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Vertex, NHS England and NICE finally reach agreement for Orkambi

Deal also includes Vertex’s other licensed cystic fibrosis medicines

orkambi

After four years of public rows, stalled discussions and frustration for patients, Vertex and NHS England have finally reached an access agreement for cystic fibrosis drug Orkambi, as well as its other CF treatments Smykevi and Kalydeco. 

The news will be long overdue for patients, who have continually fought for access to these medicines – in particular Orkambi – with people suffering from CF now set to be able to access them within 30 days.

However, the length of time the agreement took has been met with harsh criticism, the majority of which has been aimed at Vertex for its apparent inflexibility on pricing and a reluctance to comply with the National Institute for Health and Care Excellence (NICE) appraisal process.

“The UK has the second highest prevalence of cystic fibrosis of any country in the world, so today is an important and long hoped for moment for children and adults living with cystic fibrosis,” said NHS chief executive Simon Stevens (pictured below).

SS

"That fact also means that any drug company wanting to succeed commercially in this field needs to work constructively with the NHS,” he added.

The definitive agreement means that NHS patients in England will now have full access to the three medicines, with around 5000 people now eligible to take these treatments. According to a statement from NHS England, every patient in England who could benefit from these drugs now has access.

LF “This important agreement, reached in collaboration and partnership with NHS England and NICE, will allow more than 5,000 eligible cystic fibrosis patients in England to have access to CFTR modulators to treat the underlying cause of their disease,” said Ludovic Fenaux (pictured right), senior vice president, Vertex International.

The negotiation has been finalised because Vertex finally agreed to the ‘confidential commercial terms’ of the agreement – and importantly, it also agreed to submit its drugs for a full NICE appraisal. The agreement also extends to all future licence extensions of the drugs as well as the current licensed indications.

NICE, who initially rejected Orkambi after deciding it was too costly, has been able to support the agreement – due in large part to a binding condition of the deal that Vertex will have to submit its full portfolio, including its new triple therapy, for a full NICE appraisal in due course. The triple therapy, which has just received approval from the FDA in the US, is thought to be effective in up to 90% of CF patients.

mb“We are pleased an agreement has been reached between NHS England and Vertex that brings these medicines to patients. It is also welcome that the company will now re-engage with the NICE process,” said Meindert Boysen (pictured left), director of the Centre for Health Technology Evaluation at NICE.

“We look forward to working with the company and patient organisations to get ready for the appraisals, including developing the approach to the collection of evidence,” he added.

For CF patients in England, this agreement is particularly significant, as dedicated patient groups recently had to resort to setting up a buyers’ club to import generic copies of Orkambi.

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It will also provide hope that the lengthy agreement process will not be repeated for Vertex’s future CF therapies, which could be groundbreaking for those suffering with the debilitating genetic disease.

“This is a very special day and I want to thank people with cystic fibrosis, their families and everyone who has been part of this campaign for their persistence and determination to keep on fighting. We know it doesn’t end here – we will continue to fight for similar access in Wales and Northern Ireland so that all people with cystic fibrosis in the UK are able to benefit from these life-saving drugs," said David Ramsden, chief executive at the Cystic Fibrosis Trust

“Also, with news that the new triple therapy, Trikafta, which 90% of people with cystic fibrosis could stand to benefit from, could be licenced for use in the coming year, we will continue to campaign so that people with cystic fibrosis never have to wait again for the best available medicines,” he added.

Article by
Lucy Parsons

24th October 2019

From: Regulatory

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