Both sides urged to reach cystic fibrosis drug deal

Cystic fibrosis sufferers have urged the HSE and pharmaceutical company Vertex to clinch a deal on new drug Orkambi after it emerged yesterday that Germany was the latest country to begin providing it to patients.

Vertex announced it had reached a pricing and reimbursement agreement for Orkambi (lumacaftor/ivacaftor) with the German Federal Association of the Statutory Health Insurances, ahead of an expected meeting today with the HSE to further discuss the possibility of its provision here to patients.

Negotiations stalled last month amid speculation the HSE was prepared to drop plans to purchase it as the price quoted by Vertex was too high. It sparked alarm from CF sufferers, some of whom are already accessing the drug under different schemes.

Health Minister Simon Harris also intervened and had harsh words for Vertex regarding its pricing of the product, while the HSE and Vertex engaged in a public squabble over the drug.

Earlier this month, Mr Harris said: “It is unacceptable that CF patients should be used as pawns in a process like this and very regrettable that so many of them and their families have been put through such a harrowing time.”

Meetings between the sides have taken place since then and another is expected to take place today.

Confirmation that German authorities had struck a deal with Vertex was welcomed by Cystic Fibrosis Ireland, which urged both sides involved in negotiations to carry out those talks “in private and not over the airwaves”.

He called for a fair agreement to be reached as soon as possible.

Philip Watt, the chief executive of Cystic Fibrosis Ireland, said the German decision was significant, with other authorities likely to follow suit.

“We are in the middle,” he said. “We have asked Vertex to reduce the cost of Orkambi significantly but the HSE has to recognise the massive cost of manufacturing a drug for a rare disease of which CF is.

“It’s not just a matter of price gouging which is a simplistic message coming out of the HSE.”

Mr Watt said both sides involved in negotiations here should make compromises in order to reach a fair agreement.

“CFI calls for an overhaul of the system of assessing drugs for orphan diseases (rare diseases) in Ireland, including consideration of adopting the French or German drug approval systems and/or adopting a similar approach to the way cancer drugs are assessed and approved in Ireland,” he said.

Orkambi received the Drug Discovery of the Year award from the British Pharmacological Society and the French Prix Galien award for the most promising rare disease medicine this year.

David Gillen, vice-president of international medical affairs at Vertex, said the German deal recognises the clinical value of Orkambi and the need for continued investment in the development of new medicines for the two-in-three people with CF still waiting for treatment for the underlying cause of their form of the disease.

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