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Monday 23 September 2019

Pressure mounts on HSE as Germany to provide Orkambi

Appeal: Philip Watt. Pic Tom Burke
Appeal: Philip Watt. Pic Tom Burke
Eilish O'Regan

Eilish O'Regan

Pressure on the HSE to agree on a price for the cystic fibrosis drug Orkambi has increased after Germany became the third country to make it available to patients.

It comes as talks between the HSE and Vertex, the pharmaceutical company which makes the groundbreaking expensive drug, resume in Dublin today.

German health authorities, which have a system of allowing a drug to be made available for a year on a trial basis, concluded Orkambi provided "considerable additional benefit".

It will be mid-January before it makes public the price it agreed to pay for Orkambi.

Orkambi is now also available in the United States and Austria. France, which is providing it on a trial basis, will make a decision in March.

Around 500 people with cystic fibrosis in Ireland are desperate to be allowed try the drug.


But the HSE drugs committee said it was too expensive after a cost-benefit assessment.

A spokeswoman for Vertex said the German approval followed a comprehensive benefit assessment of the medicine by the German Federal Joint Committee.

She said Vertex "remains actively involved in reimbursement discussions in many other countries to make it available to all people who can benefit from this important medicine.

"Earlier this month, 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 in 2016."

Philip Watt, chief executive of Cystic Fibrosis Ireland, said: "Under the German system, authorities have a 12-month opportunity to assess the effectiveness and proposed pricing of a drug."

He called for an overhaul of the system of assessing drugs for rare diseases in this country and suggested there should be an adoption of the German trial period.

Referring to the resumed talks between the HSE and Vertex, he said both sides should make compromises in order to reach a fair agreement, including a considerable reduction in price from the manufacturer.

There needed to be a greater acknowledgment by the HSE of the very high costs and risks involved in developing a drug for rarer diseases, he added.

David Gillen, managing director and vice-president of international medical affairs at Vertex said: "The reimbursed price (in Germany) recognises the clinical value of Orkambi."

It also recognised the need for Vertex's continued investment in the research and development of new medicines for the two out of three people with cystic fibrosis still waiting for a treatment for the underlying cause of the disease, he added.

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