Cost regulators for the NHS in England and Wales are not recommending Amgen's Kyprolis as a cost-effective use of resources.
The National Institute for Health and Care Excellence has turned down the drug's routine use on the NHS in combination with lenalidomide (Celgene's Revlimid) and dexamethasone or dexamethasone alone in patients who have had at least one prior therapy.
Aside from uncertainties in the clinical evidence, NICE said the committee was unable to agree on a best cost-effectiveness estimate, because both the company's and the expert review group's approach to modelling "were highly uncertain". Also, the drug failed to qualify for end-of-life consideration.
The decision comes after Kyprolis (carfilzomib) was turned down by the Scottish Medicines Consortium back in September, as it was "not satisfied" that evidence on overall survival benefits was strong enough to justify the medicine's cost to the NHS.
Kyprolis is an intravenously-administered irreversible proteasome inhibitor that binds to the N-terminal threonine site, causing degradation of the proteins in the cell.
The drug was approved for the EU back in November, on the back of data from the pivotal Phase III ASPIRE trial, in which patients given the Kyprolis/Revlimid/dexamethasone combo had median progression-free survival of 26.3 months compared to 17.6 months for those treated with just Revlimid and dexamethasone.
Subsequently, the firm presented data from the ENDEAVOR study, in which patients treated with Kyprolis/dexamethasone achieved 50 percent greater progression-free survival of 18.7 months compared to 9.4 months in those receiving Janssen's Velcade (bortezomib)/dexamethasone.
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