EU regulators gave fingolimod preliminary marketing approval at the beginning of this year. Fingolimod is made and marketed by Novartis under the brand nameGilenya. The company applied for it to be covered by the NHS for MS patients who have not responded to current medications.
The National Institute for Clinical Excellence’s (NICE) recommendation does not mean that a drug is not approved, it only means that a drug will probably not be covered by the National Health Service (NHS) – in other words, the patient will have to pay for the prescription.
Current MS medications, such as beta interferons and Tysabri must be injected – patients either inject it themselves or have to go to hospital every few days for supervised infusion. Gilenya is an oral pill, it represents a considerable change in MS treatment.
According to an article in NEJM (New England Journal of Medicine), those on fingolimod had 50% fewer disabling relapses compared to those on interferon beta.
Professor Carole Longson, Director of the Health Technology Evaluation Centre at NICE said:
“While it’s important that people with multiple sclerosis have treatment options, NICE has to ensure that the NHS provides treatments that bring benefits that are value for money. This is so that everyone who uses the NHS can receive the best care possible.
Unfortunately our independent committee wasn’t given sufficient evidence to show that fingolimod could reduce relapses considerably better than the other treatments currently being used. Based on the available clinical evidence and economic analysis, our independent committee concluded that fingolimod would not be effective good use of NHS resources.
We encourage healthcare professionals, people with MS and our other relevant third parties to comment on our committee’s provisional recommendation so that they can contribute to the development of this guidance.”
There will now be a consultation. However, if the decision does not change, then the only way an MS patient will get fingolimod costs covered is if their PCT or hospital makes an exception and pays for it – resulting in a postcode lottery.