merrion street

The Minister for Health, Simon Harris TD has today (Tuesday 29th November) written to the Health Ministers in England, Scotland, Canada and Australia asking them to collaborate to try and make progress on accessing Orkambi at a cost effective price for cystic fibrosis patients in each of their countries.
The health services in Ireland, England, Scotland, Canada and Australia have all been considering access to Orkambi for people with cystic fibrosis and have been engaging with the pharmaceutical company, Vertex. No decision has been taken to reimburse the treatment in any of these countries to date and the Department has yet to receive the formal decision of the HSE Directorate in relation to Orkambi,

Speaking today, Minister Harris said, "Our country has a great track record of making new and innovative treatment available to patients. I am determined that this continues. Securing access to treatments for patients at an affordable price remains the key priority. However, we cannot have a situation whereby exorbitant prices make it effectively impossible to access a new treatment like Orkambi.
"Since coming to office, I have sought greater collaboration with other countries on accessing drugs. Therefore, I have now written to my counterparts in England, Scotland, Canada and Australia and asked that they would collaborate with us to try and ensure we secure access for our cystic fibrosis patients to Orkambi at an affordable and cost-effective price. We must, I believe, adopt a common approach to engaging with this pharmaceutical company to learn from each other's engagements to date and ultimately to try and achieve a fairer price for this medicine for the benefit of all of our cystic fibrosis patients and their families.

"At the weekend, I assured cystic fibrosis patients that the process for accessing Orkambi is not over but that the manufacturer must further engage on a meaningful and innovative basis and significantly reduce their price. I re-iterate that today and hope that other Health Ministers will work with me to form a collective united position with the manufacturer to deliver a better outcome for all our cystic fibrosis patients, as the next step in this process."

Notes for Editors :
What is Orkambi?
· ORKAMBI is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients age 6 years and older who have two copies of the F508del mutation (F508del/F508del) in their CFTR gene.
Is Orkambi Available For Children Under The Age Of 6 In Europe?
· The medicine is not currently licenced by the European Medicines Agency for children under 12 years of age.
· The manufacturer’s website on Orkambi states that it is not known if Orkambi is safe and effective in children under 6 years of age.
Who Is Eligible For The Medicine Which Is Under Consideration By The NCPE & The HSE?
· In line with market authorisation in Europe, the company made an application for the drug Orkambi for those patients aged 12 years and over who are homozygous for the F508del mutation in the CFTR gene.
How many patients in Ireland are eligible for the medicine?
· The National Centre for Pharmacoeconomics (NCPE) has estimated that 505 patients over the age of 12 are eligible for the treatment.
What factors were included in the assessment Process?
· As part of the NCPE assessment process consideration was given to the clinical effectiveness and health related quality of life benefits, which the new treatment may provide and whether the cost requested by the pharmaceutical company is justified. This analysis incorporated all relevant costs including reductions in the number of hospitalisations and the number of intravenous antibiotics that would be avoided.
What Is The Budget Impact Of Orkambi?
· The NCPE have estimated the 5 year budget impact of Orkambi at almost €392 million.
Have The NCPE Concluded That It Is Not Cost-Effective At Any Price?
· The NCPE noted in their assessment that the cost of the medicine would have to reduce from just under €159,000 per patient per year to below €30,000 per patient per year to satisfy their current cost-effectiveness threshold.
What Are The Next Steps?
The HSE has recently completed its most recent round of negotiations with Vertex. On foot of this, the HSE’s Drug’s Committee (together with a NCPE recommendation and other expert advice) is in the process of sending its latest recommendation on the cost-effectiveness of Orkambi to the HSE Directorate.
Useful links:
http://www.ncpe.ie/drugs/lumacaftorivacaftor-orkambi/
http://www.orkambi.com/