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Scotland turns down Vertex's Orkambi

The Scottish Medicines Consortium (SMC) has turned down Vertex’ cystic fibrosis drug Orkambi on the grounds that it is not good value for money.

Scotland’s cost-effectiveness body rejected the $272,000 a year drug as a treatment for cystic fibrosis in patients aged two and older due to “significant uncertainty around their overall health benefits in the long-term, in relation to their costs.”

Orkambi could benefit 330 people in Scotland, a region which has one of the highest incidences of cystic fibrosis in the UK.

FDA expands Vertex's cystic fibrosis drug Symdeko in paediatric patients

Vertex has announced that the FDA has chosen to expand the existing authorisation on its cystic fibrosis (CF) therapy Symdeko (tezacaftor/ivacaftor).

The drug received marketing approval in February last year in patients over 12 years old who have two copies of the F508del mutation in the CF transmembrane conductance regulator (CFTR) gene, or have at least one mutation that is responsive to tezacaftor/ivacaftor; this new approval extends the label to include patients as young as six years old.

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Pfizer supressed research showing their arthritis drug Enbrel reduced the risk of Alzheimer’s. This was the big revelation this week! The story prompted calls for greater transparency and more open science as researchers were outraged that such important findings could be suppressed.

Meanwhile MPs in the House of Commons discussed using Crown Use licensing rules to break Vertex’s IP rights over Orkambi. The discussion marked a new stage in the longstanding stale mate between the US firm and the British government.

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).

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

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Scandal dominated this week’s news after Sunrise Lee, a stripper turned Insys sales rep was alleged to have given a disreputable doctor a lap dance in an effort to persuade him to prescribe the potent opioid fentanyl to his patients. Meanwhile Vertex terminated COO Ian Smith over ‘personal behaviour’ while an Israeli biotech made the dubious claim that it had created a complete cure for cancer.

Vertex ousts COO Ian Smith over 'personal behaviour'

Boston-based firm Vertex Pharmaceuticals has fired Chief Operating Officer (COO) and interim Chief Financial Officer (CFO) Ian Smith. Smith’s termination, which is said to be unrelated to the company’s financial and business performance is effective immediately.

The company cited Smith’s “personal behaviour” which it claimed “violated Vertex's Code of Conduct and values”.

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