New agents – is the tide turning?

The last 5 years have seen a huge increase in the number of new anti-diabetes agents reaching the market, from new insulins to novel injectable and oral agents However, given changes to drug regulation following the Rosiglitazone debacle and the current financial climate, there are signs that the conveyor belt of agents is either slowing or coming to a halt. The two latest ‘blockbusters’, Novos new insulin Degludec (Tresiba) and Astra Zeneca’s SGLT2 inhibitor Dapaglafozin (Forxiga) have had major issues achieving either approval or formulary status.

Dapaglafozin ran into problems in February when NICE issued draft guidance saying that it was minded not to recommend it due to concerns about the quality and length of the trials especially where only one compared it to another active agent. There were also concerns about its cost effectiveness. This guidance has been used by local drug and therapeutics committees (DTC) to defer its formulary inclusion.

The case with Tresiba is even starker. This insulin has been gaining increasing prominence in the diabetes world – initially suggested as a once weekly agent but now marketed as a highly predictable daily basal analogue insulin. There also seems to have been some holes in Novos marketing of the insulin where its exact positioning in the therapeutic pathway is far from clear – especially as its competitor, Lantus is hardly a poor product. For example, the reduction in hypoglycaemia trumpeted at launch seems to apply to Type 2 rather than Type 1 diabetes. This aside, problems mounted in February when the FDA did not approve Tresiba pending further cardiovascular safety evidence. Furthermore, despite having received approval from European regulators, Tresiba is marketed at ~70% cost premium to Lantus (£41.50 v £72.00 for their U100 disposable pens). Given that current practice is to move away from analogue to human insulins in the majority of Type 2 diabetes due to cost effectiveness, the pricing of Tresiba does raise questions and is certainly the driver behind local DTCs not granting formulary status.

So, what is the clinician meant to make of this? Perhaps a step back is worth considering as well as more appropriate use of proven more cost effective medications such as optimal use of Metformin, human insulins unless hypoglycaemia is an issue or the really controversial step of increasing the advocacy of lifestyle changes!

Dr. Mark Freeman