News - November 2005
Open Door - November 2005 page 3
- Prescription of beta interferon and Copaxone
- Choice in healthcare
- Plan to reintroduce Tysabri announced
- Goat serum update
Prescription of beta interferon and Copaxone
The Risk-sharing Scheme, which provides access to the three beta interferon drugs (Avonex, Betaferon, Rebif) and Copaxone on the NHS, also includes a monitoring element, whereby a proportion of people receiving a prescription are followed for ten years to assess long-term efficacy of the drugs.
Although recruitment to the monitoring element is now complete, the Scheme still requires that individuals meeting the criteria set by the Association of British Neurologists (ABN) be prescribed the drugs.
However, it is becoming clear that the NHS in some areas is unwilling to fund any new prescriptions. The MS Trust is aware of problems in Sussex, Surrey, Wales and Northern Ireland.
Health Service Circular 2002/004, which underpins the Risk-sharing Scheme and gives it legal backing, clearly states that: "All patients with relapsing remitting MS, and those with secondary progressive MS in which relapses are the dominant clinical feature, who meet the criteria developed by the ABN are eligible for treatment under the scheme."
We will continue to work to ensure that the disease modifying drugs are provided equitably to anyone who is eligible to receive them. Anyone who is aware of local failure to prescribe these drugs should contact us on 01462 476700 or email the MS Trust.
Details of the ABN criteria and more information on the drugs is available in our booklet Disease Modifying Drug Therapies
Choice in healthcare
Which? have published a policy report on choice in healthcare, considering proposals from the consumer's perspective. The report examines how the proposals might work in practice, whether they will meet the healthcare priorities of individuals and the wider objectives of ensuring everybody has access to safe, effective, good quality healthcare when and where they need it. It also considers whether there are sufficient safeguards to enable people to make and take up effective choices about their care, which may involve assessing technical and scientific information at times of considerable stress and vulnerability. Warning that choice on its own will not deliver increased capacity, or improve standards and quality of care without appropriate funding and support from providers of care, the report urges governments to closely monitor changes to prevent chaos in the healthcare system.
Plans to reintroduce Tysabri announced
In September, Biogen Idec and Elan announced that they have submitted a supplemental Biologics Licence Application (sBLA) for Tysabri (natalizumab) as a treatment of relapsing remitting MS to the US Food and Drug Administration (FDA), the US drug licensing body. This follows the completion of the safety evaluation of Tysabri in 2,000 people with MS involved in clinical trials, which found no further cases of progressive multifocal leukoencephalopathy (PML), a rare neurological condition.
Last February, after only two months on the American market, Tysabri was withdrawn when two cases of PML, one fatal, were identified in participants in a clinical trial studying a combination of Tysabri and Avonex (beta interferon 1a). A third case, also fatal, was subsequently identified in a person with Crohn's disease. As well as results of the safety evaluation, the sBLA will include final two-year data from the two Phase III trials carried out in MS, and a revised label and risk management plan.
Biogen Idec and Elan also have plans to submit the data to the European Agency for the Evaluation of Medicinal (EMEA) as part of their ongoing review process.
Goat serum update
Availability of goat serum (Aimspro) in the UK is currently still under review. In July 2005, the Medicines and Healthcare Regulatory Authority (MHRA) stated that since the manufacturers contacted them in April 2003, a substantial amount of help has been offered to ensure that the product is manufactured to the safety standards expected of any drug. Since the MHRA announcement, Daval International, which makes the product, has announced that it is moving manufacture from the USA to Australia.
Sources: MHRA website; Daval International website
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Disclaimer
Open Door articles are reproduced as published. They are not updated to take account of subsequent developments. Use appropriate caution in acting on the information in any article.