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Vertex's cystic fibrosis portfolio to be made available across Northern Ireland and Wales

After drawn out negotiations and much discontent among cystic fibrosis (CF) patients and their advocates, Vertex has announced that a deal has finally been reached that will make its crucial CF medications available to patients across Wales and Northern Ireland.

On 12 November, it emerged that the Regional Pharmaceutical Procurement Service in Northern Ireland reached an agreement with the manufacturer to make available all of its currently licensed CF therapies to patients in the region.

FDA approves Vertex's Trikafta in new indication, now potentially covering 90% of cystic fibrosis patients

The FDA has granted marketing authorisation to Vertex’s Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for the treatment of cystic fibrosis (CF), it has emerged.

The approval relates specifically to patients over the age of 12 who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene – the most common in the disease.

Vertex cystic fibrosis drugs become available in Scotland after NHS rejection

Two potentially life-changing cystic fibrosis drugs are to become available for a potential pool of 400 patients in Scotland just a month after they were rejected by the NHS.

Boston-based pharmaceutical company Vertex has announced it has signed a five-year deal with the Scottish Government for Orkambi and Symkevi (lumacaftor/ivacaftor) – drugs which help improve lung health, but were to cost about £100,000 per patient.

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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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.

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