The UK’s Early Access Scheme: Breakthrough Or Mixed Blessing?
The UK's Early Access to Medicines Scheme is designed to give patients with high unmet needs access to certain therapies before they are licensed for use, but it presents a number of challenges that will only be addressed in real-world testing. Part one of a two-part series on European programs for improving patient access to new therapies.
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The year was marked by record levels of biopharma M&A activity and a strong IPO market. Measures designed to deliver early access to new medicines continued to advance on both sides of the Atlantic, while pricing came in for renewed attention as new, highly effective but extremely expensive products reached the market.
Pharmaceutical manufacturers and FDA have enthusiastically embraced the “breakthrough therapy” program as a way to more quickly bring new drugs with substantial effects to patients in need. With two years of program experience now under their belts, agency and industry representatives talk about learnings and best practices that could be applied to the development and review of drugs outside the program.
Adaptive licensing is coming to Europe and, while it will be beneficial to patients, data exclusivity considerations may render it a double-edged sword to the innovative drug industry.