NICE has very carefully considered the evidence about the effectiveness of these drugs in people with MS and how much they cost. As well as looking at the results available from clinical trials, it has heard evidence from health professionals, including neurologists, and from patients, their carers and the organisations that represent them.
MS is a disease that affects people over a very long period (often 20 years or more), but at the moment there is no evidence available about the effects of beta interferon or glatiramer acetate on the disease in the long term. Because of this, NICE had to look at ‘models’ of the cost effectiveness of the drugs. These models make estimates of how the drugs might work in the long term. The further ahead a model looks, the harder it is to be sure about what it tells us.
During 2000, NICE considered several models of the cost effectiveness of beta interferon and glatiramer acetate. There were problems with these models and so the Institute decided to commission a new model.
After considering all of the evidence, including the views and experiences of patients, NICE has issued the following advice:
- A recommendation to use these medicines cannot, presently, be justified, taking both benefits and costs into account.
- People who are currently taking beta interferon or glatiramer acetate to treat MS could suffer loss of well being if their treatment was stopped when they did not expect it. Because of this, all NHS patients who are on therapy at the date of publication of this guidance should have the option to continue treatment until they and their consultant consider it is appropriate to stop, bearing in mind the criteria established for withdrawal from treatment in the Guidelines of the Association of British Neurologists published in January 2001. This advice about continuing treatment also applies to all participating patients at the end of a clinical trial (regardless of whether they were receiving placebo or active drug) and to women whose therapy has been interrupted by pregnancy.
- The Department of Health and the National Assembly for Wales, along with the manufacturers of the beta interferon products and glatiramer acetate, have been asked to consider what action could be taken so that the NHS could obtain these drugs in a way that would be cost effective
Note: The planned review date for this guidance was November 2004. In December 2004, NICE proposed that the review be deferred until November 2006, pending data from the Department of Health risk sharing scheme. Following consultation, NICE has decided to proceed with this proposal.