Cystic fibrosis patients to be given access to ‘ground-breaking’ drugs

The cystic fibrosis (CF) drugs Orkambi and Kalydeco will be made available to people with the condition from next month, Minister for Health Simon Harris has said.

Mr Harris announced in the Dáil on Tuesday that the HSE and Vertex Pharmaceuticals had reached an agreement in principle on commercial terms for the supply the drugs to Irish patients.

“I also wish to inform the Dáil that both parties are working to finalise the contractual arrangements to complete the approval process in advance of May 1st,” he added.

The Minister said further work would be done in the coming days to bring the matter to finality. He said the protracted talks period had been an extraordinarily difficult time for CF patients, families and friends.

Stormont talks lack energy and compromise of Easter 1998

---

HR issues at National Museum taking toll, claims chairwoman

---

Taoiseach defends Attorney General’s role in Callinan controversy

---

Water charges: FF and FG pull together as report passes vote

---

He said he was “determined this process would conclude and we would get the best possible arrangement for CF patients’’ who he said had not been properly and adequately catered for in the past.

CF is an inherited chronic disease that affects the lungs and digestive system of about 1,200 children and adults in Ireland. A defective gene and its protein product cause the body to produce unusually thick, sticky mucus that clogs the lungs and leads to life-threatening lung infections and obstructs the pancreas and stops natural enzymes from helping the body break down and absorb food.

The announcement was welcomed by TDs Joan Collins and Gino Kenny who had raised the matter with the Minister.

The HSE wrote to Vertex Pharmaceuticals two weeks ago inviting company representatives to negotiations on the provision of the drug, and on another CF medication, Kalydeco.

Exchequer cost

Mr Harris did not reveal the cost of the deal but Vertex initially sought €159,000 per patient for Orkambi, which the HSE estimated would cost some €400 million over five years. The price sought by the company has since dropped to an estimated €100,000 per patient. Before the talks began, the HSE said it was willing to pay up to €75 million.

The HSE was 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.

Orkambi and Kalydeco improve quality of life for CF patients by improving lung function and reducing hospitalisations by up to 40 per cent. Approximately 600 (550 for Orkambi alone) Irish patients will benefit from the drugs.

Vertex have said new studies 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.

In March, hundreds of CF patients demonstrated outside the Dáil in support of free access for CF sufferers to Orkambi.

The drug is available in Germany, the US and Austria, but authorities in Ireland, the UK and several other European countries have balked at its high price.

Cystic Fibrosis Ireland said it “warmly welcomed” the news about the “groun-breaknig” drugs which it said would benefit some 600 cystic fibrosis patients.

“While we have yet to see the full details of the agreement that has been reached, Cystic Fibrosis Ireland understands that it will be inclusive of all patients who have the potential to benefit from Orkambi and Kalydeco because of their particular CF genotype.”