HSE in last-ditch talks to secure cystic fibrosis drug

Executive to meet Orkambi maker in bid to secure deal estimated to cost over €250m

The Health Service Executive has called in the makers of Orkambi for last-ditch talks on approving the groundbreaking cystic fibrosis (CF) drug for over 600 Irish patients.

The HSE wrote to Vertex Pharmaceuticals at the weekend inviting company representatives to negotiations on the provision of Orkambi and another CF drug, Kalydeco, in Ireland.

This week’s talks represent a final chance to secure agreement on Orkambi, which was originally expected to cost €400 million over five years.

Vertex said that while the company remains on standby to meet at any time, its future approach will depend on the feedback provided by the HSE.


‘Extremely disappointed’

“We were extremely disappointed to learn that the HSE, after more than 11 weeks without contact, and nine months of discussions, still has ‘significant challenges’ with our proposal – which was developed with its input and direction,” a spokeswoman said.

The US company has dropped its price since negotiations began almost nine months ago but the final deal may yet cost over €250 million when additional elements are taken into account. The HSE is seeking a longer-term deal that covers the cost of new CF drugs that have yet to be approved, in addition to Orkambi and Kalydeco.

Despite pleas by the CF community for an early decision, the two sides have not met since early January and there has been no contact between the HSE and the company in the past two months.

Vertex said last week it was “perplexed” by the delay in hearing back from the HSE, but Irish sources said the time has been spent on evaluating the commercial and legal aspects of the proposals made by the company at the start of the year.


Officials involved in the negotiations have been told to leave the rest of the week clear so talks can be brought to a conclusion.

Orkambi and Kalydeco improve quality of life for CF patients by improving lung function and reducing hospitalisations by up to 40 per cent.

Vertex said new studies published last week show that Kalydeco when used in combination with a newly-developed drug showed “statistically significant improvements” in lung function for CF patients with certain gene mutations.

Vertex initially sought €159,000 per patient for Orkambi and the HSE estimated the cost to the exchequer of approval would be almost €400 million over five years. Before the talks began, the HSE said it was willing to pay up to €75 million.

The price sought by the company has since dropped to an estimated €100,000 per patient.

Paul Cullen

Paul Cullen

Paul Cullen is a former heath editor of The Irish Times.