Genzyme will need to provide the National Institute for Health and Care Excellence (NICE) with more information if it wants its multiple sclerosis (MS) drug Lemtrada to be available on the NHS in England and Wales.
NICE today published draft guidance saying it was unable to recommend Lemtrada (alemtuzumab) at this point in time and needed a “series of clarifications on the evidence submitted by the manufacturer”.
It is the second time this year that Genzyme – a division of Sanofi – has received an initial knockback from NICE for an MS drug after draft guidance published in September failed to recommend oral medicine Aubagio (teriflunomide).
At the time, NICE said that there were unanswered about the use of Aubagio to be able to judge its cost-effectiveness as a first-line treatment in adults with relapsing remitting multiple sclerosis (RRMS).
It was a similar story for the intravenous infusion Lemtrada, with NICE’s Health Technology Evaluation centre director Prof Carole Longson saying the appraisal committee concluded that there were “still questions to be answered”.
“This is why we have requested more details from the manufacturer; to ensure that we have the information the Appraisal Committee needs to reach their conclusions,” she added.
Genzyme now has until January 9, 2014, to submit extra information on Lemtrada for NICE to consider in further draft guidance.
Genzyme told PMLiVE it would respond in details to NICE’s questions and noted the guidance was only a preliminary recommendation at this point.
“It is quite usual for NICE to seek further clarification and additional analyses as part of its assessment of how new medicines and treatments should be used in the NHS,” a spokesman said, adding: “We believe that there is a strong case that Lemtrada represents good value for money for the NHS.”
The company has also experienced problems regarding the trial data for Lemtrada in the US. Last year the Food and Drug Administration (FDA) sent a refuse-to-file letter last year saying Genzyme needed to present it in a way that would help the agency “better navigate the application”.
Lemtrada was approved for use in the EU in September as a treatment for RRMS to be given in two annual treatment courses.
Its active ingredient alemtuzumab was previously marketed as a treatment for chronic lymphocytic leukaemia under the Campath brand name.
However, Sanofi decided to pull Campath from market in the EU and the US in August 2012, due in part to the prospect of the drug’s use as an MS treatment.