug, which manufacturers Vertex Pharmaceuticals say will extend the life of CF patients by over 29 years. This has not been formally demonstrated and any estimate of the survival benefit was “prone to great uncertainty”, it said.
The group said it had “serious concerns” about the original and the revised pricing proposed by Vertex, which is subject to a confidentiality clause.