NICE has reversed its original decision on Novartis’ Gilenya (fingolimod), the first pill to treat multiple sclerosis, in final draft guidance.
Gilenya is now recommended after NICE assessed a public consultation which Novartis and clinicians provided additional information and analysis on the effectiveness of the medication.
Sue Webb, General Manager, UK & Ireland and Country President, Novartis UK, said the treatment “will make a real difference” to people living with MS.
The recommendation follows two previously failed appraisals. After the first in August 2011, Novartis submitted a Patient Access Scheme (PAS) to provide a discount to the NHS.
But, following another consultation, NICE said the MS pill still did not represent value for money in a separate draft guidance document last December.
However, during the second consultation period, Novartis revised its analysis for a subgroup of patients for the licensed population. Following this, NICE’s independent Appraisal Committee now believes the treatment offers value for money to the NHS, when provided under the terms of the PAS.
The subgroup of patients includes adults with highly active relapsing-remitting multiple sclerosis, whose relapses have increased or remained compared to the previous year, despite the use of beta interferons.
NICE now provisionally recommends the treatment for adults who have an unchanged or increased relapse rate or ongoing relapses compared to the past year, despite treatment.
Dr Eli Silber, a consultant neurologist at King’s College Hospital, said she was delighted NICE reversed its original decision. “We’ve waited a long time for an effective oral treatment to offer patients who are continuing to relapse on first line injections,” said Dr Silber. “Today’s decision increases treatment choice. Because it is a highly effective oral agent it may change the way MS is managed in the UK forever.
“With more active forms of MS, we have a limited window of opportunity to make a difference to patients’ lives – many are young people who are raising families and starting their careers. I want to get appropriate patients onto this therapy as quickly as possible.”