In a draft decision, England and Wales independent body that recommends whether drugs should be covered by the National Health Service, decided that at £20,000 a year fingolimod "would not be a cost effective use of NHS resources." Thousands of multiple sclerosis sufferers who do not respond to current medications were disappointed.
EU regulators gave fingolimod preliminary marketing approval at the beginning of this year. Fingolimod is made and marketed by Novartis under the brand name Gilenya. 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.
Simon Gillespie, Chief Executive of the MS Society, said:
"This is disappointing news for people with MS and it will leave some people with no effective treatment option. Access to MS treatments in the UK is very poor - in fact people with MS would be better off living almost anywhere else in Europe, and this decision will only deepen that inequality."
The MS Society says clinical trials demonstrated that Gileyna is more effective than current injectable drugs. It says NICE compared Gilenya with best supportive care, meaning when a patient is taking no medication for their conditions, when it decided on cost-effectiveness.
The MS Society also wrote on its website today:
"NICE also failed to consider the broader social and economic benefits of medicines - like that a reduction in relapses will enable a person to remain in work for longer."
"We're concerned at how this decision has been reached and now strongly encourage NICE and Novartis to work together to look at how the treatment can be better re-considered and evaluated."
Gileyna was licensed by the Medicines and Healthcare products Regulatory Agency (MHRA), after completing all safety and efficacy tests for patients with relapsing remitting MS. The treatment is specifically aimed at those with highly active relapsing remitting MS who have not responded to injection treatments, or patients with rapidly evolving severe disease. For these people, if they have no access to Gilenya, they have nothing.
Written by Christian Nordqvist