The National Institute for Health and Care Excellence (NICE) has again rejected ixazomib (Ninlaro) in combination with lenalidomide and dexamethasone (IRd) for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more previous therapies.
After NICE initially rejected Ninlaro, Takeda proposed a price reduction for it to be included in the Cancer Drugs Fund. Although this proposal reduced the cost-effectiveness estimates, the appraisal committee considered that ixazomib was still unlikely to be cost effective.
The second draft recommendation concludes that ixazomib still does not meet all the criteria required for inclusion in the Cancer Drugs Fund (CDF). This decision will not affect patients already being treated with ixazomib, either through the Named Patient Programme (NPP) or on a clinical trial.
Myeloma UK acting policy and public affairs manager Shelagh McKinlay said: “This second draft ‘no’ is disappointing, but while the consultation is ongoing there is still the potential for a positive decision to be reached”.
She added: “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. Ixazomib is not only an effective treatment option, it is the first oral treatment of its kind, offering patients much needed flexibility in how they live their lives”.
The trend in treatment for myeloma has been to try patients on new drug combinations when their disease progresses to glean small improvements in length survival, and Takeda is not the only company to experience setbacks.
In early July, Merck announced that the US Food and Drug Administration (FDA) had put a complete clinical hold on two multiple myeloma trials testing its drug Keytruda (pembrolizumab) in combination with established therapies pomalidomide or lenalidomide after an independent review found more deaths in the pembrolizumab groups than the controls. A third myeloma trial, in which one treatment arm received pembrolizumab plus lenalidomide was placed on partial hold. Pembrolizumab is an immuno-oncology drug targeting the PD-1 protein on the surface of T cells approved for the treatment of melanoma and for use in a number of other cancers.