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Springer International Publishing Switzerland 2017
1 EMA Holds Workshop on Adaptive Pathways Initiative The European Medicines Agency (EMA) has hosted a workshop with interested stakeholders on adaptive pathways—a drug-development initiative that aims to improve access to treatments for patients with high unmet needs. Although not a new regulatory pathway, adaptive pathways utilises existing legislative and regulatory tools more efficiently. It focuses on medicines that would have a significant clinical impact in patient groups with high unmet needs, and includes key stakeholders from very early in the development pathway. It also identifies the most relevant and appropriate tools to generate evidence; for example, real-world data in addition to randomised controlled trials. Using a step-wise approach, it then allows approval of medicines in small, tightly-defined patient populations until more evidence becomes available. The workshop follows a report published in July 2016 outlining a pilot project on how adaptive pathways could be applied in practice, which was met with mixed reviews from stakeholders. Some felt it was beneficial for patients, whereas others expressed concerns about its possible impact on standards of evidence for medicines approval in Europe. The main concerns raised at the workshop included the use of real-world data in the evaluation of medicines in practice, as well as the role of organisations such as health technology assessment bodies and payers and the timing of their involvement. EMA and the European Commission have said they will address the concerns raised at the workshop and determine what actions need to be taken over the coming months.
European Medicines Agency. EMA hosts workshop on adaptive pathways. 2016 Dec 13. Available from URL: http://www.ema.europa.eu/ema/index. jsp?curl=pages/news_and_events/news/2016/12/news_detail_002666.jsp& mid=WC0b01ac058004d5c1. Accessed 09 Feb 2017.
2 Drug Price Discounts Contributing to NICE Approvals Drug companies are discounting prices of cancer drugs in order to gain approvals by the National Institute for Health and Care Excellence (NICE) for the use of their drugs in the National Health Service (NHS) in England, said Nigel Hawkes in an article published in the BMJ. As a result of drug discounts, seven of the first nine drugs on the old Cancer Drugs Fund (CDF) list reviewed by NICE have now been approved in draft guidance or final guidance. NICE approved three drugs for the treatment of breast cancer in November 2016, and reversed its previous decision to reject ibrutinib for leukaemia. ‘‘Sensible pricing and in some cases better data are helping to secure access to important cancer medicines as they move out of the old Cancer Drugs Fund,’’ commented Andrew Dillon, chief executive of NICE, ‘‘As reappraised drugs now move to routine commissioning, funding in the CDF can be freed up and used for newer, innovative cancer treatments’’. Drug companies know what their drugs are worth and are now offering them ‘‘at a price they know
