- _The value of medicine or how to aggressively price a medicine It is inevitable that pricing debates will be taken up again in earnest next year, not least because one of the major stories to break towards the end of 2017 was the announcement that Spark Therapeutics historic approval for the first gene therapy for an inherited disorder was given by the FDA. Why is that significant in the pricing debate? Only because it might break a few pencil leads at HTA offices if the rumoured $1 million price tag per patient is followed through on.
- _A record-breaking year for US drug approvals? Some of this success may be down to FDA Commissioner Scott Gottlieb’s leadership, who joined the organisation in May. Under his direction, expect even more total approvals by the end of next year as the FDA looks to integrate major changes to the way it regulates medicines and medical devices – especially in the cancer space, where Gottlieb has recently outlined plans to allow for already-approved treatments to be authorised in a second indication based on supplemental applications.
- _Technology continues to amaze
- _Mergers and acquisitions set to return with a bang? What awaits for 2018? It is thought that President Trump managing to push his tax reform through the US Senate could see previously cautious US pharma companies bring their money back to North American shores for an almighty acquisition splurge. In particular, Pfizer has played it cool for the past year, waiting for the right moment to splash the cash after its previously failed attempt at a mega-tax inversion. It is unlikely to be the only company to make significant moves, as an M&A carousel loosens everyone’s pockets.
- _Personalised medicine to show even more potential
- _The North American opioid crisis
- _Nothing is certain except uncertainty (just ask those who live in the UK)
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