Minister for Health Simon Harris has told the US pharma company that makes Orkambi to "stop spinning" and get back into negotiations on a price for the cystic fibrosis drug.
Vertex Pharmaceuticals says it will only re-enter price talks on Orkambi if Government representatives with the power to make decisions are at the table.
It claims it is “imperative” the Government schedules a meeting immediately about making the drug available to CF patients and that the Minister and the head of his department and the HSE take part.
Mr Harris, speaking in the Seanad, said this was a “complete misrepresentation”. “The law of this land, passed by this House and the Dáil in 2013, makes clear that the HSE is the body with statutory responsibility for decisions on pricing and reimbursement of medicines.”
The HSE was ready for talks, and Vertex should do the same, he said. “There isn’t one rule for Vertex and a different one for everyone else. It’s time for the spinning to stop and the talking to start, in the best interests of patients. Get back in the room and get on with it.”
Vertex told The Irish Time “it’s less about who those individuals are [at talks], and more about ensuring that whoever is in attendance has the authority to make final decisions so we can come to an agreement”.
“Vertex is demonstrating our full commitment to the process and the CF community by ensuring that the appropriate decision makers from our team attend, and we urge the government to show the same commitment to their citizens.”
The company said it and the HSE had a shared goal, to help people in Ireland get Orkambi as soon as possible. “As such, we are calling on the HSE to ensure that our next meeting results in a definitive resolution to a process that has already taken too long,” it said.
“To achieve this resolution, Vertex believes it is critical that this meeting happen with the right people around the table, including the senior decision makers from both Vertex and the HSE.”
"Accordingly, we have committed that the senior decision-makers from Vertex will attend. Similarly, we have requested that the HSE commit to having the appropriate decision-makers at this meeting, including Minister Simon Harris, [HSE director general] Tony O'Brien and [Department of Health secretary general] Jim Breslin. "
A HSE spokesman said it didn’t know yet if the talks would re-start, but he expected this would happen “through the established procedures that have been and are accepted by the rest of the pharmaceutical industry”.
Orkambi, which improves lung function and reduces hospitalisations for CF patients, would cost €160,000 per patient, or €400 million for the health service over five years, according to its initial price. The HSE is willing to pay €75 million which, according to Mr Harris, would make it the sixth most expensive drug used by the Irish health system.
Mr Harris accused the company of setting its price based on the maximum amount a country could pay rather than on health benefits of the treatment or the cost of bringing it to market.