Access to disease modifying drugs
Background
'Disease modifying drugs' is an umbrella term used for the five drugs now available that can have an effect on the underlying course of MS, in people who experience relapses.
The five drugs are:
- Avonex (interferon beta-1a)
- Betaferon (interferon beta-1b)
- Copaxone (glatiramer acetate)
- Rebif (interferon beta-1a)
- Tysabri (natalizumab)
The first disease modifying drug therapy was launched in 1995, and the other products followed over the next few years with the exception of Tysabri which was only made available last year.
From launch usage of the four beta interferons and galtiramer acetate was patchy. They were much cited as an example of postcode prescribing, and it was no surprise when the Department of Health asked NICE (the National Institute for Health and Clinical Excellence) to assess the drugs and rule on whether they should be available on the NHS. The process took three years and the MS Trust was prominent in the campaign to encourage NICE allow people with MS access to the drugs.
The Risk-sharing Scheme
In February 2002, NICE ruled that whilst the beta interferons and glatiramer actetate were effective in reducing the number of relapses and in reducing the severity of those relapses, it was unclear whether they were cost-effective. NICE therefore suggested that the Department of Health should look into ways that these drugs could be available to people with MS on the NHS in a cost-effective manner.
As a result, in May 2002, the Department of Health issued Health Service Circular 2002/004 which launched the Risk-sharing Scheme. The Risk-sharing Scheme ensures that these four disease modifying drugs are available on the NHS to everyone with MS who meets the prescribing guidelines drawn up by the Association of British Neurologists.
- More information on the Risk-sharing Scheme
- Read Health Service Circular 2002/004 on the Department of Health website
A leaflet about the Scheme has been produced by the Department of Health, the Association of British Neurologists, the MS Trust, the MS Society and the four pharmaceutical companies. The leaflet explains the background to the Scheme, the governance arrangements and progress made since the launch.
Whilst Health Service Circular 2002/004 ensures availability of the beta interferons and glatiramer acetate on the NHS an important element of the Scheme is the long-term monitoring of approximately 5,000 people with MS to assess the cost effectiveness of these drugs over a period of 10 years in routine clinical practice. The MS Trust has a specific role in this research element to ensure that it is properly run and to manage the contract with the research provider.
Health Services Circular 2002/04 remains in force, and this gives anyone in England who meets the prescribing guidelines the legal right to receive treatment. In November 2006 the Department of Health contacted all Strategic Health Authorities in England to remind them of their obligation to people who meet the prescription criteria. The other devolved administrations in Scotland, Wales and Northern Ireland have also signed up to the principles enshrined in the Risk-sharing Scheme.
A briefing note was sent to PCTs and Hospital Trusts outlining their statutory duty under directions made under the NHS Act 1977 to fund treatment for eligible patients, including those who are not subject to routine monitoring.
Analysis of date within the Scheme is planned to occur every two years. The first analysis has recently been undertaken and is being prepared for publication in a peer reviewed journal. As soon as this is available we will post details on the MS Trust website.
Tysabri
Tysabri (natalizumab) is available for people with highly active relapsing remitting disease and last year received a positive NICE guidance. It is slowly becoming available within all the major centres.
Across the UK
Scotland
In Scotland people who meet the prescribing guidelines are receiving these drugs.
Wales
Additional resources have been allocated in Wales but there have been delays and problems.
Northen Ireland
After a period of problems with obtaining these drugs, the Health Minister announced new funding in Spring 2006 with a view to ending the waiting list by 2008.
How to get the disease modifying drugs
The disease modifying drugs are only prescribed by neurologists in prescribing centres