Drug reporting positive results for MS temporarily withdrawn from market
Published date: 14 Aug 2012 at 2:46PM
Makers of the cancer drug, alemtuzumab, which has been shown to benefit people with relapsing-remitting MS have reported they are applying for a licence for the medicine to be available to treat people with MS.
However, on 8 August the drug was temporarily withdrawn from the market, and it’s anticipated that if the drug secures a licence for MS, it will be sold at a higher price than it is now. The drug could be unavailable for seven to 12 months.
Beyond clinical trials, around 250 people with MS in the UK are currently taking alemtuzumab, which is administered by annual infusion in hospital over two consecutive years. Some people need further infusions, though many do not. Although the product does not yet have a licence for use with MS, the drug has been prescribed for people with MS by a small number of clinicians, mainly in the trial centres.
Researchers have reported promising clinical trial results for alemtuzumab, showing it to be more effective than beta interferon in reducing relapses and disability progression in many people with MS. However, the trials also showed the treatment resulted in clinically significant side effects for approximately one in five patients.
Genzyme, the makers of the medicine, are now in the process of applying to the European Medicines Agency for a new licence for the drug, for people with MS. Given the withdrawal of the drug, it’s anticipated that the price of the treatment will be increased from what it currently costs for cancer treatment. The withdrawal of alemtuzumab could mean that some people with MS may see their treatment delayed.
However, treatment centres have been given extra time by the regulator, the MHRA, to ensure that they have enough stock to continue treatment. With this in mind we hope that clinicians who currently prescribe the treatment to patients will have sufficient stock to be able to continue, so that people are not left without medicine.
Nick Rijke, Director of Policy & Research at the MS Society, said: "Alemtuzumab is a promising medicine for many people with relapsing-remitting MS and it’s our sincere hope that those who are receiving the treatment, and responding well, will be able to continue to access infusions during this period of withdrawal and once a licence is granted for treatment of people with MS.
"There is no good reason why people with MS who have been allowed to benefit from alemtuzumab should be denied on-going treatment. Genzyme need to come up with a scheme, quickly, that makes their product available to all those people currently being treated. In the meantime, treatment centres need to ensure they have the stock they will need for people with MS over the coming months."
British Government regulations prevent companies from increasing the established price of drugs that were originally licenced before 1 September 2007. The MS Society will write to the Secretary of State for Health, Andrew Lansley MP, urging the government to amend these regulations, so that the cut-off date no longer applies.
If the treatment is granted a new licence, the MS Society has strongly encouraged Genzyme to price the treatment reasonably so that it is available to people who stand to benefit through the NHS. NICE and other regulators decide whether drugs, at specific prices, are cost effective and should be available through the NHS. NICE have begun the long process to assess alemtuzumab and the MS Society are contributing to this appraisal.
We have also argued for a special access scheme to be set up for those people with MS already receiving alemtuzumab.