In final draft guidance, the National Institute for Health and Clinical Excellence (NICE) has reversed its previous negative view of Novartis’ Gilenya (fingolimod), the first oral treatment for multiple sclerosis (MS).

In the draft document - which is out for consultation until March 30 - NICE recommends Gilenya as a treatment option for some adults who have highly-active relapsing-remitting MS (RRMS), a form of the condition characterised by periods in which symptoms worsen and then improve. Specifically, the Institute recommends the treatment for adults who have had an unchanged or increased relapse rate, or ongoing severe relapses compared to the previous year, despite having taken other drugs such as beta interferons. 

This positive recommendation is a change from NICE's two previous draft guidances, and follows a public consultation during which Novartis and clinicians provided additional information and analyses.

These show that, for this group of RRMS patients, Gilenya will be a cost-effective option for the NHS if Novartis provides the drug at a discounted price, as proposed in its patient access scheme (PAS), said Professor Carole Longson, director of the health technology evaluation centre at NICE.

"We have published the latest version of our draft guidance on our website, so that interested parties can highlight any factual errors or appeal against our final draft recommendations," she added. If no appeals are received, NICE expects to publish its final guidance for the NHS in April.

After the Institute published its first negative draft appraisal on the use of Gilenya in RRMS last August, Novartis submitted a proposed discount (PAS) for consideration. However, despite this, NICE' independent appraisal committee concluded that, with the Incremental Cost Effectiveness Ratio (ICER) for the drug likely to be at least £40,000 per Quality-Adjusted Life Year (QALY) gained, it still did not present a cost-effective option for the NHS, and the panel was not therefore able to provisionally recommend its use in its second draft appraisal, published in December.

During the second consultation period, Novartis revised its analyses for this particular subgroup of patients, and the final most plausible ICER for this use of Gilenya was found to be £25,000-£35,000.

The decision has been widely welcomed, with consultant neurologist Dr Eli Silber stating that, because Gilenya is a highly-effective oral agent, "it may change the way MS is managed in the UK forever."

"I want to get appropriate patients onto this therapy as quickly as possible," added Dr Silber, who leads the MS service for South London, based at King's College Hospital.

The MS Society said that NICE's decision "signifies a major step forward in the treatment of MS."

"Gilenya has been found to be highly effective in trials, and taking a daily tablet will come as welcome relief from frequent, often unpleasant, injections," said Nick Rijke, director of policy and research at the Society.

The MS Trust described Gilenya as "an important addition to the small range of available disease-modifying therapies for MS."

People with MS in England and Wales have had less choice of such treatments than those in other countries, and their options have now increased, said the Trust, adding: "it is crucial now that MS specialists are able to prescribe [Gilenya] to people with highly-active MS without local restriction or re-rationing of the treatment."

Novartis said it "will be supporting the MS community to ensure that eligible patients can get started with treatment as quickly as possible, as the NICE appraisal lasted much longer than originally scheduled."

Earlier this month, the Scottish Medicines Consortium (SMC) said it would not recommend Gilenya's use in NHS Scotland for the treatment of highly-active RRMS in adults, stating that Novartis had not presented a sufficiently robust economic analysis. The MS Society said it is "deeply disappointed" by this decision and has urged the SMC to reconsider. A decision is still to be made by Northern Ireland as to whether patients there can receive Gilenya.

- On April 20, the European Medicines Agency (EMA) is due to report the findings of its formal review of Gilenya's risks and benefits, following the sudden death of one person in the US within 24 hours of receiving their first dose of the drug. Further cases of unexplained deaths are also being investigated.