Patients with multiple sclerosis will be celebrating news that cost regulators for the National Health Service in England and Wales have approved funding for Novartis' Gilenya, the world's first pill for the disease.

The National Institute for Health and Clinical Excellence has issued guidance recommending Gilenya (fingolimod) for adults who have had an unchanged or increased relapse rate, or ongoing severe relapses compared to the previous year, despite having taken other medications. 

The decision means that, by July 25 this year, patients with highly active relapsing remitting (RRMS) forms of MS who are not responding to treatment with first-line interferon injections should have access to the drug on the NHS.

According to Novartis, clinical trials showed that Gilenya was able to cut relapses by more than half compared to a standard interferon injection, offering new hope to patients unresponsive to other therapies.

The Institute was initially minded to reject the drug, but changed its mind on additional data showing that, for certain RRMS patients, Gilenya is a cost-effective option for the NHS, as long as the drugmaker provides the drug at a discounted price as proposed in its patient access scheme.

Around 27,500 people in England and Wales are though to have RRMS.

Tasigna and Glivec in for CML

Elsewhere, NICE has also published final guidance recommending the use of Novartis' Tasigna (nilotinib) and Glivec (imatinib) as a first line treatment for chronic myeloid leukaemia (CML).

Tasigna has been shown to be significantly more effective that the current standard therapy for the disease, Glivec (imatinib), and the publication of NICE guidance will finally give patients easier access to this drug at the point of diagnosis, when it can provide the greatest benefits, representatives of Novartis note.

On the downside, Bristol-Myers Squibb's Sprycel (dasatinib) was not recommended for use, as expected. While Sprycel and Tasigna were considered to be equally effective in treating CML, Novartis is offering its drug at a discounted price, making it a cost-effective option for the NHS, NICE explained.

NICE's appraisal committee previously calculated the most plausible incremental cost effectiveness ratio (ICER) for Tasigna compared with standard dose Glivec to be around £11,000 per QALY (quality-adjusted life year), while the ICER for Sprycel compared with standard dose Glivec exceeded £200,000 per QALY gained.

New Hep C drugs

There was also good news for patients with hepatitis C, after the Institute waved through Merck Sharp & Dohme's Victrelis (boceprevir) and Janssen Cilag's Incivo (telaprevir), both in combination with peginterferon alfa and ribavirin, for use on the NHS.

According to the Health Protection Agency, there are around 255,000 people with hepatitis C in England and Wales, of which 146,000 are infected chronically.

NICE's guidance recommends Victrelis and Incivo as treatment options for those with genotype 1 hepatitis C - the most common form of the disease - and with compensated liver disease who are previously untreated or unresponsive to prior therapy.

The decision to approve these drugs for use on the NHS is underpinned by clinical data showing that, when used in combination with pegylated interferon and ribavirin, they each produce higher sustained virological response rates (considered to be equivalent to a cure) than pegylated interferon and ribavirin combination therapy, which "represents a major benefit for people with genotype 1 chronic hepatitis C", noted Professor Carole Longson, Health Technology Evaluation Centre Director at NICE.