Taoiseach expects deal on CF drug Orkambi in coming weeks

Price talks on the groundbreaking but highly expensive cystic fibrosis drug Orkambi could be completed in weeks, Taoiseach Enda Kenny has said.

With cystic fibrosis patients due to protest outside the Dáil on Wednesday over access to the drug, Minister for Health Simon Harris earlier said the discussion between the HSE and manufacturer Vertex Pharmaceuticals were entering a "critical phase".

Mr Kenny told the Dáil on Wednesday that he expected Mr Harris would finalise a deal for Orkambi in a matter of weeks.

Mr Kenny said Orkambi was a drug which impacted on the quality of life of people with CF, but it was not the Minister’s responsibility to determine the value or otherwise of how it was determined.

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Transformative

He was replying to Fianna Fáil leader Micheál Martin, who said Orkambi could have a transformative affect on CF sufferers.

Talks stalled earlier this month without agreement but the Minister has sent the HSE back to the negotiating table. It is expected that if agreement is reached, he will seek the approval of Cabinet for additional funding for the deal.

Sources close to the talks say both sides are examining a 10-year deal that would fund the cost of Orkambi and another CF drug, Kalydeco.

Mr Harris said he was extremely conscious the last number of months have been an extraordinarily stressful and worrying time for many CF patients and their families.

“Given the level of investment and the scale of the potential benefits for CF patients, there are important commercial and contractual aspects which have to be agreed in the interests of patients and the health service overall.”

Several thousand people with CF and their families are expected to attend the second Dail protest organised by Jillian McNulty, who has the disease and is on a trial for Orkambi.

Frustrated with the months of negotiations, they say they do not have the luxury of waiting indefinitely for agreement on the drug, which could treat up to 550 Irish CF patients.

€400 million cost

Vertex initially sought €159,000 per patient and the HSE estimated the cost to the exchequer of approval would be almost €400 million over five years. The company has reduced its asking price since then, but the amount sought at the end of earlier talks was still well above established cost-effectiveness thresholds for new drugs. Before the talks began, the HSE said it was willing to pay up to €75 million.

Mr Martin said there had been an attempt to denigrate the drug in leaks from the Health Service Executive (HSE) and others. The drug had since had since received awards, he added.

“The bottom line is this drug has a very significant impact on quality of life and longevity of people living with CF, hospital admissions and lung functions and so forth,’’ he added.

“There is no doubt about the effectiveness of the drug itself.’’