Novo Nordisk’s next generation insulin product Tresiba has fallen foul of cost regulators in Germany after it health technology assessor IQWiG deemed the drug not to have any added benefit compared to other diabetes medicines.
The German Institute for Quality and Efficiency in Health Care (IQWiG) looked at the drug both on its own and/or combination with other blood-glucose lowering drugs – but said it found “no added benefit”.
The licence for Tresiba (insulin degludec) is for adolescents and children with type I and type II diabetes. IQWiG said however Novo did not present any specific data for type II diabetes and therefore it could not make a decision on whether this was better than a comparator drug.
Experts at IQWiG said that not only is there no added benefit when compared to other medicines, in girls there is in fact “a hint of greater harm regarding serious adverse events”.
Specifically, the Institute found that within 52 weeks, severe side effects occurred in around 15 of 100 girls who received Tresiba. In girls who received standard treatment, this was the case in only around three of 100 girls.
Tresiba will now be passed onto Germany’s highest pharmaceutical healthcare body the GBA, who make a final decision as to the pricing of the drug.
Shaky start
Tresiba is designed to take market share away from Sanofi’s $8bn blockbuster Lantus (insulin glargine) – currently the biggest selling diabetes product in the world, but soon to face competition from biosimilars.
It will also need to compete with Sanofi’s own next-gen insulin product Toujeo, which was given the FDA green light earlier this year.
The Danish firm’s new drug is however experiencing a tough first year on the market as the company suffered a major setback in the US last year after an FDA request for cardiovascular outcomes data delayed approval.
The regulator is looking at the data again with a pivotal clinical trial on the safety of the drug is expected in the next month.
Analysts at Thomson Reuters estimate that peak Tresiba sales will hit $2.2bn by 2020 – although this will depend on the outcome of the FDA’s decision on the drug, and what price it can achieve in markets with HTA bodies.