What happens after Brexit for Pharmacovigilance and Regulatory?
12th February 2020Advice for Management of Clinical trials in relation to Coronavirus
13th March 2020The UK’s medicines cost-effectiveness agency NICE has agreed to look again at its decision to turn down NHS funding of Novartis’ Aimovig for migraine prevention after an appeal.
The appeals panel has concluded the rejection of Aimovig (erenumab) last September was flawed because NICE’s technology appraisal committee “failed to consider all of the evidence about the cost-effectiveness” of the drug.
British Association for the Study of Headache chairman, Dr Mark Weatherall said: “Having found that erenumab is cost-effective versus the best supportive care in patients with chronic migraine, it cannot be right or fair to deny it to those worst affected patients who have not responded to Botox and other preventative medications.”
Pure Drug Safety is one of the leading players in the pharmacovigilance outsourcing market and the owner, Carol Kingstone commented: “At PDS we are welcoming NICE’s decision to review their previous decision on funding Aimovig to make it available for chronic migraine sufferers, if their clinician thinks it could improve their quality of life. We await the results of the review with interest.”
Aimovig became the first drug in a new class of antibody-based CGRP inhibitors to be approved in Europe when it got a green light from the European Medicines Agency (EMA) last year. It costs around £5,000 per year, although Novartis has offered the NHS a confidential discount.
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