NICE has stuck to its decision not to recommend Takeda’s multiple myeloma therapy Ninlaro for routine use in the NHS in England and Wales after a consultation process.
The agency reiterated its position that Ninlaro (ixazomib) is not cost-effective as a treatment for relapsed or refractory multiple myeloma, and that Takeda had not been able to persuade it that the drug extended life in these patients compared to current treatments.
NICE initially rejected the drug in draft guidance published in April, and has issued a second negative appraisal consultation document (ACD) for the drug that also says Ninlaro doesn’t meet the criteria for inclusion in the Cancer Drugs Fund (CDF), the fall-back option for drugs not available on the NHS.
Ninlaro was approved by the EMA last November, becoming the first orally-active proteasome inhibitor to be registered in Europe. It is indicated for use alongside Celgene’s blockbuster immunomodulatory drug Revlimid (lenalidomide) and dexamethasone.
The approval of Ninlaro is based on the results of the phase III TOURMALINE-MM1 trial, which showed patients taking Takeda’s drug lived longer without their disease worsening – an average of 20.6 months – compared to 14.7 months in participants taking the control regimen. Data from the trial is still maturing and NICE would like to see a positive effect on overall survival before it gives a green light.
Commenting on NICE’s decision, Adam Zaeske, managing director of Takeda UK and Ireland, said: ” We felt that our proposed confidential offer addressed the uncertainties NICE had in the first ACD, and are disappointed with the committee’s latest draft decision.
“While we acknowledge that NICE faces significant challenges when assessing novel combination regimens, we are committed to finding a solution and will be responding robustly during the next stages of the process,” he continued.
Patient groups also expressed their disappointment, with Myeloma UK’s acting policy and public affairs manager Shelagh McKinlay noting that “triple combination treatments such as this one are becoming the international standard in myeloma treatment and patients in the UK deserve to have access to them”.
She added that she was glad that there is still an opportunity for a positive verdict as the consultation is ongoing, saying the charity is “glad that NICE have decided to seek further views before reaching a final decision”. The second consultation period extends until 26 September.