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5 Sep 2017

Takeda disappointed as NICE issue second negative draft decision for ixazomib

Company says it is determined to work collaboratively to find a solution.

Takeda has expressed its disappointment that there will be further delay before NHS patients can gain access to ixazomib (Ninlaro) for adults with relapsed or refractory (RR) multiple myeloma (MM). The National Institute for Health and Care Excellence (NICE) has issued a second, negative appraisal consultation document (ACD) for ixazomib in combination with lenalidomide and dexamethasone (IRd), for the treatment of patients who have received one or more previous therapies.

The latest draft recommendation concludes that ixazomib still does not meet all the criteria required for inclusion in the Cancer Drugs Fund (CDF). Takeda continues to be fully committed to working closely with NICE, NHS England and the myeloma community during the consultation period and will do everything in their power to secure patient access to ixazomib.

Ixazomib is the first oral proteasome inhibitor (PI) licensed for use in Europe and, if reimbursed, would become part of the first Rd-based triplet regimen to be made available on the NHS to RRMM patients in England.

In the latest ACD, NICE acknowledged that triplet therapy is an emerging standard of care and that the data from the pivotal Phase III TOURMALINE-MM1 (TMM1) trial demonstrated that in patients treated with two or three prior therapies, the IRd regimen increased progression-free survival by approximately 9 months, when compared to the current standard of care in the UK (Rd). However, as data from the TMM1 trial is still maturing, NICE stated that the extent to which IRd prolongs overall survival compared with the current treatment for this patient group is uncertain.

Shelagh McKinlay, Policy and Public Affairs Officer at Myeloma UK, said: "This is very disappointing news for the myeloma community. Patients with myeloma need a novel, Rd-based triplet regimen; there are no others recommended for use by NICE and patients should be able to access this international standard of care on the NHS. We believe ixazomib clearly has the potential to be recommended for inclusion in the CDF which is supposed to provide access to innovative cancer drugs while further clinical evidence is gathered and used to demonstrate that these drugs are cost-effective – Takeda is collecting this data for ixazomib. We urge Takeda and NICE to work together collaboratively for a positive solution.”

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