Orkambi Agreement

This agreement is particularly important for CF patients in England, as engaged patient groups have recently had to set up a buyers` club to import generic copies of Orkambi. LONDON–(BUSINESS WIRE)-Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that it has entered into an agreement with the Federal Office of Public Health (FOPH) and the Federal Office of Social Security (FOB) for the reimbursement of ORKAMBI® (lumacaftor/ivacaftor) and SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) for eligible patients in Switzerland with cystic fibrosis (CF). Activists celebrated the news that NHS England chief executive said cystic fibrosis patients would receive the drug within a month. «Given the time it took the company to reach this agreement, there must be no further delay,» Sir Simon Stevens wrote to House of Commons Health Committee Chair Sarah Wollaston. The commission held hearings earlier this year on the impasse. The agreement provides for access to the three medicines for all current authorised indications as well as future licence extensions. After four years of public arguments, stalled discussions and frustration for patients, Vertex and NHS England have finally reached an access agreement for cystic fibrosis medicine Orkambi, along with its other treatments cf Smykevi and Kalydeco. Under the terms of the agreement announced today, appropriate patients aged 2 years and older may be treated with ORKAMBI® with two copies of the F508del mutation in the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) gene. Eligible patients aged 12 years and older with either two copies of the F508del mutation or one copy of the F508del mutation and another responsive residual function mutation in the CFTR gene may be treated with SYMDEKO®. The agreement also provides for future indication extensions for patients of different ages for SYMDEKO®. Ludovic Fenaux, Senior Vice President of Vertex International, commented on today`s news in Switzerland: «This agreement marks an important milestone for the cystic fibrosis community in Switzerland. Access to Orkambi and Symdeko is particularly important at this time, given the onset of COVID-19 and the fact that people with CF are vulnerable to infections. We are delighted that Vertex and the Swiss authorities have been able to cooperate closely and flexibly to enable this agreement, so that around 400 appropriate Swiss patients now have access to CFTR modulators to treat the underlying cause of their disease. The final agreement means that NHS patients in England now have full access to the three medicines, and around 5,000 people are now allowed to undergo these treatments.

According to a statement from NHS England, any patient in England who could benefit from these drugs now has access. Stevens said in his letter that the deal would also apply to Wales and Northern Ireland. It does not apply, however, to Scotland, which recently concluded its own agreement with Vertex. Stevens has hinted that NHS England has done better. However, La Longue, which considered the deal, has been the subject of strong criticism, most of which was aimed at Vertex because of its manifest inflexibility in pricing and reluctance to follow the National Institute for Health and Care Excellence`s (NICE) evaluation process. There will also be hope that the long process of unification will not happen again for Vertex`s future CF therapies, which could be revolutionary for those suffering from the weakening genetic disease. Cystic fibrosis patients in England now have access to three new medicines in the NHS, according to an agreement between the manufacturer and the government. . .

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