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Calls for controversial MS treatment to be made available in Ireland

MS Ireland has led calls for the drug Gilenya to be made available here after a decision by regulators in the UK. But a European agency has been investigating the manufacturer after reports of the drug’s possible role in the death of 11 people.

Novartis manufacturers the MS treatment in question.
Novartis manufacturers the MS treatment in question.
Image: STEFFEN SCHMIDT/AP/Press Association Images

THE MULTIPLE SCLEROSIS Society of Ireland (MS Ireland) has called on the government to make available in Ireland a controversial drug that it believes would much more effectively treat some forms of the disease.

The call, echoed by the drug’s manufacturer, follows the decision by the National Institute for Health and Clinical Excellence (NICE) in the UK to recommend that the drug, fingolimod - known by its brand name Gilenya - , be available on the National Health Service (NHS) for some patients with a form of MS.

It comes less than two months after a European Agency opened an investigation in to whether the medicine played a role in the deaths of at least 11 patients. The European Medicines Agency (EMA) is due to give an update on the safety of the medicine next month, the Wall Street Journal reports.

The Department of Health said that the matter was being considered by the Health Service Executive (HSE) which said that it expects “a significant budget impact with this product” if its use in treatment could be reimbursed under the High Tech Drug Scheme as MS Ireland wants.

The manufacturer, Novartis, claims that the drug is twice as effective as conventional treatment for the disease which affects some 8,000 people in Ireland. The drug itself was authorised by the Irish Medicines Board exactly a year ago and there has been no updated guidance in relation to it since.

Multiple Sclerosis

MS is an autoimmune disease which affects the brain and spinal cord. It generally affects women more than men and is more likely to affect people who have a family history of the disease.

NICE said that the treatment was a “valuable, innovative and cost-effective therapy” for dealing with highly active relapsing-remitting MS which is characterised by periods where symptoms – which include numbness, tingling, blurred vision, balance problems and muscle weakness – worsen and then improve.

This particular oral medication, manufactured by Novartis, will now likely be available to people in England and Wales through the NHS. Novartis said that steps are also being taken by healthcare systems in most EU countries to make it available. Much may hinge on the updated guidance of the EMA next month following its investigation.

However, Novartis claimed that the Department of Health had decided not to make it available to Irish patients despite it being given a positive review by the National Centre for Pharmacoeconomics (NCPE) last year.

“Novartis has submitted a proposed price as part of the high tech application process. At the price submitted the NCPE considered Gilenya ‘a cost effective therapy for the treatment of relapsing remitting multiple sclerosis patients in the Irish healthcare setting’,” a statement said.

“The price is not out of line with other European countries already reimbursed, and is within the range of disease modifying therapies in the Irish market (including VAT).”

‘Significant budget impact’

However the HSE said in a statement: “The HSE has approved – and continues to approve – all medicines for which it believes there is robust evidence that they are cost effective and budget neutral.

The HSE expects a significant budget impact with this product and is currently considering how new medicines can be introduced into clinical care pathways as and when HSE resources become available.

“The HSE is working to ensure that all appropriate arrangements and controls are in place to support optimal use and that best value is achieved.”

MS Ireland called on the the government to make it available for patients on long-term treatment plans in Ireland.

“MS Ireland believes that this disease modifying therapy would be an important addition to the choice of treatments available to people with MS,” chief executive Ava Battles said.

“It is not acceptable that people with MS in Ireland have less choice of treatments that are capable of modifying the progress of their illness than counterparts in Britain and other EU countries.

“We have written to the Minister and the Department on this matter and anticipate it will be treated as a matter of urgency.”

Read: European agency investigates Novartis drug following 11 deaths

About the author:

Hugh O'Connell

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