The manufacturer of a cystic fibrosis drug has cranked up the pressure on the Government and the HSE, accusing the latter of not offering any guidance on the decision-making criteria for any possible purchase of Orkambi and claiming “misinformation” was causing undue fear and confusion among patients.
Vertex, which makes Orkambi, made the comments in an open letter to Philip Watt, the chief executive of Cystic Fibrosis Ireland, and called on Health Minister Simon Harris to intervene after it emerged last weekend that the HSE might walk away from negotiations on buying the drug into the future because of a wrangle over its cost.
The company also warns that future investment in research and development for CF drugs could be compromised “to the potential detriment of future generations of CF patients and their families”.
In the letter sent to Mr Watt, Vertex vice president and regional general manager for Europe North Simon Lem claimed the company was calling on the minister “to intervene directly ahead of a decision by the HSE in the mutual interests of patients, clinicians and industry”.
“Having continually engaged in good faith with the HSE since Orkambi was licensed over one year ago, Vertex had hoped that an agreement was within reach and is surprised by the latest developments,” Mr Lem said.
He said the company had made a full submission to the National Centre for Pharmoeconomics as requested by the HSE.
“This was despite internationally acknowledged limitations of HTA (Health Technology Assessment) processes for the assessment of breakthrough precision medicines like Orkambi due to the cost-effectiveness thresholds not appropriate to CF and other diseases,” he said.
Vertex then met the HSE six times over five months and said it presented “a range of specific workable proposals”, yet “at no time during the process did we receive a counter-offer or guidance from the HSE on decision-making criteria”.
“Vertex therefore refutes allegations by the HSE of failing to meaningfully engage and, the publically quoted budget figure of €392m is incorrect, unrealistic and does not reflect discussions to date.”
Mr Lem said the impasse has meant seriously ill CF patients waiting for treatment while another precision medicine, Kalydeco, is available to patients in what Mr Lem said was “an inequity of access” to drugs.
“Vertex understand that the present situation and manner in which information, or misinformation, is being communicated is causing undue fear and confusion for the patient community,” he said, adding that the company was ready to meet Mr Harris at short notice to resolve the issue.
However, the minister said he was disappointed with Vertex and was meeting his counterpart in Portugal next week to discuss the importance of countries working together on acquiring medicines which he said had to be affordable to be effective.
It has also emerged that Vertex Pharmaceuticals Inc paid its chief executive $28.1m in total compensation last year. In April the Boston Globe reported that the pay package to Jeffrey M Leiden was actually 23% less than he received in 2014.
Vertex had projected that Orkambi would generate sales of at least $1bn in 2016.
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