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NICE set to knock-back Amgen's myeloma treatment Kyprolis

Cites uncertainty in clinical and cost-effectiveness analyses

Amgen's new treatment for Kyprolis has not been recommended by NICE after the UK watchdog took issue with the clinical and cost-effectiveness analyses provided for the multiple myeloma treatment.

NICE's draft guidance is part of its assessment for NHS use of Kyprolis (carflizomib) in combination with Celgene's Revlimid (lenalidomide) and dexamethasone to treat adults who have received at least one prior therapy.

Kyprolis was launched in the UK in February, having been approved by European regulators for this indication last November.

That decision came on the back of data from the ASPIRE trial, which showed patients treated with all three drugs had a progression-free survival of 26 months, compared to just over 17 months for those on Revlimid and dexamethasone alone.

But in assessing the value for money that Kyprolis would provide to the NHS in England and Wales, NICE said there were 'uncertainties' in Amgen's submission and its estimation of long-term survival.

“The committee was not confident that the most plausible cost-effectiveness estimate of carfilzomib had been presented,” the watchdog added in a statement.

In February Kyprolis became the first irreversible proteasome inhibitor to reach the UK market and then in July this year it won a new indication that allowed it to be used more widely. The drug's second indication in less than a year passed it for use with dexamethasone alone in adults with multiple myeloma who have received at least one prior therapy.

But more recently it suffered a major setback when it took on Takeda's proteasome inhibitor Velcade (bortezomib) in the head-to-head CLARION trial and failed to show a benefit on progression-free survival (PFS).

NICE's draft guidance on its use in combination with Revlimid and dexamethasone is now out for consultation, with the next appraisal committee meeting due to take place in February. Final guidance is then due to be published in May.

Article by
Dominic Tyer

9th November 2016

From: Regulatory



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