In Germany, the Criminal Code (§ 203) and professional codes require that certain relationships with clients be treated confidentially, for example the relationship between patients and their doctors and the relationship between lawyers and their clients. These professions must respect professional secrecy. In order for these and other professions to purchase cloud-based services from cloud solution providers, the cloud service provider must enter into a written agreement with the customer that guarantees professional secrecy. Under the terms of the new reimbursement agreement, SYMKEVI® will be reimbursed for people with cystic fibrosis aged 12 years and older with an F508del mutation and one of the mutations leading to residual activity (F/RF) of the CFTR protein as indicated in the Summary of Product Characteristics (SPC). It is also funded for patients homozygous for the F508del mutation in the CFTR gene. The reimbursement agreement allows wide access to KAFTRIO® for people with cystic fibrosis aged 12 years and older with an F508del mutation and minimal functional mutation. Triple therapy is also reimbursed for homozygous patients for the F508del mutation in the CFTR gene, which is a new treatment option for treating physicians. In November 2020, the Transparency Commission (TC) awarded the French health authority (HAS) KAFTRIO® an ASMR 2 rating, indicating “a significant improvement in the medical services provided”. Of the 250 listed drugs first issued by the TC in 2019, only two received such an assessment. Microsoft customer agreements are region-specific and available in multiple languages. Find the customer`s preferred location and language in one of the lists below to download the right contract. “Today`s announcement represents an important milestone for cystic fibrosis patients in France.
Thanks to this national reimbursement agreement, eligible patients aged 12 and over now have access to KAFTRIO and SYMKEVI. For people with CF, we are pleased to have reached this agreement so quickly and that the French health authorities have recognized the value of both drugs,” said Ludovic Fenaux, Senior Vice President, Vertex International. LONDON–(BUSINESS WIRE)–Jun 28, 2021– Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced a national reimbursement agreement with French health authorities for cystic fibrosis drugs KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor and SYMKEVI® (tezacaftor/ivacaftor) in combination with ivacaftor. Both medicines will be available to all eligible patients once the agreement has been published in the French Official Journal. – With this reimbursement agreement, more than 1,500 patients now have access for the first time to CFTR modulating therapy – This agreement was signed in December 2019 between France, the GCF and the World Bank for contributions to the first GCF replenishment period (GCF-1). Cystic fibrosis (CF) is a rare genetic life-shortening disease that affects more than 80,000 people worldwide. CF is a progressive multisystemic disease that affects the lungs, liver, gastrointestinal tract, sinuses, sweat glands, pancreas and reproductive system. Cystic fibrosis is caused by a defective and/or missing CFTR protein resulting from certain mutations in the CFTR gene. Although there are many types of CFTR mutations that can cause the disease, the vast majority of people with CF have at least one F508del mutation. These mutations, which can be determined by a genetic test or genotyping test, lead to cystic fibrosis by producing non-functional and/or too few CFTR proteins on the cell surface. Faulty functioning and/or the absence of CFTR protein leads to poor circulation of salt and water in and out of cells in a number of organs. In the lungs, this leads to the accumulation of abnormally thick and sticky mucus, which in many patients can cause chronic lung infections and progressive lung damage that eventually leads to death.
The median age of death is in the early 30s. Vertex is a global biotechnology company that invests in scientific innovation to develop transformative medicines for people with serious diseases. The company has several approved drugs that treat the underlying cause of cystic fibrosis (CF) — a rare and potentially fatal genetic disease — and has several ongoing clinical and research programs in CF. Beyond cystic fibrosis, Vertex has a strong portfolio of investigational small molecule drugs for other serious conditions where it has deep knowledge of causal human biology, including pain, alpha-1 antitrypsin deficiency and APOL1-mediated kidney disease. In addition, Vertex has a rapidly growing pipeline of cell and gene therapies for diseases such as sickle cell disease, beta-thalassemia, Duchenne muscular dystrophy, and type 1 diabetes mellitus. Full product information can be found in the summary of product characteristics on www.ema.europa.eu. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements made by Ludovic Fenaux, Senior Vice President, Vertex International in this press release and statements regarding reimbursement, availability and access to KAFTRIO® and SYMKEVI® for certain patients, the estimated number of patients eligible for CFTR modulator therapy, and our beliefs about the benefits of our medicines. Although Vertex believes that the forward-looking statements contained in this press release are accurate, such forward-looking statements represent only the Company`s beliefs as of the date of this press release, and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements.
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