Please login to the form below

Not currently logged in
Email:
Password:

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

Cites uncertainty in clinical and cost-effectiveness analyses
Amgen

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NICE's draft guidance is part of its assessment for NHS use of Kyprolis (carflizomib) in combination with Celgene's Revlimid (lenalidomide) and dexamethasone to treat adults who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NICE's draft guidance on its use in combination with Revlimid and dexamethasone is now out for consultation, with the next appraisal committee meeting due to take place in February.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

Share

Tags

COVID-19 Updates and Daily News

Featured jobs

PMHub

Add my company
Graphite

Graphite is a digital agency which partners with globally respected pharma and healthcare organisations to create powerful digital experiences. We...

Latest intelligence

JulAug cover image
The Chronicles of Pharma: a creative review of pharma’s journey to omnichannel
Chris Ross conducts a literary-inspired review of pharma’s pursuit of communications excellence...
The key to psoriasis innovation? Dispelling the shadow of the JAK inhibitor
Powerful therapies that can improve skin clarity dominate the psoriasis landscape, so why are most patients stuck in a cycle of ineffective topicals? Fishawack Health explores the market and reveals...
Virtual Speaker Program: A Customer Story
Learn how we helped our client develop a virtual speaker program and roll out a series of regional peer-to-peer education sessions....