Preliminary NICE ‘no’ for Takeda’s Alunbrig

The Institute is appraising the drug’s use to treat anaplastic lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer (NSCLC) in adults who have already had Pfizer’s Xalkori (crizotinib).

It concluded that clinical evidence based on single-arm studies suggests that people having Alunbrig (brigatinib) live longer than those having the standard of care after Xalkori, Novartis’ Zykadia (ceritinib), and that they live longer before their condition worsens.

However, the company’s results from its cost-effectiveness modelling "are optimistic" and its assumption about the length of treatment benefit of the drug "is clinically implausible", NICE said.

Also, the most plausible cost-effectiveness estimates for Alunbrig compared with ceritinib are more than £50,000 per QALY, and thus above what the Institute normally considers acceptable for an end-of-life treatment, and so it could not be recommended for routine use on the NHS.

Earlier this month Takeda unveiled data showing that treatment with Alunbrig resulted in superior progression-free survival compared to Xalkori as assessed by a blinded independent review committee, corresponding to a 51% reduction in the risk of disease progression or death.

The drug is yet to be approved in this setting in Europe, but it recently received backing from the European Medicines Agency’s Committee for Medicinal Products for Human Use.

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