Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) the global specialty biopharmaceutical company, is disappointed that the overall NICE Guidance excludes newly diagnosed patients with mild AD, despite the revisions published which allow some discretion for clinicians in their reliance on the MMSE when dealing with exceptional patients.
The judgment handed down by Judge Linda Dobbs on 10 August 2007 stated that NICE had acted unlawfully by issuing Guidance that, through reliance on the MMSE score, potentially discriminated against patients with learning, language or comparable difficulties. Judge Dobbs required NICE to revise its Guidance to clarify when clinical judgement may override the MMSE score.
?Clinicians have been given some discretion in the revised Guidance concerning sole reliance on the MMSE for diagnosing the severity of AD in patients with learning, language, communication or sensory disabilities, and this is to be welcomed,? states Dr Ian Howe, Medical Director of Shire. ?However, the Guidance continues to state clearly that new patients diagnosed as mild and scoring more than 20 on the MMSE will not be treated on the NHS. Clinicians tell us this continued reliance on the MMSE is problematic.?
Dr Peter Passmore, Geriatrician at Queens University Belfast, explains: ?The MMSE is a blunt instrument to test such a complex condition. It is a screening tool rather than a reliable diagnostic method. Clinicians need discretion when diagnosing to take into account subtle or ?hidden? impairments ? perhaps not as specific as learning or language difficulties ? as well as the carer?s viewpoint and how both are coping with daily living. Visual and hearing difficulties also affect the reliability of MMSE test results as do a variety of tremor and co-ordination problems.
This Guidance on drugs treatment runs somewhat counter to the Dementia Guidelines which emphasise the overall assessment of the patient, rather than placing sole reliance on the MMSE and its results, creating confusion for clinicians, Health Trusts and patients.?
?Despite the revisions, nothing has changed in practical terms,? says Professor Stephen Curran, Old Age Psychiatrist and Lead Clinician at Wakefield Memory Service. ?The revised Guidance is welcome for those patients with learning, language and other difficulties specified, but the total numbers who will benefit are very small.
In my clinic, and in my judgement, with these revisions only a handful of newly diagnosed mild patients will qualify each year for NHS support.
I will not be able to offer a treatment that works for many patients with mild Alzheimer?s disease, even though many of my patients with mild illness have had significant benefit from treatment under the previous NICE guidance.
Patients and carers I see are distressed and concerned enough ? and in my opinion this Guidance will only add to that distress.?
Dr Ian Howe concludes: ?Shire is deeply disappointed that the overall NICE Guidance excludes patients with mild Alzheimer?s disease from treatment on the NHS, particularly in light of the Government?s recently announced commitment to high quality treatment and support, together with early and accurate diagnosis.?