“The only oral drug for the treatment of a particular type of multiple sclerosis should not be prescribed on the NHS in England and Wales, draft guidance from the National Institute for Health and Clinical Excellence has said.
Despite the excitement earlier this year over the launch of the drug, fingolimod, a sphingosine-1-phosphate receptor, NICE has announced in provisional draft guidance that not only is the drug not cost effective but there was a lack of appropriate data.
Clinical specialists advising the NICE committee said that people with rapidly evolving, severe, relapsing remitting multiple sclerosis who have two or more disabling relapses a year would most likely benefit from the drug. However, the data submitted by Novartis, the drug’s manufacturer, were from studies that mainly included people with relapsing remitting multiple sclerosis whose relapses hadn’t changed and other people whose relapses increased in frequency despite treatment with an interferon beta, NICE said.
NICE’s clinical advisory committee said that it would have had to see trial data comparing fingolimod with interferon betas and with the monoclonal antibody natalizumab (recommended for use on the NHS since 2007 to treat rapidly evolving, severe, relapsing remitting multiple sclerosis). Novartis supplied the committee only with results from a placebo controlled trial and one head to head trial with Avonex, one type of interferon beta-1a.
NICE also criticised the manufacturer’s estimation of cost per quality adjusted life year of fingolimod in comparison with Avonex, saying that it was “highly uncertain and underestimated.”
Fingolimod—an oral drug, unlike other licensed disease modifying agents, which are injectable—is said to work by preventing the lymphocytes from attacking nerve cells in the brain and spinal cord.
In April this year a healthcare communications agency, Aurora Communications, acting on behalf of Novartis, said that NICE had recently announced that it would update its guidance on multiple sclerosis. Aurora offered contacts from the MS Society and the MS Trust to speak about the drug.
“This has the potential to be one of the most significant advances since injectable therapies arrived over a decade ago,” a press release stated. It added: “Preventing relapses (disabling attacks) is the key goal of treatment and fingolimod reduces relapse rates by half.”
Multiple sclerosis treatments have long been controversial for NICE. In 2002 the first big challenge was interferon beta, which it deemed to be not cost effective for treating relapsing remitting multiple sclerosis. After an outcry from patients’ groups, the MS risk sharing scheme was implemented, offering these treatments to NHS patients under certain conditions.
Novartis and the MS Society are keen to point out that access to multiple sclerosis treatments is poorer in the UK than in other countries, citing a report last year by England’s national clinical director for cancer, Mike Richards, Extent and Causes of International Drug Usage. The report offered a range of explanations for the differences in access to drugs for multiple sclerosis. Low drug use is “thought to be partly explained by a cautious and/or sceptical attitude among some neurologists regarding the benefits of treatment, including its long-term effectiveness and concerns about side effects,” it said.
Novartis’s complaint hinges on the fact that cost effectiveness has to be demonstrated in comparison with best supportive care—something they say “does not reflect current clinical practice in the UK.”
“This approach is likely to restrict treatment options in the UK to symptom management medicines only, which could result in continued relapses,” Novartis said in a statement.
The MS Society has urged NICE and Novartis to work together so that fingolimod can be reappraised.”
NICE’s appraisal document and evaluation report on fingolimod are at http://guidance.nice.org.uk/TA/Wave20/71/Consultation/Latest.