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The UK remains split right down the middle as the Brexit crisis rolls on and on, and while we have been side-tracked from one political wedge to focus on another – the race to become the new leader of the Conservative Party, and, ultimately, the next Prime Minister – there is still one issue that never fails to heal the divide: the defence of the NHS.

MPs discuss breaking Vertex's IP rights to bring Orkambi to UK

MPs yesterday discussed circumventing Vertex’s patent on cystic fibrosis medicine Orkambi (Lumacaftor/ivacaftor) as a means of breaking the deadlock and giving UK patients access to the £104,000 a year drug.

In a meeting at the House of Commons, MPs called on the Government to ramp up the pressure on the US firm, as Parliamentary Under Secretary of State for Health, Seema Kennedy, said she had “a moral obligation” to consider using ‘Crown Use’ licensing laws to break Vertex’s intellectual property (IP).

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It was revealed this week that Pfizer suppressed findings that their anti-inflammatory Enbrel reduced the risk of Alzheimer’s by 64%. The revelation came as parents of children with cystic fibrosis clubbed together to form an Orkambi buyers club to import cheap generic versions of the drug into the UK.

Parents of children with cystic fibrosis start Orkambi buyers club

Parents of children with cystic fibrosis have started an Orkambi buyers’ club to import generic versions of Vertex’s drug from Argentina into the UK.

Frustrated with the stalemate between the NHS and the Massachusetts-based firm, parents of children with cystic fibrosis have come together to import generic versions of Vertex’s £104,000 a year drug into the UK.

The price of access: Can the NHS afford Orkambi?

Published on 29/04/19 at 11:43am

The impasse over access to Vertex’s Orkambi for cystic fibrosis patients in England and Wales has revealed the cracks in the NHS’ regulatory system. Matt Fellows explores where the core issues lie in the debate, and what can be done to prevent future breakdowns in communication for the good of patients.

Vertex destroyed nearly 8,000 packs of Orkambi in 2018

Vertex destroyed nearly 8,000 packs of the $272,000 a year cystic fibrosis drug Orkambi in 2018, the company said in a letter to Sarah Wollaston MP.

The drugmaker, who are locked in negotiations with Britain’s cost effectiveness body NICE, revealed they had destroyed 7,880 packs of Orkambi after the medicines had passed their expiry date.

The revelation came after the US firm was questioned by the Health and Social Care Committee earlier this month.

Vertex doubles Q4 profits, angering cystic fibrosis drug advocates in UK

Despite ongoing controversy surrounding the currently stalled negotiations between Vertex and the NHS to make its cystic fibrosis (CF) drug Orkambi (ivacaftor/lumacaftor) available for patients at a price the health service can afford, the US firm has angered critics in the UK with the announcement of a surge in profits in the last quarter of 2018 – profits it says was driven primarily by “the strong growth in total CF product revenues”.

For the last quarter of 2018, Vertex reported an increase in revenue of 40%, while its profits for the same period more than doubled form $158 mil

Vertex's Orkambi can be used in even younger cystic fibrosis patients, says European Commission

Vertex has announced that the European Commission has decided to approve a label extension in the region for Orkambi (lumacaftor/ivacaftor) in the treatment of cystic fibrosis (CF), expanding the pool of eligible patients to include children aged between two and five years of age who have two copies of the F508del mutation.

UK Ministers call on Vertex to speed up price negotiations

After a parliamentary debate in the House of Commons regarding making Orkambi available to patients with cystic fibrosis (CF), MPs have now written to the company calling on them to show “the utmost urgency to proceed with negotiations”.

The debate comes after Vertex had rejected a counter-proposal by NHS England, in regards to the price that the service was prepared to pay for treatment was rejected by Vertex.

Orkambi is able to treat about 40% of patients with CF, compared to its breakthrough treatment, Kalydeco, which can only treat 5% of patients.

Orkambi deemed not suitable for NHS use

The National Institute for Health and Care Excellence (NICE) has issued its recommendation that the cystic fibrosis drug Orkambi (lumacaftor/ivacaftor) manufactured by Vertex Pharma should not be used on the National Health Service (NHS) in England for people with CF ages 12 and older who have two copies of the F508del mutation. The decision comes despite its earlier recognition of the drug as a “valuable new therapy for managing cystic fibrosis” with “wider benefits to society for people with cystic fibrosis and carers of people with cystic fibrosis”.

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