Italy is to reimburse Novartis’s gene therapy Kymriah (tisagenlecleucel) for use in lymphoma and leukemia after the regulatory agency AIFA agreed a new reimbursement model under which the company will be paid for the treatment in three installments but only if it proves successful.
Italy Unveils New Payment Model For Novartis’s CAR-T Kymriah
The Italian authorities have agreed a new kind of reimbursement model for Novartis's CAR-T therapy Kymriah that involves payment in instalments depending on the patient’s response to treatment.
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Payers and health technology assessment bodies in the Netherlands, Germany and Italy are either unwilling to use real-world data in assessments or cannot due to their existing frameworks, say representatives from Gilead Sciences and Autolus Therapeutics.
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The world’s first CRISPR gene editing therapy, Casgevy, has been made available to patients with sickle cell disease in England, adding to access arrangements in the US, Austria, Bahrain, Germany, Luxembourg, Italy and Saudi Arabia.
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Teva has been fined €463m – just over half a billion US dollars – over a breach of EU antitrust rules, after the European Commission found that it abused its dominant position to delay competition to Copaxone, including by misusing the patent system and disparaging rivals. The firm has strongly disagreed with the decision – which is claims is “legally untested” and “not supported by the facts” – and says it will appeal.
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The COSIsiFA initiative includes a new independent website, regular newsletters, a six-monthly bulletin, and training courses to help promote the appropriate use of medicines.
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The EU Clinical Trials Information System has achieved primary registry designation in the International Clinical Trials Registry Platform in a move that is expected to reduce regulatory burden for companies and help them lower compliance costs by aligning with publication requirements in medical journals.
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The UK government has listened to industry concerns about high clawback rates under the voluntary scheme and will review it in June in a bid to resolve the issue and “move on to bigger and more important things,” health secretary Wes Streeting says.
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England’s health technology assessment institute, NICE, is looking to “reimagine” its evaluation process with the help of AI, rather than just using this technology to speed up its existing processes.