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Government response
government response summary
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.
government response details
The National Institute for Health and Care Excellence (NICE) is the independent body that provides guidance on the prevention and treatment of ill health and the promotion of good health and social care. NICE produces a range of guidance products, including technology appraisals, clinical guidelines and quality standards. NICE’s guidance is based on a thorough assessment of the available evidence and is developed through wide consultation with stakeholders. NHS commissioners are required to fund drugs and treatments recommended by NICE technology appraisals.NICE published its final guidance on the use of Orkambi in July 2016 and did not recommend it for use in treating Cystic Fibrosis. NICE’s appraisal committee concluded that while Orkambi was clinically effective and important for managing cystic fibrosis, the benefits were not sufficient to justify its considerable cost. Officials from NHS England engaged with Vertex (the manufacturer) to explore proposals to secure a pricing structure that would enable a positive recommendation from NICE – however, Vertex was unable to come forward with a viable model that would enable the drug to be funded. NICE periodically reviews its guidance to determine whether there is significant new evidence that might affect its recommendations. NICE’s guidance on Orkambi is scheduled to be reviewed in July 2019. If significant new evidence comes to light before the scheduled date to review the drug, NICE has processes in place to bring forward a review. NICE remains open to a further approach from the company, with new evidence or a revised price. Although there has been recent correspondence between NHS England and the company, NICE has not yet received any fresh proposals from the company. A number of meetings have been held with Vertex, and the Department welcomes any further negotiations between NICE, NHS England and Vertex. Ministers are continuing to engage with Vertex, NHS England, NICE and the Cystic Fibrosis Trust to encourage the responsible parties to reach a deal.Department of Health and Social Care
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