Innovative drugs that secure reimbursement in England must be made available to all eligible patients in the country via the National Health Service within three months of a positive health technology assessment from the HTA body, NICE.
How Lilly Is Helping To Address The UK’s ‘Postcode Lottery’ For Cancer Drugs
Some innovative cancer drugs are not reaching eligible patients in the UK, despite securing positive reimbursement opinions from NICE. Eli Lilly explains how industry can be “part of the solution” through partnership initiatives.
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The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.
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Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.
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The new global GCP guideline, ICH E6(R3), enables researchers and clinical trial administrators to tailor their documentation processes, but also opens the door for more scrutiny during GCP inspections.
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A German ordinance implementing the EU Health Technology Assessment Regulation offers little clarity on how far joint clinical assessment reports should be considered by national authorities.
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The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.
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Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.