In addition, the agreement allows for the prescribing of kaftrio and other varnish-based drugs for people with rare mutations that may be covered by licensing decisions of the U.S. Food and Drug Administration (FDA). This agreement is of particular importance to CF patients in England, as groups of committed patients have recently had to resort to the creation of a buyer`s club to import generic copies of Orkambi. As part of the contract renewal, patients with NHS-England cystic fibrosis have access to caftrio (ivacaftor/tezacaftor/elexacaftor) in combination with Kalydeco (ivacaftor) 150 mg. This access is the first in Europe when the European Commission authorises the drug. The new extended agreement includes refundable access to medicines currently authorised by Vertex – KALYDECO® (ivacaftor), ORKAMBI® (lumacaftor/ivacaftor) and SYMKEVI® (Tezacaftor/Ivacaftor), as well as combined triple treatment, if authorized, as well as any additional indications authorized for all these drugs. In a statement to customers, Jefferies analyst Michael Yee wrote that the deal would increase revenue by $500 million a year. Earlier this week, Spain and Australia entered into their own access agreements with the drug producer, as he pointed out. 1.1 NHSE-I and Vertex have entered into an access agreement to allow access to treatment through ivacaftor, lumacaftor/ivacaftor, tezacaftor/ivacaftor and ivacaftor, ivacaftor and ivacaftor ivacaftor and ivacaftor and tezacaftor/Elexacaftor. NHS England and Vertex Pharmaceuticals have reached an agreement allowing access to Vertex kaftrio (ivacaftor/tezacaftor/elexacaftor), a tritherapy for cystic fibrosis (CF) in an association scheme with Kalydeco, as soon as the drug is authorised by the European Commission.
6.4 Future therapeutic indications (for ivacaftor, lumacaftor/ivacaftor, tezacaftor/ivacaftor or ivacaftor/tezacaftor/tezacaftor/elexacaftor), which have been marketed by the European Medicines Agency for the United Kingdom or the Medicines and Health Products Regulatory Agency for the duration of the interim access contract, are automatically considered to be an integral part of this agreement and formalized by a complement to the interim agreement. The NHS agreement covers Orkambi, Symkevi and Kalydeco de Vertex. Officials believe the drugs will be available to patients within 30 days. 10.2 Vertex provides assurance that existing agreements on the resources required to implement data collection and analysis will be updated within two months of the publication of this agreement to include ivacaftor/tezacaftor/elexacaftor (caftrio) with relevant third parties. However, the duration of the contract has been strongly criticized, most of which were directed at Vertex because of its obvious inflexibility in pricing and its reluctance to comply with the National Institute for Health and Care Excellence (NICE) evaluation process. This agreement concerns the treatment of patients with cystic fibrosis: the negotiations are over because Vertex has finally accepted the “confidential commercial conditions” of the agreement – and most importantly, it has also agreed to present its medicines for a full evaluation of nice.