Vertex and NHS England reach impasse over cystic fibrosis drug price

Cystic fibrosis (CF)-focused Vertex has declared that its recent negotiations with NHS England regarding the price of its drug Orkambi (ivacaftor+lumacaftor) for CF have been inconclusive.

In a statement released by Vertex, the company said: "In the latest meeting, we made the best offer in the world to NHS England, reflecting our ultimate goal to provide access to all of our medicines for all cystic fibrosis patients as soon as possible.

"Our offer also provides budget certainty to NHS England and assurance that patients will have rapid access to advances in medicines soon to come, just like agreements made in other countries.

"We find it outrageous that NHS England does not see a path forward to provide access for thousands of children and young people to the only medicines that treat the underlying cause of CF. We find it unconscionable that the government is unable to value the importance of these CF medicines and provide access."

Vertex concluded by calling on the government to intervene in the discussions, stating: "We stand ready to meet any time, any place, to ensure patient access to these life changing and transformative medicines. Patients do not have time to wait and we share their urgency."

NHS England also released a statement, which read: "This country has a long established, internationally respected independent body NICE which recommends whether or not a drug company is proposing a fair price. NICE has been clear that Vertex’s pricing is unsupportable. If Vertex really believe they are offering a reasonable deal they should waive their confidentiality clause and let patients and taxpayers judge whether it is fair."

Secretary of State for Health and Social Care Jeremy Hunt echoed NHS England’s call for Vertex to divulge the price that was being discussed. However, the company has claimed it cannot because of an NHS imposed non-disclosure agreement.

Orkambi was approved by the European Medicines Agency in 2015. This was in response to data from phase III TRAFFIC and TRANSPORT studies, which showed the drug significantly improved lung function by between 2.6% and 4% and reduced the rate of pulmonary exacerbations by 30% to 39% for those CF patients with the F508del mutation.

However, the NHS’ pricing authority the National Institute for Health and Care Excellence (NICE) rejected the drug on the basis that although it was clinically effective, its benefits were not sufficient to justify its ‘considerable cost’ of £104,000 per patient, per year of treatment.

Vertex and NHS England have been in talks over the price of Orkambi in order to reverse this decision. These efforts from both sides have been supported by a petition that forced the issue to be debated in the UK parliament in March this year. The government responded to the debate by saying: "We want patients to benefit from clinically and cost effective treatments. We welcome the dialogue between Vertex and NHS England to agree a deal that would make Orkambi available to NHS patients."

Also, Ministers in the Department of Health wrote a letter in April this year to Vertex asking it to bring the discussions to ‘an urgent resolution’.

The Cystic Fibrosis Trust chief executive David Ramsen responded to the latest development in the feud between Vertex and NHS England by saying: "We are appalled and deeply frustrated to receive Vertex and NHS England’s statements.

"People with cystic fibrosis and their families have fought hard to get these medicines. After years of being forced to wait, the CF community will simply not accept either party walking away from the table without striking a deal and we will all stand together.

"Vertex and NHS England must get back around the table quickly and ensure these medicines are made available to people with cystic fibrosis."

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