By Leela Barham.
Accessing the latest cancer drugs always seem to be controversial. Not just because of the money but also because of the complexities of accessing treatments during their development. This seems to be especially the case for young people with cancer, according to the UK’s Teenage Cancer Trust.
The trust has called for industry to do more — challenging them to not just to talk the talk, but walk the walk and commit to “tackling diseases that affect teenagers and young adults” and not only that but to get rid of “arbitrary age restrictions”.
It also wants companies to engage with the flexibilities that are emerging in Europe and the UK. This includes the adaptive licensing (AL) pilot from the European Medicines Agency (EMA). Under AL, companies can volunteer to explore a more iterative approach to licensing — starting first with a small group of patients and in discussion with everyone including patients and Health Technology Assessment (HTA) agencies — adding more patient groups over time.
It also name checks the UK’s Early Access to Medicines Scheme (EAMS). Under EAMS companies can again volunteer to put their product under the scrutiny of the Medicines and Healthcare Regulatory Authority (MHRA), paying for the privilidge, but with the opportunity to be given a promising innovative medicine designation, and later, if the data supports it, an Early Access to Medicine Scheme scientific opinion.
Teenage Cancer Trust have a long list of ‘to dos’ for others, ranging from the European Commission to Ethics Committees, individual clinicians and of course encouraging young people with cancer and their families to ask about clinical trials.
Its calls on this issue are underpinned by the experience of one teenager, Chole, who could not get on to a trial because of what amounts to the real life ‘arbitrary’ age restriction the trust wants to see industry drop. Chole was aged 17 years and 10 months, not the 18 that the commercial trial inclusion criterion on age set.
With industry reputation tarnished (GSK and China comes to mind), simply dropping an age 18 limit (but keeping those all important clinical ones that help to robustly explore safety, efficacy and benefit risk for what are vulnerable young people with cancer) could be one way to show commitment to those that matter — those patients that new treatments aim to help.